<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03043872</url>
  </required_header>
  <id_info>
    <org_study_id>D419QC00001</org_study_id>
    <secondary_id>2016-001203-23</secondary_id>
    <nct_id>NCT03043872</nct_id>
  </id_info>
  <brief_title>Durvalumab ± Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer (CASPIAN)</brief_title>
  <acronym>CASPIAN</acronym>
  <official_title>A Phase III, Randomized, Multicenter,Open-Label, Comparative Study to Determine the Efficacy of Durvalumab or Durvalumab and Tremelimumab in Combination With Platinum-Based Chemotherapy for the First-Line Treatment in Patients With Extensive Disease Small-Cell Lung Cancer (SCLC) (CASPIAN)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase III, randomized, open-label, multicenter, global study to determine the&#xD;
      efficacy and safety of combining durvalumab ± tremelimumab with platinum based chemotherapy&#xD;
      (EP) followed by durvalumab ± tremelimumab maintenance therapy versus EP alone as first-line&#xD;
      treatment in patients with extensive-stage small-cell lung cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary objective of this study is to assess the efficacy of durvalumab + tremelimumab + EP&#xD;
      treatment compared with EP and the efficacy of durvalumab + EP treatment compared with EP in&#xD;
      terms of OS.&#xD;
&#xD;
      All patients will be randomized in a 1:1:1 ratio in a stratified manner according to the&#xD;
      planned platinum-based therapy for Cycle 1 (cisplatin or carboplatin) to receive treatment&#xD;
      with durvalumab + tremelimumab + EP (Arm 1), durvalumab + EP (Arm 2), or standard of care- EP&#xD;
      (Arm 3). Arm 1 and Arm 2 patients receive the treatment until confirmed disease progression&#xD;
      while Arm 3 patients receive up to 6 cycles of EP and prophylactic cranial irradiation if&#xD;
      clinically indicated, at the Investigators' discretion.Patients who have discontinued&#xD;
      treatment due to toxicity or symptomatic deterioration, clinical progression, or who have&#xD;
      commenced subsequent anticancer therapy will be followed up until confirmed disease&#xD;
      progression and for survival.&#xD;
&#xD;
      Targeted population are adult patients (aged ≥18 years) with histologically or cytologically&#xD;
      documented extensive disease (American Joint Committee on Cancer Stage (7th edition) IV SCLC&#xD;
      [T any, N any,M1 a/b]), or T3-4 due to multiple lung nodules that are too extensive or have&#xD;
      tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan.&#xD;
      Patients must have WHO/ECOG performance status of 0 or 1.&#xD;
&#xD;
      Tumor assessments will be performed at Screening as baseline with follow-up at Week 6 ±1 week&#xD;
      from the date of randomization, at Week 12 ±1 week from the date of randomization, and then&#xD;
      every 8 weeks ±1 week until confirmed objective disease progression.&#xD;
&#xD;
      An independent data monitoring committee (IDMC) comprised of independent experts will be&#xD;
      convened to confirm the safety and tolerability of the proposed dose and schedule of&#xD;
      durvalumab ± tremelimumab in combination with platinum based chemotherapy at two early stages&#xD;
      of enrolment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 27, 2017</start_date>
  <completion_date type="Anticipated">December 29, 2023</completion_date>
  <primary_completion_date type="Actual">January 27, 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival (OS) in the Global Cohort; Assessed at Global Cohort Interim Analysis; D + EP Compared With EP</measure>
    <time_frame>From baseline until death due to any cause. Assessed until global cohort interim analysis DCO (maximum of approximately 23 months).</time_frame>
    <description>OS was defined as the time from date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. An interim analysis of OS in the global cohort was pre-specified after approximately 318 OS events occurred each between the D + EP and EP groups (60% maturity), and between the D + T + EP and EP groups (60% maturity). At the global cohort interim analysis DCO (11 March 2019), comparison of OS in the D + EP versus (vs) EP groups had crossed the pre-specified boundary. Since these results were considered final in terms of formal statistical testing, they are presented here as a primary outcome measure. Analysis of OS for D + EP vs EP and for D + T + EP vs EP at the time of the global cohort final analysis is presented separately in the subsequent primary outcome measure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OS in the Global Cohort; Assessed at Global Cohort Final Analysis; D + EP Compared With EP and D + T + EP Compared With EP</measure>
    <time_frame>From baseline until death due to any cause. Assessed until global cohort final analysis DCO (maximum of approximately 33 months).</time_frame>
    <description>OS was defined as the time from date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. This primary outcome measure presents OS for the analysis of D + EP vs EP and D + T + EP vs EP at the time of the global cohort final analysis DCO (27 January 2020). Analysis of D + EP vs EP at the global cohort interim analysis DCO is presented in the previous primary outcome measure. Analysis of D + T + EP vs D + EP (global cohort final analysis) is presented as a secondary outcome measure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OS in the China Cohort; Assessed at China Cohort First Analysis; D + EP Compared With EP</measure>
    <time_frame>From baseline until death due to any cause. Assessed until China cohort first analysis DCO (maximum of approximately 19 months).</time_frame>
    <description>OS was defined as the time from date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. An analysis of OS for D + EP vs EP in the China cohort was pre-specified at approximately 60% maturity (to ensure a similar maturity to the interim analysis of the Global cohort). This primary outcome measure presents OS for analysis of D + EP vs EP at the China cohort first analysis DCO (06 January 2020), and is comparable in terms of maturity with the interim analysis of OS for D + EP vs EP in the Global cohort. Analysis of OS for D + EP vs EP and for D + T + EP vs EP at the time of the China cohort second analysis is presented separately in the subsequent primary outcome measure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OS in the China Cohort; Assessed at China Cohort Second Analysis; D + EP Compared With EP and D + T + EP Compared With EP</measure>
    <time_frame>From baseline until death due to any cause. Assessed until China cohort second analysis DCO (maximum of approximately 29 months).</time_frame>
    <description>OS was defined as the time from date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. An analysis of OS for D + T + EP vs EP in the China cohort was pre-specified at approximately 80% maturity (to ensure a similar maturity to the final analysis of the Global cohort). This primary outcome measure presents OS for analysis of D + EP vs EP and D + T + EP vs EP at the time of the China cohort second analysis DCO (02 November 2020), and is comparable in terms of maturity with the final analysis of OS for D + EP vs EP and D + T + EP vs EP in the Global cohort. Analysis of D + EP vs EP at the China cohort first analysis DCO is presented in the previous primary outcome measure. Analysis of D + T + EP vs D + EP (China cohort second analysis) is presented as a secondary outcome measure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>OS in the Global Cohort; D + T + EP Compared With D + EP</measure>
    <time_frame>From baseline until death due to any cause. Assessed until global cohort final analysis DCO (maximum of approximately 33 months).</time_frame>
    <description>OS was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. This secondary outcome measure presents OS for the analysis of D + T + EP vs D + EP in the global cohort. The alternative treatment comparisons in the global cohort were performed as primary outcome measures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival (PFS) in the Global Cohort</measure>
    <time_frame>Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until global cohort final analysis DCO (maximum of approximately 33 months).</time_frame>
    <description>PFS (per Response Evaluation Criteria in Solid Tumors, version 1.1 [RECIST 1.1] using Investigator assessments) was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Progression (ie, PD) was defined as at least a 20% increase in the sum of diameters of target lesions (TLs), taking as reference the smallest previous sum of diameters (nadir) and an absolute increase of ≥5 millimeters (mm) for the sum from nadir. For evaluation of non-target lesions (NTLs), PD was defined as unequivocal progression of existing NTLs. Median PFS was calculated using the Kaplan-Meier technique.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR) in the Global Cohort</measure>
    <time_frame>Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until global cohort final analysis DCO (maximum of approximately 33 months).</time_frame>
    <description>ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of patients with at least 1 visit response of Complete Response (CR) or Partial Response (PR). CR was defined as disappearance of all TLs since baseline (any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to &lt;10 mm) or disappearance of all NTLs since baseline (all lymph nodes must be non-pathological in size [&lt;10 mm short axis]). PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients Alive and Progression Free at 6 Months (APF6) in the Global Cohort</measure>
    <time_frame>Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until 6 months post-randomization.</time_frame>
    <description>The APF6 was defined as the percentage of patients who were alive and progression free at 6 months from randomization (ie, PFS rate at 6 months). PFS was calculated using the Kaplan-Meier technique.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients Alive and Progression Free at 12 Months (APF12) in the Global Cohort</measure>
    <time_frame>Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until 12 months post-randomization.</time_frame>
    <description>The APF12 was defined as the percentage of patients who were alive and progression free at 12 months from randomization (ie, PFS rate at 12 months). PFS was calculated using the Kaplan-Meier technique.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients Alive at 18 Months (OS18) in the Global Cohort</measure>
    <time_frame>At 18 months post-randomization. Assessed at the global cohort final analysis DCO (27 January 2020).</time_frame>
    <description>OS18 was defined as the percentage of patients who were alive at 18 months after randomization per the Kaplan-Meier estimate of OS at 18 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK) of Durvalumab; Peak and Trough Serum Concentrations in the Global Cohort</measure>
    <time_frame>Samples were collected post-dose on Day 1 (Week 0), and pre-dose on Weeks 3 and 12. Assessed at the global cohort final analysis DCO (27 January 2020).</time_frame>
    <description>To evaluate PK, blood samples were collected at pre-specified timepoints and peak and trough serum concentrations of durvalumab were determined. Peak concentration on Week 0 is the post-infusion concentration of Week 0 (collected within 10 minutes of the end of infusion). Trough concentrations on Weeks 3 and 12 are the pre-infusion concentrations of Weeks 3 and 12, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK of Tremelimumab; Peak and Trough Serum Concentrations in the Global Cohort</measure>
    <time_frame>Samples were collected post-dose on Day 1 (Week 0), and pre-dose on Weeks 3 and 12. Assessed at the global cohort final analysis DCO (27 January 2020).</time_frame>
    <description>To evaluate PK, blood samples were collected at pre-specified timepoints and peak and trough serum concentrations of tremelimumab were determined. Peak concentration on Week 0 is the post-infusion concentration of Week 0 (collected within 10 minutes of the end of infusion). Trough concentrations on Weeks 3 and 12 are the pre-infusion concentrations of Weeks 3 and 12, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Anti-Drug Antibody (ADA) Response to Durvalumab in the Global Cohort</measure>
    <time_frame>Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of IP (ie, durvalumab). Assessed at the global cohort final analysis DCO (27 January 2020).</time_frame>
    <description>Serum sampling for ADA assessment was conducted utilizing a tiered approach (screen, confirm, titer). ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA was defined as the sum of treatment-induced ADA and treatment-boosted ADA (defined as baseline positive ADA titer that was boosted to ≥4-fold during the study period). Persistently positive was defined as having ≥2 post-baseline ADA positive measurements with ≥16 weeks between first and last positive, or an ADA positive result at the last available assessment. Transiently positive was defined as having ≥1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. Presence of neutralizing antibody (nAb) was tested for all ADA positive samples. Results are reported as number of patients with ADA responses to durvalumab for each indicated category.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With ADA Response to Tremelimumab in the Global Cohort</measure>
    <time_frame>Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of IP (ie, tremelimumab). Assessed at the global cohort final analysis DCO (27 January 2020).</time_frame>
    <description>Serum sampling for ADA assessment was conducted utilizing a tiered approach (screen, confirm, titer). ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA (or ADA incidence) was defined as the sum of treatment-induced ADA and treatment-boosted ADA (defined as baseline positive ADA titer that was boosted to ≥4-fold during the study period). Persistently positive was defined as having ≥2 post-baseline ADA positive measurements with ≥16 weeks between first and last positive, or an ADA positive result at the last available assessment. Transiently positive was defined as having ≥1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. The presence of nAb was tested for all ADA positive samples. Results are reported as number of patients with ADA responses to tremelimumab for each indicated category.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Deterioration of Health-Related Quality of Life (HRQoL) and Patient Reported Outcome (PRO) Symptoms, Assessed Using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) in the Global Cohort</measure>
    <time_frame>At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed until global cohort final analysis DCO (maximum of approximately 33 months).</time_frame>
    <description>The EORTC QLQ-Core 30 version 3 (QLQ-C30 v3) was included for assessing HRQoL. It assesses HRQoL/health status through 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), and a global health and QoL scale. 6 single-item symptom measures are also included: dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. Scores from 0 to 100 were derived for each of the 15 domains, with higher scores representing greater functioning, greater HRQoL, or greater level of symptoms. Time to deterioration (calculated using the Kaplan-Meier technique) was defined as time from randomization until the date of first clinically meaningful deterioration (a decrease in score from baseline of ≥10) that is confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Deterioration of PRO Symptoms, Assessed Using EORTC QLQ-Lung Cancer Module 13 (QLQ-LC13) in the Global Cohort</measure>
    <time_frame>At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed until global cohort final analysis DCO (maximum of approximately 33 months).</time_frame>
    <description>The EORTC QLQ-LC13 is a disease-specific 13-item self-administered questionnaire for lung cancer, to be used in conjunction with the EORTC QLQ-C30. It comprises both multi-item and single-item measures of lung cancer-associated symptoms (ie, coughing, hemoptysis, dyspnea, and pain) and side effects from conventional chemotherapy and radiotherapy (ie, hair loss, neuropathy, sore mouth, and dysphagia). Scores from 0 to 100 were derived for each symptom item, with higher scores representing greater level of symptoms. Time to deterioration (calculated using the Kaplan-Meier technique) was defined as time from randomization until the date of first clinically meaningful deterioration (an increase in score from baseline of ≥10) that is confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Primary PRO Symptoms as Assessed by EORTC QLQ in the Global Cohort; D + T + EP Compared With EP</measure>
    <time_frame>At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed up to 12 months.</time_frame>
    <description>A mixed model repeated measures (MMRM) analysis of EORTC QLQ-C30 and EORTC QLQ-LC13 was performed for 5 primary PRO symptoms (cough, dyspnea, chest pain, fatigue and appetite loss), and considered all data from baseline to PD or 12 months, excluding visits with excessive missing data (defined as &gt;75% missing data). An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items, with higher scores representing greater symptom severity. An improvement in symptoms was indicated by a negative change from baseline. A positive change from baseline indicated a deterioration of symptoms. A minimum clinically meaningful change was defined as an absolute change from baseline of ≥10. This outcome measure presents change from baseline for primary PRO symptoms (reported as adjusted means) for analysis of D + T + EP vs P. Analysis of D + EP vs EP is presented in a separate outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Primary Symptoms, Assessed Using EORTC QLQ-C30 and EORTC QLQ-LC13 in the Global Cohort; D + EP Compared With EP</measure>
    <time_frame>At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed up to 12 months.</time_frame>
    <description>A MMRM analysis of EORTC QLQ-C30 and EORTC QLQ-LC13 was performed for 5 primary PRO symptoms (cough, dyspnea, chest pain, fatigue and appetite loss), and considered all data from baseline to PD or 12 months, excluding visits with excessive missing data (defined as &gt;75% missing data). An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items, with higher scores representing greater symptom severity. An improvement in symptoms was indicated by a negative change from baseline. A positive change from baseline indicated a deterioration of symptoms. A minimum clinically meaningful change was defined as an absolute change from baseline of ≥10. This outcome measure presents change from baseline for primary PRO symptoms (reported as adjusted means) for analysis of D + EP vs EP. Analysis of D + T + EP vs EP is presented in a separate outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OS in the China Cohort; D + T + EP Compared With D + EP</measure>
    <time_frame>From baseline until death due to any cause. Assessed until China cohort second analysis DCO (maximum of approximately 29 months).</time_frame>
    <description>OS was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. This secondary outcome measure presents OS for the analysis of D + T + EP vs D + EP at the China cohort second analysis DCO (02 November 2020). The alternative treatment comparisons were performed as primary outcome measures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PFS in the China Cohort</measure>
    <time_frame>Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until China cohort second analysis DCO (maximum of approximately 29 months).</time_frame>
    <description>PFS (per RECIST 1.1 using Investigator assessments) was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Progression (ie, PD) was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir) and an absolute increase of ≥5 mm for the sum from nadir. For evaluation of NTLs, PD was defined as unequivocal progression of existing NTLs. Median PFS was calculated using the Kaplan-Meier technique.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ORR in the China Cohort</measure>
    <time_frame>Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until China cohort second analysis DCO (maximum of approximately 29 months).</time_frame>
    <description>ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of patients with at least 1 visit response of CR or PR. CR was defined as disappearance of all TLs since baseline (any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to &lt;10 mm) or disappearance of all NTLs since baseline (all lymph nodes must be non-pathological in size [&lt;10 mm short axis]). PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>APF6 in the China Cohort</measure>
    <time_frame>Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until 6 months post-randomization.</time_frame>
    <description>The APF6 was defined as the percentage of patients who were alive and progression free at 6 months from randomization (ie, PFS rate at 6 months). PFS was calculated using the Kaplan-Meier technique.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>APF12 in the China Cohort</measure>
    <time_frame>Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until 12 months post-randomization.</time_frame>
    <description>The APF12 was defined as the percentage of patients who were alive and progression free at 12 months from randomization (ie, PFS rate at 12 months). PFS was calculated using the Kaplan-Meier technique.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OS18 in the China Cohort</measure>
    <time_frame>At 18 months post-randomization. Assessed at the China cohort second analysis DCO (02 November 2020).</time_frame>
    <description>OS18 was defined as the percentage of patients who were alive at 18 months after randomization per the Kaplan-Meier estimate of OS at 18 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK of Durvalumab; Peak and Trough Serum Concentrations in the China Cohort</measure>
    <time_frame>Samples were collected post-dose on Day 1 (Week 0), and pre-dose on Weeks 3 and 12. Assessed at the China cohort second analysis DCO (02 November 2020).</time_frame>
    <description>To evaluate PK, blood samples were collected at pre-specified timepoints and peak and trough serum concentrations of durvalumab were determined. Peak concentration on Week 0 is the post-infusion concentration of Week 0 (collected within 10 minutes of the end of infusion). Trough concentrations on Weeks 3 and 12 are the pre-infusion concentrations of Weeks 3 and 12, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK of Tremelimumab; Peak and Trough Serum Concentrations in the China Cohort</measure>
    <time_frame>Samples were collected post-dose on Day 1 (Week 0), and pre-dose on Weeks 3 and 12. Assessed at the China cohort second analysis DCO (02 November 2020).</time_frame>
    <description>To evaluate PK, blood samples were collected at pre-specified timepoints and peak and trough serum concentrations of tremelimumab were determined. Peak concentration on Week 0 is the post-infusion concentration of Week 0 (collected within 10 minutes of the end of infusion). Trough concentrations on Weeks 3 and 12 are the pre-infusion concentrations of Weeks 3 and 12, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With ADA Response to Durvalumab in the China Cohort</measure>
    <time_frame>Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of IP (ie, durvalumab). Assessed at the China cohort second analysis DCO (02 November 2020).</time_frame>
    <description>Serum sampling for ADA assessment was conducted utilizing a tiered approach (screen, confirm, titer). ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA was defined as the sum of treatment-induced ADA and treatment-boosted ADA (defined as baseline positive ADA titer that was boosted to ≥4-fold during the study period). Persistently positive was defined as having ≥2 post-baseline ADA positive measurements with ≥16 weeks between first and last positive, or an ADA positive result at the last available assessment. Transiently positive was defined as having ≥1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. Presence of nAb was tested for all ADA positive samples. Results are reported as number of patients with ADA responses to durvalumab for each indicated category.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With ADA Response to Tremelimumab in the China Cohort</measure>
    <time_frame>Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of IP (ie, tremelimumab). Assessed at the China cohort second analysis DCO (02 November 2020).</time_frame>
    <description>Serum sampling for ADA assessment was conducted utilizing a tiered approach (screen, confirm, titer). ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA (or ADA incidence) was defined as the sum of treatment-induced ADA and treatment-boosted ADA (defined as baseline positive ADA titer that was boosted to ≥4-fold during the study period). Persistently positive was defined as having ≥2 post-baseline ADA positive measurements with ≥16 weeks between first and last positive, or an ADA positive result at the last available assessment. Transiently positive was defined as having ≥1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. The presence of nAb was tested for all ADA positive samples. Results are reported as number of patients with ADA responses to tremelimumab for each indicated category.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Deterioration of HRQoL and PRO Symptoms, Assessed Using EORTC QLQ in the China Cohort</measure>
    <time_frame>At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed until China cohort second analysis DCO (maximum of approximately 29 months).</time_frame>
    <description>The EORTC QLQ-C30 v3 was included for assessing HRQoL. It assesses HRQoL/health status through 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), and a global health and QoL scale. 6 single-item symptom measures are also included: dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. Scores from 0 to 100 were derived for each of the 15 domains, with higher scores representing greater functioning, greater HRQoL, or greater level of symptoms. Time to deterioration (calculated using the Kaplan-Meier technique) was defined as time from randomization until the date of first clinically meaningful deterioration (a decrease in score from baseline of ≥10) that is confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Deterioration of PRO Symptoms, Assessed Using EORTC QLQ-LC13 in the China Cohort</measure>
    <time_frame>At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed until China cohort second analysis DCO (maximum of approximately 29 months).</time_frame>
    <description>The EORTC QLQ-LC13 is a disease-specific 13-item self-administered questionnaire for lung cancer, to be used in conjunction with the EORTC QLQ-C30. It comprises both multi-item and single-item measures of lung cancer-associated symptoms (ie, coughing, hemoptysis, dyspnea, and pain) and side effects from conventional chemotherapy and radiotherapy (ie, hair loss, neuropathy, sore mouth, and dysphagia). Scores from 0 to 100 were derived for each symptom item, with higher scores representing greater level of symptoms. Time to deterioration (calculated using the Kaplan-Meier technique) was defined as time from randomization until the date of first clinically meaningful deterioration (an increase in score from baseline of ≥10) that is confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Primary PRO Symptoms, Assessed Using EORTC QLQ-C30 and EORTC QLQ-LC13 in the China Cohort; D + T + EP Compared With EP</measure>
    <time_frame>At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed up to 12 months.</time_frame>
    <description>A MMRM analysis of EORTC QLQ-C30 and EORTC QLQ-LC13 was performed for 5 primary PRO symptoms (cough, dyspnea, chest pain, fatigue and appetite loss), and considered all data from baseline to PD or 12 months, excluding visits with excessive missing data (defined as &gt;75% missing data). An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items, with higher scores representing greater symptom severity. An improvement in symptoms was indicated by a negative change from baseline. A positive change from baseline indicated a deterioration of symptoms. A minimum clinically meaningful change was defined as an absolute change from baseline of ≥10. This outcome measure presents change from baseline for primary PRO symptoms (reported as adjusted means) for analysis of D + T + EP vs EP. Analysis of D + EP vs EP is presented in a separate outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Primary Symptoms as Assessed by EORTC QLQ in the China Cohort; D + EP Compared With EP</measure>
    <time_frame>At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed up to 12 months.</time_frame>
    <description>A MMRM analysis of EORTC QLQ-C30 and EORTC QLQ-LC13 was performed for 5 primary PRO symptoms (cough, dyspnea, chest pain, fatigue and appetite loss), and considered all data from baseline to PD or 12 months, excluding visits with excessive missing data (defined as &gt;75% missing data). An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items, with higher scores representing greater symptom severity. An improvement in symptoms was indicated by a negative change from baseline. A positive change from baseline indicated a deterioration of symptoms. A minimum clinically meaningful change was defined as an absolute change from baseline of ≥10. This outcome measure presents change from baseline for primary PRO symptoms (reported as adjusted means) for analysis of D + EP vs EP. Analysis of D + T + EP vs EP is presented in a separate outcome measure.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">987</enrollment>
  <condition>Small Cell Lung Carcinoma Extensive Disease</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>durvalumab+tremelimumab+EP (carboplatin or cisplatin + etoposide)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>durvalumab+EP (carboplatin or cisplatin + etoposide)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>EP (carboplatin or cisplatin + etoposide)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Durvalumab</intervention_name>
    <description>IV infusions every 3 weeks for 12 weeks (4 cycles) and every 4 weeks thereafter until PD or other discontinuation criteria.</description>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_label>Arm 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tremelimumab</intervention_name>
    <description>IV infusions every 3 weeks for 12 weeks(4 cycles). An additional dose of tremelimumab will be administered in the week 16.</description>
    <arm_group_label>Arm 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>up to 4 cycles every 3 weeks in Arm 1 and 2, up to 6 cycles every 3 weeks in Arm 3</description>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_label>Arm 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>up to 4 cycles every 3 weeks in Arm 1 and 2, up to 6 cycles every 3 weeks in Arm 3</description>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_label>Arm 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Etoposide</intervention_name>
    <description>up to 4 cycles every 3 weeks in Arm 1 and 2, up to 6 cycles every 3 weeks in Arm 3</description>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_label>Arm 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Histologically or cytologically documented extensive disease. Brain metastases; must&#xD;
             be asymptomatic or treated and stable off steroids and anti-convulsants for at least 1&#xD;
             month prior to study treatment.&#xD;
&#xD;
          2. Suitable to receive a platinum-based chemotherapy regimen as 1st line treatment.&#xD;
&#xD;
          3. Life expectancy ≥12 weeks at Day 1.&#xD;
&#xD;
          4. ECOG 0 or 1 at enrolment.&#xD;
&#xD;
          5. No prior exposure to immune-mediated therapy excluding therapeutic anticancer&#xD;
             vaccines.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Any history of radiotherapy to the chest prior to systemic therapy or planned&#xD;
             consolidation chest radiation therapy (except paliative care outside of the chest).&#xD;
&#xD;
          2. Paraneoplastic syndrome of autoimmune nature, requiring systemic treatment or clinical&#xD;
             symptomatology suggesting worsening of PNS&#xD;
&#xD;
          3. Active infection including tuberculosis, HIV, hepatitis B anc C&#xD;
