<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/NCT02252172</url>
  </required_header>
  <id_info>
    <org_study_id>CR104762</org_study_id>
    <secondary_id>54767414MMY3008</secondary_id>
    <secondary_id>2014-002273-11</secondary_id>
    <nct_id>NCT02252172</nct_id>
  </id_info>
  <brief_title>Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma</brief_title>
  <official_title>A Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High Dose Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Research &amp; Development, LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the efficacy of daratumumab in combination with&#xD;
      lenalidomide and dexamethasone to that of lenalidomide and dexamethasone in terms of&#xD;
      progression-free survival (PFS) in participants with newly diagnosed multiple myeloma (a&#xD;
      blood cancer of plasma cells) who are not candidates for high dose chemotherapy (treatment of&#xD;
      disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 3, randomized (study drug assigned by chance), open-label (participants and&#xD;
      researchers are aware about the treatment, participants are receiving), active-controlled&#xD;
      (study in which the experimental treatment or procedure is compared to a standard treatment&#xD;
      or procedure), parallel-group (each group of participants will be treated at the same time),&#xD;
      and multicenter (when more than one hospital or medical school team work on a medical&#xD;
      research study) study in participants with newly diagnosed multiple myeloma and who are not&#xD;
      candidates for high dose chemotherapy and ASCT. All the eligible participants will be&#xD;
      randomly assigned to receive either lenalidomide and dexamethasone (Rd) (Arm A) or&#xD;
      daratumumab in combination with lenalidomide and dexamethasone (DRd) (Arm B). Daratumumab (16&#xD;
      milligram per kilogram [mg/kg]) will be administered weekly for first 8 weeks (Cycles 1 to 2)&#xD;
      of treatment and then every other week for 16 weeks (Cycles 3 to 6), then every 4 weeks (from&#xD;
      Cycle 7 and beyond) until progression of disease or unacceptable toxicity. Lenalidomide will&#xD;
      be administered at a dose of 25 mg orally on Days 1 through 21 of each 28-day cycle, and&#xD;
      dexamethasone will be administered at a dose of 40 mg once a week for both treatment arms.&#xD;
      Participants in both treatment arms will continue lenalidomide and dexamethasone until&#xD;
      disease progression or unacceptable toxicity. All participants randomized to Treatment Arm B&#xD;
      (DRd) in this study initially received daratumumab IV formulation; however, following&#xD;
      implementation of protocol amendment 8, participants still receiving treatment with&#xD;
      daratumumab IV will have the option to switch to daratumumab SC on Day 1 of any cycle, at the&#xD;
      discretion of the investigator. Daratumumab subcutaneous (SC) will be administered by SC&#xD;
      injection at a fixed dose of 1800 mg once every 4 weeks until documented progression,&#xD;
      unacceptable toxicity, or study completion. Participants in Arm A who have sponsor-confirmed&#xD;
      disease progression may have the option to receive daratumumab provided by the sponsor (in&#xD;
      any subsequent line of therapy) in the Follow-up phase. The study consists of 3 phases:&#xD;
      Screening Phase (within 21 days prior to the first dose administration on Day 1), Treatment&#xD;
      Phase (Day 1 up to discontinuation of all study treatment), and Follow-up Phase (from&#xD;
      discontinuation of all study treatment up to death, lost to follow up, consent withdrawal, or&#xD;
      study end, whichever occurs first). The maximum duration of study will be 7 years after last&#xD;
      participant is randomized. Efficacy will primarily be evaluated by PFS. Participants' safety&#xD;
      will be monitored throughout the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 2015</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Actual">September 2018</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>Primary: Progression-free Survival (PFS)</measure>
    <time_frame>From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or clinical cut-off (CCO) whichever occurs first (up to 3.5 years)</time_frame>
    <description>PFS is defined as time from date of randomization to either progressive disease (PD) or death, whichever occurs first based on computerized algorithm as per International Myeloma Working Group (IMWG) criteria. PD is defined as an increase of 25 percent (%) from the lowest response value in one of the following: serum and urine M-component (absolute increase must be greater than or equal to [&gt;=] 0.5 gram per deciliter [g/dL] and &gt;=200 milligram [mg]/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase must be greater than [&gt;]10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium &gt;11.5 mg/dL) that can be attributed solely to Plasma cell (PC) proliferative disorder.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Complete Response (CR) or Better</measure>
    <time_frame>From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)</time_frame>
    <description>CR or better is defined as percentage of participants with a CR or better (CR or stringent complete response [sCR]) based on computerized algorithm as per IMWG criteria. CR is defined as negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and less than (&lt;) 5 percent (%) PCs in bone marrow. In participants with only measurable disease by serum FLC levels a normal serum FLC ratio is required. sCR is defined as in addition to CR a normal FLC ratio, and absence of clonal PCs by immunohistochemistry or immunofluorescence or 2 to 4-color flow cytometry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Very Good Partial Response (VGPR) or Better</measure>
    <time_frame>From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)</time_frame>
    <description>VGPR or better is defined as the percentage of participants with a response of VGPR or better (VGPR, CR or sCR) based on computerized algorithm as per IMWG criteria. VGPR is defined as serum and urine M-component detectable by immunofixation but not on electrophoresis or &gt;=90% reduction in serum M-protein plus urine M-protein &lt;100 mg/24 hours. In participants with only measurable disease by serum FLC levels a &gt;90% decrease in the difference between involved and uninvolved FLC levels is required.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Negative Minimal Residual Disease (MRD)</measure>
    <time_frame>From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)</time_frame>
    <description>MRD negativity rate is defined as the percentage of participants who had negative MRD (detection of less than 1 malignant cell among 100,000 normal cells) assessment at any timepoint after the date of randomization by evaluation of bone marrow aspirates. MRD was assessed in participants who achieved CR or better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate (ORR)</measure>
    <time_frame>From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)</time_frame>
    <description>ORR is defined as the percentage of participants who achieved partial response (PR) or better (PR, VGPR, CR or sCR) based on computerized algorithm as per IMWG criteria. PR is defined as &gt;=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by &gt;=90% or to &lt;200 mg/24 hours. If the serum and urine M-protein are not measurable, a decrease of &gt;=50% in the difference between involved and uninvolved FLC levels is required. A &gt;=50% reduction in the size of soft tissue plasmacytomas is also required.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>From randomization to death, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)</time_frame>
    <description>OS was measured from the date of randomization to the date of the death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Disease Progression (TTP)</measure>
    <time_frame>From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)</time_frame>
    <description>TTP is defined as the time from the date of randomization to the date of PD based on computerized algorithm as per IMWG criteria, or death due to PD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Response</measure>
    <time_frame>From randomization to first response (PR or better) (up to 7.8 years)</time_frame>
    <description>Time to response is defined as the time from the date of randomization to the first efficacy evaluation that met criteria for PR or better based on computerized algorithm as per IMWG criteria. PR: &gt;=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by &gt;=90% or to &lt;200 mg/24 hours. If the serum and urine M-protein are not measurable, a decrease of &gt;=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria; If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, &gt;=50% reduction in bone marrow PCs is required. A &gt;=50% reduction in the size of soft tissue plasmacytomas is also required.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DoR)</measure>
    <time_frame>From first response (PR of better) to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)</time_frame>
    <description>DoR is defined as the time from the date of initial response (PR or better) to the date of PD, based on computerized algorithm as per IMWG criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Subsequent Anti-myeloma Treatment</measure>
    <time_frame>From randomization to start of first subsequent anti-myeloma treatment, death, withdrawal of consent to study participation or CCO whichever is first (up to 7.8 years)</time_frame>
    <description>Time to subsequent anti-myeloma treatment is defined as the time from randomization to the start of first line of subsequent anti-myeloma treatment or death, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free Survival on Next Line of Therapy (PFS2)</measure>
    <time_frame>From randomization to disease progression on first line of subsequent anti-myeloma therapy, death, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)</time_frame>
    <description>PFS2 is defined as the time from randomization to progression on the first line of subsequent anti-myeloma therapy or death, whichever occurs first. Disease progression on first line of subsequent anti-myeloma treatment was based on investigator judgment. Participants that were censored for PFS1 were also censored for PFS2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 Global Health Status Score to Day 1 of Cycle 3, 6, 9 and 12</measure>
    <time_frame>Baseline and Day 1 of Cycle 3, 6, 9 and 12 (each Cycle of 28 days)</time_frame>
    <description>EORTC QLQ-C30 is 30 items self-reporting questionnaire, with 1 week recall period, resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 Global Health Status (GHS) scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Questionnaire includes 28 items with 4-point Likert type responses from &quot;1-not at all&quot; to &quot;4-very much&quot; to assess functioning and symptoms; 2 items with 7-point Likert scales (1= poor and 7= excellent) for global health and overall health related QoL. Scores are transformed to 0 to 100 scale, with higher scores representing better GHS, better functioning, and more symptoms. Negative change from baseline values shows deterioration in quality of life or functioning and reduction in symptom and positive values indicate improvement and worsening of symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) to Day 1 of Cycle 3, 6, 9 and 12</measure>
    <time_frame>Baseline and Day 1 of Cycle 3, 6, 9 and 12 (each Cycle of 28 days)</time_frame>
    <description>EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The Visual Analogue Scale is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Utility Score to Day 1 of Cycle 3, 6, 9 and 12</measure>
    <time_frame>Baseline and Day 1 of Cycle 3, 6, 9 and 12 (each Cycle of 28 days)</time_frame>
    <description>EQ-5D-5L is standardized, participant-reported questionnaire to assess health-related quality of life. EQ-5D-5L includes 2 components: EQ-5D-5L health state profile (descriptive system) and EQ-5D-5L VAS. EQ-5D-5L descriptive system provides a profile of participant's health state 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. Responses to the 5-dimension scores were combined and converted into single preference-weighted health utility index score 0 (0.0- worst health state) to 1 (1.0- better health state) representing the general health status of individual (but allows for values less than 0 by United kingdom [UK] scoring algorithm).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">737</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>Lenalidomide and Dexamethasone (Rd)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive Lenalidomide 25 mg capsule orally on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously once a week. Study treatment continues until disease progression, unacceptable toxicity, or end of study (maximum up to 7 years after last subject is randomized) whichever comes first.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Daratumumab + Lenalidomide + Dexamethasone (DRd)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive Daratumumab 16 milligram per kilogram (mg/kg) by intravenous infusion, once a week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks, Lenalidomide 25 mg capsule orally on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously once a week. Following implementation of protocol amendment 8, participants still receiving treatment with daratumumab IV will have the option to switch to daratumumab SC on Day 1 of any cycle, at the discretion of the investigator. Daratumumab subcutaneous (SC) will be administered by SC injection at a fixed dose of 1800 mg once every 4 weeks until documented progression, unacceptable toxicity, or study completion. Study treatment continues until disease progression, unacceptable toxicity, or end of study (maximum up to 7 years after last subject is randomized) whichever comes first.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Daratumumab IV</intervention_name>
