<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/NCT01732926</url>
  </required_header>
  <id_info>
    <org_study_id>GS-US-313-0125</org_study_id>
    <secondary_id>2012-004034-42</secondary_id>
    <nct_id>NCT01732926</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas</brief_title>
  <acronym>Bridalveil</acronym>
  <official_title>A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gilead Sciences</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 primary objective of this study is to evaluate the addition of idelalisib to&#xD;
      bendamustine/rituximab on progression-free survival (PFS) in adults with previously treated&#xD;
      indolent non-Hodgkin lymphoma (iNHL).&#xD;
&#xD;
      An increased rate of deaths and serious adverse events (SAEs) among participants with&#xD;
      front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in&#xD;
      combination with standard therapies was observed by the independent data monitoring committee&#xD;
      (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data&#xD;
      and terminated this study in agreement with the DMC recommendation and in consultation with&#xD;
      the US Food and Drug Administration (FDA).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date type="Actual">January 2, 2013</start_date>
  <completion_date type="Actual">May 17, 2016</completion_date>
  <primary_completion_date type="Actual">May 17, 2016</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free Survival (PFS)</measure>
    <description>PFS is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphomas (iNHL) disease progression or death from any cause. Definitive iNHL disease progression is progression based on standard criteria. PFS was to be assessed by an independent review committee (IRC).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complete Response Rate (CR)</measure>
    <description>Complete response rate is defined as the proportion of participants who achieve a complete response. CR rate was to be assessed by an IRC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate (ORR)</measure>
    <description>Overall response rate is defined as the proportion of participants who achieve a complete response or partial response (or very good partial response (VGPR) or minor response (MR) for participants with Waldenstrom's). ORR was to be assessed by an IRC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lymph Node Response Rate</measure>
    <description>Lymph node response rate is defined as the proportion of participants who achieve ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Lymph node response rate was to be assessed by an IRC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <description>Overall survival is defined as the interval from randomization to death from any cause.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">475</enrollment>
  <condition>Indolent Non-Hodgkin's Lymphomas</condition>
  <arm_group>
    <arm_group_label>Rituximab + Bendamustine + Idelalisib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive rituximab + bendamustine + idelalisib.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rituximab + Bendamustine + Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive rituximab + bendamustine + placebo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Idelalisib</intervention_name>
    <description>150 mg tablet administered orally twice daily</description>
    <arm_group_label>Rituximab + Bendamustine + Idelalisib</arm_group_label>
    <other_name>Zydelig®</other_name>
    <other_name>CAL-101</other_name>
    <other_name>GS-1101</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rituximab</intervention_name>
    <description>375 mg/m^2 single-use vials administered intravenously every 4 weeks (up to a total of 6 infusions)</description>
    <arm_group_label>Rituximab + Bendamustine + Idelalisib</arm_group_label>
    <arm_group_label>Rituximab + Bendamustine + Placebo</arm_group_label>
    <other_name>Rituxan®</other_name>
    <other_name>MabThera®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bendamustine</intervention_name>
    <description>90 mg/m^2 single-use vials administered intravenously for two consecutive days every 4 weeks (up to a total of 4-6 cycles as tolerated)</description>
    <arm_group_label>Rituximab + Bendamustine + Idelalisib</arm_group_label>
    <arm_group_label>Rituximab + Bendamustine + Placebo</arm_group_label>
    <other_name>Treanda®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Tablet administered orally twice daily</description>
    <arm_group_label>Rituximab + Bendamustine + Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited&#xD;
             to the following&#xD;
&#xD;
               1. Follicular lymphoma (FL) Grade 1, 2, or 3a&#xD;
&#xD;
               2. Small lymphocytic lymphoma (SLL)&#xD;
&#xD;
               3. Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM)&#xD;
&#xD;
               4. Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  History of lymphoid malignancy other than those allowed per inclusion criteria.&#xD;
&#xD;
          -  Ongoing drug-induced liver injury, active hepatitis C, active hepatitis B, alcoholic&#xD;
             liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic&#xD;
             obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension.&#xD;
&#xD;
          -  Prior treatment with bendamustine that was not effective.&#xD;
&#xD;
        Note: Other protocol defined Inclusion/Exclusion criteria may apply.&#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>Gilead Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Gilead Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clearview Cancer Institute</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ironwood Cancer and Research Center</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Blood and Cancer Center (Bakersfield)</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Jude Heritage Healthcare (TORI)</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92835</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific Shores Medical Group</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90813</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Care Associates</name>
      <address>
        <city>Redondo Beach</city>
        <state>California</state>
        <zip>90277</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Luis Obispo Oncology and Hematology</name>
      <address>
        <city>San Luis Obispo</city>
        <state>California</state>
        <zip>93401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Santa Barbara</name>
      <address>
        <city>Santa Barbara</city>
        <state>California</state>
        <zip>93105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Coast Medical Oncology Group</name>
      <address>
        <city>Santa Maria</city>
        <state>California</state>
