<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/NCT02264990</url>
  </required_header>
  <id_info>
    <org_study_id>M14-359</org_study_id>
    <secondary_id>2014-002565-30</secondary_id>
    <nct_id>NCT02264990</nct_id>
  </id_info>
  <brief_title>Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Adults Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers</brief_title>
  <official_title>A Randomized, Open-Label, Multicenter, Phase 3 Trial Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Subjects Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and efficacy of veliparib plus&#xD;
      carboplatin and paclitaxel versus the Investigator's choice of standard chemotherapy in&#xD;
      adults with metastatic or advanced non-squamous non-small cell lung cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 30, 2014</start_date>
  <completion_date type="Actual">February 21, 2020</completion_date>
  <primary_completion_date type="Actual">November 14, 2019</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 Lung Subtype Panel Positive Subgroup</measure>
    <time_frame>From randomization up to the data cut-off date of 15 July 2019; median follow-up time was 44.5 and 45.3 months in LSP+ participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.</time_frame>
    <description>Overall survival is defined as the time from the date that the participant was randomized to the date of the participant's death. Overall survival was estimated using Kaplan-Meier methodology. Participants still alive at the data cut-off date were censored at the date they were last known to be alive.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS) in the Lung Subtype Panel Positive Subgroup</measure>
    <time_frame>From randomization up to the data cut-off date of 15 July 2019; the median follow-up time was 44.5 and 45.3 months in LSP+ participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.</time_frame>
    <description>Progression-free survival is defined as the time from the date of randomization to the date of disease progression (PD) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death (all causes of mortality), whichever occurred first.&#xD;
PD: At least a 20% increase in the size of target lesions, taking as reference the smallest size recorded since the treatment started (Baseline or after) with an absolute increase of at least 5 mm, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.&#xD;
PFS was estimated using Kaplan-Meier methodology. Participants who did not have an event of disease progression or had not died on or before the cutoff date were censored at the date of their last disease progression assessment on or before the cut-off date. Any PD and death occurring &gt; 26 weeks and &gt; 12 weeks after the previous assessment, respectively, were excluded and patients were censored at last assessment before PD or death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR) in the Lung Subtype Panel Positive Subgroup</measure>
    <time_frame>Assessed on Day 1 of Cycles 3 and 5 then every 9 weeks for 1 year or until maintenance therapy was discontinued, then every 12 weeks until radiographic progression or death; median time on follow-up was 5.2 and 6.3 months in each group, respectively.</time_frame>
    <description>Objective response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria. Response must have been confirmed at a consecutive assessment 28 days or more after the assessment at which response was first observed.&#xD;
CR: The disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm.&#xD;
PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters, persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, or any new lesions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival in All Participants</measure>
    <time_frame>From randomization up to the data cut-off date of 15 July 2019; the median OS follow-up time was 45.4 and 44.6 months in all participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.</time_frame>
    <description>Overall survival is defined as the time from the date that the participant was randomized to the date of the participant's death. OS was estimated using Kaplan-Meier methodology. Participants still alive at the data cut-off date were censored at the date they were last known to be alive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS) in All Participants</measure>
    <time_frame>From randomization up to the data cut-off date of 15 July 2019; the median follow-up time was 45.4 and 44.6 months in all participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.</time_frame>
    <description>Progression-free survival is defined as the time from the date of randomization to the date of disease progression (PD) per RECIST version 1.1 or death (all causes of mortality), whichever occurred first.&#xD;
PD: At least a 20% increase in the size of target lesions, taking as reference the smallest size recorded since the treatment started (Baseline or after) with an absolute increase of at least 5 mm, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.&#xD;
PFS was estimated using Kaplan-Meier methodology. Participants who did not have an event of disease progression or had not died on or before the cut-off date were censored at the date of their last disease progression assessment on or before the cut-off date. Any PD and death occurring &gt; 26 weeks and &gt; 12 weeks after the previous assessment, respectively, were excluded and patients were censored at last assessment before PD or death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR) in All Participants</measure>
    <time_frame>Assessed on Day 1 of Cycles 3 and 5 then every 9 weeks for 1 year or until maintenance therapy was discontinued, then every 12 weeks until radiographic progression or death; median time on follow-up was 6.7 and 5.9 months in each group, respectively.</time_frame>
    <description>Objective response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) per RECIST version 1.1 criteria. Response must have been confirmed at a consecutive assessment 28 days or more after the assessment at which response was first observed.&#xD;
CR: The disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm.&#xD;
PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters, persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, or any new lesions.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">595</enrollment>
  <condition>Non-squamous Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Veliparib + Carboplatin + Paclitaxel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 120 mg veliparib twice a day (BID) on Days -2 to 5 (7 days), carboplatin at an area under the curve (AUC) of 6 mg/mL*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.&#xD;
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Investigator's Choice Chemotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants received Investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:&#xD;
Carboplatin AUC 6 mg/mL*min + paclitaxel 200 mg/m²&#xD;
Cisplatin 75 mg/m² + pemetrexed 500 mg/m²&#xD;
Carboplatin AUC 6 or AUC 5 mg/mL*min + pemetrexed 500 mg/m²&#xD;
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>Administered by Intravenous infusion on Day 1 of each 21-day cycle</description>
    <arm_group_label>Investigator's Choice Chemotherapy</arm_group_label>
    <arm_group_label>Veliparib + Carboplatin + Paclitaxel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>Administered by Intravenous infusion on Day 1 of each 21-day cycle</description>
    <arm_group_label>Investigator's Choice Chemotherapy</arm_group_label>
    <arm_group_label>Veliparib + Carboplatin + Paclitaxel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>Administered by Intravenous infusion on Day 1 of each 21-day cycle</description>
    <arm_group_label>Investigator's Choice Chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Veliparib</intervention_name>
    <description>Oral capsule, administered twice daily for 7 days in each 21-day cycle</description>
    <arm_group_label>Veliparib + Carboplatin + Paclitaxel</arm_group_label>
    <other_name>ABT-888</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pemetrexed</intervention_name>
    <description>Administered by Intravenous infusion on Day 1 of each 21-day cycle</description>
    <arm_group_label>Investigator's Choice Chemotherapy</arm_group_label>
    <arm_group_label>Veliparib + Carboplatin + Paclitaxel</arm_group_label>
    <other_name>Alimta</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject must be ≥ 18 years of age with life expectancy &gt; 12 weeks.&#xD;
&#xD;
          -  Subject must have cytologically or histologically confirmed advanced or metastatic&#xD;
             non-squamous NSCLC and are current or former smokers.&#xD;
&#xD;
          -  Subject must have NSCLC that is not amenable to surgical resection or radiation with&#xD;
             curative intent at time of screening.&#xD;
&#xD;
          -  Subject must have at least 1 unidimensional measurable NSCLC lesion on a computed&#xD;
             tomography (CT) scan as defined by Response Evaluation Criteria in Solid Tumors&#xD;
             (RECIST) version 1.1.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with&#xD;
             polyethoxylated castor oil (Cremophor).&#xD;
&#xD;
          -  Subject has a known hypersensitivity to platinum compounds.&#xD;
&#xD;
          -  Subject has peripheral neuropathy ≥ grade 2.&#xD;
&#xD;
          -  Subject has squamous NSCLC, or an untreated known epidermal growth factor receptor&#xD;
             (EGFR) mutation of exon 19 deletion or L858R mutation in exon 21, or a known&#xD;
             anaplastic lymphoma kinase (ALK) gene rearrangement.&#xD;
&#xD;
          -  Subject has received prior cytotoxic chemotherapy or chemoradiotherapy for NSCLC.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>AbbVie Inc.</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clearview Cancer Institute /ID# 131434</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Alabama /ID# 131518</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36617</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Highlands Oncology Group /ID# 131250</name>
      <address>
        <city>Springdale</city>
        <state>Arkansas</state>
        <zip>72762</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CBCC Global Research, Inc. at /ID# 132709</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Cancer Assoc. R&amp;E /ID# 131392</name>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <zip>92024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Cancer Assoc. R&amp;E /ID# 131949</name>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <zip>92024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LA Hem-Oncology Med Group /ID# 131639</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Jude Hospital dba St Joseph /ID# 132943</name>
      <address>
        <city>Santa Rosa</city>
        <state>California</state>
        <zip>95403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icri /Id# 132942</name>
      <address>
        <city>Whittier</city>
        <state>California</state>
        <zip>90603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida - Archer /ID# 132408</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NorthShore University HealthSystem - Evanston Hospital /ID# 130200</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Goshen Center for Cancer Care /ID# 130216</name>
      <address>
        <city>Goshen</city>
        <state>Indiana</state>
        <zip>46526</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Louisville /ID# 130217</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Acadiana /ID# 133611</name>
      <address>
        <city>Lafayette</city>
        <state>Louisiana</state>
        <zip>70503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System /ID# 130234</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herbert Herman Cancer Center /ID# 130239</name>
      <address>
        <city>Lansing</city>