&#xD;
          4. Active or prior documented autoimmune or inflammatory disorders&#xD;
&#xD;
          5. Uncontrolled intercurrent illness, including but not limited to interstitial lung&#xD;
             disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>130 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Haiyi Jiang, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>AstraZeneca</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rogers</city>
        <state>Arkansas</state>
        <zip>72758</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Athens</city>
        <state>Georgia</state>
        <zip>30607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Muncie</city>
        <state>Indiana</state>
        <zip>47303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Leawood</city>
        <state>Kansas</state>
        <zip>66209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Paducah</city>
        <state>Kentucky</state>
        <zip>42003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <zip>11501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Harrisburg</city>
        <state>Pennsylvania</state>
        <zip>17109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kennewick</city>
        <state>Washington</state>
        <zip>99336</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1118AAT</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ciudad de Buenos Aires</city>
        <zip>C1426</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mar del Plata</city>
        <zip>7600</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rosario</city>
        <zip>2000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Miguel de Tucuman</city>
        <zip>T4000IAK</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Linz</city>
        <zip>4021</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wien</city>
        <zip>1140</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wien</city>
        <zip>1210</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Barretos</city>
        <zip>14784-400</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Curitiba</city>
        <zip>81520-060</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Passo Fundo</city>
        <zip>99010 260</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Porto Alegre</city>
        <zip>91350-200</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ribeirão Preto</city>
        <zip>14048-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>22793-080</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Salvador</city>
        <zip>41.950-610</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Santo André</city>
        <zip>09060-650</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>São José do Rio Preto</city>
        <zip>15090-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>São Paulo</city>
        <zip>03102-002</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Panagyurishte</city>
        <zip>4500</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Plovdiv</city>
        <zip>4000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Plovdiv</city>
        <zip>4004</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sofia</city>
        <zip>1330</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sofia</city>
        <zip>1431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sofia</city>
        <zip>1618</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sofia</city>
        <zip>1784</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Varna</city>
        <zip>9010</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Beijing</city>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Beijing</city>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Beijing</city>
        <zip>100853</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bengbu</city>
        <zip>233060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Changchun</city>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Changsha</city>
        <zip>410013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chengdu</city>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>ChongQing</city>
        <zip>400038</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hangzhou</city>
        <zip>310003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hangzhou</city>
        <zip>310006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hangzhou</city>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hefei</city>
        <zip>230601</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nanchang</city>
        <zip>330006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nanjing</city>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nanjing</city>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shanghai</city>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shanghai</city>
        <zip>200433</zip>
        <country>China</country>
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      <address>
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        <zip>197758</zip>
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      <name>Research Site</name>
      <address>
        <city>Ufa</city>
        <zip>450054</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Banska Bystrica</city>
        <zip>97517</zip>
        <country>Slovakia</country>
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      <name>Research Site</name>
      <address>
        <city>Bardejov</city>
        <zip>085 01</zip>
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      <name>Research Site</name>
      <address>
        <city>Bratislava</city>
        <zip>82606</zip>
        <country>Slovakia</country>
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      <name>Research Site</name>
      <address>
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        <zip>833 01</zip>
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      <name>Research Site</name>
      <address>
        <city>Kosice</city>
        <zip>041 91</zip>
        <country>Slovakia</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nove Zamky</city>
        <zip>940 01</zip>
        <country>Slovakia</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Trnava</city>
        <zip>91708</zip>
        <country>Slovakia</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>A Coruña</city>
        <zip>15006</zip>
        <country>Spain</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Badajoz</city>
        <zip>06008</zip>
        <country>Spain</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Badalona</city>
        <zip>08916</zip>
        <country>Spain</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Barcelona</city>
        <zip>08041</zip>
        <country>Spain</country>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Madrid</city>
        <zip>08035</zip>
        <country>Spain</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Santander</city>
        <zip>39008</zip>
        <country>Spain</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
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  <location>
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      <name>Research Site</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
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  <location>
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      <name>Research Site</name>
      <address>
        <city>Changhua</city>
        <zip>50006</zip>
        <country>Taiwan</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kaohsiung City</city>
        <zip>83301</zip>
        <country>Taiwan</country>
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    <facility>
      <name>Research Site</name>
      <address>
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        <zip>82445</zip>
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        <zip>40447</zip>
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    <facility>
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        <zip>40705</zip>
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      <address>
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        <zip>704</zip>
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      <address>
        <city>Tainan</city>
        <zip>736</zip>
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      <name>Research Site</name>
      <address>
        <city>Taipei</city>
        <zip>11217</zip>
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      <address>
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        <zip>235</zip>
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      <address>
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        <zip>06230</zip>
        <country>Turkey</country>
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      <name>Research Site</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
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  <location>
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      <address>
        <city>Edirne</city>
        <zip>22030</zip>
        <country>Turkey</country>
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      <address>
        <city>Istanbul</city>
        <zip>34030</zip>
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        <city>Izmir</city>
        <zip>35100</zip>
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      <address>
        <city>Izmir</city>
        <zip>35620</zip>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Dnipro</city>
        <zip>49102</zip>
        <country>Ukraine</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ivano-Frankivsk</city>
        <zip>76018</zip>
        <country>Ukraine</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kirovohrad</city>
        <zip>25006</zip>
        <country>Ukraine</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kryvyi Rih</city>
        <zip>50048</zip>
        <country>Ukraine</country>
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      <name>Research Site</name>
      <address>
        <city>Kyiv</city>
        <zip>03022</zip>
        <country>Ukraine</country>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Kyiv</city>
        <zip>03115</zip>
        <country>Ukraine</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lviv</city>
        <zip>79031</zip>
        <country>Ukraine</country>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Odesa</city>
        <zip>65055</zip>
        <country>Ukraine</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sumy</city>
        <zip>40022</zip>
        <country>Ukraine</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21029</zip>
        <country>Ukraine</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Zaporizhzhia</city>
        <zip>69040</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Austria</country>
    <country>Brazil</country>
    <country>Bulgaria</country>
    <country>China</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Slovakia</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>Turkey</country>
    <country>Ukraine</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;amp;parentIdentifier=D419QC00001&amp;amp;attachmentIdentifier=042de696-9399-4abc-8643-673f1237463a&amp;amp;fileName=d419qc00001-csp-v5_Redacted.pdf&amp;amp;versionIdentifier=</url>
    <description>Redacted CSP</description>
  </link>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;amp;parentIdentifier=D419QC00001&amp;amp;attachmentIdentifier=dafb894c-0f08-4319-a2fe-7389ae3ba87f&amp;amp;fileName=D419qc00001_SAP_Redacted.pdf&amp;amp;versionIdentifier=</url>
    <description>Redacted SAP</description>
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  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;amp;parentIdentifier=D419QC00001&amp;amp;attachmentIdentifier=11d0f58c-9d10-4c9a-95c3-000528295c1c&amp;amp;fileName=d419qc00001-csp-v5_Redacted.pdf&amp;amp;versionIdentifier=</url>
    <description>CSPv5_redacted</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>February 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <results_first_submitted>January 21, 2021</results_first_submitted>
  <results_first_submitted_qc>February 10, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 4, 2021</results_first_posted>
  <last_update_submitted>July 17, 2023</last_update_submitted>
  <last_update_submitted_qc>July 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Carcinoma, Small Cell Lung</keyword>
  <keyword>Oat Cell Carcinoma of Lung</keyword>
  <keyword>Oat Cell Lung Cancer</keyword>
  <keyword>Small Cell Cancer Of The Lung</keyword>
  <keyword>Small Cell Lung Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Small Cell Lung Carcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Etoposide</mesh_term>
    <mesh_term>Durvalumab</mesh_term>
    <mesh_term>Tremelimumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_time_frame>
    <ipd_access_criteria>When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_access_criteria>
    <ipd_url>https://astrazenecagroup-dt.pharmacm.com/DT/Home</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 16, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/72/NCT03043872/Prot_004.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 13, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/72/NCT03043872/SAP_005.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Study was conducted in 209 study centers across 23 countries. It included a global cohort (805 patients) and China cohort (188 patients). China cohort comprised 6 patients also in the global cohort and a further 182 patients randomized after end of global cohort recruitment. Results of the global and China cohorts were reported separately.</recruitment_details>
      <pre_assignment_details>Patients were randomized in a 1:1:1 ratio to receive treatment with durvalumab + tremelimumab + etoposide and platinum-based chemotherapy (EP), durvalumab + EP or EP alone. 987 participants were randomized in the study overall. Patients included in both cohorts for Started, Completed and Reasons for Not Completed are not double-counted for participant flow.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>All Patients: D + T + EP</title>
          <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 milligrams (mg) in combination with tremelimumab (T) 75 mg intravenous (IV) infusion every 3 weeks (Q3W) for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/meters squared [m^2]) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion every 4 weeks (Q4W) from Week 12 until progressive disease (PD), unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.</description>
        </group>
        <group group_id="P2">
          <title>All Patients: D + EP</title>
          <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.</description>
        </group>
        <group group_id="P3">
          <title>All Patients: EP</title>
          <description>For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="329"/>
                <participants group_id="P2" count="328"/>
                <participants group_id="P3" count="330"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Randomized and Included in Global Cohort Analysis</title>
              <participants_list>
                <participants group_id="P1" count="268"/>
                <participants group_id="P2" count="268"/>
                <participants group_id="P3" count="269"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Treatment in Global Cohort</title>
              <participants_list>
                <participants group_id="P1" count="266"/>
                <participants group_id="P2" count="265"/>
                <participants group_id="P3" count="266"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Randomized and Included in China Cohort Analysis</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
                <participants group_id="P2" count="61"/>
                <participants group_id="P3" count="62"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Treatment in China Cohort</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
                <participants group_id="P2" count="61"/>
                <participants group_id="P3" count="62"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Included in Both Cohorts (Global + China)</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Ongoing Study at Global Cohort Final Analysis Data Cut-off (DCO)</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
                <participants group_id="P2" count="56"/>
                <participants group_id="P3" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Ongoing Study at China Cohort Second (Final) Analysis DCO</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="52"/>
                <participants group_id="P3" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="278"/>
                <participants group_id="P2" count="276"/>
                <participants group_id="P3" count="312"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="270"/>
                <participants group_id="P2" count="269"/>
                <participants group_id="P3" count="296"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline analysis was based on the global full analysis set (FAS) (all patients randomized prior to the end of global recruitment) plus the China FAS (all randomized patients in the China cohort). Patients included in both cohorts are not double-counted for the baseline analysis represented by 'All Patients'.</population>
      <group_list>
        <group group_id="B1">
          <title>All Patients: D + T + EP</title>
          <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.</description>
        </group>
        <group group_id="B2">
          <title>All Patients: D + EP</title>
          <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.</description>
        </group>
        <group group_id="B3">
          <title>All Patients: EP</title>
          <description>For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="329"/>
            <count group_id="B2" value="328"/>
            <count group_id="B3" value="330"/>
            <count group_id="B4" value="987"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <population>Baseline data is presented for all patients, as well as separately for the global and China cohorts.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Al Patients</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="329"/>
                    <count group_id="B2" value="328"/>
                    <count group_id="B3" value="330"/>
                    <count group_id="B4" value="987"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;50</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥50 to &lt;65</title>
                  <measurement_list>
                    <measurement group_id="B1" value="175"/>
                    <measurement group_id="B2" value="195"/>
                    <measurement group_id="B3" value="169"/>
                    <measurement group_id="B4" value="539"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥65 to &lt;75</title>
                  <measurement_list>
                    <measurement group_id="B1" value="108"/>
                    <measurement group_id="B2" value="98"/>
                    <measurement group_id="B3" value="110"/>
                    <measurement group_id="B4" value="316"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥75</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Global Cohort</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="268"/>
                    <count group_id="B2" value="268"/>
                    <count group_id="B3" value="269"/>
                    <count group_id="B4" value="805"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;50</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥50 to &lt;65</title>
                  <measurement_list>
                    <measurement group_id="B1" value="138"/>
                    <measurement group_id="B2" value="157"/>
                    <measurement group_id="B3" value="137"/>
                    <measurement group_id="B4" value="432"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥65 to &lt;75</title>
                  <measurement_list>
                    <measurement group_id="B1" value="91"/>
                    <measurement group_id="B2" value="82"/>
                    <measurement group_id="B3" value="90"/>
                    <measurement group_id="B4" value="263"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥75</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>China Cohort</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="65"/>
                    <count group_id="B2" value="61"/>
                    <count group_id="B3" value="62"/>
                    <count group_id="B4" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;50</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥50 to &lt;65</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="33"/>
                    <measurement group_id="B4" value="112"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥65 to &lt;75</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥75</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>Baseline data is presented for all patients, as well as separately for the global and China cohorts.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>All Patients</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="329"/>
                    <count group_id="B2" value="328"/>
                    <count group_id="B3" value="330"/>
                    <count group_id="B4" value="987"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="74"/>
                    <measurement group_id="B2" value="86"/>
                    <measurement group_id="B3" value="95"/>
                    <measurement group_id="B4" value="255"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="255"/>
                    <measurement group_id="B2" value="242"/>
                    <measurement group_id="B3" value="235"/>
                    <measurement group_id="B4" value="732"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Global Cohort</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="268"/>
                    <count group_id="B2" value="268"/>
                    <count group_id="B3" value="269"/>
                    <count group_id="B4" value="805"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                    <measurement group_id="B2" value="78"/>
                    <measurement group_id="B3" value="85"/>
                    <measurement group_id="B4" value="229"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="202"/>
                    <measurement group_id="B2" value="190"/>
                    <measurement group_id="B3" value="184"/>
                    <measurement group_id="B4" value="576"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>China Cohort</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="65"/>
                    <count group_id="B2" value="61"/>
                    <count group_id="B3" value="62"/>
                    <count group_id="B4" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="52"/>
                    <measurement group_id="B4" value="161"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <population>Baseline data is presented for all patients, as well as separately for the global and China cohorts.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>All Patients</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="329"/>
                    <count group_id="B2" value="328"/>
                    <count group_id="B3" value="330"/>
                    <count group_id="B4" value="987"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="321"/>
                    <measurement group_id="B2" value="315"/>
                    <measurement group_id="B3" value="322"/>
                    <measurement group_id="B4" value="958"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Global Cohort</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="268"/>
                    <count group_id="B2" value="268"/>
                    <count group_id="B3" value="269"/>
                    <count group_id="B4" value="805"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="260"/>
                    <measurement group_id="B2" value="255"/>
                    <measurement group_id="B3" value="261"/>
                    <measurement group_id="B4" value="776"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>China Cohort</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="65"/>
                    <count group_id="B2" value="61"/>
                    <count group_id="B3" value="62"/>
                    <count group_id="B4" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="62"/>
                    <measurement group_id="B4" value="188"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race</title>
          <population>Baseline data is presented for all patients, as well as separately for the global and China cohorts.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>All Patients</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="329"/>
                    <count group_id="B2" value="328"/>
                    <count group_id="B3" value="330"/>
                    <count group_id="B4" value="987"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="215"/>
                    <measurement group_id="B2" value="229"/>
                    <measurement group_id="B3" value="221"/>
                    <measurement group_id="B4" value="665"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="108"/>
                    <measurement group_id="B2" value="96"/>
                    <measurement group_id="B3" value="103"/>
                    <measurement group_id="B4" value="307"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Global Cohort</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="268"/>
                    <count group_id="B2" value="268"/>
                    <count group_id="B3" value="269"/>
                    <count group_id="B4" value="805"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="215"/>
                    <measurement group_id="B2" value="229"/>
                    <measurement group_id="B3" value="221"/>
                    <measurement group_id="B4" value="665"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="42"/>
                    <measurement group_id="B4" value="125"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>China Cohort</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="65"/>
                    <count group_id="B2" value="61"/>
                    <count group_id="B3" value="62"/>
                    <count group_id="B4" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="62"/>
                    <measurement group_id="B4" value="188"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Survival (OS) in the Global Cohort; Assessed at Global Cohort Interim Analysis; D + EP Compared With EP</title>
        <description>OS was defined as the time from date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. An interim analysis of OS in the global cohort was pre-specified after approximately 318 OS events occurred each between the D + EP and EP groups (60% maturity), and between the D + T + EP and EP groups (60% maturity). At the global cohort interim analysis DCO (11 March 2019), comparison of OS in the D + EP versus (vs) EP groups had crossed the pre-specified boundary. Since these results were considered final in terms of formal statistical testing, they are presented here as a primary outcome measure. Analysis of OS for D + EP vs EP and for D + T + EP vs EP at the time of the global cohort final analysis is presented separately in the subsequent primary outcome measure.</description>
        <time_frame>From baseline until death due to any cause. Assessed until global cohort interim analysis DCO (maximum of approximately 23 months).</time_frame>
        <population>The global FAS included all patients randomized prior to the end of global recruitment. Interim analysis for OS in the global cohort was performed for comparison of the D + EP vs EP groups only.</population>
        <group_list>
          <group group_id="O1">
            <title>Global Cohort: D + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.</description>
          </group>
          <group group_id="O2">
            <title>Global Cohort: EP</title>
            <description>For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS) in the Global Cohort; Assessed at Global Cohort Interim Analysis; D + EP Compared With EP</title>
          <description>OS was defined as the time from date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. An interim analysis of OS in the global cohort was pre-specified after approximately 318 OS events occurred each between the D + EP and EP groups (60% maturity), and between the D + T + EP and EP groups (60% maturity). At the global cohort interim analysis DCO (11 March 2019), comparison of OS in the D + EP versus (vs) EP groups had crossed the pre-specified boundary. Since these results were considered final in terms of formal statistical testing, they are presented here as a primary outcome measure. Analysis of OS for D + EP vs EP and for D + T + EP vs EP at the time of the global cohort final analysis is presented separately in the subsequent primary outcome measure.</description>
          <population>The global FAS included all patients randomized prior to the end of global recruitment. Interim analysis for OS in the global cohort was performed for comparison of the D + EP vs EP groups only.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="268"/>
                <count group_id="O2" value="269"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.0" lower_limit="11.5" upper_limit="14.8"/>
                    <measurement group_id="O2" value="10.3" lower_limit="9.3" upper_limit="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>D + EP vs EP. The global cohort interim analysis of OS was based on a Lan-DeMets alpha spending function with O'Brien Fleming type boundary, using the actual number of events observed as a proportion of the planned total. Boundary for declaring statistical significance was 0.0178 for a 4% overall alpha. Hazard Ratio (HR) &lt;1 favors D + EP to be associated with a longer OS than EP.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0047</p_value>
            <p_value_desc>Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.73</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.591</ci_lower_limit>
            <ci_upper_limit>0.909</ci_upper_limit>
            <estimate_desc>The HR and confidence intervals (CIs) were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>OS in the Global Cohort; Assessed at Global Cohort Final Analysis; D + EP Compared With EP and D + T + EP Compared With EP</title>
        <description>OS was defined as the time from date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. This primary outcome measure presents OS for the analysis of D + EP vs EP and D + T + EP vs EP at the time of the global cohort final analysis DCO (27 January 2020). Analysis of D + EP vs EP at the global cohort interim analysis DCO is presented in the previous primary outcome measure. Analysis of D + T + EP vs D + EP (global cohort final analysis) is presented as a secondary outcome measure.</description>
        <time_frame>From baseline until death due to any cause. Assessed until global cohort final analysis DCO (maximum of approximately 33 months).</time_frame>
        <population>The global FAS included all patients randomized prior to the end of global recruitment.</population>
        <group_list>
          <group group_id="O1">
            <title>Global Cohort: D + T + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.</description>
          </group>
          <group group_id="O2">
            <title>Global Cohort: D + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.</description>
          </group>
          <group group_id="O3">
            <title>Global Cohort: EP</title>
            <description>For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.</description>
          </group>
        </group_list>
        <measure>
          <title>OS in the Global Cohort; Assessed at Global Cohort Final Analysis; D + EP Compared With EP and D + T + EP Compared With EP</title>