    <description>Daratumumab will be administered at a dose of 16 milligram per kilogram (mg/kg) by intravenous (IV) infusion, once a week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression of disease, unacceptable toxicity, or end of study (maximum up to 7 years).</description>
    <arm_group_label>Lenalidomide and Dexamethasone (Rd)</arm_group_label>
    <other_name>JNJ-54767414</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lenalidomide</intervention_name>
    <description>Lenalidomide 25 mg capsule orally on Day 1 through Day 21 of each 28-day cycle.</description>
    <arm_group_label>Daratumumab + Lenalidomide + Dexamethasone (DRd)</arm_group_label>
    <arm_group_label>Lenalidomide and Dexamethasone (Rd)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Dexamethasone 40 mg orally or intravenously once in a week.</description>
    <arm_group_label>Daratumumab + Lenalidomide + Dexamethasone (DRd)</arm_group_label>
    <arm_group_label>Lenalidomide and Dexamethasone (Rd)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Daratumumab SC</intervention_name>
    <description>Daratumumab SC will be administered by SC injection at a fixed dose of 1800 mg once every 4 weeks until documented progression, unacceptable toxicity, or study end. Following implementation of protocol amendment 8, participants still receiving treatment with daratumumab IV will have the option to switch to daratumumab SC on Day 1 of any cycle, at the discretion of the investigator.</description>
    <arm_group_label>Daratumumab + Lenalidomide + Dexamethasone (DRd)</arm_group_label>
    <other_name>JNJ-54767414</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant must have documented multiple myeloma satisfying the CRAB (calcium&#xD;
             elevation, renal insufficiency, anemia and bone abnormalities) criteria, monoclonal&#xD;
             plasma cells in the bone marrow greater than or equal to (&gt;=) 10 percent (%) or&#xD;
             presence of a biopsy proven plasmacytoma and measurable disease as defined by any of&#xD;
             the following: (a) immunoglobulin (Ig) G myeloma (serum monoclonal paraprotein&#xD;
             [M-protein] level &gt;=1.0 gram/deciliter [g/dL] or urine M-protein level &gt;=200&#xD;
             milligram[mg]/24 hours[hrs]; or (b) IgA, IgM, IgD, or IgE multiple myeloma (serum&#xD;
             M-protein level &gt;=0.5 g/dL or urine M-protein level &gt;=200 mg/24 hrs); or (c) light&#xD;
             chain multiple myeloma without measurable disease in serum or urine (serum&#xD;
             immunoglobulin free light chain &gt;=10 mg/dL and abnormal serum immunoglobulin kappa&#xD;
             lambda free light chain ratio)&#xD;
&#xD;
          -  Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status&#xD;
             score of 0, 1, or 2&#xD;
&#xD;
          -  Participants who are newly diagnosed and not considered for high-dose chemotherapy due&#xD;
             to: being age &gt;=65 years; or participants less than (&lt;) 65 years with presence of&#xD;
             important comorbid condition(s) likely to have a negative impact on tolerability of&#xD;
             high dose chemotherapy with stem cell transplantation. Sponsor review and approval of&#xD;
             participants below 65 years of age is required before randomization&#xD;
&#xD;
          -  Women of childbearing potential must commit to either abstain continuously from sexual&#xD;
             intercourse or to use 2 methods of reliable birth control simultaneously as deemed&#xD;
             appropriate by the Investigator. Contraception must begin 4 weeks prior to dosing and&#xD;
             must continue for 3 months after the last dose of daratumumab&#xD;
&#xD;
          -  Man, who is sexually active with a woman of child-bearing potential must agree to use&#xD;
             a latex or synthetic condom, even if he had a successful vasectomy, must agree to use&#xD;
             an adequate contraception method as deemed appropriate by the Investigator, and must&#xD;
             also agree to not donate sperm during the study and for 4 weeks after last dose of&#xD;
             lenalidomide and 4 months after last dose of daratumumab&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant has a diagnosis of primary amyloidosis, monoclonal gammopathy of&#xD;
             undetermined significance (presence of serum M-protein &lt;3 g/dL; absence of lytic bone&#xD;
             lesions, anemia, hypercalcemia, and renal insufficiency related to the M-protein), or&#xD;
             smoldering multiple myeloma (asymptomatic multiple myeloma with absence of related&#xD;
             organ or tissue impairment end organ damage)&#xD;
&#xD;
          -  Participant has a diagnosis of Waldenström's disease, or other conditions in which IgM&#xD;
             M protein is present in the absence of a clonal plasma cell infiltration with lytic&#xD;
             bone lesions&#xD;
&#xD;
          -  Participant has a history of malignancy (other than multiple myeloma) within 5 years&#xD;
             before the date of randomization (exceptions are squamous and basal cell carcinomas of&#xD;
             the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the&#xD;
             Investigator, with concurrence with the Sponsor's medical monitor, is considered cured&#xD;
             with minimal risk of recurrence within 5 years)&#xD;
&#xD;
          -  Participant has prior or current systemic therapy or SCT for multiple myeloma, with&#xD;
             the exception of an emergency use of a short course (equivalent of dexamethasone 40&#xD;
             mg/day for 4 days) of corticosteroids before treatment&#xD;
&#xD;
          -  Participant has had radiation therapy within 14 days of randomization&#xD;
&#xD;
          -  Participant has known chronic obstructive pulmonary disease (COPD) (defined as a&#xD;
             forced expiratory volume in 1 second [FEV1] &lt;50% of predicted normal), persistent&#xD;
             asthma, or a history of asthma within the last 2 years (controlled intermittent asthma&#xD;
             or controlled mild persistent asthma is allowed)&#xD;
&#xD;
          -  Participants with known or suspected COPD must have a FEV1 test during Screening&#xD;
&#xD;
          -  Participant is known to be seropositive for human immunodeficiency virus (HIV) or&#xD;
             hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg] or&#xD;
             antibodies to hepatitis B surface and core antigens [anti-HBs and anti-HBc,&#xD;
             respectively]) or hepatitis C (anti-HCV antibody positive or HCV-ribonucleic acid&#xD;
             [RNA] quantitation positive)&#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>Janssen Research &amp; Development, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Research &amp; Development, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Berkeley</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>El Cajon</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Greenbrae</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oceanside</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>West Hills</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Whittier</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fort Collins</city>
        <state>Colorado</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Glenwood Springs</city>
        <state>Colorado</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Norwalk</city>
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        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Washington</city>
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        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Boca Raton</city>
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        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Boynton Beach</city>
        <state>Florida</state>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Lake City</city>
        <state>Florida</state>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Weston</city>
        <state>Florida</state>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Macon</city>
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        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Marietta</city>
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        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Niles</city>
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        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
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  <location>
    <facility>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Lafayette</city>
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  <location>
    <facility>
      <address>
        <city>Marrero</city>
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        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Shreveport</city>
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  <location>
    <facility>
      <address>
        <city>Annapolis</city>
        <state>Maryland</state>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Frederick</city>
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        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Detroit</city>
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        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Duluth</city>
        <state>Minnesota</state>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <country>United States</country>
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  <location>
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      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Hooksett</city>
        <state>New Hampshire</state>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Brick</city>
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        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Hackensack</city>
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        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Livingston</city>
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        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Plainfield</city>
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        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Somerville</city>
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  <location>
    <facility>
      <address>
        <city>Summit</city>
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  <location>
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      <address>
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        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>New York</city>
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  <location>
    <facility>
      <address>
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  <location>
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  <location>
    <facility>
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  <location>
    <facility>
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        <country>United States</country>
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  <location>
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      <address>
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  <location>
    <facility>
      <address>
        <city>Canton</city>
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        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Columbus</city>
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        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Bend</city>
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  <location>
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      <address>
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  <location>
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  <location>
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      <address>
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  <location>
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  <location>
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  <location>
    <facility>
      <address>
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  <location>
    <facility>
      <address>
        <city>Arlington</city>
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        <country>United States</country>
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  <location>
    <facility>
      <address>
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        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Fort Sam Houston</city>
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  <location>
    <facility>
      <address>
        <city>Fort Worth</city>
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        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Plano</city>
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        <country>United States</country>
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  <location>
    <facility>
      <address>
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        <state>Texas</state>
        <country>United States</country>
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  <location>
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  <location>
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  <location>
    <facility>
      <address>
        <city>Spokane</city>
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  <location>
    <facility>
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  <location>
    <facility>
      <address>
        <city>Fitzroy</city>
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  <location>
    <facility>
      <address>
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  <location>