        <zip>93454</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Joseph Heritage Healthcare System</name>
      <address>
        <city>Santa Rosa</city>
        <state>California</state>
        <zip>95403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Vallejo Medical Center</name>
      <address>
        <city>Vallejo</city>
        <state>California</state>
        <zip>94589</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sylvester Comprehensive Cancer Center/UMHC</name>
      <address>
        <city>Deerfield Beach</city>
        <state>Florida</state>
        <zip>33442</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Specialists of North Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Georgia Oncology Centers, PC</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Joliet Oncology Hematology Associates Ltd.</name>
      <address>
        <city>Joliet</city>
        <state>Illinois</state>
        <zip>60435</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rutgers Cancer Institute of New Jersey</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Shore Hematology/Oncology Associates</name>
      <address>
        <city>East Setauket</city>
        <state>New York</state>
        <zip>11733</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Signal Point Clinical Research Center, LLC</name>
      <address>
        <city>Middletown</city>
        <state>Ohio</state>
        <zip>45042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hollings Cancer Center</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bon Secours Saint Francis Hospital</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology, P.A.</name>
      <address>
        <city>Bedford</city>
        <state>Texas</state>
        <zip>76022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charles A. Sammons Cancer Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology, P.A.</name>
      <address>
        <city>Denton</city>
        <state>Texas</state>
        <zip>76210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brooke Army Medical Center</name>
      <address>
        <city>Fort Sam Houston</city>
        <state>Texas</state>
        <zip>78234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology, P.A.</name>
      <address>
        <city>Harlingen</city>
        <state>Texas</state>
        <zip>78550-8321</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology, P.A.</name>
      <address>
        <city>Weslaco</city>
        <state>Texas</state>
        <zip>78596-6608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Medical Specialists</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aurora BayCare Medical Center</name>
      <address>
        <city>Green Bay</city>
        <state>Wisconsin</state>
        <zip>54308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Froedtert Hospital and Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prince of Wales Hospital</name>
      <address>
        <city>Randwick</city>
        <state>New South Wales</state>
        <zip>2031</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haematology and Oncology Clinics of Australia Gold Coast</name>
      <address>
        <city>South Brisbane</city>
        <state>Queensland</state>
        <zip>4101</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Adelaide Hospital</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adelaide Cancer Centre</name>
      <address>
        <city>Kurralta Park</city>
        <state>South Australia</state>
        <zip>5037</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Box Hill Hospital</name>
      <address>
        <city>Box Hill</city>
        <state>Victoria</state>
        <zip>3128</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monash Medical Centre</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Vincent's Hospital</name>
      <address>
        <city>Fitzroy</city>
        <state>Victoria</state>
        <zip>3065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western Hospital</name>
      <address>
        <city>Footscray</city>
        <state>Victoria</state>
        <zip>3011</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Perth Hospital</name>
      <address>
        <city>Perth</city>
        <state>Western Australia</state>
        <zip>6000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tom Baker Cancer Center</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 2T9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cross Cancer Institute</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fraser Clinical Trials, Inc.</name>
      <address>
        <city>New Westminster</city>
        <state>British Columbia</state>
        <zip>V3L 3W4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BC Cancer Agency - Vancouver Centre</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 4E6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth II Health Sciences Centre, Centre for Clinical Research</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 1V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Victoria Regional Health Centre</name>
      <address>
        <city>Barrie</city>
        <state>Ontario</state>
        <zip>L4M 6M2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Charles Lemoyne</name>
      <address>
        <city>Greenfield Park</city>
        <state>Quebec</state>
        <zip>J4V 2H1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McGill University Health Centre</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H4A 3JI</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Sherbrooke</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1H 5N4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Affilie Universitaire de Quebec</name>
      <address>
        <city>Quebec</city>
        <zip>G1J 1Z4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CancerCare Manitoba</name>
      <address>
        <city>Winnipeg</city>
        <zip>R3E 0V9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultní Nemocnice Ostrava</name>
      <address>
        <city>Ostrava - Poruba</city>
        <state>Severomoravsky KRAJ</state>
        <zip>708 52</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultní nemocnice Brno</name>
      <address>
        <city>Brno</city>
        <zip>625 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultní nemocnice Hradec Králové</name>
      <address>
        <city>Hradec Králové</city>
        <zip>500 05</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHR Metz</name>
      <address>
        <city>Metz Cedex 03</city>
        <state>Alsace</state>
        <zip>57085</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Strasbourg - Hôpital Hautepierre</name>
      <address>
        <city>Strasbourg Cedex</city>
        <state>Alsace</state>
        <zip>67098</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Bergonié</name>
      <address>