          <description>OS was defined as the time from date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. This primary outcome measure presents OS for the analysis of D + EP vs EP and D + T + EP vs EP at the time of the global cohort final analysis DCO (27 January 2020). Analysis of D + EP vs EP at the global cohort interim analysis DCO is presented in the previous primary outcome measure. Analysis of D + T + EP vs D + EP (global cohort final analysis) is presented as a secondary outcome measure.</description>
          <population>The global FAS included all patients randomized prior to the end of global recruitment.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="268"/>
                <count group_id="O2" value="268"/>
                <count group_id="O3" value="269"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.4" lower_limit="9.6" upper_limit="12.0"/>
                    <measurement group_id="O2" value="12.9" lower_limit="11.3" upper_limit="14.7"/>
                    <measurement group_id="O3" value="10.5" lower_limit="9.3" upper_limit="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>D + EP vs EP. HR &lt;1 favors D + EP to be associated with a longer OS than EP.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0032</p_value>
            <p_value_desc>Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.75</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.625</ci_lower_limit>
            <ci_upper_limit>0.910</ci_upper_limit>
            <estimate_desc>The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>D + T + EP vs EP. The alpha level applied at the global cohort final analysis was adjusted (using a generalized Haybittle-Peto method) to account for actual alpha spent at the interim analysis based on the actual final total number of events, and thus maintain control of overall Type I error. Boundary for declaring statistical significance was 0.0418 for a 5% overall alpha.&#xD;
HR &lt;1 favors D + T + EP to be associated with a longer OS than EP.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0451</p_value>
            <p_value_desc>Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.682</ci_lower_limit>
            <ci_upper_limit>0.995</ci_upper_limit>
            <estimate_desc>The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>OS in the China Cohort; Assessed at China Cohort First Analysis; D + EP Compared With EP</title>
        <description>OS was defined as the time from date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. An analysis of OS for D + EP vs EP in the China cohort was pre-specified at approximately 60% maturity (to ensure a similar maturity to the interim analysis of the Global cohort). This primary outcome measure presents OS for analysis of D + EP vs EP at the China cohort first analysis DCO (06 January 2020), and is comparable in terms of maturity with the interim analysis of OS for D + EP vs EP in the Global cohort. Analysis of OS for D + EP vs EP and for D + T + EP vs EP at the time of the China cohort second analysis is presented separately in the subsequent primary outcome measure.</description>
        <time_frame>From baseline until death due to any cause. Assessed until China cohort first analysis DCO (maximum of approximately 19 months).</time_frame>
        <population>The China FAS included all randomized patients in the China cohort. China cohort first analysis for OS was performed for comparison of the D + EP vs EP groups only.</population>
        <group_list>
          <group group_id="O1">
            <title>China Cohort: D + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.</description>
          </group>
          <group group_id="O2">
            <title>China Cohort: EP</title>
            <description>For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.</description>
          </group>
        </group_list>
        <measure>
          <title>OS in the China Cohort; Assessed at China Cohort First Analysis; D + EP Compared With EP</title>
          <description>OS was defined as the time from date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. An analysis of OS for D + EP vs EP in the China cohort was pre-specified at approximately 60% maturity (to ensure a similar maturity to the interim analysis of the Global cohort). This primary outcome measure presents OS for analysis of D + EP vs EP at the China cohort first analysis DCO (06 January 2020), and is comparable in terms of maturity with the interim analysis of OS for D + EP vs EP in the Global cohort. Analysis of OS for D + EP vs EP and for D + T + EP vs EP at the time of the China cohort second analysis is presented separately in the subsequent primary outcome measure.</description>
          <population>The China FAS included all randomized patients in the China cohort. China cohort first analysis for OS was performed for comparison of the D + EP vs EP groups only.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.4" lower_limit="12.3" upper_limit="NA">Upper limit of 95% CI could not be calculated as it was not reached.</measurement>
                    <measurement group_id="O2" value="10.9" lower_limit="8.9" upper_limit="14.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>D + EP vs EP. HR &lt;1 favors D + EP to be associated with a longer OS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0664</p_value>
            <p_value_desc>Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.65</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.414</ci_lower_limit>
            <ci_upper_limit>1.029</ci_upper_limit>
            <estimate_desc>The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>OS in the China Cohort; Assessed at China Cohort Second Analysis; D + EP Compared With EP and D + T + EP Compared With EP</title>
        <description>OS was defined as the time from date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. An analysis of OS for D + T + EP vs EP in the China cohort was pre-specified at approximately 80% maturity (to ensure a similar maturity to the final analysis of the Global cohort). This primary outcome measure presents OS for analysis of D + EP vs EP and D + T + EP vs EP at the time of the China cohort second analysis DCO (02 November 2020), and is comparable in terms of maturity with the final analysis of OS for D + EP vs EP and D + T + EP vs EP in the Global cohort. Analysis of D + EP vs EP at the China cohort first analysis DCO is presented in the previous primary outcome measure. Analysis of D + T + EP vs D + EP (China cohort second analysis) is presented as a secondary outcome measure.</description>
        <time_frame>From baseline until death due to any cause. Assessed until China cohort second analysis DCO (maximum of approximately 29 months).</time_frame>
        <population>The China FAS included all randomized patients in the China cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>China Cohort: D + T + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.</description>
          </group>
          <group group_id="O2">
            <title>China Cohort: D + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.</description>
          </group>
          <group group_id="O3">
            <title>China Cohort: EP</title>
            <description>For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.</description>
          </group>
        </group_list>
        <measure>
          <title>OS in the China Cohort; Assessed at China Cohort Second Analysis; D + EP Compared With EP and D + T + EP Compared With EP</title>
          <description>OS was defined as the time from date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. An analysis of OS for D + T + EP vs EP in the China cohort was pre-specified at approximately 80% maturity (to ensure a similar maturity to the final analysis of the Global cohort). This primary outcome measure presents OS for analysis of D + EP vs EP and D + T + EP vs EP at the time of the China cohort second analysis DCO (02 November 2020), and is comparable in terms of maturity with the final analysis of OS for D + EP vs EP and D + T + EP vs EP in the Global cohort. Analysis of D + EP vs EP at the China cohort first analysis DCO is presented in the previous primary outcome measure. Analysis of D + T + EP vs D + EP (China cohort second analysis) is presented as a secondary outcome measure.</description>
          <population>The China FAS included all randomized patients in the China cohort.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="61"/>
                <count group_id="O3" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.1" lower_limit="11.3" upper_limit="18.6"/>
                    <measurement group_id="O2" value="14.4" lower_limit="12.3" upper_limit="17.0"/>
                    <measurement group_id="O3" value="10.9" lower_limit="8.9" upper_limit="14.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>D + EP vs EP. HR &lt;1 favors D + EP to be associated with a longer OS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.1455</p_value>
            <p_value_desc>Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.75</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.504</ci_lower_limit>
            <ci_upper_limit>1.106</ci_upper_limit>
            <estimate_desc>The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>D + T + EP vs EP. HR &lt;1 favors D + T + EP to be associated with a longer OS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0314</p_value>
            <p_value_desc>Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.65</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.439</ci_lower_limit>
            <ci_upper_limit>0.964</ci_upper_limit>
            <estimate_desc>The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>OS in the Global Cohort; D + T + EP Compared With D + EP</title>
        <description>OS was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. This secondary outcome measure presents OS for the analysis of D + T + EP vs D + EP in the global cohort. The alternative treatment comparisons in the global cohort were performed as primary outcome measures.</description>
        <time_frame>From baseline until death due to any cause. Assessed until global cohort final analysis DCO (maximum of approximately 33 months).</time_frame>
        <population>The global FAS included all patients randomized prior to the end of global recruitment.</population>
        <group_list>
          <group group_id="O1">
            <title>Global Cohort: D + T + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.</description>
          </group>
          <group group_id="O2">
            <title>Global Cohort: D + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.</description>
          </group>
        </group_list>
        <measure>
          <title>OS in the Global Cohort; D + T + EP Compared With D + EP</title>
          <description>OS was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. This secondary outcome measure presents OS for the analysis of D + T + EP vs D + EP in the global cohort. The alternative treatment comparisons in the global cohort were performed as primary outcome measures.</description>
          <population>The global FAS included all patients randomized prior to the end of global recruitment.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="268"/>
                <count group_id="O2" value="268"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.4" lower_limit="9.6" upper_limit="12.0"/>
                    <measurement group_id="O2" value="12.9" lower_limit="11.3" upper_limit="14.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>D + T + EP vs D + EP. HR &lt;1 favors D + T + EP to be associated with a longer OS than D + EP.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4352</p_value>
            <p_value_desc>Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.890</ci_lower_limit>
            <ci_upper_limit>1.309</ci_upper_limit>
            <estimate_desc>The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-Free Survival (PFS) in the Global Cohort</title>
        <description>PFS (per Response Evaluation Criteria in Solid Tumors, version 1.1 [RECIST 1.1] using Investigator assessments) was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Progression (ie, PD) was defined as at least a 20% increase in the sum of diameters of target lesions (TLs), taking as reference the smallest previous sum of diameters (nadir) and an absolute increase of ≥5 millimeters (mm) for the sum from nadir. For evaluation of non-target lesions (NTLs), PD was defined as unequivocal progression of existing NTLs. Median PFS was calculated using the Kaplan-Meier technique.</description>
        <time_frame>Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until global cohort final analysis DCO (maximum of approximately 33 months).</time_frame>
        <population>The global FAS included all patients randomized prior to the end of global recruitment.</population>
        <group_list>
          <group group_id="O1">
            <title>Global Cohort: D + T + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.</description>
          </group>
          <group group_id="O2">
            <title>Global Cohort: D + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.</description>
          </group>
          <group group_id="O3">
            <title>Global Cohort: EP</title>
            <description>For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-Free Survival (PFS) in the Global Cohort</title>
          <description>PFS (per Response Evaluation Criteria in Solid Tumors, version 1.1 [RECIST 1.1] using Investigator assessments) was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Progression (ie, PD) was defined as at least a 20% increase in the sum of diameters of target lesions (TLs), taking as reference the smallest previous sum of diameters (nadir) and an absolute increase of ≥5 millimeters (mm) for the sum from nadir. For evaluation of non-target lesions (NTLs), PD was defined as unequivocal progression of existing NTLs. Median PFS was calculated using the Kaplan-Meier technique.</description>
          <population>The global FAS included all patients randomized prior to the end of global recruitment.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="268"/>
                <count group_id="O2" value="268"/>
                <count group_id="O3" value="269"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" lower_limit="4.7" upper_limit="5.9"/>
                    <measurement group_id="O2" value="5.1" lower_limit="4.7" upper_limit="6.2"/>
                    <measurement group_id="O3" value="5.4" lower_limit="4.8" upper_limit="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>D + EP vs EP. HR &lt;1 favors D + EP to be associated with a longer PFS than EP.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0157</p_value>
            <p_value_desc>Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.665</ci_lower_limit>
            <ci_upper_limit>0.959</ci_upper_limit>
            <estimate_desc>The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>D + T + EP vs EP. HR &lt;1 favors D + T + EP to be associated with a longer PFS than EP.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0568</p_value>
            <p_value_desc>Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.84</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.696</ci_lower_limit>
            <ci_upper_limit>1.005</ci_upper_limit>
            <estimate_desc>The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>D + T + EP vs D + EP. HR &lt;1 favors D + T + EP to be associated with a longer PFS than D + EP.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7540</p_value>
            <p_value_desc>Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.857</ci_lower_limit>
            <ci_upper_limit>1.235</ci_upper_limit>
            <estimate_desc>The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Objective Response Rate (ORR) in the Global Cohort</title>
        <description>ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of patients with at least 1 visit response of Complete Response (CR) or Partial Response (PR). CR was defined as disappearance of all TLs since baseline (any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to &lt;10 mm) or disappearance of all NTLs since baseline (all lymph nodes must be non-pathological in size [&lt;10 mm short axis]). PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters).</description>
        <time_frame>Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until global cohort final analysis DCO (maximum of approximately 33 months).</time_frame>
        <population>The global FAS included all patients randomized prior to the end of global recruitment. The denominator was a subset of the FAS population who had measurable disease at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Global Cohort: D + T + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.</description>
          </group>
          <group group_id="O2">
            <title>Global Cohort: D + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.</description>
          </group>
          <group group_id="O3">
            <title>Global Cohort: EP</title>
            <description>For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate (ORR) in the Global Cohort</title>
          <description>ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of patients with at least 1 visit response of Complete Response (CR) or Partial Response (PR). CR was defined as disappearance of all TLs since baseline (any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to &lt;10 mm) or disappearance of all NTLs since baseline (all lymph nodes must be non-pathological in size [&lt;10 mm short axis]). PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters).</description>
          <population>The global FAS included all patients randomized prior to the end of global recruitment. The denominator was a subset of the FAS population who had measurable disease at baseline.</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="267"/>
                <count group_id="O2" value="268"/>
                <count group_id="O3" value="269"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.2"/>
                    <measurement group_id="O2" value="79.5"/>
                    <measurement group_id="O3" value="70.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>D + EP vs EP. An odds ratio &gt;1 favors D + EP.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0177</p_value>
            <p_value_desc>Analysis was performed using a logistic regression model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin). P-value is based on twice the change in log-likelihood resulting from addition of a treatment factor to the model.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.61</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.086</ci_lower_limit>
            <ci_upper_limit>2.401</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>D + T + EP vs EP. An odds ratio &gt;1 favors D + T + EP.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3611</p_value>
            <p_value_desc>Analysis was performed using a logistic regression model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin). P-value is based on twice the change in log-likelihood resulting from addition of a treatment factor to the model.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.19</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.817</ci_lower_limit>
            <ci_upper_limit>1.746</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients Alive and Progression Free at 6 Months (APF6) in the Global Cohort</title>
        <description>The APF6 was defined as the percentage of patients who were alive and progression free at 6 months from randomization (ie, PFS rate at 6 months). PFS was calculated using the Kaplan-Meier technique.</description>
        <time_frame>Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until 6 months post-randomization.</time_frame>
        <population>The global FAS included all patients randomized prior to the end of global recruitment.</population>
        <group_list>
          <group group_id="O1">
            <title>Global Cohort: D + T + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.</description>
          </group>
          <group group_id="O2">
            <title>Global Cohort: D + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.</description>
          </group>
          <group group_id="O3">
            <title>Global Cohort: EP</title>
            <description>For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients Alive and Progression Free at 6 Months (APF6) in the Global Cohort</title>
          <description>The APF6 was defined as the percentage of patients who were alive and progression free at 6 months from randomization (ie, PFS rate at 6 months). PFS was calculated using the Kaplan-Meier technique.</description>
          <population>The global FAS included all patients randomized prior to the end of global recruitment.</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="268"/>
                <count group_id="O2" value="268"/>
                <count group_id="O3" value="269"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.2" lower_limit="37.1" upper_limit="49.1"/>
                    <measurement group_id="O2" value="45.4" lower_limit="39.3" upper_limit="51.3"/>
                    <measurement group_id="O3" value="45.8" lower_limit="39.5" upper_limit="51.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients Alive and Progression Free at 12 Months (APF12) in the Global Cohort</title>
        <description>The APF12 was defined as the percentage of patients who were alive and progression free at 12 months from randomization (ie, PFS rate at 12 months). PFS was calculated using the Kaplan-Meier technique.</description>
        <time_frame>Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until 12 months post-randomization.</time_frame>
        <population>The global FAS included all patients randomized prior to the end of global recruitment.</population>
        <group_list>
          <group group_id="O1">
            <title>Global Cohort: D + T + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.</description>
          </group>
          <group group_id="O2">
            <title>Global Cohort: D + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.</description>
          </group>
          <group group_id="O3">
            <title>Global Cohort: EP</title>
            <description>For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients Alive and Progression Free at 12 Months (APF12) in the Global Cohort</title>
          <description>The APF12 was defined as the percentage of patients who were alive and progression free at 12 months from randomization (ie, PFS rate at 12 months). PFS was calculated using the Kaplan-Meier technique.</description>
          <population>The global FAS included all patients randomized prior to the end of global recruitment.</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="268"/>
                <count group_id="O2" value="268"/>
                <count group_id="O3" value="269"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.9" lower_limit="12.6" upper_limit="21.7"/>
                    <measurement group_id="O2" value="17.9" lower_limit="13.5" upper_limit="22.8"/>
                    <measurement group_id="O3" value="5.3" lower_limit="2.9" upper_limit="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients Alive at 18 Months (OS18) in the Global Cohort</title>
        <description>OS18 was defined as the percentage of patients who were alive at 18 months after randomization per the Kaplan-Meier estimate of OS at 18 months.</description>
        <time_frame>At 18 months post-randomization. Assessed at the global cohort final analysis DCO (27 January 2020).</time_frame>
        <population>The global FAS included all patients randomized prior to the end of global recruitment.</population>
        <group_list>
          <group group_id="O1">
            <title>Global Cohort: D + T + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.</description>
          </group>
          <group group_id="O2">
            <title>Global Cohort: D + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.</description>
          </group>
          <group group_id="O3">
            <title>Global Cohort: EP</title>
            <description>For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients Alive at 18 Months (OS18) in the Global Cohort</title>
          <description>OS18 was defined as the percentage of patients who were alive at 18 months after randomization per the Kaplan-Meier estimate of OS at 18 months.</description>
          <population>The global FAS included all patients randomized prior to the end of global recruitment.</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="268"/>
                <count group_id="O2" value="268"/>
                <count group_id="O3" value="269"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.7" lower_limit="25.2" upper_limit="36.4"/>
                    <measurement group_id="O2" value="32.0" lower_limit="26.5" upper_limit="37.7"/>
                    <measurement group_id="O3" value="24.8" lower_limit="19.7" upper_limit="30.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK) of Durvalumab; Peak and Trough Serum Concentrations in the Global Cohort</title>
        <description>To evaluate PK, blood samples were collected at pre-specified timepoints and peak and trough serum concentrations of durvalumab were determined. Peak concentration on Week 0 is the post-infusion concentration of Week 0 (collected within 10 minutes of the end of infusion). Trough concentrations on Weeks 3 and 12 are the pre-infusion concentrations of Weeks 3 and 12, respectively.</description>
        <time_frame>Samples were collected post-dose on Day 1 (Week 0), and pre-dose on Weeks 3 and 12. Assessed at the global cohort final analysis DCO (27 January 2020).</time_frame>
        <population>The global PK analysis set included all patients randomized prior to the end of global recruitment who received at least 1 dose of investigational product (IP), per the protocol for whom any post-dose PK data were available. PK for durvalumab was performed for the D + T + EP and D + EP groups only.</population>
        <group_list>
          <group group_id="O1">
            <title>Global Cohort: D + T + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.</description>
          </group>
          <group group_id="O2">
            <title>Global Cohort: D + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK) of Durvalumab; Peak and Trough Serum Concentrations in the Global Cohort</title>
          <description>To evaluate PK, blood samples were collected at pre-specified timepoints and peak and trough serum concentrations of durvalumab were determined. Peak concentration on Week 0 is the post-infusion concentration of Week 0 (collected within 10 minutes of the end of infusion). Trough concentrations on Weeks 3 and 12 are the pre-infusion concentrations of Weeks 3 and 12, respectively.</description>
          <population>The global PK analysis set included all patients randomized prior to the end of global recruitment who received at least 1 dose of investigational product (IP), per the protocol for whom any post-dose PK data were available. PK for durvalumab was performed for the D + T + EP and D + EP groups only.</population>
          <units>micrograms/milliliter (μg/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="257"/>
                <count group_id="O2" value="261"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 0: peak concentration</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="239"/>
                    <count group_id="O2" value="226"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="447.3" spread="78.21"/>
                    <measurement group_id="O2" value="502.6" spread="30.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3: trough concentration</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="232"/>
                    <count group_id="O2" value="237"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.86" spread="74.36"/>
                    <measurement group_id="O2" value="109.5" spread="64.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12: trough concentration</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="173"/>
                    <count group_id="O2" value="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="199.2" spread="49.58"/>
                    <measurement group_id="O2" value="239.3" spread="50.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK of Tremelimumab; Peak and Trough Serum Concentrations in the Global Cohort</title>
        <description>To evaluate PK, blood samples were collected at pre-specified timepoints and peak and trough serum concentrations of tremelimumab were determined. Peak concentration on Week 0 is the post-infusion concentration of Week 0 (collected within 10 minutes of the end of infusion). Trough concentrations on Weeks 3 and 12 are the pre-infusion concentrations of Weeks 3 and 12, respectively.</description>
        <time_frame>Samples were collected post-dose on Day 1 (Week 0), and pre-dose on Weeks 3 and 12. Assessed at the global cohort final analysis DCO (27 January 2020).</time_frame>
        <population>The global PK analysis set included all patients randomized prior to the end of global recruitment who received at least 1 dose of IP, per the protocol for whom any post-dose PK data were available. PK for tremelimumab was performed for the D + T + EP group only.</population>
        <group_list>
          <group group_id="O1">
            <title>Global Cohort: D + T + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>PK of Tremelimumab; Peak and Trough Serum Concentrations in the Global Cohort</title>
          <description>To evaluate PK, blood samples were collected at pre-specified timepoints and peak and trough serum concentrations of tremelimumab were determined. Peak concentration on Week 0 is the post-infusion concentration of Week 0 (collected within 10 minutes of the end of infusion). Trough concentrations on Weeks 3 and 12 are the pre-infusion concentrations of Weeks 3 and 12, respectively.</description>
          <population>The global PK analysis set included all patients randomized prior to the end of global recruitment who received at least 1 dose of IP, per the protocol for whom any post-dose PK data were available. PK for tremelimumab was performed for the D + T + EP group only.</population>
          <units>μg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="257"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 0: peak concentration</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="236"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.77" spread="52.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3: trough concentration</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="227"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.245" spread="81.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12: trough concentration</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.576" spread="59.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Anti-Drug Antibody (ADA) Response to Durvalumab in the Global Cohort</title>
        <description>Serum sampling for ADA assessment was conducted utilizing a tiered approach (screen, confirm, titer). ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA was defined as the sum of treatment-induced ADA and treatment-boosted ADA (defined as baseline positive ADA titer that was boosted to ≥4-fold during the study period). Persistently positive was defined as having ≥2 post-baseline ADA positive measurements with ≥16 weeks between first and last positive, or an ADA positive result at the last available assessment. Transiently positive was defined as having ≥1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. Presence of neutralizing antibody (nAb) was tested for all ADA positive samples. Results are reported as number of patients with ADA responses to durvalumab for each indicated category.</description>
        <time_frame>Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of IP (ie, durvalumab). Assessed at the global cohort final analysis DCO (27 January 2020).</time_frame>
        <population>The global ADA evaluable patients included those in the global safety analysis set who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result. ADA for durvalumab was performed for the D + T + EP and D + EP groups only. The denominator was durvalumab ADA evaluable patients.</population>
        <group_list>
          <group group_id="O1">
            <title>Global Cohort: D + T + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.</description>
          </group>
          <group group_id="O2">
            <title>Global Cohort: D + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Anti-Drug Antibody (ADA) Response to Durvalumab in the Global Cohort</title>