    <facility>
      <address>
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  <location>
    <facility>
      <address>
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  <location>
    <facility>
      <address>
        <city>Nedlands</city>
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  <location>
    <facility>
      <address>
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  <location>
    <facility>
      <address>
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  <location>
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  <location>
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  <location>
    <facility>
      <address>
        <city>Linz</city>
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  <location>
    <facility>
      <address>
        <city>Salzburg</city>
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    <facility>
      <address>
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  <location>
    <facility>
      <address>
        <city>Wien Wien</city>
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      <address>
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  <location>
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      <address>
        <city>Brussels</city>
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  <location>
    <facility>
      <address>
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  <location>
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      <address>
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  <location>
    <facility>
      <address>
        <city>Liege</city>
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        <state>Alberta</state>
        <country>Canada</country>
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  <location>
    <facility>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
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  <location>
    <facility>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
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  <location>
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      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <country>Canada</country>
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  <location>
    <facility>
      <address>
        <city>Greenfield Park</city>
        <country>Canada</country>
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  <location>
    <facility>
      <address>
        <city>N/a N/a</city>
        <country>Canada</country>
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  <location>
    <facility>
      <address>
        <city>Nova Scotia</city>
        <country>Canada</country>
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  <location>
    <facility>
      <address>
        <city>Quebec</city>
        <country>Canada</country>
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  <location>
    <facility>
      <address>
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        <country>Denmark</country>
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  <location>
    <facility>
      <address>
        <city>Odense</city>
        <country>Denmark</country>
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  <location>
    <facility>
      <address>
        <city>Vejle</city>
        <country>Denmark</country>
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    <facility>
      <address>
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        <country>France</country>
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  <location>
    <facility>
      <address>
        <city>Angers</city>
        <country>France</country>
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  <location>
    <facility>
      <address>
        <city>Bayonne Cedex</city>
        <country>France</country>
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  <location>
    <facility>
      <address>
        <city>Bretagne</city>
        <country>France</country>
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  <location>
    <facility>
      <address>
        <city>Caen</city>
        <country>France</country>
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  <location>
    <facility>
      <address>
        <city>Cergy Pontoise</city>
        <country>France</country>
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  <location>
    <facility>
      <address>
        <city>Chalons Sur Saone</city>
        <country>France</country>
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  <location>
    <facility>
      <address>
        <city>Clermont-Ferrand</city>
        <country>France</country>
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  <location>
    <facility>
      <address>
        <city>Creteil</city>
        <country>France</country>
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  <location>
    <facility>
      <address>
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        <country>France</country>
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  <location>
    <facility>
      <address>
        <city>Dunkerque Cedex 1</city>
        <country>France</country>
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  <location>
    <facility>
      <address>
        <city>Grenoble Cedex 9</city>
        <country>France</country>
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  <location>
    <facility>
      <address>
        <city>La Roche sur Yon Cedex 9</city>
        <country>France</country>
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  <location>
    <facility>
      <address>
        <city>Le Chesnay Cedex</city>
        <country>France</country>
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  <location>
    <facility>
      <address>
        <city>Le Mans</city>
        <country>France</country>
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  <location>
    <facility>
      <address>
        <city>Lille Cedex</city>
        <country>France</country>
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  <location>
    <facility>
      <address>
        <city>Lille</city>
        <country>France</country>
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  <location>
    <facility>
      <address>
        <city>Limoges</city>
        <country>France</country>
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  <location>
    <facility>
      <address>
        <city>Lyon, Pierre-Benite</city>
        <country>France</country>
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  <location>
    <facility>
      <address>
        <city>Marseille Cedex 9</city>
        <country>France</country>
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  <location>
    <facility>
      <address>
        <city>Metz-Tessy</city>
        <country>France</country>
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  <location>
    <facility>
      <address>
        <city>Montivilliers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mulhouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nice N/a</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Paris Cedex 12</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Paris, 75</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>PERIGUEUX cedex</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Perpignan</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pessac</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Poitiers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Reims</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rouen Cedex</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint Brieuc Cedex 1</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint Priest en Jarez</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>St Malo Cedex</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>St Quentin Cedex</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Toulouse Cedex 9</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>TOURS Cedex 9</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Vandoeuvre Les Nancy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Aschaffenburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bad Berka</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bonn</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Braunschweig</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dresden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Essen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Frankfurt</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hannover</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Heidelberg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hessen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kiel</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Koblenz</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mainz</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mannheim</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rostock</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Schwerin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Stuttgart</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tuebingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ulm</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Villingen-Schwenningen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Galway</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hadera</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nahariya</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Petah Tikva</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tel-Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hilversum</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hoofddorp</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tilburg</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Falun</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Göteborg</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Halmstad</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Helsingborg</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Huddinge</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lulea</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lund</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Örebro</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Aberdeen</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Canterbury</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dundee</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Leeds</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oxford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Plymouth, Devon</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Southampton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Truro</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wolverhampton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Ireland</country>
    <country>Israel</country>
    <country>Netherlands</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>New Zealand</country>
  </removed_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <results_first_submitted>September 24, 2019</results_first_submitted>
  <results_first_submitted_qc>December 20, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">January 9, 2020</results_first_posted>
  <last_update_submitted>August 15, 2023</last_update_submitted>
  <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multiple Myeloma</keyword>
  <keyword>Daratumumab</keyword>
  <keyword>JNJ-54767414</keyword>
  <keyword>Lenalidomide</keyword>
  <keyword>Dexamethasone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Myeloma</mesh_term>
    <mesh_term>Neoplasms, Plasma Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Lenalidomide</mesh_term>
    <mesh_term>Daratumumab</mesh_term>
    <mesh_term>Antibodies, Monoclonal</mesh_term>
  </intervention_browse>
  <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>June 12, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/72/NCT02252172/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 3, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/72/NCT02252172/SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Lenalidomide + Dexamethasone (Rd)</title>
          <description>Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity.</description>
        </group>
        <group group_id="P2">
          <title>Daratumumab + Lenalidomide + Dexamethasone (DRd)</title>
          <description>Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="369"/>
                <participants group_id="P2" count="368"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="365"/>
                <participants group_id="P2" count="364"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="90"/>
                <participants group_id="P2" count="69"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="279"/>
                <participants group_id="P2" count="299"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Ongoing</title>
              <participants_list>
                <participants group_id="P1" count="276"/>
                <participants group_id="P2" count="298"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Lenalidomide + Dexamethasone (Rd)</title>
          <description>Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity.</description>
        </group>
        <group group_id="B2">
          <title>Daratumumab + Lenalidomide + Dexamethasone (DRd)</title>
          <description>Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity.</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="369"/>
            <count group_id="B2" value="368"/>
            <count group_id="B3" value="737"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74.2" spread="5.66"/>
                    <measurement group_id="B2" value="74.0" spread="5.44"/>
                    <measurement group_id="B3" value="74.1" spread="5.55"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="174"/>
                    <measurement group_id="B2" value="179"/>