        <city>Bordeaux Cedex</city>
        <state>Aquitaine</state>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Henri-Becquerel</name>
      <address>
        <city>Rouen Cedex 1</city>
        <state>Haute-normandie</state>
        <zip>76038</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Necker-Enfants Malades</name>
      <address>
        <city>Paris</city>
        <state>Ile-de-france</state>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Jean Bernard</name>
      <address>
        <city>Le Mans</city>
        <state>PAYS DE LA Loire</state>
        <zip>72000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Lyon Sud</name>
      <address>
        <city>Pierre Bénite Cedex</city>
        <state>Rhone-alpes</state>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Brest</name>
      <address>
        <city>Brest Cedex</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Dunkerque</name>
      <address>
        <city>Dunkerque</city>
        <zip>59385</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Départmental La Roche sur Yon</name>
      <address>
        <city>La Roche sur Yon</city>
        <zip>85925</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Léon Bérard</name>
      <address>
        <city>Lyon Cedex 08</city>
        <zip>69373</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Paoli Calmettes</name>
      <address>
        <city>Marseille</city>
        <zip>13273</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Hôtel-Dieu</name>
      <address>
        <city>Nantes cedex 1</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Poitiers</name>
      <address>
        <city>Poitiers Cedex</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Régional et Universitaire - Hôpital Bretonneau</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH</name>
      <address>
        <city>Villingen-Schwenningen</city>
        <state>Baden-wuerttemberg</state>
        <zip>78054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gemeinschaftspraxis Dres. Söling Und Siehl</name>
      <address>
        <city>Kassel</city>
        <state>Hessen</state>
        <zip>34117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vivantes Klinikum am Urban</name>
      <address>
        <city>Berlin</city>
        <zip>10967</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite - Campus Virchow</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum der Ludwig-Maximilians-Universität München</name>
      <address>
        <city>München</city>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barzilai Medical Center</name>
      <address>
        <city>Ashkelon</city>
        <zip>78278</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soroka University Medical Center</name>
      <address>
        <city>Beer Sheva</city>
        <zip>84101</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rambam Health Corp.</name>
      <address>
        <city>Haifa</city>
        <zip>31096</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah Medical Organization, Ein Kerem</name>
      <address>
        <city>Jerusalem</city>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro di Riferimento Oncologico di Aviano</name>
      <address>
        <city>Aviano</city>
        <zip>33081</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spedali Civili Di Brescia Azienda Ospedaliera</name>
      <address>
        <city>Brescia</city>
        <zip>25123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Azienda Ospedaliera Universitaria San Martino</name>
      <address>
        <city>Genova</city>
        <zip>16132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Raffaele-IRCCS</name>
      <address>
        <city>Milano</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Ospedale Niguarda Ca' Granda</name>
      <address>
        <city>Milano</city>
        <zip>20162</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria (AOU) &quot;Maggiore della Carita&quot; di Novara</name>
      <address>
        <city>Novara</city>
        <zip>28100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Ospedali Riuniti Marche Nord</name>
      <address>
        <city>Pesaro</city>
        <zip>61122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto</name>
      <address>
        <city>Piacenza</city>
        <zip>29100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Senese - Policlinico S. Maria alle Scotte</name>
      <address>
        <city>Siena</city>
        <zip>53100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Città della Salute e della Scienza di Torino</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dong-A University Medical Center</name>
      <address>
        <city>Busan</city>
        <zip>602-715</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>138-736</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniwersyteckie Centrum Kliniczne</name>
      <address>
        <city>Gdansk</city>
        <zip>80-952</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Malopolskie Centrum Medyczne S.C.</name>
      <address>
        <city>Kraków</city>
        <zip>30-510</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Kliniczny nr 1, Katedra i Klinika Hematoonkologii i Transplantacji Szpiku</name>
      <address>
        <city>Lublin</city>
        <zip>20-081</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wojewódzki Szpital Specjalistyczny im. Mikolaja Kopernika w Lodzi</name>
      <address>
        <city>Lódz</city>
        <zip>93-510</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurskim</name>
      <address>
        <city>Olsztyn</city>
        <zip>10-228</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku</name>
      <address>
        <city>Slupsk</city>
        <zip>76-200</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centralny Szpital Kliniczny MSW w Warszawie</name>
      <address>
        <city>Warszawa</city>
        <zip>02-507</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instytut Hematologii i Transfuzjologii</name>
      <address>
        <city>Warszawa</city>
        <zip>02-776</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Onkologii i Hipertermii</name>
      <address>
        <city>Warszawa</city>
        <zip>02-781</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sverdlovsk Regional Clinical Hospital #1</name>
      <address>
        <city>Ekaterinburg</city>
        <zip>620102</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central City Hospital # 7</name>
      <address>
        <city>Ekaterinburg</city>
        <zip>620137</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>N. N. Blokhin Russian Cancer Research Center</name>
      <address>
        <city>Moscow</city>
        <zip>115478</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nizhny Novgorod Regional Clinical Hospital n.a. N.A. Semashko</name>
      <address>
        <city>Nizhniy Novgorod</city>