        <state>Michigan</state>
        <zip>48912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University-School of Medicine /ID# 131651</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center at Cooper - Camden /ID# 131490</name>
      <address>
        <city>Camden</city>
        <state>New Jersey</state>
        <zip>08103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gabrail Cancer Center Research /ID# 130205</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <zip>44718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ Oklahoma HSC /ID# 132888</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albert Einstein Medical Center /ID# 134498</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allegheny General Hospital /ID# 134049</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Jones Clinic, PC /ID# 130215</name>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <zip>38138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Southwestern Medical Center /ID# 130236</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390-7208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ Texas HSC San Antonio /ID# 132972</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coiba /Id# 132153</name>
      <address>
        <city>Berazategui, Buenos Aires</city>
        <zip>1884</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Investigacion Pergamino /ID# 132152</name>
      <address>
        <city>Pergamino</city>
        <zip>2700</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Britanico /ID# 134874</name>
      <address>
        <city>Rosario, Santa FE</city>
        <zip>2000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Oncologia de Rosa /ID# 132150</name>
      <address>
        <city>Rosario, Santa FE</city>
        <zip>2000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St George Hospital /ID# 132481</name>
      <address>
        <city>Kogarah</city>
        <state>New South Wales</state>
        <zip>2217</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Medical Day Care Ctr /ID# 132482</name>
      <address>
        <city>Wollongong</city>
        <state>New South Wales</state>
        <zip>2500</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Flinders Centre for Innovation /ID# 134288</name>
      <address>
        <city>Bedford Park</city>
        <state>South Australia</state>
        <zip>5042</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Hobart Hospital /ID# 132477</name>
      <address>
        <city>Hobart</city>
        <state>Tasmania</state>
        <zip>7000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qe Ii Hsc /Id# 133408</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 1V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Victoria Hospital /ID# 132161</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 4L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Windsor Regional Hospital /ID# 135989</name>
      <address>
        <city>Windsor</city>
        <state>Ontario</state>
        <zip>N9C 3Z4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CSSS Alphonse-Desjardins, CHAU de Levis /ID# 132155</name>
      <address>
        <city>Quebec City</city>
        <state>Quebec</state>
        <zip>G6V 3Z1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krajska nemocnice Liberec a.s. /ID# 132694</name>
      <address>
        <city>Liberec</city>
        <zip>602 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ Hosp Ostrava-Poruba /ID# 132690</name>
      <address>
        <city>Ostrava</city>
        <zip>708 52</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multiscan s.r.o. /ID# 132689</name>
      <address>
        <city>Pardubice</city>
        <zip>532 03</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vseobecna Fakultni Nemocnice /ID# 135118</name>
      <address>
        <city>Prague</city>
        <zip>128 08</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odense Universitets Hospital /ID# 131912</name>
      <address>
        <city>Odense C</city>
        <state>Syddanmark</state>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Satakunnan Sairaanhoitopiiri /ID# 133632</name>
      <address>
        <city>Pori</city>
        <zip>28500</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vaasa Central Hospital /ID# 131930</name>
      <address>
        <city>Vaasa</city>
        <zip>65130</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite-Univ. Berlin, Benjamin-Franklin /ID# 131927</name>
      <address>
        <city>Berlin</city>
        <zip>12203</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lungen Clinic Grosshansdorf /ID# 131928</name>
      <address>
        <city>Grosshansdorf</city>
        <zip>22927</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ Klinik Eppendorf Hamburg /ID# 131926</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik Loewenstein GmbH /ID# 131925</name>
      <address>
        <city>Löwenstein</city>
        <zip>74245</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 133441</name>
      <address>
        <city>Miskolc</city>
        <state>Borsod-Abauj-Zemplen</state>
        <zip>3529</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orszagos Koranyi Pulmonologiai Intezet /ID# 132738</name>
      <address>
        <city>Budapest XII</city>
        <state>Budapest</state>
        <zip>1122</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Debreceni Egyetem Klinikai Kozpont /ID# 132742</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Koch Robert Hospital /ID# 133440</name>
      <address>
        <city>Edelény</city>
        <zip>3780</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veszprem Megyei Tudogyogyintez /ID# 132739</name>
      <address>
        <city>Farkasgyepu</city>
        <zip>8582</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Petz Aladar Megyei Oktato Korh /ID# 132741</name>
      <address>
        <city>Gyor</city>
        <zip>9023</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Matrahaza Gyogyintezet /ID# 132743</name>
      <address>
        <city>Kékesteto</city>
        <zip>3233</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Assaf Harofeh Medical Center /ID# 132830</name>
      <address>
        <city>Be'er Ya'akov</city>
        <zip>70300</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shaare Zedek Medical Center /ID# 132834</name>
      <address>
        <city>Jerusalem</city>
        <zip>91031</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meir Medical Center /ID# 132832</name>
      <address>
        <city>Kfar Saba</city>
        <zip>4428164</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheba Medical Center /ID# 132833</name>
      <address>
        <city>Ramat Gan</city>
        <zip>5239424</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aichi Cancer Center Hospital /ID# 134129</name>
      <address>
        <city>Nagoya-shi</city>
        <state>Aichi</state>
        <zip>464-8681</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kurume University Hospital /ID# 134117</name>
      <address>
        <city>Kurume-shi</city>
        <state>Fukuoka</state>
        <zip>830-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hokkaido University Hospital /ID# 134123</name>
      <address>
        <city>Sapporo-shi</city>
        <state>Hokkaido</state>
        <zip>060-8648</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanagawa Cardiovascular and Respiratory Center /ID# 134127</name>
      <address>
        <city>Yokohama-shi</city>
        <state>Kanagawa</state>
        <zip>236-0051</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sendai Kousei Hospital /ID# 135491</name>
      <address>
        <city>Sendai-shi</city>
        <state>Miyagi</state>
        <zip>980-0873</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kindai University Hospital /ID# 134112</name>
      <address>
        <city>Osaka-sayama-shi</city>
        <state>Osaka</state>
        <zip>589-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka City General Hospital /ID# 134115</name>
      <address>
        <city>Osaka-shi</city>
        <state>Osaka</state>
        <zip>534-0021</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital /ID# 135129</name>
      <address>
        <city>Chuo-ku</city>
        <state>Tokyo</state>
        <zip>104-0045</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cancer Institute Hospital Of JFCR /ID# 135492</name>
      <address>
        <city>Koto-ku</city>
        <state>Tokyo</state>
        <zip>135-8550</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yamaguchi - Ube Medical Center /ID# 135284</name>
      <address>
        <city>Ube-shi</city>
        <state>Yamaguchi</state>
        <zip>755-0241</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hiroshima Citizens Hospital /ID# 135130</name>
      <address>
        <city>Hiroshima</city>
        <zip>730-8518</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kishiwada City Hospital /ID# 136548</name>
      <address>
        <city>Kishiwada</city>
        <zip>596-8501</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dong-A University Hospital /ID# 131609</name>
      <address>
        <city>Busan</city>
        <state>Busan Gwang Yeogsi</state>
        <zip>49201</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National Univ Bundang ho /ID# 131610</name>
      <address>
        <city>Seongnam</city>
        <state>Gyeonggido</state>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inha University Hospital /ID# 147924</name>
      <address>
        <city>Jung-gu</city>
        <state>Incheon Gwang Yeogsi</state>
        <zip>22332</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chonnam National University Hospital /ID# 131612</name>
      <address>
        <city>Gwangju</city>
        <state>Jeonranamdo</state>
        <zip>61469</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center /ID# 132471</name>
      <address>
        <city>Seoul</city>
        <state>Seoul Teugbyeolsi</state>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chungbuk National Univ Hosp /ID# 131611</name>
      <address>
        <city>Cheongju</city>
        <zip>28644</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vrije Universiteit Medisch Centrum /ID# 131967</name>
      <address>
        <city>Amsterdam</city>
        <zip>1081 HV</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Catharina Ziekenhuis /ID# 131966</name>
      <address>
        <city>Eindhoven</city>
        <zip>5623 EJ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ziekenhuis St. Jansdal /ID# 131965</name>
      <address>
        <city>Harderwijk</city>
        <zip>3844 DG</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Antonius Ziekenhuis /ID# 133635</name>
      <address>
        <city>Nieuwegein</city>
        <zip>3435 CM</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jeroen Bosch Ziekenhuis /ID# 131968</name>
      <address>
        <city>S Hertogenbosch</city>
        <zip>5223 GZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Canterbury District Health Boa /ID# 132469</name>
      <address>
        <city>Christchurch</city>
        <zip>8011</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellington Hospital (Capital and Coast District Health Board) /ID# 132470</name>
      <address>
        <city>Wellington</city>
        <zip>6021</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 137085</name>
      <address>
        <city>Moscow</city>
        <state>Moskva</state>
        <zip>115478</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sverdlovsk Regional Oncology Center Dispensary /ID# 132375</name>
      <address>
        <city>Ekaterinburg</city>
        <state>Sverdlovskaya Oblast</state>
        <zip>620043</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>archangel Clinical Oncology /ID# 132376</name>
      <address>
        <city>Arkhangelsk</city>
        <zip>163045</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moscow Regional Onc Dispensary /ID# 132381</name>