                    <measurement group_id="B3" value="353"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="195"/>
                    <measurement group_id="B2" value="189"/>
                    <measurement group_id="B3" value="384"/>
                  </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>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="352"/>
                    <measurement group_id="B2" value="347"/>
                    <measurement group_id="B3" value="699"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="15"/>
                  </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>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</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>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="339"/>
                    <measurement group_id="B2" value="336"/>
                    <measurement group_id="B3" value="675"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>AUSTRALIA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AUSTRIA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BELGIUM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CANADA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DENMARK</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FRANCE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="155"/>
                    <measurement group_id="B2" value="157"/>
                    <measurement group_id="B3" value="312"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GERMANY</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IRELAND</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ISRAEL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ITALY</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NETHERLANDS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SWEDEN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>UNITED KINGDOM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>UNITED STATES</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74"/>
                    <measurement group_id="B2" value="77"/>
                    <measurement group_id="B3" value="151"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stage of Disease (ISS)</title>
          <description>The International Staging System (ISS) consists of following 3 stages - Stage I: serum beta2-microglobulin less than (&lt;) 3.5 milligram per liter (mg/L) and albumin greater than or equal to (&gt;=) 3.5 gram per 100 Milliliter (g/100 mL); Stage II: neither stage I nor stage III and Stage III: serum beta2-microglobulin &gt;= 5.5 mg/L.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Stage I</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="103"/>
                    <measurement group_id="B2" value="98"/>
                    <measurement group_id="B3" value="201"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stage II</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="156"/>
                    <measurement group_id="B2" value="163"/>
                    <measurement group_id="B3" value="319"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stage III</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="110"/>
                    <measurement group_id="B2" value="107"/>
                    <measurement group_id="B3" value="217"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time from Multiple Myeloma (MM) diagnosis</title>
          <description>Time from MM diagnosis is the time from diagnosis of multiple myeloma to randomization in each treatment group.</description>
          <units>months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.3" spread="1.4"/>
                    <measurement group_id="B2" value="1.4" spread="1.5"/>
                    <measurement group_id="B3" value="1.3" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Primary: Progression-free Survival (PFS)</title>
        <description>PFS is defined as time from date of randomization to either progressive disease (PD) or death, whichever occurs first based on computerized algorithm as per International Myeloma Working Group (IMWG) criteria. PD is defined as an increase of 25 percent (%) from the lowest response value in one of the following: serum and urine M-component (absolute increase must be greater than or equal to [&gt;=] 0.5 gram per deciliter [g/dL] and &gt;=200 milligram [mg]/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase must be greater than [&gt;]10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium &gt;11.5 mg/dL) that can be attributed solely to Plasma cell (PC) proliferative disorder.</description>
        <time_frame>From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or clinical cut-off (CCO) whichever occurs first (up to 3.5 years)</time_frame>
        <population>Intent-to-treat (ITT) population included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Lenalidomide + Dexamethasone (Rd)</title>
            <description>Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O2">
            <title>Daratumumab + Lenalidomide + Dexamethasone (DRd)</title>
            <description>Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity.</description>
          </group>
        </group_list>
        <measure>
          <title>Primary: Progression-free Survival (PFS)</title>
          <description>PFS is defined as time from date of randomization to either progressive disease (PD) or death, whichever occurs first based on computerized algorithm as per International Myeloma Working Group (IMWG) criteria. PD is defined as an increase of 25 percent (%) from the lowest response value in one of the following: serum and urine M-component (absolute increase must be greater than or equal to [&gt;=] 0.5 gram per deciliter [g/dL] and &gt;=200 milligram [mg]/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase must be greater than [&gt;]10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium &gt;11.5 mg/dL) that can be attributed solely to Plasma cell (PC) proliferative disorder.</description>
          <population>Intent-to-treat (ITT) population included all randomized participants.</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="369"/>
                <count group_id="O2" value="368"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.87" lower_limit="28.94" upper_limit="NA">Here NA signifies upper limit of confidence interval (CI) was not estimable due to an insufficient number of events.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Here NA signifies Median and CI was not estimable due to an insufficient number of events.</measurement>
                  </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>
            <p_value>&lt;0.0001</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.56</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.43</ci_lower_limit>
            <ci_upper_limit>0.73</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Complete Response (CR) or Better</title>
        <description>CR or better is defined as percentage of participants with a CR or better (CR or stringent complete response [sCR]) based on computerized algorithm as per IMWG criteria. CR is defined as negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and less than (&lt;) 5 percent (%) PCs in bone marrow. In participants with only measurable disease by serum FLC levels a normal serum FLC ratio is required. sCR is defined as in addition to CR a normal FLC ratio, and absence of clonal PCs by immunohistochemistry or immunofluorescence or 2 to 4-color flow cytometry.</description>
        <time_frame>From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)</time_frame>
        <posting_date>12/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Very Good Partial Response (VGPR) or Better</title>
        <description>VGPR or better is defined as the percentage of participants with a response of VGPR or better (VGPR, CR or sCR) based on computerized algorithm as per IMWG criteria. VGPR is defined as serum and urine M-component detectable by immunofixation but not on electrophoresis or &gt;=90% reduction in serum M-protein plus urine M-protein &lt;100 mg/24 hours. In participants with only measurable disease by serum FLC levels a &gt;90% decrease in the difference between involved and uninvolved FLC levels is required.</description>
        <time_frame>From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)</time_frame>
        <posting_date>12/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Negative Minimal Residual Disease (MRD)</title>
        <description>MRD negativity rate is defined as the percentage of participants who had negative MRD (detection of less than 1 malignant cell among 100,000 normal cells) assessment at any timepoint after the date of randomization by evaluation of bone marrow aspirates. MRD was assessed in participants who achieved CR or better.</description>
        <time_frame>From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)</time_frame>
        <posting_date>12/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Response Rate (ORR)</title>
        <description>ORR is defined as the percentage of participants who achieved partial response (PR) or better (PR, VGPR, CR or sCR) based on computerized algorithm as per IMWG criteria. PR is defined as &gt;=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by &gt;=90% or to &lt;200 mg/24 hours. If the serum and urine M-protein are not measurable, a decrease of &gt;=50% in the difference between involved and uninvolved FLC levels is required. A &gt;=50% reduction in the size of soft tissue plasmacytomas is also required.</description>
        <time_frame>From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)</time_frame>
        <posting_date>12/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>OS was measured from the date of randomization to the date of the death.</description>
        <time_frame>From randomization to death, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)</time_frame>
        <posting_date>12/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Disease Progression (TTP)</title>
        <description>TTP is defined as the time from the date of randomization to the date of PD based on computerized algorithm as per IMWG criteria, or death due to PD.</description>
        <time_frame>From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)</time_frame>
        <posting_date>12/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Response</title>
        <description>Time to response is defined as the time from the date of randomization to the first efficacy evaluation that met criteria for PR or better based on computerized algorithm as per IMWG criteria. PR: &gt;=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by &gt;=90% or to &lt;200 mg/24 hours. If the serum and urine M-protein are not measurable, a decrease of &gt;=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria; If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, &gt;=50% reduction in bone marrow PCs is required. A &gt;=50% reduction in the size of soft tissue plasmacytomas is also required.</description>
        <time_frame>From randomization to first response (PR or better) (up to 7.8 years)</time_frame>
        <posting_date>12/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response (DoR)</title>
        <description>DoR is defined as the time from the date of initial response (PR or better) to the date of PD, based on computerized algorithm as per IMWG criteria.</description>
        <time_frame>From first response (PR of better) to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)</time_frame>
        <posting_date>12/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Subsequent Anti-myeloma Treatment</title>
        <description>Time to subsequent anti-myeloma treatment is defined as the time from randomization to the start of first line of subsequent anti-myeloma treatment or death, whichever occurs first.</description>
        <time_frame>From randomization to start of first subsequent anti-myeloma treatment, death, withdrawal of consent to study participation or CCO whichever is first (up to 7.8 years)</time_frame>
        <posting_date>12/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-free Survival on Next Line of Therapy (PFS2)</title>
        <description>PFS2 is defined as the time from randomization to progression on the first line of subsequent anti-myeloma therapy or death, whichever occurs first. Disease progression on first line of subsequent anti-myeloma treatment was based on investigator judgment. Participants that were censored for PFS1 were also censored for PFS2.</description>
        <time_frame>From randomization to disease progression on first line of subsequent anti-myeloma therapy, death, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)</time_frame>
        <posting_date>12/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 Global Health Status Score to Day 1 of Cycle 3, 6, 9 and 12</title>
        <description>EORTC QLQ-C30 is 30 items self-reporting questionnaire, with 1 week recall period, resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 Global Health Status (GHS) scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Questionnaire includes 28 items with 4-point Likert type responses from &quot;1-not at all&quot; to &quot;4-very much&quot; to assess functioning and symptoms; 2 items with 7-point Likert scales (1= poor and 7= excellent) for global health and overall health related QoL. Scores are transformed to 0 to 100 scale, with higher scores representing better GHS, better functioning, and more symptoms. Negative change from baseline values shows deterioration in quality of life or functioning and reduction in symptom and positive values indicate improvement and worsening of symptoms.</description>
        <time_frame>Baseline and Day 1 of Cycle 3, 6, 9 and 12 (each Cycle of 28 days)</time_frame>
        <population>ITT population included all randomized participants. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable in this outcome measure. Here 'n' (number analyzed) signifies number of participants analyzed at specified timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Lenalidomide + Dexamethasone (Rd)</title>