        <zip>603126</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ryazan Regional Clinical Hospital</name>
      <address>
        <city>Ryazan</city>
        <zip>390039</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FGU Russian Scientific Research Institute of Hematology and Transfusiology</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>191024</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FSI &quot;V.A. Almazov Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies&quot;</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197341</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Petersburg I.P. Pavlov State Medical University</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>197022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saratov State Medical University</name>
      <address>
        <city>Saratov</city>
        <zip>140012</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budgetary Healthcare Institution &quot;Volgograd Regional Clinical Oncology Dispensary #1&quot;</name>
      <address>
        <city>Volgograd</city>
        <zip>400138</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Puerta de Hierro</name>
      <address>
        <city>Majadahonda</city>
        <state>Madrid</state>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Germans Trias i Pujol</name>
      <address>
        <city>Badalona</city>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Princesa</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Marañon</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario de Salamanca</name>
      <address>
        <city>Salamanca</city>
        <zip>37007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Canarias</name>
      <address>
        <city>San Cristobal de La Laguna</city>
        <zip>38320</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocio</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari i Politecnic La Fé de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska Universitetssjukhuset</name>
      <address>
        <city>Huddinge</city>
        <state>Stockholm</state>
        <zip>141 86</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Länssjukhuset Ryhov</name>
      <address>
        <city>Jönköping</city>
        <zip>551 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Changhua Christian Hospital</name>
      <address>
        <city>Changhua city</city>
        <zip>500</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China Medical University Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>404</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cheng-Kung University Hospital</name>
      <address>
        <city>Tainan</city>
        <zip>70403</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>10002</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kent and Canterbury Hospital</name>
      <address>
        <city>Canterbury</city>
        <state>England</state>
        <zip>CT1 3NG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Coventry</name>
      <address>
        <city>Coventry</city>
        <state>England</state>
        <zip>CV2 2DX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Bournemouth General Hospital</name>
      <address>
        <city>Dorset</city>
        <state>England</state>
        <zip>BH7 7DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leeds Teaching Hospitals NHS Trust</name>
      <address>
        <city>Leeds</city>
        <state>England</state>
        <zip>LS9 7TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barts and The London NHS Trust</name>
      <address>
        <city>London</city>
        <state>England</state>
        <zip>EC1M 6BQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College London Hospitals National Health Society Foundation Trust</name>
      <address>
        <city>London</city>
        <state>England</state>
        <zip>NW1 2PG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guys and Saint Thomas NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <state>England</state>
        <zip>SE1 9RT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Imperial College Healthcare NHS Trust</name>
      <address>
        <city>London</city>
        <state>England</state>
        <zip>W12 0NN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maidstone Hospital</name>
      <address>
        <city>Maidstone</city>
        <state>England</state>
        <zip>ME16 9QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christie Hospital NHS Foundation Trust</name>
      <address>
        <city>Manchester</city>
        <state>England</state>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oxford University Hospitals NHS Trust</name>
      <address>
        <city>Oxford</city>
        <state>England</state>
        <zip>OX3 7LE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southampton General Hospital</name>
      <address>
        <city>Southampton</city>
        <state>England</state>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Vernon Hospital</name>
      <address>
        <city>Middlesex</city>
        <zip>HA6 2RN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Cross Hospital</name>
      <address>
        <city>Wolverhampton</city>
        <zip>WV10 0QP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Taiwan</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
    <country>Singapore</country>
  </removed_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <results_first_submitted>March 30, 2017</results_first_submitted>
  <results_first_submitted_qc>March 30, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">May 11, 2017</results_first_posted>
  <last_update_submitted>October 19, 2018</last_update_submitted>
  <last_update_submitted_qc>October 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>iNHL</keyword>
  <keyword>indolent NHL</keyword>
  <keyword>follicular lymphoma</keyword>
  <keyword>CAL-101</keyword>
  <keyword>rituximab</keyword>
  <keyword>bendamustine</keyword>
  <keyword>small lymphocytic lymphoma</keyword>
  <keyword>lymphoplasmacytoid lymphoma</keyword>
  <keyword>Waldenstrom macroglobulinemia</keyword>
  <keyword>LPL</keyword>
  <keyword>WM</keyword>
  <keyword>Marginal zone lymphoma</keyword>
  <keyword>MZL</keyword>
  <keyword>SLL</keyword>
  <keyword>FL</keyword>
  <keyword>GS-1101</keyword>
  <keyword>PI3K inhibitor</keyword>
  <keyword>idelalisib</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rituximab</mesh_term>
    <mesh_term>Bendamustine Hydrochloride</mesh_term>
    <mesh_term>Idelalisib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>18 months after study completion</ipd_time_frame>
    <ipd_access_criteria>A secured external environment with username, password, and RSA code.</ipd_access_criteria>