      <address>
        <city>Balashikha</city>
        <zip>143900</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Belgorod Oncology Dispensary /ID# 142638</name>
      <address>
        <city>Belgorod</city>
        <zip>308010</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moscow Res Onc Inst Hertsen /ID# 132370</name>
      <address>
        <city>Moscow</city>
        <zip>125284</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Regional Budgetary Healthcare Institution &quot; Murmansk Regional Oncology Dis /ID# 137087</name>
      <address>
        <city>Murmansk</city>
        <zip>183047</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orenburg Regional Clinical Onc /ID# 132371</name>
      <address>
        <city>Orenburg</city>
        <zip>460021</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Strategic medical systems LLC /ID# 206383</name>
      <address>
        <city>Sankt-Peterburg</city>
        <zip>192148</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ogarev Mordovia State Univ /ID# 132377</name>
      <address>
        <city>Saransk</city>
        <zip>430005</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LLC BioEq Ltd. /ID# 132372</name>
      <address>
        <city>St. Petersburg</city>
        <zip>197342</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>N.N. Petrov Research Inst Onc /ID# 137084</name>
      <address>
        <city>St. Petersburg</city>
        <zip>197758</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GVI Oncology /ID# 133268</name>
      <address>
        <city>Port Elizabeth</city>
        <state>Eastern Cape</state>
        <zip>6006</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Albert, Bouwer and Jordaan Incorporated /ID# 131775</name>
      <address>
        <city>Pretoria</city>
        <state>Gauteng</state>
        <zip>0044</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mary Potter Oncology Centre /ID# 131776</name>
      <address>
        <city>Pretoria</city>
        <state>Gauteng</state>
        <zip>0181</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Oncology Centre /ID# 131773</name>
      <address>
        <city>Durban</city>
        <state>Kwazulu-Natal</state>
        <zip>4091</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Netcare Oncology Intervent Ctr /ID# 131777</name>
      <address>
        <city>Cape Town</city>
        <state>Western Cape</state>
        <zip>7460</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cape Town Oncology Trials /ID# 132734</name>
      <address>
        <city>Cape Town</city>
        <state>Western Cape</state>
        <zip>7570</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GVI Rondebosch Oncology Centre /ID# 132732</name>
      <address>
        <city>Cape Town</city>
        <state>Western Cape</state>
        <zip>7700</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sandton Oncology Medical Group /ID# 131774</name>
      <address>
        <city>Johannesburg</city>
        <zip>2196</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Duran i Reynals /ID# 132879</name>
      <address>
        <city>L'Hospitalet de Llobregat</city>
        <state>Barcelona</state>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Fundacion Alcorcon /ID# 132909</name>
      <address>
        <city>Alcorcon</city>
        <zip>28922</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Alicante /ID# 132881</name>
      <address>
        <city>Alicante</city>
        <zip>03010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Dexeus - Grupo Quironsalud /ID# 132876</name>
      <address>
        <city>Barcelona</city>
        <zip>08028</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Vall d'Hebron /ID# 132871</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Anderson Madrid /ID# 132905</name>
      <address>
        <city>Madrid</city>
        <zip>28033</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz /ID# 132870</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario HM Sanchinarro /ID# 132869</name>
      <address>
        <city>Madrid</city>
        <zip>28050</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario de Valencia /ID# 132873</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China Medical University Hosp /ID# 131870</name>
      <address>
        <city>Taichung City</city>
        <state>Taichung</state>
        <zip>40447</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dalin Tzu Chi General Hospital /ID# 131872</name>
      <address>
        <city>Dalin Township</city>
        <zip>622</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Medical University Hospital /ID# 133817</name>
      <address>
        <city>Taipei City</city>
        <zip>11031</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hosp /ID# 131871</name>
      <address>
        <city>Taipei City</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hacettepe University Medical Faculty /ID# 131913</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ankara Univ Medical Faculty /ID# 131914</name>
      <address>
        <city>Ankara</city>
        <zip>06590</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uludag University Medical Faculty /ID# 131915</name>
      <address>
        <city>Bursa</city>
        <zip>16059</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dicle Universitesi Tip /ID# 136570</name>
      <address>
        <city>Diyarbakir</city>
        <zip>21200</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gaziantep Universitesi Med /ID# 131917</name>
      <address>
        <city>Gaziantep</city>
        <zip>27310</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Suat Seren Gogus Has /ID# 136568</name>
      <address>
        <city>Izmir</city>
        <zip>35110</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inonu University /ID# 136569</name>
      <address>
        <city>Malatya</city>
        <zip>44280</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leicester Royal Infirmary /ID# 133930</name>
      <address>
        <city>Leicester</city>
        <state>England</state>
        <zip>LE1 5WW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cheltenham General Hospital /ID# 131951</name>
      <address>
        <city>Cheltenham</city>
        <state>Gloucestershire</state>
        <zip>GL53 7AN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norfolk and Norwich Univ Hosp /ID# 131953</name>
      <address>
        <city>Norwich</city>
        <state>Norfolk</state>
        <zip>NR4 7UY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal United Hospitals Bath /ID# 132851</name>
      <address>
        <city>Bath</city>
        <zip>BA1 3NG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Belfast City Hospital /ID# 132858</name>
      <address>
        <city>Belfast</city>
        <zip>BT9 7AB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart of England NHS Foundation Trust /ID# 132855</name>
      <address>
        <city>Birmingham</city>
        <zip>B9 5SS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Blackburn Hospital /ID# 132853</name>
      <address>
        <city>Blackburn</city>
        <zip>BB2 3HH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colchester General Hospital /ID# 133929</name>
      <address>
        <city>Colchester</city>
        <zip>CO4 5JL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Castle Hill Hospital /ID# 135489</name>
      <address>
        <city>Cottingham</city>
        <zip>HU16 5JQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scunthorpe General Hospital /ID# 133931</name>
      <address>
        <city>Doncaster</city>
        <zip>DN15 7BH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>James Paget University Hosp /ID# 131954</name>
      <address>
        <city>Great Yarmouth</city>
        <zip>NR31 6LA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Gwent Hospital /ID# 133935</name>
      <address>
        <city>Gwent</city>
        <zip>NP20 2UB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huddersfield Royal Infirmary /ID# 132854</name>
      <address>
        <city>Huddersfield</city>
        <zip>HD3 3EA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charing Cross Hospital /ID# 131959</name>
      <address>
        <city>London</city>
        <zip>W6 8RF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Hospital /ID# 131661</name>
      <address>
        <city>Newcastle Upon Tyne</city>
        <zip>NE7 7DN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>York Hospital /ID# 132859</name>
      <address>
        <city>York</city>
        <zip>YO31 8HE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>Finland</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Netherlands</country>
    <country>New Zealand</country>
    <country>Russian Federation</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
    <country>France</country>
  </removed_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>October 9, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <results_first_submitted>February 8, 2021</results_first_submitted>
  <results_first_submitted_qc>February 8, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 26, 2021</results_first_posted>
  <disposition_first_submitted>October 26, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>October 26, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">October 29, 2020</disposition_first_posted>
  <last_update_submitted>February 8, 2021</last_update_submitted>
  <last_update_submitted_qc>February 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>veliparib</keyword>
  <keyword>carboplatin</keyword>
  <keyword>paclitaxel</keyword>
  <keyword>cisplatin</keyword>
  <keyword>pemetrexed</keyword>
  <keyword>Poly Adenosine diphosphate (ADP)-ribose Polymerase (PARP)</keyword>
  <keyword>Metastatic</keyword>
  <keyword>Non-squamous</keyword>
  <keyword>Non-small cell lung cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Pemetrexed</mesh_term>
    <mesh_term>Veliparib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.</ipd_time_frame>
    <ipd_access_criteria>Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.</ipd_access_criteria>
    <ipd_url>https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html</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>May 9, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/90/NCT02264990/Prot_000.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>November 6, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/90/NCT02264990/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were enrolled at 131 sites in 20 countries (Argentina, Australia, Canada, Czech Republic, Denmark, Finland, Germany, Hungary, Israel, Japan, South Korea, Netherlands, New Zealand, Russian Federation, South Africa, Spain, Taiwan, Turkey, United Kingdom, and United States).</recruitment_details>
      <pre_assignment_details>Participants were randomized in a 1:1 ratio to veliparib in combination with carboplatin and paclitaxel (C/P) or investigator's choice of platinum doublet chemotherapy. Randomization was stratified by smoking status (current versus former), by the investigators' preferred platinum doublet therapy (carboplatin/paclitaxel versus cisplatin/pemetrexed versus carboplatin/pemetrexed), by gender (male versus female) and by Eastern Cooperative Oncology Group (ECOG) performance status (0 versus 1).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Investigator's Choice Chemotherapy</title>
          <description>Participants received investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:&#xD;
Carboplatin at an area under the curve (AUC) of 6 mg/mL*min + paclitaxel 200 mg/m²&#xD;
Cisplatin 75 mg/m² + pemetrexed 500 mg/m²&#xD;
Carboplatin AUC 6 or AUC 5 mg/mL*min + pemetrexed 500 mg/m²&#xD;
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.</description>
        </group>
        <group group_id="P2">
          <title>Veliparib + Carboplatin + Paclitaxel</title>
          <description>Participants received 120 mg veliparib twice a day (BID) on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.&#xD;