            <description>Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O2">
            <title>Daratumumab + Lenalidomide + Dexamethasone (DRd)</title>
            <description>Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 Global Health Status Score to Day 1 of Cycle 3, 6, 9 and 12</title>
          <description>EORTC QLQ-C30 is 30 items self-reporting questionnaire, with 1 week recall period, resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 Global Health Status (GHS) scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Questionnaire includes 28 items with 4-point Likert type responses from &quot;1-not at all&quot; to &quot;4-very much&quot; to assess functioning and symptoms; 2 items with 7-point Likert scales (1= poor and 7= excellent) for global health and overall health related QoL. Scores are transformed to 0 to 100 scale, with higher scores representing better GHS, better functioning, and more symptoms. Negative change from baseline values shows deterioration in quality of life or functioning and reduction in symptom and positive values indicate improvement and worsening of symptoms.</description>
          <population>ITT population included all randomized participants. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable in this outcome measure. Here 'n' (number analyzed) signifies number of participants analyzed at specified timepoints.</population>
          <units>Score on scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="348"/>
                <count group_id="O2" value="354"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Global health status score: Cycle 3 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="272"/>
                    <count group_id="O2" value="303"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" lower_limit="-0.7" upper_limit="3.7"/>
                    <measurement group_id="O2" value="4.5" lower_limit="2.4" upper_limit="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Global health status score: Cycle 6 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="255"/>
                    <count group_id="O2" value="295"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6" lower_limit="3.3" upper_limit="7.9"/>
                    <measurement group_id="O2" value="6.4" lower_limit="4.3" upper_limit="8.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Global health status score: Cycle 9 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="214"/>
                    <count group_id="O2" value="268"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" lower_limit="4.6" upper_limit="9.4"/>
                    <measurement group_id="O2" value="8.2" lower_limit="6" upper_limit="10.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Global health status score: Cycle 12 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="209"/>
                    <count group_id="O2" value="260"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" lower_limit="2.9" upper_limit="7.9"/>
                    <measurement group_id="O2" value="8.4" lower_limit="6.1" upper_limit="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) to Day 1 of Cycle 3, 6, 9 and 12</title>
        <description>EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The Visual Analogue Scale is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.</description>
        <time_frame>Baseline and Day 1 of Cycle 3, 6, 9 and 12 (each Cycle of 28 days)</time_frame>
        <population>ITT population included all randomized participants. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable in this outcome measure. Here 'n' signifies number of participants analyzed at specified timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Lenalidomide + Dexamethasone (Rd)</title>
            <description>Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O2">
            <title>Daratumumab + Lenalidomide + Dexamethasone (DRd)</title>
            <description>Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) to Day 1 of Cycle 3, 6, 9 and 12</title>
          <description>EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The Visual Analogue Scale is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.</description>
          <population>ITT population included all randomized participants. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable in this outcome measure. Here 'n' signifies number of participants analyzed at specified timepoints.</population>
          <units>Score on scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="346"/>
                <count group_id="O2" value="349"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Cycle 3 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="262"/>
                    <count group_id="O2" value="290"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" lower_limit="0.6" upper_limit="4.4"/>
                    <measurement group_id="O2" value="4.9" lower_limit="3" upper_limit="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Cycle 6 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="240"/>
                    <count group_id="O2" value="280"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7" lower_limit="3.7" upper_limit="7.7"/>
                    <measurement group_id="O2" value="8" lower_limit="6.1" upper_limit="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Cycle 9 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="207"/>
                    <count group_id="O2" value="256"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7" lower_limit="5.6" upper_limit="9.8"/>
                    <measurement group_id="O2" value="10.2" lower_limit="8.2" upper_limit="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Cycle 12 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="206"/>
                    <count group_id="O2" value="247"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" lower_limit="2.8" upper_limit="7"/>
                    <measurement group_id="O2" value="10.1" lower_limit="8.1" upper_limit="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Utility Score to Day 1 of Cycle 3, 6, 9 and 12</title>
        <description>EQ-5D-5L is standardized, participant-reported questionnaire to assess health-related quality of life. EQ-5D-5L includes 2 components: EQ-5D-5L health state profile (descriptive system) and EQ-5D-5L VAS. EQ-5D-5L descriptive system provides a profile of participant's health state 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. Responses to the 5-dimension scores were combined and converted into single preference-weighted health utility index score 0 (0.0- worst health state) to 1 (1.0- better health state) representing the general health status of individual (but allows for values less than 0 by United kingdom [UK] scoring algorithm).</description>
        <time_frame>Baseline and Day 1 of Cycle 3, 6, 9 and 12 (each Cycle of 28 days)</time_frame>
        <population>ITT population included all randomized participants. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable in this outcome measure. Here 'n' signifies number of participants analyzed at specified timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Lenalidomide + Dexamethasone (Rd)</title>
            <description>Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O2">
            <title>Daratumumab + Lenalidomide + Dexamethasone (DRd)</title>
            <description>Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Utility Score to Day 1 of Cycle 3, 6, 9 and 12</title>
          <description>EQ-5D-5L is standardized, participant-reported questionnaire to assess health-related quality of life. EQ-5D-5L includes 2 components: EQ-5D-5L health state profile (descriptive system) and EQ-5D-5L VAS. EQ-5D-5L descriptive system provides a profile of participant's health state 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. Responses to the 5-dimension scores were combined and converted into single preference-weighted health utility index score 0 (0.0- worst health state) to 1 (1.0- better health state) representing the general health status of individual (but allows for values less than 0 by United kingdom [UK] scoring algorithm).</description>
          <population>ITT population included all randomized participants. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable in this outcome measure. Here 'n' signifies number of participants analyzed at specified timepoints.</population>
          <units>Score on scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="346"/>
                <count group_id="O2" value="349"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Cycle 3 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="262"/>
                    <count group_id="O2" value="291"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08" lower_limit="0.057" upper_limit="0.102"/>
                    <measurement group_id="O2" value="0.107" lower_limit="0.085" upper_limit="0.128"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Cycle 6 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="240"/>
                    <count group_id="O2" value="280"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.116" lower_limit="0.092" upper_limit="0.139"/>
                    <measurement group_id="O2" value="0.136" lower_limit="0.114" upper_limit="0.158"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Cycle 9 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="207"/>
                    <count group_id="O2" value="256"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.124" lower_limit="0.1" upper_limit="0.149"/>
                    <measurement group_id="O2" value="0.124" lower_limit="0.101" upper_limit="0.146"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Cycle 12 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="206"/>
                    <count group_id="O2" value="247"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.113" lower_limit="0.088" upper_limit="0.138"/>
                    <measurement group_id="O2" value="0.141" lower_limit="0.118" upper_limit="0.164"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 3.5 years</time_frame>
      <desc>Safety population was defined as participants who have received at least 1 administration of any study treatment (partial or complete).</desc>
      <group_list>
        <group group_id="E1">
          <title>Lenalidomide + Dexamethasone (Rd)</title>
          <description>Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity.</description>
        </group>
        <group group_id="E2">
          <title>Daratumumab + Lenalidomide + Dexamethasone (DRd)</title>
          <description>Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 20.0</default_vocab>
        <default_assessment>Non-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="76" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="62" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="229" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="229" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Anaemia Macrocytic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Disseminated Intravascular Coagulation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Febrile Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Heparin-Induced Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Coronary Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Acute Myocardial Infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Angina Pectoris</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis Coronary Artery</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Atrial Flutter</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Atrial Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Atrioventricular Block</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Atrioventricular Block Complete</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Cardiac Amyloidosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Cardiac Arrest</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Cardiac Failure</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Cardiac Failure Acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Cardiac Failure Chronic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Cardiac Failure Congestive</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Cardio-Respiratory Arrest</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Cardiogenic Shock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Coronary Artery Disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Coronary Artery Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Hypertensive Heart Disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Myocardial Ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Myocarditis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Pericardial Effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Stress Cardiomyopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Ventricular Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Corneal Dystrophy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Deafness Bilateral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal Insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blepharitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Retinal Artery Occlusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Retinal Detachment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Retinal Vein Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Abdominal Pain Upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Colitis Ischaemic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Diarrhoea Haemorrhagic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Diverticular Perforation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Diverticulum</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Diverticulum Intestinal Haemorrhagic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Enterovesical