    <ipd_url>http://www.gilead.com/research/disclosure-and-transparency</ipd_url>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were enrolled at study sites in the North America, Europe, and Asia Pacific. The first participant was screened on 02 January 2013. The last study visit occurred on 17 May 2016.</recruitment_details>
      <pre_assignment_details>581 participants were screened.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Idelalisib + Bendamustine + Rituximab</title>
          <description>Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions)&#xD;
+ rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)</description>
        </group>
        <group group_id="P2">
          <title>Placebo + Bendamustine + Rituximab</title>
          <description>Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="320"/>
                <participants group_id="P2" count="155"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
                <participants group_id="P2" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="267"/>
                <participants group_id="P2" count="110"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Study Terminated by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="168"/>
                <participants group_id="P2" count="80"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other Reason</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Initiation of Other Anti-Cancer Therapy</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Blind Broken by Subject or Study Site</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The Intent to Treat (ITT) Analysis Set: all participants who were randomized regardless of whether they received any study treatment</population>
      <group_list>
        <group group_id="B1">
          <title>Idelalisib + Bendamustine + Rituximab</title>
          <description>Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)</description>
        </group>
        <group group_id="B2">
          <title>Placebo + Bendamustine + Rituximab</title>
          <description>Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)</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="320"/>
            <count group_id="B2" value="155"/>
            <count group_id="B3" value="475"/>
          </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="62" spread="10.5"/>
                    <measurement group_id="B2" value="62" spread="11.1"/>
                    <measurement group_id="B3" value="62" spread="10.9"/>
                  </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="132"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="190"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="188"/>
                    <measurement group_id="B2" value="97"/>
                    <measurement group_id="B3" value="285"/>
                  </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>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="247"/>
                    <measurement group_id="B2" value="122"/>
                    <measurement group_id="B3" value="369"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Permitted</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="62"/>
                  </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>
              <title>Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="262"/>
                    <measurement group_id="B2" value="129"/>
                    <measurement group_id="B3" value="391"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Permitted</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="60"/>
                  </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>Russian Federation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Czech Republic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sweden</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Taiwan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Korea, Republic of</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Israel</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Progression-free Survival (PFS)</title>
        <description>PFS is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphomas (iNHL) disease progression or death from any cause. Definitive iNHL disease progression is progression based on standard criteria. PFS was to be assessed by an independent review committee (IRC).</description>
        <population>Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Idelalisib + Bendamustine + Rituximab</title>
            <description>Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Bendamustine + Rituximab</title>
            <description>Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-free Survival (PFS)</title>
          <description>PFS is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphomas (iNHL) disease progression or death from any cause. Definitive iNHL disease progression is progression based on standard criteria. PFS was to be assessed by an independent review committee (IRC).</description>
          <population>Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Complete Response Rate (CR)</title>
        <description>Complete response rate is defined as the proportion of participants who achieve a complete response. CR rate was to be assessed by an IRC.</description>
        <population>Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Idelalisib + Bendamustine + Rituximab</title>
            <description>Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Bendamustine + Rituximab</title>
            <description>Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)</description>
          </group>
        </group_list>
        <measure>
          <title>Complete Response Rate (CR)</title>
          <description>Complete response rate is defined as the proportion of participants who achieve a complete response. CR rate was to be assessed by an IRC.</description>
          <population>Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Response Rate (ORR)</title>
        <description>Overall response rate is defined as the proportion of participants who achieve a complete response or partial response (or very good partial response (VGPR) or minor response (MR) for participants with Waldenstrom's). ORR was to be assessed by an IRC.</description>
        <population>Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Idelalisib + Bendamustine + Rituximab</title>
            <description>Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Bendamustine + Rituximab</title>
            <description>Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Response Rate (ORR)</title>
          <description>Overall response rate is defined as the proportion of participants who achieve a complete response or partial response (or very good partial response (VGPR) or minor response (MR) for participants with Waldenstrom's). ORR was to be assessed by an IRC.</description>
          <population>Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lymph Node Response Rate</title>