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="297"/>
                <participants group_id="P2" count="298"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Treatment</title>
              <participants_list>
                <participants group_id="P1" count="288"/>
                <participants group_id="P2" count="293"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Maintenance Therapy</title>
              <participants_list>
                <participants group_id="P1" count="148"/>
                <participants group_id="P2" count="123"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
                <participants group_id="P2" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="260"/>
                <participants group_id="P2" count="259"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="255"/>
                <participants group_id="P2" count="250"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The intention-to-treat (ITT) population included all randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Investigator's Choice Chemotherapy</title>
          <description>Participants received investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:&#xD;
Carboplatin AUC 6 mg/mL*min + paclitaxel 200 mg/m²&#xD;
Cisplatin 75 mg/m² + pemetrexed 500 mg/m²&#xD;
Carboplatin AUC 6 or AUC 5 mg/mL*min + pemetrexed 500 mg/m²&#xD;
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.</description>
        </group>
        <group group_id="B2">
          <title>Veliparib + Carboplatin + Paclitaxel</title>
          <description>Participants received 120 mg veliparib BID on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.&#xD;
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.</description>
        </group>
        <group group_id="B3">
          <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="297"/>
            <count group_id="B2" value="298"/>
            <count group_id="B3" value="595"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="297"/>
                    <count group_id="B2" value="298"/>
                    <count group_id="B3" value="595"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.1" spread="8.99"/>
                    <measurement group_id="B2" value="62.7" spread="9.02"/>
                    <measurement group_id="B3" value="62.9" spread="9.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="297"/>
                    <count group_id="B2" value="298"/>
                    <count group_id="B3" value="595"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt; 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="153"/>
                    <measurement group_id="B2" value="163"/>
                    <measurement group_id="B3" value="316"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥ 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="144"/>
                    <measurement group_id="B2" value="135"/>
                    <measurement group_id="B3" value="279"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="297"/>
                    <count group_id="B2" value="298"/>
                    <count group_id="B3" value="595"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="90"/>
                    <measurement group_id="B2" value="92"/>
                    <measurement group_id="B3" value="182"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="207"/>
                    <measurement group_id="B2" value="206"/>
                    <measurement group_id="B3" value="413"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="297"/>
                    <count group_id="B2" value="298"/>
                    <count group_id="B3" value="595"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="275"/>
                    <measurement group_id="B2" value="272"/>
                    <measurement group_id="B3" value="547"/>
                  </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="297"/>
                    <count group_id="B2" value="298"/>
                    <count group_id="B3" value="595"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="233"/>
                    <measurement group_id="B2" value="229"/>
                    <measurement group_id="B3" value="462"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="110"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="297"/>
                    <count group_id="B2" value="298"/>
                    <count group_id="B3" value="595"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>US and Western Europe and Australia and Canada</title>
                  <measurement_list>
                    <measurement group_id="B1" value="177"/>
                    <measurement group_id="B2" value="157"/>
                    <measurement group_id="B3" value="334"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Eastern Europe/Russia</title>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="88"/>
                    <measurement group_id="B3" value="156"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Japan</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="72"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="297"/>
                    <count group_id="B2" value="298"/>
                    <count group_id="B3" value="595"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Current smoker</title>
                  <measurement_list>
                    <measurement group_id="B1" value="153"/>
                    <measurement group_id="B2" value="152"/>
                    <measurement group_id="B3" value="305"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Past smoker</title>
                  <measurement_list>
                    <measurement group_id="B1" value="144"/>
                    <measurement group_id="B2" value="146"/>
                    <measurement group_id="B3" value="290"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Investigators' Preferred Platinum Doublet Therapy</title>
          <description>The investigator's preferred choice of platinum doublet therapy, prior to randomization, which was used as a stratification factor. Note that while the investigator's pre-randomization preferred choice for the doublet is summarized, all participants on the veliparib arm received carboplatin and paclitaxel as chemotherapy.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="297"/>
                    <count group_id="B2" value="298"/>
                    <count group_id="B3" value="595"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Carboplatin/paclitaxel</title>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="70"/>
                    <measurement group_id="B3" value="141"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cisplatin/pemetrexed</title>
                  <measurement_list>
                    <measurement group_id="B1" value="95"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="195"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Carboplatin/pemetrexed</title>
                  <measurement_list>
                    <measurement group_id="B1" value="131"/>
                    <measurement group_id="B2" value="128"/>
                    <measurement group_id="B3" value="259"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Eastern Cooperative Oncology Group (ECOG) Performance Status</title>
          <description>ECOG performance status is used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis.&#xD;
0 = Fully Active;&#xD;
1 = Restricted activity but ambulatory;&#xD;
2 = Ambulatory but unable to carry out work activities;&#xD;
3 = Limited Self-Care;&#xD;
4 = Completely Disabled, No self-care</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="297"/>
                    <count group_id="B2" value="298"/>
                    <count group_id="B3" value="595"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Grade 0 (fully active)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="113"/>
                    <measurement group_id="B2" value="116"/>
                    <measurement group_id="B3" value="229"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1 (restricted but ambulatory)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="184"/>
                    <measurement group_id="B2" value="182"/>
                    <measurement group_id="B3" value="366"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Lung Subtype Panel (LSP) Assay Results</title>
          <description>LSP positive: Patients with tumors classified as positive for the gene expression-based lung subtype panel (LSP) biomarker&#xD;
LSP negative: Patients with tumors classified as negative for the gene expression-based lung subtype panel (LSP) biomarker</description>
          <population>Participants with a tumor tissue sample available with sufficient tumor content for LSP status evaluation, and with an analytically valid LSP result.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="93"/>
                    <count group_id="B2" value="114"/>
                    <count group_id="B3" value="207"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>LSP positive</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="80"/>
                  </measurement_list>
                </category>
                <category>
                  <title>LSP negative</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Survival (OS) in the Lung Subtype Panel Positive Subgroup</title>
        <description>Overall survival is defined as the time from the date that the participant was randomized to the date of the participant's death. Overall survival was estimated using Kaplan-Meier methodology. Participants still alive at the data cut-off date were censored at the date they were last known to be alive.</description>
        <time_frame>From randomization up to the data cut-off date of 15 July 2019; median follow-up time was 44.5 and 45.3 months in LSP+ participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.</time_frame>
        <population>Participants in the ITT population who were LSP positive (LSP+)</population>
        <group_list>
          <group group_id="O1">
            <title>Investigator's Choice Chemotherapy</title>
            <description>Participants received investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:&#xD;
Carboplatin AUC 6 mg/mL*min + paclitaxel 200 mg/m²&#xD;
Cisplatin 75 mg/m² + pemetrexed 500 mg/m²&#xD;
Carboplatin AUC 6 or AUC 5 mg/mL*min + pemetrexed 500 mg/m²&#xD;
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.</description>
          </group>
          <group group_id="O2">
            <title>Veliparib + Carboplatin + Paclitaxel</title>
            <description>Participants received 120 mg veliparib BID on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.&#xD;
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS) in the Lung Subtype Panel Positive Subgroup</title>
          <description>Overall survival is defined as the time from the date that the participant was randomized to the date of the participant's death. Overall survival was estimated using Kaplan-Meier methodology. Participants still alive at the data cut-off date were censored at the date they were last known to be alive.</description>
          <population>Participants in the ITT population who were LSP positive (LSP+)</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="40"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.2" lower_limit="5.1" upper_limit="11.7"/>
                    <measurement group_id="O2" value="11.2" lower_limit="7.5" upper_limit="15.8"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>A fixed sequence testing procedure was used for analyses of the primary and secondary efficacy endpoints to control for the familywise error rate. If veliparib plus C/P treatment was not statistically significantly better compared to the investigators' choice of standard therapy for the primary efficacy endpoint of OS in LSP+ participants, then statistical significance would not be declared for any of the secondary efficacy endpoints.</non_inferiority_desc>