Fistula</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Faecaloma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Gastric Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Gastric Ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Inguinal Hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Inguinal Hernia Strangulated</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Intestinal Ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Intestinal Obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Large Intestinal Obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Large Intestine Perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Melaena</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Oesophageal Achalasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Pancreatitis Acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Pneumoperitoneum</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Rectal Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Small Intestinal Obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Subileus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Upper Gastrointestinal Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Chest Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Extravasation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>General Physical Health Deterioration</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Granuloma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Multiple Organ Dysfunction Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Non-Cardiac Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Oedema Peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Peripheral Swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Sudden Cardiac Death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Sudden Death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Systemic Inflammatory Response Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Hepatic Failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Bile Duct Stone</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Cholecystitis Acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Cholestasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Hepatic Failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Hepatocellular Injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Anal Abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Appendicitis Perforated</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Arthritis Bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Arthritis Infective</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Bacterial Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Bronchiolitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Campylobacter Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Clostridium Difficile Colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Colonic Abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Corona Virus Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Device Related Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Endocarditis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Endocarditis Staphylococcal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Escherichia Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Escherichia Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Escherichia Urinary Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Viral Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Groin Abscess</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Haematoma Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Infected Cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Klebsiella Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Klebsiella Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Lower Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Lower Respiratory Tract Infection Bacterial</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Lower Respiratory Tract Infection Viral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Lung Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Metapneumovirus Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Myocarditis Infectious</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Neutropenic Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Neutropenic Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Nocardiosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Oesophageal Candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Otitis Externa</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Pleural Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Pneumocystis Jirovecii Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Pneumocystis Jirovecii Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="48" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Pulmonary Mycosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Respiratory Syncytial Virus Bronchiolitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Respiratory Syncytial Virus Infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Salmonellosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Sepsis Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Septic Arthritis Staphylococcal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Septic Embolus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Septic Shock</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Skin Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Soft Tissue Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Spinal Cord Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Staphylococcal Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Subcutaneous Abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Ureteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection Bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Varicella Zoster Virus Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Vascular Stent Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Vestibular Neuronitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Viral Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Accidental Overdose</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Acetabulum Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Clavicle Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Craniocerebral Injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Face Injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Facial Bones Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Femoral Neck Fracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Femur Fracture</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Foot Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Head Injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Hip Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Humerus Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Limb Injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Open Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Pelvic Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Periorbital Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Postoperative Fever</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Pubis Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Rib Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Spinal Compression Fracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Spinal Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Sternal Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Subdural Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Tendon Rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Upper Limb Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood Creatinine Increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>C-Reactive Protein Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>International Normalised Ratio Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Lipase Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Occult Blood Positive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Oxygen Saturation Decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Transaminases Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Troponin I Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased Appetite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Diabetes Mellitus Inadequate Control</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Failure to Thrive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Hypovolaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Type 1 Diabetes Mellitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Bone Lesion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Bone Pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Chondrocalcinosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Chondrocalcinosis Pyrophosphate</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Crystal Arthropathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Intervertebral Disc Compression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Intervertebral Disc Protrusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Jaw Fistula</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Lumbar Spinal Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Muscle Spasms</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Muscular Weakness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Musculoskeletal Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Musculoskeletal Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Neck Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Osteolysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Osteonecrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Osteonecrosis of Jaw</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Osteoporosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Pain in Extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Pathological Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Primary Sequestrum</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Spinal Pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma Gastric</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Adrenal Adenoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Basal Cell Carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Breast Cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Cancer Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Colorectal Adenocarcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Diffuse Large B-Cell Lymphoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Stromal Tumour</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Invasive Lobular Breast Carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Keratoacanthoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Leiomyosarcoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Lung Neoplasm Malignant</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Mantle Cell Lymphoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Meningioma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Neuroendocrine Carcinoma of the Skin</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Porocarcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Prostate Cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Prostatic Adenoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Small Cell Lung Cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Squamous Cell Carcinoma of Skin</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Transitional Cell Carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Brain Stem Infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Cerebral Infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Cerebrovascular Accident</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Cognitive Disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Dementia Alzheimer's Type</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Focal Dyscognitive Seizures</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Generalised Tonic-Clonic Seizure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Haemorrhage Intracranial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Haemorrhagic Stroke</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Hepatic Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Hyperaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Ischaemic Stroke</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Nervous System Disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Neuralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Orthostatic Intolerance</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Peripheral Motor Neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Post Herpetic Neuralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Spinal Cord Compression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Transient Ischaemic Attack</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Vith Nerve Paralysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device Dislocation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional State</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Eating Disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Major Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Mental Status Changes</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Personality Change</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Psychotic Disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </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" subjects_affected="14" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Bladder Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Chronic Kidney Disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Renal Disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Renal Failure</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Renal Impairment</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Urethral Caruncle</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Urinary Retention</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign Prostatic Hyperplasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Genital Prolapse</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Pelvic Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Vaginal Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Pulmonary Oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Bronchiectasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Bronchopneumopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Bronchospasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Chronic Obstructive Pulmonary Disease</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Lung Disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Pleural Effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Pleurisy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Pleuritic Pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Pulmonary Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Respiratory Distress</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Respiratory Failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Febrile Neutrophilic Dermatosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Dermatitis Exfoliative</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Drug Reaction with Eosinophilia and Systemic Symptoms</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Purpura</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Rash Generalised</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Rash Maculo-Papular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Skin Ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Stevens-Johnson Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Air Embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Aortic Aneurysm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Aortic Aneurysm Rupture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Arteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Deep Vein Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Orthostatic Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Peripheral Arterial Occlusive Disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Peripheral Artery Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Peripheral Ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Phlebitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Superior Vena Cava Occlusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Venous Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA Version 20.0</default_vocab>
        <default_assessment>Non-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="355" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="362" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="136" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="126" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="68" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" subjects_affected="45" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="66" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="154" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="207" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="68" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="68" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="55" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="52" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Vision Blurred</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="40" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Abdominal Pain Upper</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="129" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="148" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="166" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="204" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Dry Mouth</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="83" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="115" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="43" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="60" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="85" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="116" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="45" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="104" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="145" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Oedema Peripheral</sub_title>
                <counts group_id="E1" subjects_affected="107" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="140" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Peripheral Swelling</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="58" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="70" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="73" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="100" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Oral Candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="41" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="50" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="81" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="60" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Viral Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="46" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="55" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood Creatinine Increased</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Weight Decreased</sub_title>
                <counts group_id="E1" subjects_affected="63" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="101" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Weight Increased</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased Appetite</sub_title>
                <counts group_id="E1" subjects_affected="54" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="78" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="50" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="49" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="60" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="72" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="63" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="69" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="93" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="114" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Bone Pain</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="34" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Muscle Spasms</sub_title>
                <counts group_id="E1" subjects_affected="79" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="106" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Muscular Weakness</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Musculoskeletal Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="41" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Musculoskeletal Pain</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="49" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Neck Pain</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Pain in Extremity</sub_title>
                <counts group_id="E1" subjects_affected="50" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="59" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="57" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="69" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="35" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="40" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="39" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="68" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="58" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Peripheral Sensory Neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="54" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="87" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="51" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="57" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="32" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Confusional State</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="107" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="109" subjects_at_risk="364"/>
              </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" subjects_affected="15" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Chronic Kidney Disease</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Renal Impairment</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="59" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="100" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="56" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="97" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Dyspnoea Exertional</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Oropharyngeal Pain</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dry Skin</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="32" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="43" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="57" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Rash Generalised</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Rash Maculo-Papular</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep Vein Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="46" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="365"/>
                <counts group_id="E2" subjects_affected="34" subjects_at_risk="364"/>
              </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>If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Director</name_or_title>
      <organization>Janssen Research &amp; Development, LLC</organization>
      <phone>844-434-4210</phone>
      <email>ClinicalTrialDisclosure@its.jnj.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/NCT02252172
org study id: CR104762
secondary id: 54767414MMY3008
secondary id: 2014-002273-11
nct id: NCT02252172
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to compare the efficacy of daratumumab in combination with
      lenalidomide and dexamethasone to that of lenalidomide and dexamethasone in terms of
      progression-free survival (PFS) in participants with newly diagnosed multiple myeloma (a
      blood cancer of plasma cells) who are not candidates for high dose chemotherapy (treatment of
      disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT).
This is a Phase 3, randomized (study drug assigned by chance), open-label (participants and
      researchers are aware about the treatment, participants are receiving), active-controlled
      (study in which the experimental treatment or procedure is compared to a standard treatment
      or procedure), parallel-group (each group of participants will be treated at the same time),
      and multicenter (when more than one hospital or medical school team work on a medical
      research study) study in participants with newly diagnosed multiple myeloma and who are not
      candidates for high dose chemotherapy and ASCT. All the eligible participants will be
      randomly assigned to receive either lenalidomide and dexamethasone (Rd) (Arm A) or
      daratumumab in combination with lenalidomide and dexamethasone (DRd) (Arm B). Daratumumab (16
      milligram per kilogram [mg/kg]) will be administered weekly for first 8 weeks (Cycles 1 to 2)
      of treatment and then every other week for 16 weeks (Cycles 3 to 6), then every 4 weeks (from
      Cycle 7 and beyond) until progression of disease or unacceptable toxicity. Lenalidomide will
      be administered at a dose of 25 mg orally on Days 1 through 21 of each 28-day cycle, and
      dexamethasone will be administered at a dose of 40 mg once a week for both treatment arms.
      Participants in both treatment arms will continue lenalidomide and dexamethasone until
      disease progression or unacceptable toxicity. All participants randomized to Treatment Arm B
      (DRd) in this study initially received daratumumab IV formulation; however, following
      implementation of protocol amendment 8, participants still receiving treatment with
      daratumumab IV will have the option to switch to daratumumab SC on Day 1 of any cycle, at the
      discretion of the investigator. Daratumumab subcutaneous (SC) will be administered by SC
      injection at a fixed dose of 1800 mg once every 4 weeks until documented progression,
      unacceptable toxicity, or study completion. Participants in Arm A who have sponsor-confirmed
      disease progression may have the option to receive daratumumab provided by the sponsor (in
      any subsequent line of therapy) in the Follow-up phase. The study consists of 3 phases:
      Screening Phase (within 21 days prior to the first dose administration on Day 1), Treatment
      Phase (Day 1 up to discontinuation of all study treatment), and Follow-up Phase (from
      discontinuation of all study treatment up to death, lost to follow up, consent withdrawal, or
      study end, whichever occurs first). The maximum duration of study will be 7 years after last
      participant is randomized. Efficacy will primarily be evaluated by PFS. Participants' safety
      will be monitored throughout the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Primary: Progression-free Survival (PFS)
time frame: From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or clinical cut-off (CCO) whichever occurs first (up to 3.5 years)
description: PFS is defined as time from date of randomization to either progressive disease (PD) or death, whichever occurs first based on computerized algorithm as per International Myeloma Working Group (IMWG) criteria. PD is defined as an increase of 25 percent (%) from the lowest response value in one of the following: serum and urine M-component (absolute increase must be greater than or equal to [>=] 0.5 gram per deciliter [g/dL] and >=200 milligram [mg]/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase must be greater than [>]10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to Plasma cell (PC) proliferative disorder.