          <description>Serum sampling for ADA assessment was conducted utilizing a tiered approach (screen, confirm, titer). ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA was defined as the sum of treatment-induced ADA and treatment-boosted ADA (defined as baseline positive ADA titer that was boosted to ≥4-fold during the study period). Persistently positive was defined as having ≥2 post-baseline ADA positive measurements with ≥16 weeks between first and last positive, or an ADA positive result at the last available assessment. Transiently positive was defined as having ≥1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. Presence of neutralizing antibody (nAb) was tested for all ADA positive samples. Results are reported as number of patients with ADA responses to durvalumab for each indicated category.</description>
          <population>The global ADA evaluable patients included those in the global safety analysis set who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result. ADA for durvalumab was performed for the D + T + EP and D + EP groups only. The denominator was durvalumab ADA evaluable patients.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="191"/>
                <count group_id="O2" value="205"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ADA positive at any visit (ADA prevalence)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-emergent ADA positive (ADA incidence)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-boosted ADA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-induced ADA (ADA positive post-baseline only)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA positive at baseline only</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA positive post-baseline and positive at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Persistently positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Transiently positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>nAb positive at any visit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With ADA Response to Tremelimumab in the Global Cohort</title>
        <description>Serum sampling for ADA assessment was conducted utilizing a tiered approach (screen, confirm, titer). ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA (or ADA incidence) was defined as the sum of treatment-induced ADA and treatment-boosted ADA (defined as baseline positive ADA titer that was boosted to ≥4-fold during the study period). Persistently positive was defined as having ≥2 post-baseline ADA positive measurements with ≥16 weeks between first and last positive, or an ADA positive result at the last available assessment. Transiently positive was defined as having ≥1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. The presence of nAb was tested for all ADA positive samples. Results are reported as number of patients with ADA responses to tremelimumab for each indicated category.</description>
        <time_frame>Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of IP (ie, tremelimumab). Assessed at the global cohort final analysis DCO (27 January 2020).</time_frame>
        <population>The global ADA evaluable patients included those in the global safety analysis set who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result. ADA for tremelimumab was performed for the D + T + EP group only. The denominator was tremelimumab ADA evaluable patients.</population>
        <group_list>
          <group group_id="O1">
            <title>Global Cohort: D + T + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With ADA Response to Tremelimumab in the Global Cohort</title>
          <description>Serum sampling for ADA assessment was conducted utilizing a tiered approach (screen, confirm, titer). ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA (or ADA incidence) was defined as the sum of treatment-induced ADA and treatment-boosted ADA (defined as baseline positive ADA titer that was boosted to ≥4-fold during the study period). Persistently positive was defined as having ≥2 post-baseline ADA positive measurements with ≥16 weeks between first and last positive, or an ADA positive result at the last available assessment. Transiently positive was defined as having ≥1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. The presence of nAb was tested for all ADA positive samples. Results are reported as number of patients with ADA responses to tremelimumab for each indicated category.</description>
          <population>The global ADA evaluable patients included those in the global safety analysis set who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result. ADA for tremelimumab was performed for the D + T + EP group only. The denominator was tremelimumab ADA evaluable patients.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="178"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ADA positive at any visit (ADA prevalence)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-emergent ADA positive (ADA incidence)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-boosted ADA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-induced ADA (ADA positive post-baseline only)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA positive at baseline only</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA positive post-baseline and positive at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Persistently positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Transiently positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>nAb positive at any visit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Deterioration of Health-Related Quality of Life (HRQoL) and Patient Reported Outcome (PRO) Symptoms, Assessed Using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) in the Global Cohort</title>
        <description>The EORTC QLQ-Core 30 version 3 (QLQ-C30 v3) was included for assessing HRQoL. It assesses HRQoL/health status through 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), and a global health and QoL scale. 6 single-item symptom measures are also included: dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. Scores from 0 to 100 were derived for each of the 15 domains, with higher scores representing greater functioning, greater HRQoL, or greater level of symptoms. Time to deterioration (calculated using the Kaplan-Meier technique) was defined as time from randomization until the date of first clinically meaningful deterioration (a decrease in score from baseline of ≥10) that is confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration.</description>
        <time_frame>At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed until global cohort final analysis DCO (maximum of approximately 33 months).</time_frame>
        <population>The global FAS included all patients randomized prior to the end of global recruitment. For QLQ-C30 function scales and global health status/HRQoL, only patients with baseline scores ≥10 (and with data available) were included in the analysis. For QLQ-C30 symptom scales/items, only patients with baseline scores ≤90 (and with data available) were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Global Cohort: D + T + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.</description>
          </group>
          <group group_id="O2">
            <title>Global Cohort: D + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.</description>
          </group>
          <group group_id="O3">
            <title>Global Cohort: EP</title>
            <description>For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Deterioration of Health-Related Quality of Life (HRQoL) and Patient Reported Outcome (PRO) Symptoms, Assessed Using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) in the Global Cohort</title>
          <description>The EORTC QLQ-Core 30 version 3 (QLQ-C30 v3) was included for assessing HRQoL. It assesses HRQoL/health status through 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), and a global health and QoL scale. 6 single-item symptom measures are also included: dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. Scores from 0 to 100 were derived for each of the 15 domains, with higher scores representing greater functioning, greater HRQoL, or greater level of symptoms. Time to deterioration (calculated using the Kaplan-Meier technique) was defined as time from randomization until the date of first clinically meaningful deterioration (a decrease in score from baseline of ≥10) that is confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration.</description>
          <population>The global FAS included all patients randomized prior to the end of global recruitment. For QLQ-C30 function scales and global health status/HRQoL, only patients with baseline scores ≥10 (and with data available) were included in the analysis. For QLQ-C30 symptom scales/items, only patients with baseline scores ≤90 (and with data available) were included in the analysis.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="262"/>
                <count group_id="O2" value="261"/>
                <count group_id="O3" value="260"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>QLQ-C30 Global Health Status / HRQoL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="247"/>
                    <count group_id="O2" value="239"/>
                    <count group_id="O3" value="232"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.2" lower_limit="5.8" upper_limit="8.3"/>
                    <measurement group_id="O2" value="8.4" lower_limit="7.3" upper_limit="11.0"/>
                    <measurement group_id="O3" value="7.4" lower_limit="6.5" upper_limit="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-C30 Cognitive Functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="251"/>
                    <count group_id="O2" value="245"/>
                    <count group_id="O3" value="242"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" lower_limit="5.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="8.4" lower_limit="7.3" upper_limit="10.3"/>
                    <measurement group_id="O3" value="6.0" lower_limit="5.2" upper_limit="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-C30 Emotional Functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="248"/>
                    <count group_id="O2" value="242"/>
                    <count group_id="O3" value="240"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.6" lower_limit="6.6" upper_limit="9.5"/>
                    <measurement group_id="O2" value="11.8" lower_limit="8.6" upper_limit="16.6"/>
                    <measurement group_id="O3" value="7.3" lower_limit="6.7" upper_limit="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-C30 Physical Functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="247"/>
                    <count group_id="O2" value="244"/>
                    <count group_id="O3" value="240"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" lower_limit="5.0" upper_limit="6.9"/>
                    <measurement group_id="O2" value="8.4" lower_limit="7.4" upper_limit="12.0"/>
                    <measurement group_id="O3" value="6.5" lower_limit="6.0" upper_limit="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-C30 Role Functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="236"/>
                    <count group_id="O2" value="231"/>
                    <count group_id="O3" value="226"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="4.1" upper_limit="6.5"/>
                    <measurement group_id="O2" value="7.4" lower_limit="5.7" upper_limit="10.2"/>
                    <measurement group_id="O3" value="5.9" lower_limit="4.5" upper_limit="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-C30 Social Functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="244"/>
                    <count group_id="O2" value="237"/>
                    <count group_id="O3" value="236"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2" lower_limit="5.0" upper_limit="7.4"/>
                    <measurement group_id="O2" value="7.4" lower_limit="6.5" upper_limit="8.8"/>
                    <measurement group_id="O3" value="6.3" lower_limit="4.9" upper_limit="7.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-C30 Fatigue</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="242"/>
                    <count group_id="O2" value="244"/>
                    <count group_id="O3" value="232"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" lower_limit="3.1" upper_limit="4.7"/>
                    <measurement group_id="O2" value="5.5" lower_limit="4.0" upper_limit="6.6"/>
                    <measurement group_id="O3" value="4.5" lower_limit="3.5" upper_limit="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-C30 Nausea / Vomiting</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="252"/>
                    <count group_id="O2" value="245"/>
                    <count group_id="O3" value="244"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5" lower_limit="6.1" upper_limit="8.6"/>
                    <measurement group_id="O2" value="8.4" lower_limit="6.6" upper_limit="10.2"/>
                    <measurement group_id="O3" value="6.6" lower_limit="5.6" upper_limit="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-C30 Pain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="243"/>
                    <count group_id="O2" value="240"/>
                    <count group_id="O3" value="233"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.9" lower_limit="6.0" upper_limit="7.7"/>
                    <measurement group_id="O2" value="8.0" lower_limit="6.8" upper_limit="10.4"/>
                    <measurement group_id="O3" value="6.7" lower_limit="6.2" upper_limit="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-C30 Appetite Loss</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="236"/>
                    <count group_id="O2" value="231"/>
                    <count group_id="O3" value="224"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.9" lower_limit="5.6" upper_limit="8.5"/>
                    <measurement group_id="O2" value="8.3" lower_limit="6.8" upper_limit="11.0"/>
                    <measurement group_id="O3" value="6.6" lower_limit="5.5" upper_limit="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-C30 Constipation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="243"/>
                    <count group_id="O2" value="240"/>
                    <count group_id="O3" value="229"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.5" lower_limit="7.1" upper_limit="10.8"/>
                    <measurement group_id="O2" value="11.5" lower_limit="8.3" upper_limit="14.7"/>
                    <measurement group_id="O3" value="7.3" lower_limit="6.2" upper_limit="9.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-C30 Diarrhea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="250"/>
                    <count group_id="O2" value="244"/>
                    <count group_id="O3" value="244"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.9" lower_limit="7.5" upper_limit="10.8"/>
                    <measurement group_id="O2" value="14.7" lower_limit="9.4" upper_limit="21.1"/>
                    <measurement group_id="O3" value="7.7" lower_limit="7.1" upper_limit="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-C30 Dyspnea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="227"/>
                    <count group_id="O2" value="225"/>
                    <count group_id="O3" value="218"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.2" lower_limit="5.6" upper_limit="8.3"/>
                    <measurement group_id="O2" value="9.0" lower_limit="7.6" upper_limit="12.7"/>
                    <measurement group_id="O3" value="7.5" lower_limit="6.6" upper_limit="9.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-C30 Insomnia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="226"/>
                    <count group_id="O2" value="226"/>
                    <count group_id="O3" value="210"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1" lower_limit="6.1" upper_limit="8.6"/>
                    <measurement group_id="O2" value="8.6" lower_limit="7.1" upper_limit="11.8"/>
                    <measurement group_id="O3" value="7.3" lower_limit="6.4" upper_limit="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Deterioration of PRO Symptoms, Assessed Using EORTC QLQ-Lung Cancer Module 13 (QLQ-LC13) in the Global Cohort</title>
        <description>The EORTC QLQ-LC13 is a disease-specific 13-item self-administered questionnaire for lung cancer, to be used in conjunction with the EORTC QLQ-C30. It comprises both multi-item and single-item measures of lung cancer-associated symptoms (ie, coughing, hemoptysis, dyspnea, and pain) and side effects from conventional chemotherapy and radiotherapy (ie, hair loss, neuropathy, sore mouth, and dysphagia). Scores from 0 to 100 were derived for each symptom item, with higher scores representing greater level of symptoms. Time to deterioration (calculated using the Kaplan-Meier technique) was defined as time from randomization until the date of first clinically meaningful deterioration (an increase in score from baseline of ≥10) that is confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration.</description>
        <time_frame>At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed until global cohort final analysis DCO (maximum of approximately 33 months).</time_frame>
        <population>The global FAS included all patients randomized prior to the end of global recruitment. For QLQ-L13 symptom scales/items, only patients with baseline scores ≤90 (and with data available) were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Global Cohort: D + T + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.</description>
          </group>
          <group group_id="O2">
            <title>Global Cohort: D + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.</description>
          </group>
          <group group_id="O3">
            <title>Global Cohort: EP</title>
            <description>For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Deterioration of PRO Symptoms, Assessed Using EORTC QLQ-Lung Cancer Module 13 (QLQ-LC13) in the Global Cohort</title>
          <description>The EORTC QLQ-LC13 is a disease-specific 13-item self-administered questionnaire for lung cancer, to be used in conjunction with the EORTC QLQ-C30. It comprises both multi-item and single-item measures of lung cancer-associated symptoms (ie, coughing, hemoptysis, dyspnea, and pain) and side effects from conventional chemotherapy and radiotherapy (ie, hair loss, neuropathy, sore mouth, and dysphagia). Scores from 0 to 100 were derived for each symptom item, with higher scores representing greater level of symptoms. Time to deterioration (calculated using the Kaplan-Meier technique) was defined as time from randomization until the date of first clinically meaningful deterioration (an increase in score from baseline of ≥10) that is confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration.</description>
          <population>The global FAS included all patients randomized prior to the end of global recruitment. For QLQ-L13 symptom scales/items, only patients with baseline scores ≤90 (and with data available) were included in the analysis.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="262"/>
                <count group_id="O2" value="261"/>
                <count group_id="O3" value="260"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>QLQ-LC13 Coughing</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="233"/>
                    <count group_id="O2" value="230"/>
                    <count group_id="O3" value="230"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7" lower_limit="6.9" upper_limit="10.8"/>
                    <measurement group_id="O2" value="9.3" lower_limit="8.0" upper_limit="14.1"/>
                    <measurement group_id="O3" value="7.7" lower_limit="6.7" upper_limit="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-LC13 Dyspnea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="249"/>
                    <count group_id="O2" value="241"/>
                    <count group_id="O3" value="240"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3" lower_limit="4.9" upper_limit="7.4"/>
                    <measurement group_id="O2" value="6.5" lower_limit="5.5" upper_limit="7.8"/>
                    <measurement group_id="O3" value="5.5" lower_limit="4.6" upper_limit="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-LC13 Hemoptysis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="252"/>
                    <count group_id="O2" value="243"/>
                    <count group_id="O3" value="245"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.4" lower_limit="8.9" upper_limit="18.6"/>
                    <measurement group_id="O2" value="18.3" lower_limit="14.5" upper_limit="NA">Upper limit of 95% CI could not be calculated as it was not reached.</measurement>
                    <measurement group_id="O3" value="10.8" lower_limit="8.4" upper_limit="11.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-LC13 Pain in Arm or Shoulder</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="245"/>
                    <count group_id="O2" value="241"/>
                    <count group_id="O3" value="238"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1" lower_limit="6.3" upper_limit="8.3"/>
                    <measurement group_id="O2" value="9.7" lower_limit="8.1" upper_limit="15.1"/>
                    <measurement group_id="O3" value="7.6" lower_limit="6.6" upper_limit="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-LC13 Pain in Chest</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="243"/>
                    <count group_id="O2" value="239"/>
                    <count group_id="O3" value="240"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.5" lower_limit="7.2" upper_limit="10.8"/>
                    <measurement group_id="O2" value="11.5" lower_limit="8.4" upper_limit="15.8"/>
                    <measurement group_id="O3" value="7.9" lower_limit="7.2" upper_limit="9.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-LC13 Pain in Other Parts</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="245"/>
                    <count group_id="O2" value="236"/>
                    <count group_id="O3" value="231"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.4" lower_limit="6.5" upper_limit="8.7"/>
                    <measurement group_id="O2" value="7.8" lower_limit="6.6" upper_limit="9.3"/>
                    <measurement group_id="O3" value="6.6" lower_limit="5.1" upper_limit="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Primary PRO Symptoms as Assessed by EORTC QLQ in the Global Cohort; D + T + EP Compared With EP</title>
        <description>A mixed model repeated measures (MMRM) analysis of EORTC QLQ-C30 and EORTC QLQ-LC13 was performed for 5 primary PRO symptoms (cough, dyspnea, chest pain, fatigue and appetite loss), and considered all data from baseline to PD or 12 months, excluding visits with excessive missing data (defined as &gt;75% missing data). An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items, with higher scores representing greater symptom severity. An improvement in symptoms was indicated by a negative change from baseline. A positive change from baseline indicated a deterioration of symptoms. A minimum clinically meaningful change was defined as an absolute change from baseline of ≥10. This outcome measure presents change from baseline for primary PRO symptoms (reported as adjusted means) for analysis of D + T + EP vs P. Analysis of D + EP vs EP is presented in a separate outcome measure.</description>
        <time_frame>At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed up to 12 months.</time_frame>
        <population>The global FAS included all patients randomized prior to the end of global recruitment. For each symptom scale, only patients with data available were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Global Cohort: D + T + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.</description>
          </group>
          <group group_id="O2">
            <title>Global Cohort: EP</title>
            <description>For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Primary PRO Symptoms as Assessed by EORTC QLQ in the Global Cohort; D + T + EP Compared With EP</title>
          <description>A mixed model repeated measures (MMRM) analysis of EORTC QLQ-C30 and EORTC QLQ-LC13 was performed for 5 primary PRO symptoms (cough, dyspnea, chest pain, fatigue and appetite loss), and considered all data from baseline to PD or 12 months, excluding visits with excessive missing data (defined as &gt;75% missing data). An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items, with higher scores representing greater symptom severity. An improvement in symptoms was indicated by a negative change from baseline. A positive change from baseline indicated a deterioration of symptoms. A minimum clinically meaningful change was defined as an absolute change from baseline of ≥10. This outcome measure presents change from baseline for primary PRO symptoms (reported as adjusted means) for analysis of D + T + EP vs P. Analysis of D + EP vs EP is presented in a separate outcome measure.</description>
          <population>The global FAS included all patients randomized prior to the end of global recruitment. For each symptom scale, only patients with data available were included in the analysis.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="262"/>
                <count group_id="O2" value="260"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>EORTC QLQ-LC13 Cough</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="239"/>
                    <count group_id="O2" value="232"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.1" spread="1.74"/>
                    <measurement group_id="O2" value="-14.6" spread="1.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EORTC QLQ-LC13 Dyspnea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="239"/>
                    <count group_id="O2" value="232"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.8" spread="1.60"/>
                    <measurement group_id="O2" value="-6.6" spread="1.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EORTC QLQ-LC13 Chest pain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="239"/>
                    <count group_id="O2" value="232"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.4" spread="1.65"/>
                    <measurement group_id="O2" value="-7.0" spread="1.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EORTC QLQ-C30 Fatigue</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="239"/>
                    <count group_id="O2" value="233"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.1" spread="1.84"/>
                    <measurement group_id="O2" value="-6.3" spread="1.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EORTC QLQ-C30 Appetite loss</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="239"/>
                    <count group_id="O2" value="233"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.7" spread="2.02"/>
                    <measurement group_id="O2" value="-9.5" spread="2.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Primary Symptoms, Assessed Using EORTC QLQ-C30 and EORTC QLQ-LC13 in the Global Cohort; D + EP Compared With EP</title>
        <description>A MMRM analysis of EORTC QLQ-C30 and EORTC QLQ-LC13 was performed for 5 primary PRO symptoms (cough, dyspnea, chest pain, fatigue and appetite loss), and considered all data from baseline to PD or 12 months, excluding visits with excessive missing data (defined as &gt;75% missing data). An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items, with higher scores representing greater symptom severity. An improvement in symptoms was indicated by a negative change from baseline. A positive change from baseline indicated a deterioration of symptoms. A minimum clinically meaningful change was defined as an absolute change from baseline of ≥10. This outcome measure presents change from baseline for primary PRO symptoms (reported as adjusted means) for analysis of D + EP vs EP. Analysis of D + T + EP vs EP is presented in a separate outcome measure.</description>
        <time_frame>At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed up to 12 months.</time_frame>
        <population>The global FAS included all patients randomized prior to the end of global recruitment. For each symptom scale, only patients with data available were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Global Cohort: D + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.</description>
          </group>
          <group group_id="O2">
            <title>Global Cohort: EP</title>
            <description>For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Primary Symptoms, Assessed Using EORTC QLQ-C30 and EORTC QLQ-LC13 in the Global Cohort; D + EP Compared With EP</title>
          <description>A MMRM analysis of EORTC QLQ-C30 and EORTC QLQ-LC13 was performed for 5 primary PRO symptoms (cough, dyspnea, chest pain, fatigue and appetite loss), and considered all data from baseline to PD or 12 months, excluding visits with excessive missing data (defined as &gt;75% missing data). An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items, with higher scores representing greater symptom severity. An improvement in symptoms was indicated by a negative change from baseline. A positive change from baseline indicated a deterioration of symptoms. A minimum clinically meaningful change was defined as an absolute change from baseline of ≥10. This outcome measure presents change from baseline for primary PRO symptoms (reported as adjusted means) for analysis of D + EP vs EP. Analysis of D + T + EP vs EP is presented in a separate outcome measure.</description>
          <population>The global FAS included all patients randomized prior to the end of global recruitment. For each symptom scale, only patients with data available were included in the analysis.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="261"/>
                <count group_id="O2" value="260"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>EORTC QLQ-LC13 Cough</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="232"/>
                    <count group_id="O2" value="232"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.0" spread="1.64"/>
                    <measurement group_id="O2" value="-15.4" spread="1.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EORTC QLQ-LC13 Dyspnea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="232"/>
                    <count group_id="O2" value="232"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.1" spread="1.44"/>
                    <measurement group_id="O2" value="-6.5" spread="1.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EORTC QLQ-LC13 Chest pain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="232"/>
                    <count group_id="O2" value="232"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.8" spread="1.59"/>
                    <measurement group_id="O2" value="-7.2" spread="1.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EORTC QLQ-C30 Fatigue</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="233"/>
                    <count group_id="O2" value="233"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.8" spread="1.62"/>
                    <measurement group_id="O2" value="-4.5" spread="1.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EORTC QLQ-C30 Appetite loss</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="233"/>
                    <count group_id="O2" value="233"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.1" spread="1.73"/>
                    <measurement group_id="O2" value="-7.6" spread="1.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>OS in the China Cohort; D + T + EP Compared With D + EP</title>
        <description>OS was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. This secondary outcome measure presents OS for the analysis of D + T + EP vs D + EP at the China cohort second analysis DCO (02 November 2020). The alternative treatment comparisons were performed as primary outcome measures.</description>
        <time_frame>From baseline until death due to any cause. Assessed until China cohort second analysis DCO (maximum of approximately 29 months).</time_frame>