            <p_value>0.113</p_value>
            <p_value_desc>Statistical significance was determined by a two-sided P value ≤ 0.05.</p_value_desc>
            <method>Log Rank</method>
            <method_desc>Log rank test stratified by ECOG performance status, investigators' preferred platinum therapy, and gender.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.644</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.396</ci_lower_limit>
            <ci_upper_limit>1.048</ci_upper_limit>
            <estimate_desc>Hazard ratio obtained using the covariate adjusted Cox Proportional Hazard Model with covariates being ECOG performance status, investigators' preferred platinum therapy, and gender.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression Free Survival (PFS) in the Lung Subtype Panel Positive Subgroup</title>
        <description>Progression-free survival is defined as the time from the date of randomization to the date of disease progression (PD) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death (all causes of mortality), whichever occurred first.&#xD;
PD: At least a 20% increase in the size of target lesions, taking as reference the smallest size recorded since the treatment started (Baseline or after) with an absolute increase of at least 5 mm, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.&#xD;
PFS was estimated using Kaplan-Meier methodology. Participants who did not have an event of disease progression or had not died on or before the cutoff date were censored at the date of their last disease progression assessment on or before the cut-off date. Any PD and death occurring &gt; 26 weeks and &gt; 12 weeks after the previous assessment, respectively, were excluded and patients were censored at last assessment before PD or death.</description>
        <time_frame>From randomization up to the data cut-off date of 15 July 2019; the median follow-up time was 44.5 and 45.3 months in LSP+ participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.</time_frame>
        <population>Participants in the ITT population who were LSP positive</population>
        <group_list>
          <group group_id="O1">
            <title>Investigator's Choice Chemotherapy</title>
            <description>Participants received investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:&#xD;
Carboplatin AUC 6 mg/mL*min + paclitaxel 200 mg/m²&#xD;
Cisplatin 75 mg/m² + pemetrexed 500 mg/m²&#xD;
Carboplatin AUC 6 or AUC 5 mg/mL*min + pemetrexed 500 mg/m²&#xD;
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.</description>
          </group>
          <group group_id="O2">
            <title>Veliparib + Carboplatin + Paclitaxel</title>
            <description>Participants received 120 mg veliparib BID on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.&#xD;
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival (PFS) in the Lung Subtype Panel Positive Subgroup</title>
          <description>Progression-free survival is defined as the time from the date of randomization to the date of disease progression (PD) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death (all causes of mortality), whichever occurred first.&#xD;
PD: At least a 20% increase in the size of target lesions, taking as reference the smallest size recorded since the treatment started (Baseline or after) with an absolute increase of at least 5 mm, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.&#xD;
PFS was estimated using Kaplan-Meier methodology. Participants who did not have an event of disease progression or had not died on or before the cutoff date were censored at the date of their last disease progression assessment on or before the cut-off date. Any PD and death occurring &gt; 26 weeks and &gt; 12 weeks after the previous assessment, respectively, were excluded and patients were censored at last assessment before PD or death.</description>
          <population>Participants in the ITT population who were LSP positive</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="40"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2" lower_limit="2.8" upper_limit="6.2"/>
                    <measurement group_id="O2" value="6.3" lower_limit="3.5" upper_limit="7.4"/>
                  </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>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.260</p_value>
            <method>Log Rank</method>
            <method_desc>Log-rank test stratified by investigator's preferred platinum therapy, gender, and ECOG performance status.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.647</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.388</ci_lower_limit>
            <ci_upper_limit>1.080</ci_upper_limit>
            <estimate_desc>The hazard ratio was obtained using the covariate adjusted Cox Proportional Hazard Model with covariates of ECOG performance status, investigators' preferred platinum therapy, and gender.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Objective Response Rate (ORR) in the Lung Subtype Panel Positive Subgroup</title>
        <description>Objective response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria. Response must have been confirmed at a consecutive assessment 28 days or more after the assessment at which response was first observed.&#xD;
CR: The disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm.&#xD;
PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters, persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, or any new lesions.</description>
        <time_frame>Assessed on Day 1 of Cycles 3 and 5 then every 9 weeks for 1 year or until maintenance therapy was discontinued, then every 12 weeks until radiographic progression or death; median time on follow-up was 5.2 and 6.3 months in each group, respectively.</time_frame>
        <population>Participants in the ITT population who were LSP positive</population>
        <group_list>
          <group group_id="O1">
            <title>Investigator's Choice Chemotherapy</title>
            <description>Participants received investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:&#xD;
Carboplatin AUC 6 mg/mL*min + paclitaxel 200 mg/m²&#xD;
Cisplatin 75 mg/m² + pemetrexed 500 mg/m²&#xD;
Carboplatin AUC 6 or AUC 5 mg/mL*min + pemetrexed 500 mg/m²&#xD;
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.</description>
          </group>
          <group group_id="O2">
            <title>Veliparib + Carboplatin + Paclitaxel</title>
            <description>Participants received 120 mg veliparib BID on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.&#xD;
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate (ORR) in the Lung Subtype Panel Positive Subgroup</title>
          <description>Objective response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria. Response must have been confirmed at a consecutive assessment 28 days or more after the assessment at which response was first observed.&#xD;
CR: The disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm.&#xD;
PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters, persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, or any new lesions.</description>
          <population>Participants in the ITT population who were LSP positive</population>
          <units>percentage of participants</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="40"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.0" lower_limit="16.6" upper_limit="46.5"/>
                    <measurement group_id="O2" value="22.5" lower_limit="10.8" upper_limit="38.5"/>
                  </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>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.455</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Logistic regression adjusted for the covariates of ECOG performance status, investigators' preferred platinum therapy, and gender.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.66</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.23</ci_lower_limit>
            <ci_upper_limit>1.90</ci_upper_limit>
            <estimate_desc>Odds ratio is from covariate adjusted logistic regression with the covariates being ECOG performance status, investigators' preferred platinum therapy, and gender.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival in All Participants</title>
        <description>Overall survival is defined as the time from the date that the participant was randomized to the date of the participant's death. OS was estimated using Kaplan-Meier methodology. Participants still alive at the data cut-off date were censored at the date they were last known to be alive.</description>
        <time_frame>From randomization up to the data cut-off date of 15 July 2019; the median OS follow-up time was 45.4 and 44.6 months in all participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.</time_frame>
        <population>Participants in the ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Investigator's Choice Chemotherapy</title>
            <description>Participants received Investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:&#xD;
Carboplatin AUC 6 mg/mL*min + paclitaxel 200 mg/m²&#xD;
Cisplatin 75 mg/m² + pemetrexed 500 mg/m²&#xD;
Carboplatin AUC 6 or AUC 5 mg/mL*min + pemetrexed 500 mg/m²&#xD;
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.</description>
          </group>
          <group group_id="O2">
            <title>Veliparib + Carboplatin + Paclitaxel</title>
            <description>Participants received 120 mg veliparib BID on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.&#xD;
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival in All Participants</title>
          <description>Overall survival is defined as the time from the date that the participant was randomized to the date of the participant's death. OS was estimated using Kaplan-Meier methodology. Participants still alive at the data cut-off date were censored at the date they were last known to be alive.</description>
          <population>Participants in the ITT population</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="297"/>
                <count group_id="O2" value="298"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.1" lower_limit="10.0" upper_limit="13.7"/>
                    <measurement group_id="O2" value="12.1" lower_limit="10.4" upper_limit="14.9"/>
                  </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>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.846</p_value>
            <method>Log Rank</method>
            <method_desc>Log rank test stratified by LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.986</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.827</ci_lower_limit>
            <ci_upper_limit>1.176</ci_upper_limit>
            <estimate_desc>The hazard ratio was obtained using the covariate adjusted Cox Proportional Hazard Model with covariates of LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression Free Survival (PFS) in All Participants</title>
        <description>Progression-free survival is defined as the time from the date of randomization to the date of disease progression (PD) per RECIST version 1.1 or death (all causes of mortality), whichever occurred first.&#xD;
PD: At least a 20% increase in the size of target lesions, taking as reference the smallest size recorded since the treatment started (Baseline or after) with an absolute increase of at least 5 mm, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.&#xD;
PFS was estimated using Kaplan-Meier methodology. Participants who did not have an event of disease progression or had not died on or before the cut-off date were censored at the date of their last disease progression assessment on or before the cut-off date. Any PD and death occurring &gt; 26 weeks and &gt; 12 weeks after the previous assessment, respectively, were excluded and patients were censored at last assessment before PD or death.</description>