measure: Percentage of Participants With Complete Response (CR) or Better
time frame: From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)
description: CR or better is defined as percentage of participants with a CR or better (CR or stringent complete response [sCR]) based on computerized algorithm as per IMWG criteria. CR is defined as negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and less than (<) 5 percent (%) PCs in bone marrow. In participants with only measurable disease by serum FLC levels a normal serum FLC ratio is required. sCR is defined as in addition to CR a normal FLC ratio, and absence of clonal PCs by immunohistochemistry or immunofluorescence or 2 to 4-color flow cytometry.
measure: Percentage of Participants With Very Good Partial Response (VGPR) or Better
time frame: From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)
description: VGPR or better is defined as the percentage of participants with a response of VGPR or better (VGPR, CR or sCR) based on computerized algorithm as per IMWG criteria. VGPR is defined as serum and urine M-component detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours. In participants with only measurable disease by serum FLC levels a >90% decrease in the difference between involved and uninvolved FLC levels is required.
measure: Percentage of Participants With Negative Minimal Residual Disease (MRD)
time frame: From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)
description: MRD negativity rate is defined as the percentage of participants who had negative MRD (detection of less than 1 malignant cell among 100,000 normal cells) assessment at any timepoint after the date of randomization by evaluation of bone marrow aspirates. MRD was assessed in participants who achieved CR or better.
measure: Overall Response Rate (ORR)
time frame: From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)
description: ORR is defined as the percentage of participants who achieved partial response (PR) or better (PR, VGPR, CR or sCR) based on computerized algorithm as per IMWG criteria. PR is defined as >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200 mg/24 hours. If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required. A >=50% reduction in the size of soft tissue plasmacytomas is also required.
measure: Overall Survival (OS)
time frame: From randomization to death, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)
description: OS was measured from the date of randomization to the date of the death.
measure: Time to Disease Progression (TTP)
time frame: From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)
description: TTP is defined as the time from the date of randomization to the date of PD based on computerized algorithm as per IMWG criteria, or death due to PD.
measure: Time to Response
time frame: From randomization to first response (PR or better) (up to 7.8 years)
description: Time to response is defined as the time from the date of randomization to the first efficacy evaluation that met criteria for PR or better based on computerized algorithm as per IMWG criteria. PR: >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200 mg/24 hours. If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria; If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow PCs is required. A >=50% reduction in the size of soft tissue plasmacytomas is also required.
measure: Duration of Response (DoR)
time frame: From first response (PR of better) to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)
description: DoR is defined as the time from the date of initial response (PR or better) to the date of PD, based on computerized algorithm as per IMWG criteria.
measure: Time to Subsequent Anti-myeloma Treatment
time frame: From randomization to start of first subsequent anti-myeloma treatment, death, withdrawal of consent to study participation or CCO whichever is first (up to 7.8 years)
description: Time to subsequent anti-myeloma treatment is defined as the time from randomization to the start of first line of subsequent anti-myeloma treatment or death, whichever occurs first.
measure: Progression-free Survival on Next Line of Therapy (PFS2)
time frame: From randomization to disease progression on first line of subsequent anti-myeloma therapy, death, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)
description: PFS2 is defined as the time from randomization to progression on the first line of subsequent anti-myeloma therapy or death, whichever occurs first. Disease progression on first line of subsequent anti-myeloma treatment was based on investigator judgment. Participants that were censored for PFS1 were also censored for PFS2.
measure: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 Global Health Status Score to Day 1 of Cycle 3, 6, 9 and 12
time frame: Baseline and Day 1 of Cycle 3, 6, 9 and 12 (each Cycle of 28 days)
description: EORTC QLQ-C30 is 30 items self-reporting questionnaire, with 1 week recall period, resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 Global Health Status (GHS) scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Questionnaire includes 28 items with 4-point Likert type responses from "1-not at all" to "4-very much" to assess functioning and symptoms; 2 items with 7-point Likert scales (1= poor and 7= excellent) for global health and overall health related QoL. Scores are transformed to 0 to 100 scale, with higher scores representing better GHS, better functioning, and more symptoms. Negative change from baseline values shows deterioration in quality of life or functioning and reduction in symptom and positive values indicate improvement and worsening of symptoms.
measure: Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) to Day 1 of Cycle 3, 6, 9 and 12
time frame: Baseline and Day 1 of Cycle 3, 6, 9 and 12 (each Cycle of 28 days)
description: EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The Visual Analogue Scale is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
measure: Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Utility Score to Day 1 of Cycle 3, 6, 9 and 12
time frame: Baseline and Day 1 of Cycle 3, 6, 9 and 12 (each Cycle of 28 days)
description: EQ-5D-5L is standardized, participant-reported questionnaire to assess health-related quality of life. EQ-5D-5L includes 2 components: EQ-5D-5L health state profile (descriptive system) and EQ-5D-5L VAS. EQ-5D-5L descriptive system provides a profile of participant's health state 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. Responses to the 5-dimension scores were combined and converted into single preference-weighted health utility index score 0 (0.0- worst health state) to 1 (1.0- better health state) representing the general health status of individual (but allows for values less than 0 by United kingdom [UK] scoring algorithm).
arm group label: Lenalidomide and Dexamethasone (Rd)
arm group type: Active Comparator
description: Participants will receive Lenalidomide 25 mg capsule orally on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously once a week. Study treatment continues until disease progression, unacceptable toxicity, or end of study (maximum up to 7 years after last subject is randomized) whichever comes first.
arm group label: Daratumumab + Lenalidomide + Dexamethasone (DRd)
arm group type: Active Comparator
description: Participants will receive Daratumumab 16 milligram per kilogram (mg/kg) by intravenous infusion, once a week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks, Lenalidomide 25 mg capsule orally on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously once a week. Following implementation of protocol amendment 8, participants still receiving treatment with daratumumab IV will have the option to switch to daratumumab SC on Day 1 of any cycle, at the discretion of the investigator. Daratumumab subcutaneous (SC) will be administered by SC injection at a fixed dose of 1800 mg once every 4 weeks until documented progression, unacceptable toxicity, or study completion. Study treatment continues until disease progression, unacceptable toxicity, or end of study (maximum up to 7 years after last subject is randomized) whichever comes first.
intervention type: Drug
intervention name: Daratumumab IV
description: Daratumumab will be administered at a dose of 16 milligram per kilogram (mg/kg) by intravenous (IV) infusion, once a week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression of disease, unacceptable toxicity, or end of study (maximum up to 7 years).
arm group label: Lenalidomide and Dexamethasone (Rd)
other name: JNJ-54767414
intervention type: Drug
intervention name: Lenalidomide
description: Lenalidomide 25 mg capsule orally on Day 1 through Day 21 of each 28-day cycle.
arm group label: Daratumumab + Lenalidomide + Dexamethasone (DRd)
arm group label: Lenalidomide and Dexamethasone (Rd)
intervention type: Drug
intervention name: Dexamethasone
description: Dexamethasone 40 mg orally or intravenously once in a week.
arm group label: Daratumumab + Lenalidomide + Dexamethasone (DRd)
arm group label: Lenalidomide and Dexamethasone (Rd)
intervention type: Drug
intervention name: Daratumumab SC
description: Daratumumab SC will be administered by SC injection at a fixed dose of 1800 mg once every 4 weeks until documented progression, unacceptable toxicity, or study end. Following implementation of protocol amendment 8, participants still receiving treatment with daratumumab IV will have the option to switch to daratumumab SC on Day 1 of any cycle, at the discretion of the investigator.
arm group label: Daratumumab + Lenalidomide + Dexamethasone (DRd)
other name: JNJ-54767414
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Janssen Research & Development, LLC Clinical Trial
role: Study Director
affiliation: Janssen Research & Development, LLC
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country: Australia
country: Austria
country: Belgium
country: Canada
country: Denmark
country: France
country: Germany
country: Ireland
country: Israel
country: Netherlands
country: Sweden
country: United Kingdom
country: United States
country: New Zealand
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
mesh term: Dexamethasone
mesh term: Lenalidomide
mesh term: Daratumumab
mesh term: Antibodies, Monoclonal
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