        <population>The China FAS included all randomized patients in the China cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>China Cohort: D + T + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.</description>
          </group>
          <group group_id="O2">
            <title>China Cohort: D + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.</description>
          </group>
        </group_list>
        <measure>
          <title>OS in the China Cohort; D + T + EP Compared With D + EP</title>
          <description>OS was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. This secondary outcome measure presents OS for the analysis of D + T + EP vs D + EP at the China cohort second analysis DCO (02 November 2020). The alternative treatment comparisons were performed as primary outcome measures.</description>
          <population>The China FAS included all randomized patients in the China cohort.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.1" lower_limit="11.3" upper_limit="18.6"/>
                    <measurement group_id="O2" value="14.4" lower_limit="12.3" upper_limit="17.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>D + T + EP vs D + EP. HR &lt;1 favors D + T + EP to be associated with a longer OS than D + EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.4470</p_value>
            <p_value_desc>Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.574</ci_lower_limit>
            <ci_upper_limit>1.277</ci_upper_limit>
            <estimate_desc>The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PFS in the China Cohort</title>
        <description>PFS (per RECIST 1.1 using Investigator assessments) was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Progression (ie, PD) was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir) and an absolute increase of ≥5 mm for the sum from nadir. For evaluation of NTLs, PD was defined as unequivocal progression of existing NTLs. Median PFS was calculated using the Kaplan-Meier technique.</description>
        <time_frame>Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until China cohort second analysis DCO (maximum of approximately 29 months).</time_frame>
        <population>The China FAS included all randomized patients in the China cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>China Cohort: D + T + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.</description>
          </group>
          <group group_id="O2">
            <title>China Cohort: D + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.</description>
          </group>
          <group group_id="O3">
            <title>China Cohort: EP</title>
            <description>For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.</description>
          </group>
        </group_list>
        <measure>
          <title>PFS in the China Cohort</title>
          <description>PFS (per RECIST 1.1 using Investigator assessments) was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Progression (ie, PD) was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir) and an absolute increase of ≥5 mm for the sum from nadir. For evaluation of NTLs, PD was defined as unequivocal progression of existing NTLs. Median PFS was calculated using the Kaplan-Meier technique.</description>
          <population>The China FAS included all randomized patients in the China cohort.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="61"/>
                <count group_id="O3" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6" lower_limit="4.8" upper_limit="6.6"/>
                    <measurement group_id="O2" value="4.9" lower_limit="4.7" upper_limit="5.5"/>
                    <measurement group_id="O3" value="5.5" lower_limit="4.9" upper_limit="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>D + EP vs EP. HR &lt;1 favors D + EP to be associated with a longer PFS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.8934</p_value>
            <p_value_desc>Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.97</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.661</ci_lower_limit>
            <ci_upper_limit>1.437</ci_upper_limit>
            <estimate_desc>The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>D + T + EP vs EP. HR &lt;1 favors D + T + EP to be associated with a longer PFS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.1035</p_value>
            <p_value_desc>Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.72</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.487</ci_lower_limit>
            <ci_upper_limit>1.068</ci_upper_limit>
            <estimate_desc>The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>D + T + EP vs D + EP. HR &lt;1 favors D + T + EP to be associated with a longer PFS than D + EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.1673</p_value>
            <p_value_desc>Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.76</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.522</ci_lower_limit>
            <ci_upper_limit>1.116</ci_upper_limit>
            <estimate_desc>The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ORR in the China Cohort</title>
        <description>ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of patients with at least 1 visit response of CR or PR. CR was defined as disappearance of all TLs since baseline (any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to &lt;10 mm) or disappearance of all NTLs since baseline (all lymph nodes must be non-pathological in size [&lt;10 mm short axis]). PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters).</description>
        <time_frame>Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until China cohort second analysis DCO (maximum of approximately 29 months).</time_frame>
        <population>The China FAS included all randomized patients in the China cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>China Cohort: D + T + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.</description>
          </group>
          <group group_id="O2">
            <title>China Cohort: D + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.</description>
          </group>
          <group group_id="O3">
            <title>China Cohort: EP</title>
            <description>For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.</description>
          </group>
        </group_list>
        <measure>
          <title>ORR in the China Cohort</title>
          <description>ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of patients with at least 1 visit response of CR or PR. CR was defined as disappearance of all TLs since baseline (any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to &lt;10 mm) or disappearance of all NTLs since baseline (all lymph nodes must be non-pathological in size [&lt;10 mm short axis]). PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters).</description>
          <population>The China FAS included all randomized patients in the China cohort.</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="61"/>
                <count group_id="O3" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.6"/>
                    <measurement group_id="O2" value="78.7"/>
                    <measurement group_id="O3" value="72.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>D + EP vs EP. An odds ratio &gt;1 favors D + EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.4320</p_value>
            <p_value_desc>Analysis was performed using a logistic regression model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin). P-value is based on twice the change in log-likelihood resulting from addition of a treatment factor to the model.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.39</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.610</ci_lower_limit>
            <ci_upper_limit>3.244</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>D + T + EP vs EP. An odds ratio &gt;1 favors D + T + EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0986</p_value>
            <p_value_desc>Analysis was performed using a logistic regression model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin). P-value is based on twice the change in log-likelihood resulting from addition of a treatment factor to the model.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.874</ci_lower_limit>
            <ci_upper_limit>5.118</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>APF6 in the China Cohort</title>
        <description>The APF6 was defined as the percentage of patients who were alive and progression free at 6 months from randomization (ie, PFS rate at 6 months). PFS was calculated using the Kaplan-Meier technique.</description>
        <time_frame>Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until 6 months post-randomization.</time_frame>
        <population>The China FAS included all randomized patients in the China cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>China Cohort: D + T + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.</description>
          </group>
          <group group_id="O2">
            <title>China Cohort: D + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.</description>
          </group>
          <group group_id="O3">
            <title>China Cohort: EP</title>
            <description>For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.</description>
          </group>
        </group_list>
        <measure>
          <title>APF6 in the China Cohort</title>
          <description>The APF6 was defined as the percentage of patients who were alive and progression free at 6 months from randomization (ie, PFS rate at 6 months). PFS was calculated using the Kaplan-Meier technique.</description>
          <population>The China FAS included all randomized patients in the China cohort.</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="61"/>
                <count group_id="O3" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.7" lower_limit="31.2" upper_limit="55.5"/>
                    <measurement group_id="O2" value="35.2" lower_limit="23.3" upper_limit="47.4"/>
                    <measurement group_id="O3" value="43.1" lower_limit="29.8" upper_limit="55.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>APF12 in the China Cohort</title>
        <description>The APF12 was defined as the percentage of patients who were alive and progression free at 12 months from randomization (ie, PFS rate at 12 months). PFS was calculated using the Kaplan-Meier technique.</description>
        <time_frame>Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until 12 months post-randomization.</time_frame>
        <population>The China FAS included all randomized patients in the China cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>China Cohort: D + T + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.</description>
          </group>
          <group group_id="O2">
            <title>China Cohort: D + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.</description>
          </group>
          <group group_id="O3">
            <title>China Cohort: EP</title>
            <description>For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.</description>
          </group>
        </group_list>
        <measure>
          <title>APF12 in the China Cohort</title>
          <description>The APF12 was defined as the percentage of patients who were alive and progression free at 12 months from randomization (ie, PFS rate at 12 months). PFS was calculated using the Kaplan-Meier technique.</description>
          <population>The China FAS included all randomized patients in the China cohort.</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="61"/>
                <count group_id="O3" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.0" lower_limit="12.0" upper_limit="31.9"/>
                    <measurement group_id="O2" value="12.3" lower_limit="5.4" upper_limit="22.2"/>
                    <measurement group_id="O3" value="6.2" lower_limit="1.6" upper_limit="15.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>OS18 in the China Cohort</title>
        <description>OS18 was defined as the percentage of patients who were alive at 18 months after randomization per the Kaplan-Meier estimate of OS at 18 months.</description>
        <time_frame>At 18 months post-randomization. Assessed at the China cohort second analysis DCO (02 November 2020).</time_frame>
        <population>The China FAS included all randomized patients in the China cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>China Cohort: D + T + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.</description>
          </group>
          <group group_id="O2">
            <title>China Cohort: D + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.</description>
          </group>
          <group group_id="O3">
            <title>China Cohort: EP</title>
            <description>For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.</description>
          </group>
        </group_list>
        <measure>
          <title>OS18 in the China Cohort</title>
          <description>OS18 was defined as the percentage of patients who were alive at 18 months after randomization per the Kaplan-Meier estimate of OS at 18 months.</description>
          <population>The China FAS included all randomized patients in the China cohort.</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="61"/>
                <count group_id="O3" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.0" lower_limit="28.1" upper_limit="51.6"/>
                    <measurement group_id="O2" value="36.1" lower_limit="24.3" upper_limit="48.0"/>
                    <measurement group_id="O3" value="23.4" lower_limit="13.6" upper_limit="34.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK of Durvalumab; Peak and Trough Serum Concentrations in the China Cohort</title>
        <description>To evaluate PK, blood samples were collected at pre-specified timepoints and peak and trough serum concentrations of durvalumab were determined. Peak concentration on Week 0 is the post-infusion concentration of Week 0 (collected within 10 minutes of the end of infusion). Trough concentrations on Weeks 3 and 12 are the pre-infusion concentrations of Weeks 3 and 12, respectively.</description>
        <time_frame>Samples were collected post-dose on Day 1 (Week 0), and pre-dose on Weeks 3 and 12. Assessed at the China cohort second analysis DCO (02 November 2020).</time_frame>
        <population>The China PK analysis set included all patients in the China cohort who received at least 1 dose of IP, per the protocol for whom any post-dose PK data were available. PK for durvalumab was performed for the D + T + EP and D + EP groups only.</population>
        <group_list>
          <group group_id="O1">
            <title>China Cohort: D + T + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.</description>
          </group>
          <group group_id="O2">
            <title>China Cohort: D + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.</description>
          </group>
        </group_list>
        <measure>
          <title>PK of Durvalumab; Peak and Trough Serum Concentrations in the China Cohort</title>
          <description>To evaluate PK, blood samples were collected at pre-specified timepoints and peak and trough serum concentrations of durvalumab were determined. Peak concentration on Week 0 is the post-infusion concentration of Week 0 (collected within 10 minutes of the end of infusion). Trough concentrations on Weeks 3 and 12 are the pre-infusion concentrations of Weeks 3 and 12, respectively.</description>
          <population>The China PK analysis set included all patients in the China cohort who received at least 1 dose of IP, per the protocol for whom any post-dose PK data were available. PK for durvalumab was performed for the D + T + EP and D + EP groups only.</population>
          <units>μg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 0: peak concentration</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="429.4" spread="19.49"/>
                    <measurement group_id="O2" value="432.0" spread="91.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3: trough concentration</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.21" spread="46.14"/>
                    <measurement group_id="O2" value="96.24" spread="64.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12: trough concentration</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="151.0" spread="29.82"/>
                    <measurement group_id="O2" value="194.4" spread="53.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK of Tremelimumab; Peak and Trough Serum Concentrations in the China Cohort</title>
        <description>To evaluate PK, blood samples were collected at pre-specified timepoints and peak and trough serum concentrations of tremelimumab were determined. Peak concentration on Week 0 is the post-infusion concentration of Week 0 (collected within 10 minutes of the end of infusion). Trough concentrations on Weeks 3 and 12 are the pre-infusion concentrations of Weeks 3 and 12, respectively.</description>
        <time_frame>Samples were collected post-dose on Day 1 (Week 0), and pre-dose on Weeks 3 and 12. Assessed at the China cohort second analysis DCO (02 November 2020).</time_frame>
        <population>The China PK analysis set included all patients in the China cohort who received at least 1 dose of IP, per the protocol for whom any post-dose PK data were available. PK for tremelimumab was performed for the D + T + EP group only.</population>
        <group_list>
          <group group_id="O1">
            <title>China Cohort: D + T + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>PK of Tremelimumab; Peak and Trough Serum Concentrations in the China Cohort</title>
          <description>To evaluate PK, blood samples were collected at pre-specified timepoints and peak and trough serum concentrations of tremelimumab were determined. Peak concentration on Week 0 is the post-infusion concentration of Week 0 (collected within 10 minutes of the end of infusion). Trough concentrations on Weeks 3 and 12 are the pre-infusion concentrations of Weeks 3 and 12, respectively.</description>
          <population>The China PK analysis set included all patients in the China cohort who received at least 1 dose of IP, per the protocol for whom any post-dose PK data were available. PK for tremelimumab was performed for the D + T + EP group only.</population>
          <units>μg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 0: peak concentration</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.34" spread="27.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3: trough concentration</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.530" spread="60.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12: trough concentration</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.523" spread="43.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With ADA Response to Durvalumab in the China Cohort</title>
        <description>Serum sampling for ADA assessment was conducted utilizing a tiered approach (screen, confirm, titer). ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA was defined as the sum of treatment-induced ADA and treatment-boosted ADA (defined as baseline positive ADA titer that was boosted to ≥4-fold during the study period). Persistently positive was defined as having ≥2 post-baseline ADA positive measurements with ≥16 weeks between first and last positive, or an ADA positive result at the last available assessment. Transiently positive was defined as having ≥1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. Presence of nAb was tested for all ADA positive samples. Results are reported as number of patients with ADA responses to durvalumab for each indicated category.</description>
        <time_frame>Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of IP (ie, durvalumab). Assessed at the China cohort second analysis DCO (02 November 2020).</time_frame>
        <population>The China ADA evaluable patients included those in the China safety analysis set who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result. ADA for durvalumab was performed for the D + T + EP and D + EP groups only. The denominator was durvalumab ADA evaluable patients.</population>
        <group_list>
          <group group_id="O1">
            <title>China Cohort: D + T + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.</description>
          </group>
          <group group_id="O2">
            <title>China Cohort: D + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With ADA Response to Durvalumab in the China Cohort</title>
          <description>Serum sampling for ADA assessment was conducted utilizing a tiered approach (screen, confirm, titer). ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA was defined as the sum of treatment-induced ADA and treatment-boosted ADA (defined as baseline positive ADA titer that was boosted to ≥4-fold during the study period). Persistently positive was defined as having ≥2 post-baseline ADA positive measurements with ≥16 weeks between first and last positive, or an ADA positive result at the last available assessment. Transiently positive was defined as having ≥1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. Presence of nAb was tested for all ADA positive samples. Results are reported as number of patients with ADA responses to durvalumab for each indicated category.</description>
          <population>The China ADA evaluable patients included those in the China safety analysis set who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result. ADA for durvalumab was performed for the D + T + EP and D + EP groups only. The denominator was durvalumab ADA evaluable patients.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ADA positive at any visit (ADA prevalence)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-emergent ADA positive (ADA incidence)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-boosted ADA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-induced ADA (ADA positive post-baseline only)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA positive at baseline only</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA positive post-baseline and positive at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Persistently positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Transiently positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>nAb positive at any visit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With ADA Response to Tremelimumab in the China Cohort</title>
        <description>Serum sampling for ADA assessment was conducted utilizing a tiered approach (screen, confirm, titer). ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA (or ADA incidence) was defined as the sum of treatment-induced ADA and treatment-boosted ADA (defined as baseline positive ADA titer that was boosted to ≥4-fold during the study period). Persistently positive was defined as having ≥2 post-baseline ADA positive measurements with ≥16 weeks between first and last positive, or an ADA positive result at the last available assessment. Transiently positive was defined as having ≥1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. The presence of nAb was tested for all ADA positive samples. Results are reported as number of patients with ADA responses to tremelimumab for each indicated category.</description>
        <time_frame>Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of IP (ie, tremelimumab). Assessed at the China cohort second analysis DCO (02 November 2020).</time_frame>
        <population>The China ADA evaluable patients included those in the China safety analysis set who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result. ADA for tremelimumab was performed for the D + T + EP group only. The denominator was tremelimumab ADA evaluable patients.</population>
        <group_list>
          <group group_id="O1">
            <title>China Cohort: D + T + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With ADA Response to Tremelimumab in the China Cohort</title>
          <description>Serum sampling for ADA assessment was conducted utilizing a tiered approach (screen, confirm, titer). ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA (or ADA incidence) was defined as the sum of treatment-induced ADA and treatment-boosted ADA (defined as baseline positive ADA titer that was boosted to ≥4-fold during the study period). Persistently positive was defined as having ≥2 post-baseline ADA positive measurements with ≥16 weeks between first and last positive, or an ADA positive result at the last available assessment. Transiently positive was defined as having ≥1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. The presence of nAb was tested for all ADA positive samples. Results are reported as number of patients with ADA responses to tremelimumab for each indicated category.</description>
          <population>The China ADA evaluable patients included those in the China safety analysis set who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result. ADA for tremelimumab was performed for the D + T + EP group only. The denominator was tremelimumab ADA evaluable patients.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ADA positive at any visit (ADA prevalence)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-emergent ADA positive (ADA incidence)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-boosted ADA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-induced ADA (ADA positive post-baseline only)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA positive at baseline only</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA positive post-baseline and positive at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Persistently positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Transiently positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>nAb positive at any visit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Deterioration of HRQoL and PRO Symptoms, Assessed Using EORTC QLQ in the China Cohort</title>
        <description>The EORTC QLQ-C30 v3 was included for assessing HRQoL. It assesses HRQoL/health status through 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), and a global health and QoL scale. 6 single-item symptom measures are also included: dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. Scores from 0 to 100 were derived for each of the 15 domains, with higher scores representing greater functioning, greater HRQoL, or greater level of symptoms. Time to deterioration (calculated using the Kaplan-Meier technique) was defined as time from randomization until the date of first clinically meaningful deterioration (a decrease in score from baseline of ≥10) that is confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration.</description>
        <time_frame>At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed until China cohort second analysis DCO (maximum of approximately 29 months).</time_frame>
        <population>The China FAS included all randomized patients in the China cohort. For QLQ-C30 function scales and global health status/HRQoL, only patients with baseline scores ≥10 (and with data available) were included in the analysis. For QLQ-C30 symptom scales/items, only patients with baseline scores ≤90 (and with data available) were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>China Cohort: D + T + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.</description>
          </group>
          <group group_id="O2">
            <title>China Cohort: D + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.</description>
          </group>
          <group group_id="O3">
            <title>China Cohort: EP</title>
            <description>For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Deterioration of HRQoL and PRO Symptoms, Assessed Using EORTC QLQ in the China Cohort</title>
          <description>The EORTC QLQ-C30 v3 was included for assessing HRQoL. It assesses HRQoL/health status through 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), and a global health and QoL scale. 6 single-item symptom measures are also included: dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. Scores from 0 to 100 were derived for each of the 15 domains, with higher scores representing greater functioning, greater HRQoL, or greater level of symptoms. Time to deterioration (calculated using the Kaplan-Meier technique) was defined as time from randomization until the date of first clinically meaningful deterioration (a decrease in score from baseline of ≥10) that is confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration.</description>
          <population>The China FAS included all randomized patients in the China cohort. For QLQ-C30 function scales and global health status/HRQoL, only patients with baseline scores ≥10 (and with data available) were included in the analysis. For QLQ-C30 symptom scales/items, only patients with baseline scores ≤90 (and with data available) were included in the analysis.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="61"/>
                <count group_id="O3" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>QLQ-C30 Global Health Status / HRQoL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="57"/>
                    <count group_id="O3" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.5" lower_limit="6.8" upper_limit="NA">Upper limit of 95% CI could not be calculated as it was not reached.</measurement>
                    <measurement group_id="O2" value="15.1" lower_limit="7.6" upper_limit="NA">Upper limit of 95% CI could not be calculated as it was not reached.</measurement>
                    <measurement group_id="O3" value="7.8" lower_limit="6.5" upper_limit="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-C30 Cognitive Functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="58"/>
                    <count group_id="O3" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.6" lower_limit="4.9" upper_limit="NA">Upper limit of 95% CI could not be calculated as it was not reached.</measurement>
                    <measurement group_id="O2" value="6.8" lower_limit="2.3" upper_limit="NA">Upper limit of 95% CI could not be calculated as it was not reached.</measurement>
                    <measurement group_id="O3" value="6.9" lower_limit="5.7" upper_limit="NA">Upper limit of 95% CI could not be calculated as it was not reached.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-C30 Emotional Functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="58"/>
                    <count group_id="O3" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.4" lower_limit="6.8" upper_limit="NA">Upper limit of 95% CI could not be calculated as it was not reached.</measurement>
                    <measurement group_id="O2" value="15.5" lower_limit="5.8" upper_limit="NA">Upper limit of 95% CI could not be calculated as it was not reached.</measurement>
                    <measurement group_id="O3" value="10.0" lower_limit="6.9" upper_limit="NA">Upper limit of 95% CI could not be calculated as it was not reached.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-C30 Physical Functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="58"/>
                    <count group_id="O3" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.8" lower_limit="6.0" upper_limit="NA">Upper limit of 95% CI could not be calculated as it was not reached.</measurement>
                    <measurement group_id="O2" value="9.3" lower_limit="5.8" upper_limit="NA">Upper limit of 95% CI could not be calculated as it was not reached.</measurement>
                    <measurement group_id="O3" value="7.3" lower_limit="5.7" upper_limit="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-C30 Role Functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="56"/>
                    <count group_id="O3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.8" lower_limit="4.9" upper_limit="21.3"/>
                    <measurement group_id="O2" value="6.4" lower_limit="4.2" upper_limit="13.9"/>
                    <measurement group_id="O3" value="6.2" lower_limit="4.1" upper_limit="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-C30 Social Functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="57"/>
                    <count group_id="O3" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7" lower_limit="4.3" upper_limit="14.1"/>
                    <measurement group_id="O2" value="5.8" lower_limit="3.9" upper_limit="13.3"/>
                    <measurement group_id="O3" value="6.5" lower_limit="3.3" upper_limit="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-C30 Fatigue</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="58"/>