        <description>Lymph node response rate is defined as the proportion of participants who achieve ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Lymph node response rate was to be assessed by an IRC.</description>
        <population>Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Idelalisib + Bendamustine + Rituximab</title>
            <description>Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Bendamustine + Rituximab</title>
            <description>Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)</description>
          </group>
        </group_list>
        <measure>
          <title>Lymph Node Response Rate</title>
          <description>Lymph node response rate is defined as the proportion of participants who achieve ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Lymph node response rate was to be assessed by an IRC.</description>
          <population>Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>Overall survival is defined as the interval from randomization to death from any cause.</description>
        <population>Due to the early termination of the study, efficacy data were not mature for all participants, and therefore the prespecified analyses were not conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Idelalisib + Bendamustine + Rituximab</title>
            <description>Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Bendamustine + Rituximab</title>
            <description>Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>Overall survival is defined as the interval from randomization to death from any cause.</description>
          <population>Due to the early termination of the study, efficacy data were not mature for all participants, and therefore the prespecified analyses were not conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 34 months plus 30 days</time_frame>
      <desc>Safety Analysis Set: all participants who took at least 1 dose of study drug</desc>
      <group_list>
        <group group_id="E1">
          <title>Idelalisib + Bendamustine + Rituximab</title>
          <description>Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)</description>
        </group>
        <group group_id="E2">
          <title>Placebo + Bendamustine + Rituximab</title>
          <description>Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="229" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="58" subjects_at_risk="155"/>
              </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="8" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Aplasia pure red cell</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Autoimmune haemolytic anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Febrile bone marrow aplasia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="45" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Haemolytic anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Arrhythmia supraventricular</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Coronary artery stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Dilatation ventricular</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Right ventricular failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Tachyarrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Ventricular arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Ophthalmoplegia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Colitis ischaemic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Faecaloma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Gastric haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Gastrointestinal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Gingival pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Incarcerated umbilical hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Oesophageal ulcer haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Device related thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Hypothermia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="67" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Cholestasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Hepatitis toxic</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Hepatocellular injury</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Hepatotoxicity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Anal abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Arthritis infective</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Aspergillus infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Atypical pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Bronchiolitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Campylobacter infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Candida infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus hepatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus infection</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus viraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Dengue fever</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Empyema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Encephalitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Enteritis infectious</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Gastroenteritis norovirus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Gingivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Groin abscess</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Haematoma infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Herpes simplex</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Infected skin ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Infectious colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Listeria sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection fungal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Neutropenic sepsis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Oesophageal candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Otitis media chronic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pneumocystis jirovecii infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pneumocystis jirovecii pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pneumonia chlamydial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pneumonia cytomegaloviral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pneumonia fungal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pseudomonal bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pseudomonal sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Salmonellosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Staphylococcal sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Systemic mycosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Varicella</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Varicella zoster virus infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Craniocerebral injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Lower limb fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Sacroiliac fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Splenic rupture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Stoma site haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Blood lactate dehydrogenase increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Electrocardiogram QT prolonged</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </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="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Tumour lysis syndrome</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </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="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Polyarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Anal cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>B-cell lymphoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Clear cell renal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Endometrial adenocarcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Lung adenocarcinoma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Malignant melanoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Myelodysplastic syndrome</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Oesophageal carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Plasma cell myeloma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Richter's syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Balance disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Central nervous system lesion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Complex regional pain syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Embolic stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Facial paralysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Mixed dementia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Spinal cord compression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>VIth nerve paralysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </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="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </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="6" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Nephrotic syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Prostatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </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="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Aspiration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Bronchitis chronic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Hydrothorax</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Lung disorder</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Lung infiltration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Organising pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pleurisy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pulmonary fibrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pulmonary hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pulmonary mass</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Angioedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Dermatitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Dermatitis exfoliative</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Generalised erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pustular psoriasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Rash generalised</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Stevens-Johnson syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Toxic epidermal necrolysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Toxic skin eruption</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Hypovolaemic shock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Internal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="315" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="147" subjects_at_risk="155"/>
              </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="51" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="122" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="54" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="39" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="74" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="158" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="159" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="65" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="100" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="43" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="39" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="103" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="51" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="135" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="58" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="65" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="51" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="41" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="155"/>
              </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="65" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="52" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="155"/>
              </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="22" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="45" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="155"/>
              </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="71" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="37" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="155"/>
              </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="20" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="54" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="105" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="155"/>
              </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>After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:&#xD;
The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or&#xD;
The study has been completed at all study sites for at least 2 years</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Clinical Trial Disclosures</name_or_title>
      <organization>Gilead Sciences</organization>
      <email>ClinicalTrialDisclosures@gilead.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/NCT01732926
org study id: GS-US-313-0125
secondary id: 2012-004034-42
nct id: NCT01732926
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The primary objective of this study is to evaluate the addition of idelalisib to
      bendamustine/rituximab on progression-free survival (PFS) in adults with previously treated
      indolent non-Hodgkin lymphoma (iNHL).