        <time_frame>From randomization up to the data cut-off date of 15 July 2019; the median follow-up time was 45.4 and 44.6 months in all participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.</time_frame>
        <population>Participants in the ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Investigator's Choice Chemotherapy</title>
            <description>Participants received Investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:&#xD;
Carboplatin AUC 6 mg/mL*min + paclitaxel 200 mg/m²&#xD;
Cisplatin 75 mg/m² + pemetrexed 500 mg/m²&#xD;
Carboplatin AUC 6 or AUC 5 mg/mL*min + pemetrexed 500 mg/m²&#xD;
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.</description>
          </group>
          <group group_id="O2">
            <title>Veliparib + Carboplatin + Paclitaxel</title>
            <description>Participants received 120 mg veliparib BID on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.&#xD;
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival (PFS) in All Participants</title>
          <description>Progression-free survival is defined as the time from the date of randomization to the date of disease progression (PD) per RECIST version 1.1 or death (all causes of mortality), whichever occurred first.&#xD;
PD: At least a 20% increase in the size of target lesions, taking as reference the smallest size recorded since the treatment started (Baseline or after) with an absolute increase of at least 5 mm, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.&#xD;
PFS was estimated using Kaplan-Meier methodology. Participants who did not have an event of disease progression or had not died on or before the cut-off date were censored at the date of their last disease progression assessment on or before the cut-off date. Any PD and death occurring &gt; 26 weeks and &gt; 12 weeks after the previous assessment, respectively, were excluded and patients were censored at last assessment before PD or death.</description>
          <population>Participants in the ITT population</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="297"/>
                <count group_id="O2" value="298"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7" lower_limit="5.6" upper_limit="7.2"/>
                    <measurement group_id="O2" value="5.9" lower_limit="5.0" upper_limit="6.5"/>
                  </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>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.473</p_value>
            <method>Log Rank</method>
            <method_desc>Log rank test stratified by LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.035</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.867</ci_lower_limit>
            <ci_upper_limit>1.235</ci_upper_limit>
            <estimate_desc>The hazard ratio was obtained using the covariate adjusted Cox Proportional Hazard Model with covariates of LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Objective Response Rate (ORR) in All Participants</title>
        <description>Objective response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) per RECIST version 1.1 criteria. Response must have been confirmed at a consecutive assessment 28 days or more after the assessment at which response was first observed.&#xD;
CR: The disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm.&#xD;
PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters, persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, or any new lesions.</description>
        <time_frame>Assessed on Day 1 of Cycles 3 and 5 then every 9 weeks for 1 year or until maintenance therapy was discontinued, then every 12 weeks until radiographic progression or death; median time on follow-up was 6.7 and 5.9 months in each group, respectively.</time_frame>
        <population>Participants in the ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Investigator's Choice Chemotherapy</title>
            <description>Participants received Investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:&#xD;
Carboplatin AUC 6 mg/mL*min + paclitaxel 200 mg/m²&#xD;
Cisplatin 75 mg/m² + pemetrexed 500 mg/m²&#xD;
Carboplatin AUC 6 or AUC 5 mg/mL*min + pemetrexed 500 mg/m²&#xD;
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.</description>
          </group>
          <group group_id="O2">
            <title>Veliparib + Carboplatin + Paclitaxel</title>
            <description>Participants received 120 mg veliparib BID on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.&#xD;
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate (ORR) in All Participants</title>
          <description>Objective response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) per RECIST version 1.1 criteria. Response must have been confirmed at a consecutive assessment 28 days or more after the assessment at which response was first observed.&#xD;
CR: The disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm.&#xD;
PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters, persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, or any new lesions.</description>
          <population>Participants in the ITT population</population>
          <units>percentage of participants</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="297"/>
                <count group_id="O2" value="298"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.0" lower_limit="23.9" upper_limit="34.5"/>
                    <measurement group_id="O2" value="26.2" lower_limit="21.3" upper_limit="31.6"/>
                  </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>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.409</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Logistic regression adjusted for the covariates of LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.59</ci_lower_limit>
            <ci_upper_limit>1.24</ci_upper_limit>
            <estimate_desc>Odds ratio is from covariate adjusted logistic regression with the covariates being LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.</time_frame>
      <desc>All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).</desc>
      <group_list>
        <group group_id="E1">
          <title>Investigator's Choice Chemotherapy</title>
          <description>Participants received investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:&#xD;
Carboplatin AUC 6 mg/mL*min + paclitaxel 200 mg/m²&#xD;
Cisplatin 75 mg/m² + pemetrexed 500 mg/m²&#xD;
Carboplatin AUC 6 or AUC 5 mg/mL*min + pemetrexed 500 mg/m²&#xD;
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.</description>
        </group>
        <group group_id="E2">
          <title>Veliparib + Carboplatin + Paclitaxel</title>
          <description>Participants received 120 mg veliparib twice a day (BID) on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.&#xD;
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 21.0</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="255" subjects_at_risk="297"/>
                <counts group_id="E2" subjects_affected="250" subjects_at_risk="298"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="98" subjects_at_risk="288"/>
                <counts group_id="E2" subjects_affected="121" subjects_at_risk="293"/>
              </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="17" subjects_affected="15" subjects_at_risk="288"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>FEBRILE NEUTROPENIA</sub_title>
                <counts group_id="E1" events="10" subjects_affected="7" subjects_at_risk="288"/>
                <counts group_id="E2" events="15" subjects_affected="13" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>LEUKOPENIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>LYMPHADENITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>NEUTROPENIA</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="288"/>
                <counts group_id="E2" events="9" subjects_affected="6" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>PANCYTOPENIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>THROMBOCYTOPENIA</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="288"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="293"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>ARTERIOSPASM CORONARY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>ATRIAL FIBRILLATION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="288"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>ATRIAL FLUTTER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>CARDIAC ARREST</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>CARDIAC FAILURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>CARDIAC FAILURE ACUTE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>CARDIO-RESPIRATORY ARREST</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>CARDIOPULMONARY FAILURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>LEFT VENTRICULAR FAILURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>PERICARDIAL EFFUSION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>PERICARDITIS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>SUPRAVENTRICULAR TACHYCARDIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>ABDOMINAL PAIN</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="288"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>APHTHOUS ULCER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>ASCITES</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>COLITIS ISCHAEMIC</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>COLITIS ULCERATIVE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>CONSTIPATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="288"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>GASTRITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>HAEMATEMESIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>INTESTINAL OBSTRUCTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>MESENTERIC VEIN THROMBOSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="288"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>OESOPHAGEAL STENOSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>OESOPHAGITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>RECTAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>VOMITING</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="288"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="293"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>ASTHENIA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="288"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>CATHETER SITE HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>CHEST PAIN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>DISEASE PROGRESSION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>GENERAL PHYSICAL HEALTH DETERIORATION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>MALAISE</sub_title>
                <counts group_id="E1" events="6" subjects_affected="3" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>MULTIPLE ORGAN DYSFUNCTION SYNDROME</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>NON-CARDIAC CHEST PAIN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>PERIPHERAL SWELLING</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>PYREXIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>SUDDEN DEATH</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>SYSTEMIC INFLAMMATORY RESPONSE SYNDROME</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>HEPATIC FUNCTION ABNORMAL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>ANAPHYLACTIC SHOCK</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>DRUG HYPERSENSITIVITY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="293"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>ABDOMINAL ABSCESS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>APPENDICITIS PERFORATED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>BACTERAEMIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>BRONCHITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>CELLULITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>CLOSTRIDIUM DIFFICILE COLITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>DEVICE RELATED INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>DIARRHOEA INFECTIOUS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>EMPYEMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>GASTROENTERITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>HERPES ZOSTER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>INFECTION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>INFLUENZA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>LOWER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>LUNG INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>LYMPHANGITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>NEUTROPENIC SEPSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>PERITONSILLAR ABSCESS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>PNEUMONIA</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="288"/>