                    <count group_id="O3" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" lower_limit="2.3" upper_limit="6.8"/>
                    <measurement group_id="O2" value="5.3" lower_limit="2.9" upper_limit="9.6"/>
                    <measurement group_id="O3" value="3.9" lower_limit="2.2" upper_limit="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-C30 Nausea / Vomiting</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="58"/>
                    <count group_id="O3" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.4" lower_limit="4.7" upper_limit="NA">Upper limit of 95% CI could not be calculated as it was not reached.</measurement>
                    <measurement group_id="O2" value="9.3" lower_limit="3.9" upper_limit="15.5"/>
                    <measurement group_id="O3" value="8.2" lower_limit="5.7" upper_limit="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-C30 Pain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="57"/>
                    <count group_id="O3" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6" lower_limit="4.9" upper_limit="17.3"/>
                    <measurement group_id="O2" value="6.2" lower_limit="5.5" upper_limit="15.1"/>
                    <measurement group_id="O3" value="6.5" lower_limit="4.6" upper_limit="8.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-C30 Appetite Loss</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="57"/>
                    <count group_id="O3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.4" lower_limit="2.6" upper_limit="NA">Upper limit of 95% CI could not be calculated as it was not reached.</measurement>
                    <measurement group_id="O2" value="5.8" lower_limit="3.3" upper_limit="NA">Upper limit of 95% CI could not be calculated as it was not reached.</measurement>
                    <measurement group_id="O3" value="6.9" lower_limit="5.7" upper_limit="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-C30 Constipation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="58"/>
                    <count group_id="O3" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="6.8" upper_limit="NA">Median and upper limit of 95% CI could not be calculated as they were not reached.</measurement>
                    <measurement group_id="O2" value="12.0" lower_limit="5.8" upper_limit="NA">Upper limit of 95% CI could not be calculated as it was not reached.</measurement>
                    <measurement group_id="O3" value="10.9" lower_limit="8.6" upper_limit="NA">Upper limit of 95% CI could not be calculated as it was not reached.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-C30 Diarrhea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="58"/>
                    <count group_id="O3" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.3" lower_limit="9.8" upper_limit="NA">Upper limit of 95% CI could not be calculated as it was not reached.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="13.3" upper_limit="NA">Upper limit of 95% CI could not be calculated as it was not reached.</measurement>
                    <measurement group_id="O3" value="10.1" lower_limit="8.2" upper_limit="NA">Upper limit of 95% CI could not be calculated as it was not reached.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-C30 Dyspnea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="57"/>
                    <count group_id="O3" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.6" lower_limit="6.0" upper_limit="NA">Upper limit of 95% CI could not be calculated as it was not reached.</measurement>
                    <measurement group_id="O2" value="15.5" lower_limit="9.3" upper_limit="NA">Upper limit of 95% CI could not be calculated as it was not reached.</measurement>
                    <measurement group_id="O3" value="7.3" lower_limit="5.7" upper_limit="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-C30 Insomnia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="57"/>
                    <count group_id="O3" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.3" lower_limit="5.2" upper_limit="NA">Upper limit of 95% CI could not be calculated as it was not reached.</measurement>
                    <measurement group_id="O2" value="15.5" lower_limit="5.6" upper_limit="NA">Upper limit of 95% CI could not be calculated as it was not reached.</measurement>
                    <measurement group_id="O3" value="7.8" lower_limit="6.3" upper_limit="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Deterioration of PRO Symptoms, Assessed Using EORTC QLQ-LC13 in the China Cohort</title>
        <description>The EORTC QLQ-LC13 is a disease-specific 13-item self-administered questionnaire for lung cancer, to be used in conjunction with the EORTC QLQ-C30. It comprises both multi-item and single-item measures of lung cancer-associated symptoms (ie, coughing, hemoptysis, dyspnea, and pain) and side effects from conventional chemotherapy and radiotherapy (ie, hair loss, neuropathy, sore mouth, and dysphagia). Scores from 0 to 100 were derived for each symptom item, with higher scores representing greater level of symptoms. Time to deterioration (calculated using the Kaplan-Meier technique) was defined as time from randomization until the date of first clinically meaningful deterioration (an increase in score from baseline of ≥10) that is confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration.</description>
        <time_frame>At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed until China cohort second analysis DCO (maximum of approximately 29 months).</time_frame>
        <population>The China FAS included all randomized patients in the China cohort. For QLQ-L13 symptom scales/items, only patients with baseline scores ≤90 (and with data available) were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>China Cohort: D + T + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.</description>
          </group>
          <group group_id="O2">
            <title>China Cohort: D + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.</description>
          </group>
          <group group_id="O3">
            <title>China Cohort: EP</title>
            <description>For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Deterioration of PRO Symptoms, Assessed Using EORTC QLQ-LC13 in the China Cohort</title>
          <description>The EORTC QLQ-LC13 is a disease-specific 13-item self-administered questionnaire for lung cancer, to be used in conjunction with the EORTC QLQ-C30. It comprises both multi-item and single-item measures of lung cancer-associated symptoms (ie, coughing, hemoptysis, dyspnea, and pain) and side effects from conventional chemotherapy and radiotherapy (ie, hair loss, neuropathy, sore mouth, and dysphagia). Scores from 0 to 100 were derived for each symptom item, with higher scores representing greater level of symptoms. Time to deterioration (calculated using the Kaplan-Meier technique) was defined as time from randomization until the date of first clinically meaningful deterioration (an increase in score from baseline of ≥10) that is confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration.</description>
          <population>The China FAS included all randomized patients in the China cohort. For QLQ-L13 symptom scales/items, only patients with baseline scores ≤90 (and with data available) were included in the analysis.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="61"/>
                <count group_id="O3" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>QLQ-LC13 Coughing</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="58"/>
                    <count group_id="O2" value="56"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="6.8" upper_limit="NA">Median and upper limit of 95% CI could not be calculated as they were not reached.</measurement>
                    <measurement group_id="O2" value="15.5" lower_limit="5.8" upper_limit="NA">Upper limit of 95% CI could not be calculated as it was not reached.</measurement>
                    <measurement group_id="O3" value="8.6" lower_limit="6.8" upper_limit="NA">Upper limit of 95% CI could not be calculated as it was not reached.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-LC13 Dyspnea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="58"/>
                    <count group_id="O3" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.9" lower_limit="3.4" upper_limit="NA">Upper limit of 95% CI could not be calculated as it was not reached.</measurement>
                    <measurement group_id="O2" value="8.1" lower_limit="5.3" upper_limit="15.5"/>
                    <measurement group_id="O3" value="4.7" lower_limit="2.5" upper_limit="8.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-LC13 Hemoptysis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="58"/>
                    <count group_id="O3" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="17.3" upper_limit="NA">Median and upper limit of 95% CI could not be calculated as they were not reached.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="11.2" upper_limit="NA">Median and upper limit of 95% CI could not be calculated as they were not reached.</measurement>
                    <measurement group_id="O3" value="10.1" lower_limit="6.9" upper_limit="NA">Upper limit of 95% CI could not be calculated as it was not reached.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-LC13 Pain in Arm or Shoulder</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="6.9" upper_limit="NA">Median and upper limit of 95% CI could not be calculated as they were not reached.</measurement>
                    <measurement group_id="O2" value="15.5" lower_limit="5.6" upper_limit="NA">Upper limit of 95% CI could not be calculated as it was not reached.</measurement>
                    <measurement group_id="O3" value="8.6" lower_limit="6.3" upper_limit="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-LC13 Pain in Chest</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="6.8" upper_limit="NA">Median and upper limit of 95% CI could not be calculated as they were not reached.</measurement>
                    <measurement group_id="O2" value="15.5" lower_limit="6.8" upper_limit="NA">Upper limit of 95% CI could not be calculated as it was not reached.</measurement>
                    <measurement group_id="O3" value="10.0" lower_limit="6.9" upper_limit="NA">Upper limit of 95% CI could not be calculated as it was not reached.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QLQ-LC13 Pain in Other Parts</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="58"/>
                    <count group_id="O3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="7.0" upper_limit="NA">Median and upper limit of 95% CI could not be calculated as they were not reached.</measurement>
                    <measurement group_id="O2" value="9.3" lower_limit="6.2" upper_limit="NA">Upper limit of 95% CI could not be calculated as it was not reached.</measurement>
                    <measurement group_id="O3" value="8.6" lower_limit="5.7" upper_limit="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Primary PRO Symptoms, Assessed Using EORTC QLQ-C30 and EORTC QLQ-LC13 in the China Cohort; D + T + EP Compared With EP</title>
        <description>A MMRM analysis of EORTC QLQ-C30 and EORTC QLQ-LC13 was performed for 5 primary PRO symptoms (cough, dyspnea, chest pain, fatigue and appetite loss), and considered all data from baseline to PD or 12 months, excluding visits with excessive missing data (defined as &gt;75% missing data). An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items, with higher scores representing greater symptom severity. An improvement in symptoms was indicated by a negative change from baseline. A positive change from baseline indicated a deterioration of symptoms. A minimum clinically meaningful change was defined as an absolute change from baseline of ≥10. This outcome measure presents change from baseline for primary PRO symptoms (reported as adjusted means) for analysis of D + T + EP vs EP. Analysis of D + EP vs EP is presented in a separate outcome measure.</description>
        <time_frame>At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed up to 12 months.</time_frame>
        <population>The China FAS included all randomized patients in the China cohort. For each symptom scale, only patients with data available were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>China Cohort: D + T + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.</description>
          </group>
          <group group_id="O2">
            <title>China Cohort: EP</title>
            <description>For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Primary PRO Symptoms, Assessed Using EORTC QLQ-C30 and EORTC QLQ-LC13 in the China Cohort; D + T + EP Compared With EP</title>
          <description>A MMRM analysis of EORTC QLQ-C30 and EORTC QLQ-LC13 was performed for 5 primary PRO symptoms (cough, dyspnea, chest pain, fatigue and appetite loss), and considered all data from baseline to PD or 12 months, excluding visits with excessive missing data (defined as &gt;75% missing data). An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items, with higher scores representing greater symptom severity. An improvement in symptoms was indicated by a negative change from baseline. A positive change from baseline indicated a deterioration of symptoms. A minimum clinically meaningful change was defined as an absolute change from baseline of ≥10. This outcome measure presents change from baseline for primary PRO symptoms (reported as adjusted means) for analysis of D + T + EP vs EP. Analysis of D + EP vs EP is presented in a separate outcome measure.</description>
          <population>The China FAS included all randomized patients in the China cohort. For each symptom scale, only patients with data available were included in the analysis.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>EORTC QLQ-LC13 Cough</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.8" spread="2.49"/>
                    <measurement group_id="O2" value="-12.9" spread="2.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EORTC QLQ-LC13 Dyspnea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.6" spread="2.21"/>
                    <measurement group_id="O2" value="-0.8" spread="2.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EORTC QLQ-LC13 Chest pain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.1" spread="2.16"/>
                    <measurement group_id="O2" value="-5.4" spread="2.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EORTC QLQ-C30 Fatigue</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" spread="2.10"/>
                    <measurement group_id="O2" value="2.9" spread="2.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EORTC QLQ-C30 Appetite loss</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="2.36"/>
                    <measurement group_id="O2" value="0.8" spread="2.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Primary Symptoms as Assessed by EORTC QLQ in the China Cohort; D + EP Compared With EP</title>
        <description>A MMRM analysis of EORTC QLQ-C30 and EORTC QLQ-LC13 was performed for 5 primary PRO symptoms (cough, dyspnea, chest pain, fatigue and appetite loss), and considered all data from baseline to PD or 12 months, excluding visits with excessive missing data (defined as &gt;75% missing data). An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items, with higher scores representing greater symptom severity. An improvement in symptoms was indicated by a negative change from baseline. A positive change from baseline indicated a deterioration of symptoms. A minimum clinically meaningful change was defined as an absolute change from baseline of ≥10. This outcome measure presents change from baseline for primary PRO symptoms (reported as adjusted means) for analysis of D + EP vs EP. Analysis of D + T + EP vs EP is presented in a separate outcome measure.</description>
        <time_frame>At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed up to 12 months.</time_frame>
        <population>The China FAS included all randomized patients in the China cohort. For each symptom scale, only patients with data available were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>China Cohort: D + EP</title>
            <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.</description>
          </group>
          <group group_id="O2">
            <title>China Cohort: EP</title>
            <description>For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Primary Symptoms as Assessed by EORTC QLQ in the China Cohort; D + EP Compared With EP</title>
          <description>A MMRM analysis of EORTC QLQ-C30 and EORTC QLQ-LC13 was performed for 5 primary PRO symptoms (cough, dyspnea, chest pain, fatigue and appetite loss), and considered all data from baseline to PD or 12 months, excluding visits with excessive missing data (defined as &gt;75% missing data). An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items, with higher scores representing greater symptom severity. An improvement in symptoms was indicated by a negative change from baseline. A positive change from baseline indicated a deterioration of symptoms. A minimum clinically meaningful change was defined as an absolute change from baseline of ≥10. This outcome measure presents change from baseline for primary PRO symptoms (reported as adjusted means) for analysis of D + EP vs EP. Analysis of D + T + EP vs EP is presented in a separate outcome measure.</description>
          <population>The China FAS included all randomized patients in the China cohort. For each symptom scale, only patients with data available were included in the analysis.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>EORTC QLQ-LC13 Cough</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="58"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.9" spread="2.66"/>
                    <measurement group_id="O2" value="-16.7" spread="2.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EORTC QLQ-LC13 Dyspnea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="58"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.2" spread="1.93"/>
                    <measurement group_id="O2" value="-3.0" spread="1.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EORTC QLQ-LC13 Chest pain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="58"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.7" spread="1.93"/>
                    <measurement group_id="O2" value="-7.7" spread="1.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EORTC QLQ-C30 Fatigue</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="58"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="2.06"/>
                    <measurement group_id="O2" value="0.8" spread="2.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EORTC QLQ-C30 Appetite loss</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="58"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" spread="2.47"/>
                    <measurement group_id="O2" value="-2.2" spread="2.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO for each cohort; maximum of approximately 33 months for the Global cohort and maximum of approximately 29 months for the China cohort. Serious AEs and Deaths were collected through LTFU analysis in patients still receiving durvalumab (or within 90 days of discontinuing treatment); up to approximately 4 years.</time_frame>
      <desc>TEAEs included those from first administration of study treatment up to and including 90 days after last dose of study treatment or up to date of initiation of the first subsequent anticancer therapy (whichever occurred first). Data from the global cohort and China cohort safety analysis sets was summarised separately. 6 patients in the China cohort were also included in the global cohort.</desc>
      <group_list>
        <group group_id="E1">
          <title>Global Cohort: D + T + EP</title>
          <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.</description>
        </group>
        <group group_id="E2">
          <title>Global Cohort: D + EP</title>
          <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.</description>
        </group>
        <group group_id="E3">
          <title>Global Cohort: EP</title>
          <description>For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.</description>
        </group>
        <group group_id="E4">
          <title>China Cohort: D + T + EP</title>
          <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.</description>
        </group>
        <group group_id="E5">
          <title>China Cohort: D + EP</title>
          <description>During Chemotherapy:&#xD;
Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).&#xD;
Post-Chemotherapy:&#xD;
Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.</description>
        </group>
        <group group_id="E6">
          <title>China Cohort: EP</title>
          <description>For chemotherapy (EP), patients received etoposide (80-100 mg/m^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="225" subjects_at_risk="266"/>
                <counts group_id="E2" subjects_affected="218" subjects_at_risk="265"/>
                <counts group_id="E3" subjects_affected="247" subjects_at_risk="266"/>
                <counts group_id="E4" subjects_affected="50" subjects_at_risk="65"/>
                <counts group_id="E5" subjects_affected="51" subjects_at_risk="61"/>
                <counts group_id="E6" subjects_affected="55" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="126" subjects_at_risk="266"/>
                <counts group_id="E2" subjects_affected="86" subjects_at_risk="265"/>
                <counts group_id="E3" subjects_affected="97" subjects_at_risk="266"/>
                <counts group_id="E4" subjects_affected="31" subjects_at_risk="65"/>
                <counts group_id="E5" subjects_affected="26" subjects_at_risk="61"/>
                <counts group_id="E6" subjects_affected="22" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="11" subjects_affected="9" subjects_at_risk="266"/>
                <counts group_id="E2" events="8" subjects_affected="5" subjects_at_risk="265"/>
                <counts group_id="E3" events="14" subjects_affected="12" subjects_at_risk="266"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Bone marrow failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="65"/>
                <counts group_id="E5" events="6" subjects_affected="6" subjects_at_risk="61"/>
                <counts group_id="E6" events="11" subjects_affected="7" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="266"/>
                <counts group_id="E2" events="15" subjects_affected="12" subjects_at_risk="265"/>
                <counts group_id="E3" events="13" subjects_affected="12" subjects_at_risk="266"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Granulocytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Haematotoxicity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="266"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="265"/>
                <counts group_id="E3" events="12" subjects_affected="7" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="266"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="265"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="11" subjects_affected="9" subjects_at_risk="266"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="266"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Cardiac dysfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Cardiac failure chronic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Cardiopulmonary failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Left ventricular failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Myocarditis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal insufficiency</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hypoparathyroidism</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hypopituitarism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Inappropriate antidiuretic hormone secretion</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Secondary adrenocortical insufficiency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Angle closure glaucoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Retinopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Vitreous detachment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Acute abdomen</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Food poisoning</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Large intestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Large intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Oesophageal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="266"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="265"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="266"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Condition aggravated</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="266"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Drowning</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Sudden cardiac death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="266"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Drug-induced liver injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hepatic failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hepatitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hepatotoxicity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Immune-mediated hepatitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Contrast media allergy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Anal abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Bacterial prostatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Device related sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hepatitis C</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Infectious pleural effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Kidney infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Lung abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pneumocystis jirovecii pneumonia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="17" subjects_affected="16" subjects_at_risk="266"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="265"/>
                <counts group_id="E3" events="12" subjects_affected="11" subjects_at_risk="266"/>
                <counts group_id="E4" events="9" subjects_affected="9" subjects_at_risk="65"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="61"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Systemic candida</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Urinary tract infection bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Urinary tract infection pseudomonal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Vascular device infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accidental exposure to product</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Craniocerebral injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Lumbar vertebral fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Meniscus injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Radiation pneumonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Body temperature increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Influenza B virus test positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Liver function test increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus inadequate control</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Diabetic ketosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Diabetic metabolic decompensation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Electrolyte imbalance</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="266"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="265"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="266"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Ketoacidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Tumour lysis syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Type 1 diabetes mellitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Osteonecrosis of jaw</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Clear cell renal cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Invasive ductal breast carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Laryngeal cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Metastases to bone</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Non-Hodgkin's lymphoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Rectal cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Small intestine leiomyosarcoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Tumour associated fever</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Altered state of consciousness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Brain oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Cerebral ischaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Cerebrovascular insufficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Myasthenia gravis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Neurotoxicity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Vasogenic cerebral oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Adjustment disorder with depressed mood</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="265"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Azotaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Renal artery thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory distress syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Aspiration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Bronchospasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Choking</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="266"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Chylothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Lung disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="265"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="266"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="265"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="266"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pneumothorax spontaneous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pulmonary artery thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pulmonary haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis allergic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Dermatomyositis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Stevens-Johnson syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic aneurysm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Arterial stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Embolism arterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Peripheral artery thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Phlebitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Superior vena cava occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Superior vena cava syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Vena cava thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="249" subjects_at_risk="266"/>
                <counts group_id="E2" subjects_affected="247" subjects_at_risk="265"/>
                <counts group_id="E3" subjects_affected="248" subjects_at_risk="266"/>
                <counts group_id="E4" subjects_affected="65" subjects_at_risk="65"/>
                <counts group_id="E5" subjects_affected="61" subjects_at_risk="61"/>
                <counts group_id="E6" subjects_affected="61" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="115" subjects_affected="94" subjects_at_risk="266"/>
                <counts group_id="E2" events="110" subjects_affected="97" subjects_at_risk="265"/>
                <counts group_id="E3" events="150" subjects_affected="116" subjects_at_risk="266"/>
                <counts group_id="E4" events="79" subjects_affected="47" subjects_at_risk="65"/>
                <counts group_id="E5" events="58" subjects_affected="44" subjects_at_risk="61"/>
                <counts group_id="E6" events="62" subjects_affected="44" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Bone marrow failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="6" subjects_affected="5" subjects_at_risk="65"/>