      An increased rate of deaths and serious adverse events (SAEs) among participants with
      front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in
      combination with standard therapies was observed by the independent data monitoring committee
      (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data
      and terminated this study in agreement with the DMC recommendation and in consultation with
      the US Food and Drug Administration (FDA).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Progression-free Survival (PFS)
description: PFS is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphomas (iNHL) disease progression or death from any cause. Definitive iNHL disease progression is progression based on standard criteria. PFS was to be assessed by an independent review committee (IRC).
measure: Complete Response Rate (CR)
description: Complete response rate is defined as the proportion of participants who achieve a complete response. CR rate was to be assessed by an IRC.
measure: Overall Response Rate (ORR)
description: Overall response rate is defined as the proportion of participants who achieve a complete response or partial response (or very good partial response (VGPR) or minor response (MR) for participants with Waldenstrom's). ORR was to be assessed by an IRC.
measure: Lymph Node Response Rate
description: Lymph node response rate is defined as the proportion of participants who achieve ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Lymph node response rate was to be assessed by an IRC.
measure: Overall Survival (OS)
description: Overall survival is defined as the interval from randomization to death from any cause.
arm group label: Rituximab + Bendamustine + Idelalisib
arm group type: Experimental
description: Participants will receive rituximab + bendamustine + idelalisib.
arm group label: Rituximab + Bendamustine + Placebo
arm group type: Experimental
description: Participants will receive rituximab + bendamustine + placebo.
intervention type: Drug
intervention name: Idelalisib
description: 150 mg tablet administered orally twice daily
arm group label: Rituximab + Bendamustine + Idelalisib
other name: Zydelig®
other name: CAL-101
other name: GS-1101
intervention type: Drug
intervention name: Rituximab
description: 375 mg/m^2 single-use vials administered intravenously every 4 weeks (up to a total of 6 infusions)
arm group label: Rituximab + Bendamustine + Idelalisib
arm group label: Rituximab + Bendamustine + Placebo
other name: Rituxan®
other name: MabThera®
intervention type: Drug
intervention name: Bendamustine
description: 90 mg/m^2 single-use vials administered intravenously for two consecutive days every 4 weeks (up to a total of 4-6 cycles as tolerated)
arm group label: Rituximab + Bendamustine + Idelalisib
arm group label: Rituximab + Bendamustine + Placebo
other name: Treanda®
intervention type: Drug
intervention name: Placebo
description: Tablet administered orally twice daily
arm group label: Rituximab + Bendamustine + Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gilead Study Director
role: Study Director
affiliation: Gilead Sciences
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country: Australia
country: Canada
country: Czechia
country: France
country: Germany
country: Israel
country: Italy
country: Korea, Republic of
country: Poland
country: Russian Federation
country: Spain
country: Sweden
country: Taiwan
country: United Kingdom
country: United States
country: Czech Republic
country: Singapore
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, Non-Hodgkin
mesh term: Rituximab
mesh term: Bendamustine Hydrochloride
mesh term: Idelalisib
sharing ipd: Yes
ipd description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: 18 months after study completion
ipd access criteria: A secured external environment with username, password, and RSA code.
ipd url: http://www.gilead.com/research/disclosure-and-transparency
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
point of contact: 