                <counts group_id="E2" events="26" subjects_affected="19" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>PNEUMONIA BACTERIAL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>PNEUMONIA PSEUDOMONAL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>PSEUDOMONAL SEPSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>PULMONARY SEPSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>PYELONEPHRITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>SEPSIS</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>SEPTIC SHOCK</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>URINARY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="288"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>VASCULAR DEVICE INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>VIRAL UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>FALL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>FEMORAL NECK FRACTURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>HEART INJURY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>HIP FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>LUMBAR VERTEBRAL FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>RADIATION OESOPHAGITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>SPINAL COMPRESSION FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>C-REACTIVE PROTEIN INCREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </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="2" subjects_affected="2" subjects_at_risk="288"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>DEHYDRATION</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>HYPOCALCAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>HYPOGLYCAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>HYPONATRAEMIA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>TYPE 2 DIABETES MELLITUS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ARTHRALGIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>BACK PAIN</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="288"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>BONE PAIN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>MUSCULOSKELETAL CHEST PAIN</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>MUSCULOSKELETAL PAIN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>PAIN IN EXTREMITY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>CANCER PAIN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>GASTRIC CANCER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>MALIGNANT NEOPLASM PROGRESSION</sub_title>
                <counts group_id="E1" events="12" subjects_affected="10" subjects_at_risk="288"/>
                <counts group_id="E2" events="19" subjects_affected="14" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>MALIGNANT PLEURAL EFFUSION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>METASTASES TO BONE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>METASTASES TO CENTRAL NERVOUS SYSTEM</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>METASTASES TO MENINGES</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>PERICARDIAL EFFUSION MALIGNANT</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>CEREBRAL INFARCTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>CEREBRAL ISCHAEMIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>CEREBROVASCULAR ACCIDENT</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>COGNITIVE DISORDER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>PERIPHERAL SENSORY NEUROPATHY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>SPINAL CORD COMPRESSION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>CONFUSIONAL STATE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>DELIRIUM</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>DEPRESSION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>DISORIENTATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </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="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>AZOTAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>HAEMATURIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>RENAL FAILURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>RENAL IMPAIRMENT</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>URINARY RETENTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE RESPIRATORY FAILURE</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>DYSPNOEA</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="288"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>DYSPNOEA EXERTIONAL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>HAEMOPTYSIS</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>HYPOXIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>ORGANISING PNEUMONIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>PLEURAL EFFUSION</sub_title>
                <counts group_id="E1" events="9" subjects_affected="6" subjects_at_risk="288"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>PLEURITIC PAIN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>PNEUMONIA ASPIRATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>PNEUMOTHORAX</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>PRODUCTIVE COUGH</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>PULMONARY EMBOLISM</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="288"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>PULMONARY HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>RESPIRATORY DISTRESS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>RESPIRATORY FAILURE</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="288"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>RHINORRHOEA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>SUBCUTANEOUS EMPHYSEMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>ANEURYSM</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>AXILLARY VEIN THROMBOSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="288"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>DEEP VEIN THROMBOSIS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>HYPOTENSION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>HYPOVOLAEMIC SHOCK</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>ORTHOSTATIC HYPOTENSION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>VENOUS THROMBOSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="288"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="293"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 21.0</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="269" subjects_at_risk="288"/>
                <counts group_id="E2" subjects_affected="275" subjects_at_risk="293"/>
              </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="197" subjects_affected="107" subjects_at_risk="288"/>
                <counts group_id="E2" events="212" subjects_affected="112" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>LEUKOPENIA</sub_title>
                <counts group_id="E1" events="77" subjects_affected="40" subjects_at_risk="288"/>
                <counts group_id="E2" events="77" subjects_affected="43" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>NEUTROPENIA</sub_title>
                <counts group_id="E1" events="175" subjects_affected="89" subjects_at_risk="288"/>
                <counts group_id="E2" events="210" subjects_affected="104" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>THROMBOCYTOPENIA</sub_title>
                <counts group_id="E1" events="102" subjects_affected="54" subjects_at_risk="288"/>
                <counts group_id="E2" events="155" subjects_affected="76" subjects_at_risk="293"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>CONSTIPATION</sub_title>
                <counts group_id="E1" events="113" subjects_affected="92" subjects_at_risk="288"/>
                <counts group_id="E2" events="81" subjects_affected="69" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" events="60" subjects_affected="47" subjects_at_risk="288"/>
                <counts group_id="E2" events="70" subjects_affected="51" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" events="202" subjects_affected="131" subjects_at_risk="288"/>
                <counts group_id="E2" events="121" subjects_affected="86" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>STOMATITIS</sub_title>
                <counts group_id="E1" events="32" subjects_affected="30" subjects_at_risk="288"/>
                <counts group_id="E2" events="24" subjects_affected="19" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>VOMITING</sub_title>
                <counts group_id="E1" events="99" subjects_affected="73" subjects_at_risk="288"/>
                <counts group_id="E2" events="48" subjects_affected="39" subjects_at_risk="293"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>ASTHENIA</sub_title>
                <counts group_id="E1" events="50" subjects_affected="30" subjects_at_risk="288"/>
                <counts group_id="E2" events="58" subjects_affected="29" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" events="117" subjects_affected="89" subjects_at_risk="288"/>
                <counts group_id="E2" events="108" subjects_affected="80" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>OEDEMA PERIPHERAL</sub_title>
                <counts group_id="E1" events="36" subjects_affected="24" subjects_at_risk="288"/>
                <counts group_id="E2" events="16" subjects_affected="13" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>PYREXIA</sub_title>
                <counts group_id="E1" events="21" subjects_affected="16" subjects_at_risk="288"/>
                <counts group_id="E2" events="17" subjects_affected="15" subjects_at_risk="293"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>WEIGHT DECREASED</sub_title>
                <counts group_id="E1" events="25" subjects_affected="24" subjects_at_risk="288"/>
                <counts group_id="E2" events="17" subjects_affected="14" subjects_at_risk="293"/>
              </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="109" subjects_affected="79" subjects_at_risk="288"/>
                <counts group_id="E2" events="79" subjects_affected="63" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>HYPERGLYCAEMIA</sub_title>
                <counts group_id="E1" events="15" subjects_affected="11" subjects_at_risk="288"/>
                <counts group_id="E2" events="24" subjects_affected="24" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>HYPOMAGNESAEMIA</sub_title>
                <counts group_id="E1" events="19" subjects_affected="16" subjects_at_risk="288"/>
                <counts group_id="E2" events="22" subjects_affected="21" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>HYPONATRAEMIA</sub_title>
                <counts group_id="E1" events="14" subjects_affected="12" subjects_at_risk="288"/>
                <counts group_id="E2" events="18" subjects_affected="16" subjects_at_risk="293"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ARTHRALGIA</sub_title>
                <counts group_id="E1" events="35" subjects_affected="26" subjects_at_risk="288"/>
                <counts group_id="E2" events="45" subjects_affected="39" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>BACK PAIN</sub_title>