                <counts group_id="E5" events="9" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E6" events="12" subjects_affected="4" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="266"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="265"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="266"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="65"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E6" events="4" subjects_affected="4" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="69" subjects_affected="33" subjects_at_risk="266"/>
                <counts group_id="E2" events="87" subjects_affected="40" subjects_at_risk="265"/>
                <counts group_id="E3" events="69" subjects_affected="32" subjects_at_risk="266"/>
                <counts group_id="E4" events="73" subjects_affected="28" subjects_at_risk="65"/>
                <counts group_id="E5" events="65" subjects_affected="31" subjects_at_risk="61"/>
                <counts group_id="E6" events="69" subjects_affected="22" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" events="12" subjects_affected="8" subjects_at_risk="266"/>
                <counts group_id="E2" events="10" subjects_affected="5" subjects_at_risk="265"/>
                <counts group_id="E3" events="13" subjects_affected="8" subjects_at_risk="266"/>
                <counts group_id="E4" events="11" subjects_affected="6" subjects_at_risk="65"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E6" events="3" subjects_affected="2" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="213" subjects_affected="112" subjects_at_risk="266"/>
                <counts group_id="E2" events="221" subjects_affected="110" subjects_at_risk="265"/>
                <counts group_id="E3" events="234" subjects_affected="119" subjects_at_risk="266"/>
                <counts group_id="E4" events="50" subjects_affected="26" subjects_at_risk="65"/>
                <counts group_id="E5" events="40" subjects_affected="22" subjects_at_risk="61"/>
                <counts group_id="E6" events="55" subjects_affected="19" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="68" subjects_affected="50" subjects_at_risk="266"/>
                <counts group_id="E2" events="63" subjects_affected="41" subjects_at_risk="265"/>
                <counts group_id="E3" events="83" subjects_affected="48" subjects_at_risk="266"/>
                <counts group_id="E4" events="28" subjects_affected="15" subjects_at_risk="65"/>
                <counts group_id="E5" events="25" subjects_affected="13" subjects_at_risk="61"/>
                <counts group_id="E6" events="23" subjects_affected="14" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" events="26" subjects_affected="26" subjects_at_risk="266"/>
                <counts group_id="E2" events="28" subjects_affected="26" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="11" subjects_affected="11" subjects_at_risk="65"/>
                <counts group_id="E5" events="8" subjects_affected="7" subjects_at_risk="61"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="33" subjects_affected="28" subjects_at_risk="266"/>
                <counts group_id="E2" events="26" subjects_affected="25" subjects_at_risk="265"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="266"/>
                <counts group_id="E4" events="14" subjects_affected="13" subjects_at_risk="65"/>
                <counts group_id="E5" events="7" subjects_affected="7" subjects_at_risk="61"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="54" subjects_affected="40" subjects_at_risk="266"/>
                <counts group_id="E2" events="37" subjects_affected="27" subjects_at_risk="265"/>
                <counts group_id="E3" events="34" subjects_affected="29" subjects_at_risk="266"/>
                <counts group_id="E4" events="26" subjects_affected="16" subjects_at_risk="65"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="61"/>
                <counts group_id="E6" events="5" subjects_affected="5" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="21" subjects_affected="18" subjects_at_risk="266"/>
                <counts group_id="E2" events="16" subjects_affected="14" subjects_at_risk="265"/>
                <counts group_id="E3" events="8" subjects_affected="7" subjects_at_risk="266"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="65"/>
                <counts group_id="E5" events="9" subjects_affected="7" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="65" subjects_affected="54" subjects_at_risk="266"/>
                <counts group_id="E2" events="53" subjects_affected="43" subjects_at_risk="265"/>
                <counts group_id="E3" events="71" subjects_affected="52" subjects_at_risk="266"/>
                <counts group_id="E4" events="39" subjects_affected="25" subjects_at_risk="65"/>
                <counts group_id="E5" events="29" subjects_affected="24" subjects_at_risk="61"/>
                <counts group_id="E6" events="29" subjects_affected="22" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="266"/>
                <counts group_id="E4" events="6" subjects_affected="4" subjects_at_risk="65"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="126" subjects_affected="85" subjects_at_risk="266"/>
                <counts group_id="E2" events="147" subjects_affected="89" subjects_at_risk="265"/>
                <counts group_id="E3" events="140" subjects_affected="88" subjects_at_risk="266"/>
                <counts group_id="E4" events="72" subjects_affected="31" subjects_at_risk="65"/>
                <counts group_id="E5" events="51" subjects_affected="20" subjects_at_risk="61"/>
                <counts group_id="E6" events="59" subjects_affected="27" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="23" subjects_affected="21" subjects_at_risk="266"/>
                <counts group_id="E2" events="10" subjects_affected="8" subjects_at_risk="265"/>
                <counts group_id="E3" events="9" subjects_affected="8" subjects_at_risk="266"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="44" subjects_affected="36" subjects_at_risk="266"/>
                <counts group_id="E2" events="65" subjects_affected="39" subjects_at_risk="265"/>
                <counts group_id="E3" events="56" subjects_affected="42" subjects_at_risk="266"/>
                <counts group_id="E4" events="62" subjects_affected="30" subjects_at_risk="65"/>
                <counts group_id="E5" events="35" subjects_affected="19" subjects_at_risk="61"/>
                <counts group_id="E6" events="57" subjects_affected="23" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="47" subjects_affected="37" subjects_at_risk="266"/>
                <counts group_id="E2" events="50" subjects_affected="42" subjects_at_risk="265"/>
                <counts group_id="E3" events="50" subjects_affected="39" subjects_at_risk="266"/>
                <counts group_id="E4" events="11" subjects_affected="10" subjects_at_risk="65"/>
                <counts group_id="E5" events="8" subjects_affected="6" subjects_at_risk="61"/>
                <counts group_id="E6" events="7" subjects_affected="7" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="61" subjects_affected="53" subjects_at_risk="266"/>
                <counts group_id="E2" events="61" subjects_affected="48" subjects_at_risk="265"/>
                <counts group_id="E3" events="55" subjects_affected="46" subjects_at_risk="266"/>
                <counts group_id="E4" events="7" subjects_affected="6" subjects_at_risk="65"/>
                <counts group_id="E5" events="7" subjects_affected="7" subjects_at_risk="61"/>
                <counts group_id="E6" events="8" subjects_affected="6" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="266"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="265"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="266"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="65"/>
                <counts group_id="E5" events="7" subjects_affected="6" subjects_at_risk="61"/>
                <counts group_id="E6" events="6" subjects_affected="4" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="14" subjects_affected="10" subjects_at_risk="266"/>
                <counts group_id="E2" events="17" subjects_affected="14" subjects_at_risk="265"/>
                <counts group_id="E3" events="8" subjects_affected="7" subjects_at_risk="266"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="15" subjects_affected="12" subjects_at_risk="266"/>
                <counts group_id="E2" events="19" subjects_affected="16" subjects_at_risk="265"/>
                <counts group_id="E3" events="10" subjects_affected="9" subjects_at_risk="266"/>
                <counts group_id="E4" events="7" subjects_affected="3" subjects_at_risk="65"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="53" subjects_affected="36" subjects_at_risk="266"/>
                <counts group_id="E2" events="24" subjects_affected="22" subjects_at_risk="265"/>
                <counts group_id="E3" events="18" subjects_affected="16" subjects_at_risk="266"/>
                <counts group_id="E4" events="33" subjects_affected="23" subjects_at_risk="65"/>
                <counts group_id="E5" events="9" subjects_affected="6" subjects_at_risk="61"/>
                <counts group_id="E6" events="8" subjects_affected="5" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="266"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="12" subjects_affected="10" subjects_at_risk="65"/>
                <counts group_id="E5" events="8" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E6" events="3" subjects_affected="2" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="266"/>
                <counts group_id="E2" events="13" subjects_affected="10" subjects_at_risk="265"/>
                <counts group_id="E3" events="8" subjects_affected="7" subjects_at_risk="266"/>
                <counts group_id="E4" events="8" subjects_affected="7" subjects_at_risk="65"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="266"/>
                <counts group_id="E2" events="10" subjects_affected="8" subjects_at_risk="265"/>
                <counts group_id="E3" events="13" subjects_affected="13" subjects_at_risk="266"/>
                <counts group_id="E4" events="7" subjects_affected="5" subjects_at_risk="65"/>
                <counts group_id="E5" events="4" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E6" events="5" subjects_affected="5" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="18" subjects_affected="17" subjects_at_risk="266"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="265"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="266"/>
                <counts group_id="E4" events="19" subjects_affected="12" subjects_at_risk="65"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="266"/>
                <counts group_id="E2" events="16" subjects_affected="12" subjects_at_risk="265"/>
                <counts group_id="E3" events="13" subjects_affected="11" subjects_at_risk="266"/>
                <counts group_id="E4" events="5" subjects_affected="4" subjects_at_risk="65"/>
                <counts group_id="E5" events="7" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E6" events="4" subjects_affected="3" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="25" subjects_affected="20" subjects_at_risk="266"/>
                <counts group_id="E2" events="21" subjects_affected="16" subjects_at_risk="265"/>
                <counts group_id="E3" events="15" subjects_affected="12" subjects_at_risk="266"/>
                <counts group_id="E4" events="24" subjects_affected="17" subjects_at_risk="65"/>
                <counts group_id="E5" events="6" subjects_affected="6" subjects_at_risk="61"/>
                <counts group_id="E6" events="10" subjects_affected="6" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="266"/>
                <counts group_id="E2" events="12" subjects_affected="11" subjects_at_risk="265"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="266"/>
                <counts group_id="E4" events="5" subjects_affected="4" subjects_at_risk="65"/>
                <counts group_id="E5" events="8" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="22" subjects_affected="19" subjects_at_risk="266"/>
                <counts group_id="E2" events="21" subjects_affected="16" subjects_at_risk="265"/>
                <counts group_id="E3" events="11" subjects_affected="9" subjects_at_risk="266"/>
                <counts group_id="E4" events="12" subjects_affected="11" subjects_at_risk="65"/>
                <counts group_id="E5" events="13" subjects_affected="11" subjects_at_risk="61"/>
                <counts group_id="E6" events="7" subjects_affected="5" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="266"/>
                <counts group_id="E2" events="17" subjects_affected="13" subjects_at_risk="265"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="266"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E6" events="4" subjects_affected="4" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="266"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="265"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="266"/>
                <counts group_id="E4" events="12" subjects_affected="7" subjects_at_risk="65"/>
                <counts group_id="E5" events="4" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E6" events="6" subjects_affected="3" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="266"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="265"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="266"/>
                <counts group_id="E4" events="9" subjects_affected="6" subjects_at_risk="65"/>
                <counts group_id="E5" events="9" subjects_affected="5" subjects_at_risk="61"/>
                <counts group_id="E6" events="8" subjects_affected="5" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Blood lactate dehydrogenase increased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="266"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="265"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="266"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E5" events="3" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E6" events="10" subjects_affected="5" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Blood urea increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E6" events="8" subjects_affected="4" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Blood urine present</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E6" events="5" subjects_affected="5" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="266"/>
                <counts group_id="E2" events="13" subjects_affected="13" subjects_at_risk="265"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="266"/>
                <counts group_id="E4" events="6" subjects_affected="4" subjects_at_risk="65"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E6" events="4" subjects_affected="4" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="266"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="265"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="266"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="65"/>
                <counts group_id="E5" events="7" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E6" events="8" subjects_affected="3" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="16" subjects_affected="11" subjects_at_risk="266"/>
                <counts group_id="E2" events="42" subjects_affected="26" subjects_at_risk="265"/>
                <counts group_id="E3" events="49" subjects_affected="31" subjects_at_risk="266"/>
                <counts group_id="E4" events="52" subjects_affected="22" subjects_at_risk="65"/>
                <counts group_id="E5" events="44" subjects_affected="28" subjects_at_risk="61"/>
                <counts group_id="E6" events="71" subjects_affected="21" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="266"/>
                <counts group_id="E2" events="20" subjects_affected="16" subjects_at_risk="265"/>
                <counts group_id="E3" events="22" subjects_affected="14" subjects_at_risk="266"/>
                <counts group_id="E4" events="15" subjects_affected="10" subjects_at_risk="65"/>
                <counts group_id="E5" events="11" subjects_affected="10" subjects_at_risk="61"/>
                <counts group_id="E6" events="17" subjects_affected="11" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="20" subjects_affected="19" subjects_at_risk="266"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="265"/>
                <counts group_id="E3" events="10" subjects_affected="9" subjects_at_risk="266"/>
                <counts group_id="E4" events="8" subjects_affected="7" subjects_at_risk="65"/>
                <counts group_id="E5" events="12" subjects_affected="10" subjects_at_risk="61"/>
                <counts group_id="E6" events="6" subjects_affected="5" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="11" subjects_affected="9" subjects_at_risk="266"/>
                <counts group_id="E2" events="21" subjects_affected="14" subjects_at_risk="265"/>
                <counts group_id="E3" events="22" subjects_affected="17" subjects_at_risk="266"/>
                <counts group_id="E4" events="34" subjects_affected="16" subjects_at_risk="65"/>
                <counts group_id="E5" events="27" subjects_affected="17" subjects_at_risk="61"/>
                <counts group_id="E6" events="54" subjects_affected="24" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="64" subjects_affected="57" subjects_at_risk="266"/>
                <counts group_id="E2" events="60" subjects_affected="48" subjects_at_risk="265"/>
                <counts group_id="E3" events="54" subjects_affected="46" subjects_at_risk="266"/>
                <counts group_id="E4" events="40" subjects_affected="27" subjects_at_risk="65"/>
                <counts group_id="E5" events="46" subjects_affected="27" subjects_at_risk="61"/>
                <counts group_id="E6" events="54" subjects_affected="27" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="5" subjects_at_risk="266"/>
                <counts group_id="E2" events="14" subjects_affected="10" subjects_at_risk="265"/>
                <counts group_id="E3" events="11" subjects_affected="9" subjects_at_risk="266"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="5" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E6" events="5" subjects_affected="3" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="5" subjects_at_risk="266"/>
                <counts group_id="E2" events="10" subjects_affected="5" subjects_at_risk="265"/>
                <counts group_id="E3" events="9" subjects_affected="7" subjects_at_risk="266"/>
                <counts group_id="E4" events="5" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E5" events="5" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="266"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="6" subjects_affected="4" subjects_at_risk="65"/>
                <counts group_id="E5" events="10" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E6" events="14" subjects_affected="6" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" events="14" subjects_affected="9" subjects_at_risk="266"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="265"/>
                <counts group_id="E3" events="8" subjects_affected="5" subjects_at_risk="266"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="65"/>
                <counts group_id="E5" events="4" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E6" events="6" subjects_affected="4" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="266"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="265"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="266"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E6" events="6" subjects_affected="4" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hypochloraemia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="266"/>
                <counts group_id="E4" events="9" subjects_affected="5" subjects_at_risk="65"/>
                <counts group_id="E5" events="6" subjects_affected="5" subjects_at_risk="61"/>
                <counts group_id="E6" events="6" subjects_affected="3" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="22" subjects_affected="19" subjects_at_risk="266"/>
                <counts group_id="E2" events="21" subjects_affected="17" subjects_at_risk="265"/>
                <counts group_id="E3" events="13" subjects_affected="11" subjects_at_risk="266"/>
                <counts group_id="E4" events="18" subjects_affected="9" subjects_at_risk="65"/>
                <counts group_id="E5" events="12" subjects_affected="9" subjects_at_risk="61"/>
                <counts group_id="E6" events="18" subjects_affected="12" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" events="18" subjects_affected="15" subjects_at_risk="266"/>
                <counts group_id="E2" events="20" subjects_affected="18" subjects_at_risk="265"/>
                <counts group_id="E3" events="14" subjects_affected="13" subjects_at_risk="266"/>
                <counts group_id="E4" events="5" subjects_affected="4" subjects_at_risk="65"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E6" events="4" subjects_affected="2" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="28" subjects_affected="20" subjects_at_risk="266"/>
                <counts group_id="E2" events="34" subjects_affected="26" subjects_at_risk="265"/>
                <counts group_id="E3" events="11" subjects_affected="9" subjects_at_risk="266"/>
                <counts group_id="E4" events="28" subjects_affected="18" subjects_at_risk="65"/>
                <counts group_id="E5" events="13" subjects_affected="10" subjects_at_risk="61"/>
                <counts group_id="E6" events="20" subjects_affected="16" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hypoproteinaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="266"/>
                <counts group_id="E4" events="5" subjects_affected="3" subjects_at_risk="65"/>
                <counts group_id="E5" events="6" subjects_affected="5" subjects_at_risk="61"/>
                <counts group_id="E6" events="9" subjects_affected="5" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="33" subjects_affected="30" subjects_at_risk="266"/>
                <counts group_id="E2" events="32" subjects_affected="24" subjects_at_risk="265"/>
                <counts group_id="E3" events="24" subjects_affected="18" subjects_at_risk="266"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="65"/>
                <counts group_id="E5" events="4" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E6" events="6" subjects_affected="5" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="15" subjects_affected="14" subjects_at_risk="266"/>
                <counts group_id="E2" events="11" subjects_affected="10" subjects_at_risk="265"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="266"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="266"/>
                <counts group_id="E2" events="16" subjects_affected="12" subjects_at_risk="265"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="266"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="20" subjects_affected="15" subjects_at_risk="266"/>
                <counts group_id="E2" events="27" subjects_affected="23" subjects_at_risk="265"/>
                <counts group_id="E3" events="13" subjects_affected="12" subjects_at_risk="266"/>
                <counts group_id="E4" events="7" subjects_affected="6" subjects_at_risk="65"/>
                <counts group_id="E5" events="8" subjects_affected="6" subjects_at_risk="61"/>
                <counts group_id="E6" events="7" subjects_affected="5" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="31" subjects_affected="29" subjects_at_risk="266"/>
                <counts group_id="E2" events="19" subjects_affected="17" subjects_at_risk="265"/>
                <counts group_id="E3" events="25" subjects_affected="22" subjects_at_risk="266"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="65"/>
                <counts group_id="E5" events="6" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E6" events="3" subjects_affected="2" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="17" subjects_affected="17" subjects_at_risk="266"/>
                <counts group_id="E2" events="19" subjects_affected="18" subjects_at_risk="265"/>
                <counts group_id="E3" events="15" subjects_affected="13" subjects_at_risk="266"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="27" subjects_affected="25" subjects_at_risk="266"/>
                <counts group_id="E2" events="28" subjects_affected="23" subjects_at_risk="265"/>
                <counts group_id="E3" events="14" subjects_affected="13" subjects_at_risk="266"/>
                <counts group_id="E4" events="8" subjects_affected="6" subjects_at_risk="65"/>
                <counts group_id="E5" events="8" subjects_affected="6" subjects_at_risk="61"/>
                <counts group_id="E6" events="13" subjects_affected="8" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" events="8" subjects_affected="3" subjects_at_risk="266"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E3" events="5" subjects_affected="3" subjects_at_risk="266"/>
                <counts group_id="E4" events="22" subjects_affected="14" subjects_at_risk="65"/>
                <counts group_id="E5" events="14" subjects_affected="9" subjects_at_risk="61"/>
                <counts group_id="E6" events="14" subjects_affected="10" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="32" subjects_affected="28" subjects_at_risk="266"/>
                <counts group_id="E2" events="36" subjects_affected="35" subjects_at_risk="265"/>
                <counts group_id="E3" events="20" subjects_affected="19" subjects_at_risk="266"/>
                <counts group_id="E4" events="13" subjects_affected="11" subjects_at_risk="65"/>
                <counts group_id="E5" events="8" subjects_affected="8" subjects_at_risk="61"/>
                <counts group_id="E6" events="5" subjects_affected="5" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="31" subjects_affected="24" subjects_at_risk="266"/>
                <counts group_id="E2" events="36" subjects_affected="32" subjects_at_risk="265"/>
                <counts group_id="E3" events="30" subjects_affected="27" subjects_at_risk="266"/>
                <counts group_id="E4" events="5" subjects_affected="3" subjects_at_risk="65"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E6" events="5" subjects_affected="4" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="21" subjects_affected="18" subjects_at_risk="266"/>
                <counts group_id="E2" events="13" subjects_affected="12" subjects_at_risk="265"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="266"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E5" events="7" subjects_affected="7" subjects_at_risk="61"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" events="18" subjects_affected="10" subjects_at_risk="266"/>
                <counts group_id="E2" events="16" subjects_affected="10" subjects_at_risk="265"/>
                <counts group_id="E3" events="20" subjects_affected="9" subjects_at_risk="266"/>
                <counts group_id="E4" events="6" subjects_affected="5" subjects_at_risk="65"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="266"/>
                <counts group_id="E2" events="11" subjects_affected="10" subjects_at_risk="265"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="266"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="65"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="266"/>
                <counts group_id="E2" events="11" subjects_affected="10" subjects_at_risk="265"/>
                <counts group_id="E3" events="8" subjects_affected="7" subjects_at_risk="266"/>
                <counts group_id="E4" events="11" subjects_affected="9" subjects_at_risk="65"/>
                <counts group_id="E5" events="7" subjects_affected="6" subjects_at_risk="61"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="80" subjects_affected="79" subjects_at_risk="266"/>
                <counts group_id="E2" events="84" subjects_affected="84" subjects_at_risk="265"/>
                <counts group_id="E3" events="94" subjects_affected="92" subjects_at_risk="266"/>
                <counts group_id="E4" events="29" subjects_affected="28" subjects_at_risk="65"/>
                <counts group_id="E5" events="29" subjects_affected="29" subjects_at_risk="61"/>
                <counts group_id="E6" events="27" subjects_affected="27" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="52" subjects_affected="40" subjects_at_risk="266"/>
                <counts group_id="E2" events="33" subjects_affected="21" subjects_at_risk="265"/>
                <counts group_id="E3" events="10" subjects_affected="10" subjects_at_risk="266"/>
                <counts group_id="E4" events="14" subjects_affected="4" subjects_at_risk="65"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="52" subjects_affected="37" subjects_at_risk="266"/>
                <counts group_id="E2" events="20" subjects_affected="16" subjects_at_risk="265"/>
                <counts group_id="E3" events="10" subjects_affected="10" subjects_at_risk="266"/>
                <counts group_id="E4" events="37" subjects_affected="25" subjects_at_risk="65"/>
                <counts group_id="E5" events="16" subjects_affected="12" subjects_at_risk="61"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="15" subjects_affected="13" subjects_at_risk="266"/>
                <counts group_id="E2" events="25" subjects_affected="16" subjects_at_risk="265"/>
                <counts group_id="E3" events="8" subjects_affected="7" subjects_at_risk="266"/>
                <counts group_id="E4" events="13" subjects_affected="6" subjects_at_risk="65"/>
                <counts group_id="E5" events="12" subjects_affected="7" subjects_at_risk="61"/>
                <counts group_id="E6" events="8" subjects_affected="3" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Analysis of the China cohort was performed to evaluate the consistency of efficacy and safety in Chinese patients with the global cohort in order to meet regulatory requirements and was not powered for a formal assessment of statistical significance.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Global Clinical Lead</name_or_title>
      <organization>AstraZeneca</organization>
      <phone>1-877-240-9479</phone>
      <email>information.center@astrazeneca.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03043872
org study id: D419QC00001
secondary id: 2016-001203-23
nct id: NCT03043872
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a phase III, randomized, open-label, multicenter, global study to determine the
      efficacy and safety of combining durvalumab ± tremelimumab with platinum based chemotherapy
      (EP) followed by durvalumab ± tremelimumab maintenance therapy versus EP alone as first-line
      treatment in patients with extensive-stage small-cell lung cancer
Primary objective of this study is to assess the efficacy of durvalumab + tremelimumab + EP
      treatment compared with EP and the efficacy of durvalumab + EP treatment compared with EP in
      terms of OS.

      All patients will be randomized in a 1:1:1 ratio in a stratified manner according to the
      planned platinum-based therapy for Cycle 1 (cisplatin or carboplatin) to receive treatment
      with durvalumab + tremelimumab + EP (Arm 1), durvalumab + EP (Arm 2), or standard of care- EP
      (Arm 3). Arm 1 and Arm 2 patients receive the treatment until confirmed disease progression
      while Arm 3 patients receive up to 6 cycles of EP and prophylactic cranial irradiation if
      clinically indicated, at the Investigators' discretion.Patients who have discontinued
      treatment due to toxicity or symptomatic deterioration, clinical progression, or who have
      commenced subsequent anticancer therapy will be followed up until confirmed disease
      progression and for survival.

      Targeted population are adult patients (aged ≥18 years) with histologically or cytologically
      documented extensive disease (American Joint Committee on Cancer Stage (7th edition) IV SCLC
      [T any, N any,M1 a/b]), or T3-4 due to multiple lung nodules that are too extensive or have
      tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan.
      Patients must have WHO/ECOG performance status of 0 or 1.

      Tumor assessments will be performed at Screening as baseline with follow-up at Week 6 ±1 week
      from the date of randomization, at Week 12 ±1 week from the date of randomization, and then
      every 8 weeks ±1 week until confirmed objective disease progression.

      An independent data monitoring committee (IDMC) comprised of independent experts will be
      convened to confirm the safety and tolerability of the proposed dose and schedule of
      durvalumab ± tremelimumab in combination with platinum based chemotherapy at two early stages
      of enrolment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Survival (OS) in the Global Cohort; Assessed at Global Cohort Interim Analysis; D + EP Compared With EP
time frame: From baseline until death due to any cause. Assessed until global cohort interim analysis DCO (maximum of approximately 23 months).
description: OS was defined as the time from date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. An interim analysis of OS in the global cohort was pre-specified after approximately 318 OS events occurred each between the D + EP and EP groups (60% maturity), and between the D + T + EP and EP groups (60% maturity). At the global cohort interim analysis DCO (11 March 2019), comparison of OS in the D + EP versus (vs) EP groups had crossed the pre-specified boundary. Since these results were considered final in terms of formal statistical testing, they are presented here as a primary outcome measure. Analysis of OS for D + EP vs EP and for D + T + EP vs EP at the time of the global cohort final analysis is presented separately in the subsequent primary outcome measure.
measure: OS in the Global Cohort; Assessed at Global Cohort Final Analysis; D + EP Compared With EP and D + T + EP Compared With EP
time frame: From baseline until death due to any cause. Assessed until global cohort final analysis DCO (maximum of approximately 33 months).
description: OS was defined as the time from date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. This primary outcome measure presents OS for the analysis of D + EP vs EP and D + T + EP vs EP at the time of the global cohort final analysis DCO (27 January 2020). Analysis of D + EP vs EP at the global cohort interim analysis DCO is presented in the previous primary outcome measure. Analysis of D + T + EP vs D + EP (global cohort final analysis) is presented as a secondary outcome measure.
measure: OS in the China Cohort; Assessed at China Cohort First Analysis; D + EP Compared With EP
time frame: From baseline until death due to any cause. Assessed until China cohort first analysis DCO (maximum of approximately 19 months).
description: OS was defined as the time from date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. An analysis of OS for D + EP vs EP in the China cohort was pre-specified at approximately 60% maturity (to ensure a similar maturity to the interim analysis of the Global cohort). This primary outcome measure presents OS for analysis of D + EP vs EP at the China cohort first analysis DCO (06 January 2020), and is comparable in terms of maturity with the interim analysis of OS for D + EP vs EP in the Global cohort. Analysis of OS for D + EP vs EP and for D + T + EP vs EP at the time of the China cohort second analysis is presented separately in the subsequent primary outcome measure.
measure: OS in the China Cohort; Assessed at China Cohort Second Analysis; D + EP Compared With EP and D + T + EP Compared With EP
time frame: From baseline until death due to any cause. Assessed until China cohort second analysis DCO (maximum of approximately 29 months).
description: OS was defined as the time from date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. An analysis of OS for D + T + EP vs EP in the China cohort was pre-specified at approximately 80% maturity (to ensure a similar maturity to the final analysis of the Global cohort). This primary outcome measure presents OS for analysis of D + EP vs EP and D + T + EP vs EP at the time of the China cohort second analysis DCO (02 November 2020), and is comparable in terms of maturity with the final analysis of OS for D + EP vs EP and D + T + EP vs EP in the Global cohort. Analysis of D + EP vs EP at the China cohort first analysis DCO is presented in the previous primary outcome measure. Analysis of D + T + EP vs D + EP (China cohort second analysis) is presented as a secondary outcome measure.
measure: OS in the Global Cohort; D + T + EP Compared With D + EP
time frame: From baseline until death due to any cause. Assessed until global cohort final analysis DCO (maximum of approximately 33 months).
description: OS was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. This secondary outcome measure presents OS for the analysis of D + T + EP vs D + EP in the global cohort. The alternative treatment comparisons in the global cohort were performed as primary outcome measures.
measure: Progression-Free Survival (PFS) in the Global Cohort
time frame: Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until global cohort final analysis DCO (maximum of approximately 33 months).
description: PFS (per Response Evaluation Criteria in Solid Tumors, version 1.1 [RECIST 1.1] using Investigator assessments) was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Progression (ie, PD) was defined as at least a 20% increase in the sum of diameters of target lesions (TLs), taking as reference the smallest previous sum of diameters (nadir) and an absolute increase of ≥5 millimeters (mm) for the sum from nadir. For evaluation of non-target lesions (NTLs), PD was defined as unequivocal progression of existing NTLs. Median PFS was calculated using the Kaplan-Meier technique.
measure: Objective Response Rate (ORR) in the Global Cohort
time frame: Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until global cohort final analysis DCO (maximum of approximately 33 months).
description: ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of patients with at least 1 visit response of Complete Response (CR) or Partial Response (PR). CR was defined as disappearance of all TLs since baseline (any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to <10 mm) or disappearance of all NTLs since baseline (all lymph nodes must be non-pathological in size [<10 mm short axis]). PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters).
measure: Percentage of Patients Alive and Progression Free at 6 Months (APF6) in the Global Cohort
time frame: Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until 6 months post-randomization.
description: The APF6 was defined as the percentage of patients who were alive and progression free at 6 months from randomization (ie, PFS rate at 6 months). PFS was calculated using the Kaplan-Meier technique.
measure: Percentage of Patients Alive and Progression Free at 12 Months (APF12) in the Global Cohort
time frame: Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until 12 months post-randomization.
description: The APF12 was defined as the percentage of patients who were alive and progression free at 12 months from randomization (ie, PFS rate at 12 months). PFS was calculated using the Kaplan-Meier technique.
measure: Percentage of Patients Alive at 18 Months (OS18) in the Global Cohort
time frame: At 18 months post-randomization. Assessed at the global cohort final analysis DCO (27 January 2020).
description: OS18 was defined as the percentage of patients who were alive at 18 months after randomization per the Kaplan-Meier estimate of OS at 18 months.
measure: Pharmacokinetics (PK) of Durvalumab; Peak and Trough Serum Concentrations in the Global Cohort
time frame: Samples were collected post-dose on Day 1 (Week 0), and pre-dose on Weeks 3 and 12. Assessed at the global cohort final analysis DCO (27 January 2020).
description: To evaluate PK, blood samples were collected at pre-specified timepoints and peak and trough serum concentrations of durvalumab were determined. Peak concentration on Week 0 is the post-infusion concentration of Week 0 (collected within 10 minutes of the end of infusion). Trough concentrations on Weeks 3 and 12 are the pre-infusion concentrations of Weeks 3 and 12, respectively.
measure: PK of Tremelimumab; Peak and Trough Serum Concentrations in the Global Cohort
time frame: Samples were collected post-dose on Day 1 (Week 0), and pre-dose on Weeks 3 and 12. Assessed at the global cohort final analysis DCO (27 January 2020).
description: To evaluate PK, blood samples were collected at pre-specified timepoints and peak and trough serum concentrations of tremelimumab were determined. Peak concentration on Week 0 is the post-infusion concentration of Week 0 (collected within 10 minutes of the end of infusion). Trough concentrations on Weeks 3 and 12 are the pre-infusion concentrations of Weeks 3 and 12, respectively.
measure: Number of Patients With Anti-Drug Antibody (ADA) Response to Durvalumab in the Global Cohort
time frame: Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of IP (ie, durvalumab). Assessed at the global cohort final analysis DCO (27 January 2020).
description: Serum sampling for ADA assessment was conducted utilizing a tiered approach (screen, confirm, titer). ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA was defined as the sum of treatment-induced ADA and treatment-boosted ADA (defined as baseline positive ADA titer that was boosted to ≥4-fold during the study period). Persistently positive was defined as having ≥2 post-baseline ADA positive measurements with ≥16 weeks between first and last positive, or an ADA positive result at the last available assessment. Transiently positive was defined as having ≥1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. Presence of neutralizing antibody (nAb) was tested for all ADA positive samples. Results are reported as number of patients with ADA responses to durvalumab for each indicated category.
measure: Number of Patients With ADA Response to Tremelimumab in the Global Cohort
time frame: Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of IP (ie, tremelimumab). Assessed at the global cohort final analysis DCO (27 January 2020).
description: Serum sampling for ADA assessment was conducted utilizing a tiered approach (screen, confirm, titer). ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA (or ADA incidence) was defined as the sum of treatment-induced ADA and treatment-boosted ADA (defined as baseline positive ADA titer that was boosted to ≥4-fold during the study period). Persistently positive was defined as having ≥2 post-baseline ADA positive measurements with ≥16 weeks between first and last positive, or an ADA positive result at the last available assessment. Transiently positive was defined as having ≥1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. The presence of nAb was tested for all ADA positive samples. Results are reported as number of patients with ADA responses to tremelimumab for each indicated category.
measure: Time to Deterioration of Health-Related Quality of Life (HRQoL) and Patient Reported Outcome (PRO) Symptoms, Assessed Using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) in the Global Cohort
time frame: At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed until global cohort final analysis DCO (maximum of approximately 33 months).
description: The EORTC QLQ-Core 30 version 3 (QLQ-C30 v3) was included for assessing HRQoL. It assesses HRQoL/health status through 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), and a global health and QoL scale. 6 single-item symptom measures are also included: dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. Scores from 0 to 100 were derived for each of the 15 domains, with higher scores representing greater functioning, greater HRQoL, or greater level of symptoms. Time to deterioration (calculated using the Kaplan-Meier technique) was defined as time from randomization until the date of first clinically meaningful deterioration (a decrease in score from baseline of ≥10) that is confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration.
measure: Time to Deterioration of PRO Symptoms, Assessed Using EORTC QLQ-Lung Cancer Module 13 (QLQ-LC13) in the Global Cohort
time frame: At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed until global cohort final analysis DCO (maximum of approximately 33 months).
description: The EORTC QLQ-LC13 is a disease-specific 13-item self-administered questionnaire for lung cancer, to be used in conjunction with the EORTC QLQ-C30. It comprises both multi-item and single-item measures of lung cancer-associated symptoms (ie, coughing, hemoptysis, dyspnea, and pain) and side effects from conventional chemotherapy and radiotherapy (ie, hair loss, neuropathy, sore mouth, and dysphagia). Scores from 0 to 100 were derived for each symptom item, with higher scores representing greater level of symptoms. Time to deterioration (calculated using the Kaplan-Meier technique) was defined as time from randomization until the date of first clinically meaningful deterioration (an increase in score from baseline of ≥10) that is confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration.
measure: Change From Baseline in Primary PRO Symptoms as Assessed by EORTC QLQ in the Global Cohort; D + T + EP Compared With EP
time frame: At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed up to 12 months.
description: A mixed model repeated measures (MMRM) analysis of EORTC QLQ-C30 and EORTC QLQ-LC13 was performed for 5 primary PRO symptoms (cough, dyspnea, chest pain, fatigue and appetite loss), and considered all data from baseline to PD or 12 months, excluding visits with excessive missing data (defined as >75% missing data). An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items, with higher scores representing greater symptom severity. An improvement in symptoms was indicated by a negative change from baseline. A positive change from baseline indicated a deterioration of symptoms. A minimum clinically meaningful change was defined as an absolute change from baseline of ≥10. This outcome measure presents change from baseline for primary PRO symptoms (reported as adjusted means) for analysis of D + T + EP vs P. Analysis of D + EP vs EP is presented in a separate outcome measure.
measure: Change From Baseline in Primary Symptoms, Assessed Using EORTC QLQ-C30 and EORTC QLQ-LC13 in the Global Cohort; D + EP Compared With EP
time frame: At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed up to 12 months.
description: A MMRM analysis of EORTC QLQ-C30 and EORTC QLQ-LC13 was performed for 5 primary PRO symptoms (cough, dyspnea, chest pain, fatigue and appetite loss), and considered all data from baseline to PD or 12 months, excluding visits with excessive missing data (defined as >75% missing data). An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items, with higher scores representing greater symptom severity. An improvement in symptoms was indicated by a negative change from baseline. A positive change from baseline indicated a deterioration of symptoms. A minimum clinically meaningful change was defined as an absolute change from baseline of ≥10. This outcome measure presents change from baseline for primary PRO symptoms (reported as adjusted means) for analysis of D + EP vs EP. Analysis of D + T + EP vs EP is presented in a separate outcome measure.
measure: OS in the China Cohort; D + T + EP Compared With D + EP
time frame: From baseline until death due to any cause. Assessed until China cohort second analysis DCO (maximum of approximately 29 months).
description: OS was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. This secondary outcome measure presents OS for the analysis of D + T + EP vs D + EP at the China cohort second analysis DCO (02 November 2020). The alternative treatment comparisons were performed as primary outcome measures.
measure: PFS in the China Cohort
time frame: Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until China cohort second analysis DCO (maximum of approximately 29 months).
description: PFS (per RECIST 1.1 using Investigator assessments) was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Progression (ie, PD) was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir) and an absolute increase of ≥5 mm for the sum from nadir. For evaluation of NTLs, PD was defined as unequivocal progression of existing NTLs. Median PFS was calculated using the Kaplan-Meier technique.
measure: ORR in the China Cohort
time frame: Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until China cohort second analysis DCO (maximum of approximately 29 months).
description: ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of patients with at least 1 visit response of CR or PR. CR was defined as disappearance of all TLs since baseline (any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to <10 mm) or disappearance of all NTLs since baseline (all lymph nodes must be non-pathological in size [<10 mm short axis]). PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters).
measure: APF6 in the China Cohort
time frame: Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until 6 months post-randomization.
description: The APF6 was defined as the percentage of patients who were alive and progression free at 6 months from randomization (ie, PFS rate at 6 months). PFS was calculated using the Kaplan-Meier technique.
measure: APF12 in the China Cohort
time frame: Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until 12 months post-randomization.
description: The APF12 was defined as the percentage of patients who were alive and progression free at 12 months from randomization (ie, PFS rate at 12 months). PFS was calculated using the Kaplan-Meier technique.
measure: OS18 in the China Cohort
time frame: At 18 months post-randomization. Assessed at the China cohort second analysis DCO (02 November 2020).
description: OS18 was defined as the percentage of patients who were alive at 18 months after randomization per the Kaplan-Meier estimate of OS at 18 months.
measure: PK of Durvalumab; Peak and Trough Serum Concentrations in the China Cohort
time frame: Samples were collected post-dose on Day 1 (Week 0), and pre-dose on Weeks 3 and 12. Assessed at the China cohort second analysis DCO (02 November 2020).
description: To evaluate PK, blood samples were collected at pre-specified timepoints and peak and trough serum concentrations of durvalumab were determined. Peak concentration on Week 0 is the post-infusion concentration of Week 0 (collected within 10 minutes of the end of infusion). Trough concentrations on Weeks 3 and 12 are the pre-infusion concentrations of Weeks 3 and 12, respectively.
measure: PK of Tremelimumab; Peak and Trough Serum Concentrations in the China Cohort
time frame: Samples were collected post-dose on Day 1 (Week 0), and pre-dose on Weeks 3 and 12. Assessed at the China cohort second analysis DCO (02 November 2020).
description: To evaluate PK, blood samples were collected at pre-specified timepoints and peak and trough serum concentrations of tremelimumab were determined. Peak concentration on Week 0 is the post-infusion concentration of Week 0 (collected within 10 minutes of the end of infusion). Trough concentrations on Weeks 3 and 12 are the pre-infusion concentrations of Weeks 3 and 12, respectively.
measure: Number of Patients With ADA Response to Durvalumab in the China Cohort
time frame: Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of IP (ie, durvalumab). Assessed at the China cohort second analysis DCO (02 November 2020).
description: Serum sampling for ADA assessment was conducted utilizing a tiered approach (screen, confirm, titer). ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA was defined as the sum of treatment-induced ADA and treatment-boosted ADA (defined as baseline positive ADA titer that was boosted to ≥4-fold during the study period). Persistently positive was defined as having ≥2 post-baseline ADA positive measurements with ≥16 weeks between first and last positive, or an ADA positive result at the last available assessment. Transiently positive was defined as having ≥1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. Presence of nAb was tested for all ADA positive samples. Results are reported as number of patients with ADA responses to durvalumab for each indicated category.
measure: Number of Patients With ADA Response to Tremelimumab in the China Cohort
time frame: Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of IP (ie, tremelimumab). Assessed at the China cohort second analysis DCO (02 November 2020).
description: Serum sampling for ADA assessment was conducted utilizing a tiered approach (screen, confirm, titer). ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA (or ADA incidence) was defined as the sum of treatment-induced ADA and treatment-boosted ADA (defined as baseline positive ADA titer that was boosted to ≥4-fold during the study period). Persistently positive was defined as having ≥2 post-baseline ADA positive measurements with ≥16 weeks between first and last positive, or an ADA positive result at the last available assessment. Transiently positive was defined as having ≥1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. The presence of nAb was tested for all ADA positive samples. Results are reported as number of patients with ADA responses to tremelimumab for each indicated category.
measure: Time to Deterioration of HRQoL and PRO Symptoms, Assessed Using EORTC QLQ in the China Cohort
time frame: At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed until China cohort second analysis DCO (maximum of approximately 29 months).
description: The EORTC QLQ-C30 v3 was included for assessing HRQoL. It assesses HRQoL/health status through 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), and a global health and QoL scale. 6 single-item symptom measures are also included: dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. Scores from 0 to 100 were derived for each of the 15 domains, with higher scores representing greater functioning, greater HRQoL, or greater level of symptoms. Time to deterioration (calculated using the Kaplan-Meier technique) was defined as time from randomization until the date of first clinically meaningful deterioration (a decrease in score from baseline of ≥10) that is confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration.
measure: Time to Deterioration of PRO Symptoms, Assessed Using EORTC QLQ-LC13 in the China Cohort
time frame: At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed until China cohort second analysis DCO (maximum of approximately 29 months).
description: The EORTC QLQ-LC13 is a disease-specific 13-item self-administered questionnaire for lung cancer, to be used in conjunction with the EORTC QLQ-C30. It comprises both multi-item and single-item measures of lung cancer-associated symptoms (ie, coughing, hemoptysis, dyspnea, and pain) and side effects from conventional chemotherapy and radiotherapy (ie, hair loss, neuropathy, sore mouth, and dysphagia). Scores from 0 to 100 were derived for each symptom item, with higher scores representing greater level of symptoms. Time to deterioration (calculated using the Kaplan-Meier technique) was defined as time from randomization until the date of first clinically meaningful deterioration (an increase in score from baseline of ≥10) that is confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration.
measure: Change From Baseline in Primary PRO Symptoms, Assessed Using EORTC QLQ-C30 and EORTC QLQ-LC13 in the China Cohort; D + T + EP Compared With EP
time frame: At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed up to 12 months.
description: A MMRM analysis of EORTC QLQ-C30 and EORTC QLQ-LC13 was performed for 5 primary PRO symptoms (cough, dyspnea, chest pain, fatigue and appetite loss), and considered all data from baseline to PD or 12 months, excluding visits with excessive missing data (defined as >75% missing data). An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items, with higher scores representing greater symptom severity. An improvement in symptoms was indicated by a negative change from baseline. A positive change from baseline indicated a deterioration of symptoms. A minimum clinically meaningful change was defined as an absolute change from baseline of ≥10. This outcome measure presents change from baseline for primary PRO symptoms (reported as adjusted means) for analysis of D + T + EP vs EP. Analysis of D + EP vs EP is presented in a separate outcome measure.
measure: Change From Baseline in Primary Symptoms as Assessed by EORTC QLQ in the China Cohort; D + EP Compared With EP
time frame: At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed up to 12 months.
description: A MMRM analysis of EORTC QLQ-C30 and EORTC QLQ-LC13 was performed for 5 primary PRO symptoms (cough, dyspnea, chest pain, fatigue and appetite loss), and considered all data from baseline to PD or 12 months, excluding visits with excessive missing data (defined as >75% missing data). An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items, with higher scores representing greater symptom severity. An improvement in symptoms was indicated by a negative change from baseline. A positive change from baseline indicated a deterioration of symptoms. A minimum clinically meaningful change was defined as an absolute change from baseline of ≥10. This outcome measure presents change from baseline for primary PRO symptoms (reported as adjusted means) for analysis of D + EP vs EP. Analysis of D + T + EP vs EP is presented in a separate outcome measure.
arm group label: Arm 1
arm group type: Experimental
description: durvalumab+tremelimumab+EP (carboplatin or cisplatin + etoposide)
arm group label: Arm 2
arm group type: Experimental
description: durvalumab+EP (carboplatin or cisplatin + etoposide)
arm group label: Arm 3
arm group type: Active Comparator
description: EP (carboplatin or cisplatin + etoposide)
intervention type: Drug
intervention name: Durvalumab
description: IV infusions every 3 weeks for 12 weeks (4 cycles) and every 4 weeks thereafter until PD or other discontinuation criteria.
arm group label: Arm 1
arm group label: Arm 2
intervention type: Drug
intervention name: Tremelimumab
description: IV infusions every 3 weeks for 12 weeks(4 cycles). An additional dose of tremelimumab will be administered in the week 16.
arm group label: Arm 1
intervention type: Drug
intervention name: Carboplatin
description: up to 4 cycles every 3 weeks in Arm 1 and 2, up to 6 cycles every 3 weeks in Arm 3
arm group label: Arm 1
arm group label: Arm 2
arm group label: Arm 3
intervention type: Drug
intervention name: Cisplatin
description: up to 4 cycles every 3 weeks in Arm 1 and 2, up to 6 cycles every 3 weeks in Arm 3
arm group label: Arm 1
arm group label: Arm 2
arm group label: Arm 3
intervention type: Drug
intervention name: Etoposide
description: up to 4 cycles every 3 weeks in Arm 1 and 2, up to 6 cycles every 3 weeks in Arm 3
arm group label: Arm 1
arm group label: Arm 2
arm group label: Arm 3
criteria: 
gender: All
minimum age: 18 Years
maximum age: 130 Years
healthy volunteers: No
last name: Haiyi Jiang, M.D.
role: Study Director
affiliation: AstraZeneca
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country: Argentina
country: Austria
country: Brazil
country: Bulgaria
country: China
country: Czechia
country: France
country: Germany
country: Hungary
country: Israel
country: Italy
country: Japan
country: Korea, Republic of
country: Netherlands
country: Poland
country: Romania
country: Russian Federation
country: Slovakia
country: Spain
country: Taiwan
country: Turkey
country: Ukraine
country: United States
country: Czech Republic
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D419QC00001&amp;attachmentIdentifier=042de696-9399-4abc-8643-673f1237463a&amp;fileName=d419qc00001-csp-v5_Redacted.pdf&amp;versionIdentifier=
description: Redacted CSP
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D419QC00001&amp;attachmentIdentifier=dafb894c-0f08-4319-a2fe-7389ae3ba87f&amp;fileName=D419qc00001_SAP_Redacted.pdf&amp;versionIdentifier=
description: Redacted SAP
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D419QC00001&amp;attachmentIdentifier=11d0f58c-9d10-4c9a-95c3-000528295c1c&amp;fileName=d419qc00001-csp-v5_Redacted.pdf&amp;versionIdentifier=
description: CSPv5_redacted
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Lung Neoplasms
mesh term: Small Cell Lung Carcinoma
mesh term: Carboplatin
mesh term: Etoposide
mesh term: Durvalumab
mesh term: Tremelimumab
sharing ipd: Yes
ipd description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
ipd access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
ipd url: https://astrazenecagroup-dt.pharmacm.com/DT/Home
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Analysis of the China cohort was performed to evaluate the consistency of efficacy and safety in Chinese patients with the global cohort in order to meet regulatory requirements and was not powered for a formal assessment of statistical significance.
point of contact: 