                <counts group_id="E1" events="24" subjects_affected="22" subjects_at_risk="288"/>
                <counts group_id="E2" events="21" subjects_affected="17" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>BONE PAIN</sub_title>
                <counts group_id="E1" events="13" subjects_affected="9" subjects_at_risk="288"/>
                <counts group_id="E2" events="21" subjects_affected="15" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>MYALGIA</sub_title>
                <counts group_id="E1" events="22" subjects_affected="17" subjects_at_risk="288"/>
                <counts group_id="E2" events="50" subjects_affected="38" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>PAIN IN EXTREMITY</sub_title>
                <counts group_id="E1" events="19" subjects_affected="15" subjects_at_risk="288"/>
                <counts group_id="E2" events="17" subjects_affected="15" subjects_at_risk="293"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>DIZZINESS</sub_title>
                <counts group_id="E1" events="25" subjects_affected="22" subjects_at_risk="288"/>
                <counts group_id="E2" events="17" subjects_affected="17" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>DYSGEUSIA</sub_title>
                <counts group_id="E1" events="33" subjects_affected="29" subjects_at_risk="288"/>
                <counts group_id="E2" events="20" subjects_affected="19" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>PERIPHERAL SENSORY NEUROPATHY</sub_title>
                <counts group_id="E1" events="51" subjects_affected="42" subjects_at_risk="288"/>
                <counts group_id="E2" events="195" subjects_affected="131" subjects_at_risk="293"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>INSOMNIA</sub_title>
                <counts group_id="E1" events="30" subjects_affected="30" subjects_at_risk="288"/>
                <counts group_id="E2" events="39" subjects_affected="37" subjects_at_risk="293"/>
              </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="31" subjects_affected="29" subjects_at_risk="288"/>
                <counts group_id="E2" events="32" subjects_affected="27" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>DYSPNOEA</sub_title>
                <counts group_id="E1" events="30" subjects_affected="25" subjects_at_risk="288"/>
                <counts group_id="E2" events="46" subjects_affected="42" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>HICCUPS</sub_title>
                <counts group_id="E1" events="29" subjects_affected="21" subjects_at_risk="288"/>
                <counts group_id="E2" events="27" subjects_affected="17" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>OROPHARYNGEAL PAIN</sub_title>
                <counts group_id="E1" events="16" subjects_affected="15" subjects_at_risk="288"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="293"/>
              </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="40" subjects_affected="34" subjects_at_risk="288"/>
                <counts group_id="E2" events="160" subjects_affected="137" subjects_at_risk="293"/>
              </event>
              <event>
                <sub_title>RASH</sub_title>
                <counts group_id="E1" events="29" subjects_affected="25" subjects_at_risk="288"/>
                <counts group_id="E2" events="16" subjects_affected="13" subjects_at_risk="293"/>
              </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>AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Medical Services</name_or_title>
      <organization>AbbVie</organization>
      <phone>800-633-9110</phone>
      <email>abbvieclinicaltrials@abbvie.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/NCT02264990
org study id: M14-359
secondary id: 2014-002565-30
nct id: NCT02264990
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of this study is to evaluate the safety and efficacy of veliparib plus
      carboplatin and paclitaxel versus the Investigator's choice of standard chemotherapy in
      adults with metastatic or advanced non-squamous non-small cell lung cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Survival (OS) in the Lung Subtype Panel Positive Subgroup
time frame: From randomization up to the data cut-off date of 15 July 2019; median follow-up time was 44.5 and 45.3 months in LSP+ participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.
description: Overall survival is defined as the time from the date that the participant was randomized to the date of the participant's death. Overall survival was estimated using Kaplan-Meier methodology. Participants still alive at the data cut-off date were censored at the date they were last known to be alive.
measure: Progression Free Survival (PFS) in the Lung Subtype Panel Positive Subgroup
time frame: From randomization up to the data cut-off date of 15 July 2019; the median follow-up time was 44.5 and 45.3 months in LSP+ participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.
description: Progression-free survival is defined as the time from the date of randomization to the date of disease progression (PD) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death (all causes of mortality), whichever occurred first.
PD: At least a 20% increase in the size of target lesions, taking as reference the smallest size recorded since the treatment started (Baseline or after) with an absolute increase of at least 5 mm, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.
PFS was estimated using Kaplan-Meier methodology. Participants who did not have an event of disease progression or had not died on or before the cutoff date were censored at the date of their last disease progression assessment on or before the cut-off date. Any PD and death occurring > 26 weeks and > 12 weeks after the previous assessment, respectively, were excluded and patients were censored at last assessment before PD or death.
measure: Objective Response Rate (ORR) in the Lung Subtype Panel Positive Subgroup
time frame: Assessed on Day 1 of Cycles 3 and 5 then every 9 weeks for 1 year or until maintenance therapy was discontinued, then every 12 weeks until radiographic progression or death; median time on follow-up was 5.2 and 6.3 months in each group, respectively.
description: Objective response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria. Response must have been confirmed at a consecutive assessment 28 days or more after the assessment at which response was first observed.
CR: The disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters, persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, or any new lesions.
measure: Overall Survival in All Participants
time frame: From randomization up to the data cut-off date of 15 July 2019; the median OS follow-up time was 45.4 and 44.6 months in all participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.
description: Overall survival is defined as the time from the date that the participant was randomized to the date of the participant's death. OS was estimated using Kaplan-Meier methodology. Participants still alive at the data cut-off date were censored at the date they were last known to be alive.
measure: Progression Free Survival (PFS) in All Participants
time frame: From randomization up to the data cut-off date of 15 July 2019; the median follow-up time was 45.4 and 44.6 months in all participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.
description: Progression-free survival is defined as the time from the date of randomization to the date of disease progression (PD) per RECIST version 1.1 or death (all causes of mortality), whichever occurred first.
PD: At least a 20% increase in the size of target lesions, taking as reference the smallest size recorded since the treatment started (Baseline or after) with an absolute increase of at least 5 mm, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.
PFS was estimated using Kaplan-Meier methodology. Participants who did not have an event of disease progression or had not died on or before the cut-off date were censored at the date of their last disease progression assessment on or before the cut-off date. Any PD and death occurring > 26 weeks and > 12 weeks after the previous assessment, respectively, were excluded and patients were censored at last assessment before PD or death.
measure: Objective Response Rate (ORR) in All Participants
time frame: Assessed on Day 1 of Cycles 3 and 5 then every 9 weeks for 1 year or until maintenance therapy was discontinued, then every 12 weeks until radiographic progression or death; median time on follow-up was 6.7 and 5.9 months in each group, respectively.
description: Objective response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) per RECIST version 1.1 criteria. Response must have been confirmed at a consecutive assessment 28 days or more after the assessment at which response was first observed.
CR: The disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters, persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, or any new lesions.
arm group label: Veliparib + Carboplatin + Paclitaxel
arm group type: Experimental
description: Participants received 120 mg veliparib twice a day (BID) on Days -2 to 5 (7 days), carboplatin at an area under the curve (AUC) of 6 mg/mL*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
arm group label: Investigator's Choice Chemotherapy
arm group type: Active Comparator
description: Participants received Investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:
Carboplatin AUC 6 mg/mL*min + paclitaxel 200 mg/m²
Cisplatin 75 mg/m² + pemetrexed 500 mg/m²
Carboplatin AUC 6 or AUC 5 mg/mL*min + pemetrexed 500 mg/m²
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
intervention type: Drug
intervention name: Paclitaxel
description: Administered by Intravenous infusion on Day 1 of each 21-day cycle
arm group label: Investigator's Choice Chemotherapy
arm group label: Veliparib + Carboplatin + Paclitaxel
intervention type: Drug
intervention name: Carboplatin
description: Administered by Intravenous infusion on Day 1 of each 21-day cycle
arm group label: Investigator's Choice Chemotherapy
arm group label: Veliparib + Carboplatin + Paclitaxel
intervention type: Drug
intervention name: Cisplatin
description: Administered by Intravenous infusion on Day 1 of each 21-day cycle
arm group label: Investigator's Choice Chemotherapy
intervention type: Drug
intervention name: Veliparib
description: Oral capsule, administered twice daily for 7 days in each 21-day cycle
arm group label: Veliparib + Carboplatin + Paclitaxel
other name: ABT-888
intervention type: Drug
intervention name: Pemetrexed
description: Administered by Intravenous infusion on Day 1 of each 21-day cycle
arm group label: Investigator's Choice Chemotherapy
arm group label: Veliparib + Carboplatin + Paclitaxel
other name: Alimta
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: AbbVie Inc.
role: Study Director
affiliation: AbbVie
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country: Argentina
country: Australia
country: Canada
country: Czechia
country: Denmark
country: Finland
country: Germany
country: Hungary
country: Israel
country: Japan
country: Korea, Republic of
country: Netherlands
country: New Zealand
country: Russian Federation
country: South Africa
country: Spain
country: Taiwan
country: Turkey
country: United Kingdom
country: United States
country: Czech Republic
country: France
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Paclitaxel
mesh term: Carboplatin
mesh term: Pemetrexed
mesh term: Veliparib
sharing ipd: Yes
ipd description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
ipd access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
ipd url: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
provided document: 
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participant flow: 
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certain agreements: 
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