<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/NCT01732913</url>
  </required_header>
  <id_info>
    <org_study_id>GS-US-313-0124</org_study_id>
    <nct_id>NCT01732913</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas</brief_title>
  <acronym>Yosemite</acronym>
  <official_title>A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With 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 effect of the addition of idelalisib&#xD;
      to rituximab on progression-free survival (PFS) in adults with previously treated indolent&#xD;
      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 16, 2013</start_date>
  <completion_date type="Actual">May 18, 2016</completion_date>
  <primary_completion_date type="Actual">May 18, 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</measure>
    <description>Progression-free survival (PFS) is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphoma (iNHL) disease progression or death from any cause. PFS was to be assessed by an independent review committee (IRC).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate</measure>
    <description>Overall Response Rate (ORR) is defined as the proportion of participants who achieve a complete response or partial response (or very good partial response or minor response 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>Complete Response Rate</measure>
    <description>Complete response rate is defined as the proportion of participants who achieve a complete response. Complete response rate was to be assessed by an IRC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</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">295</enrollment>
  <condition>Indolent Non-Hodgkin's Lymphomas</condition>
  <arm_group>
    <arm_group_label>Rituximab + idelalisib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive rituximab + idelalisib.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rituximab + Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive rituximab + placebo. Following confirmation of iNHL disease progression by the independent review committee and unblinding, participants may be eligible to receive open-label idelalisib 150 mg twice daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Tablets administered orally twice daily</description>
    <arm_group_label>Rituximab + Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rituximab</intervention_name>
    <description>375 mg/m^2 administered intravenously weekly for 4 weeks, then every 8 weeks (up to a total of 8 infusions)</description>
    <arm_group_label>Rituximab + Placebo</arm_group_label>
    <arm_group_label>Rituximab + idelalisib</arm_group_label>
    <other_name>Rituxan®</other_name>
    <other_name>MabThera®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Idelalisib</intervention_name>
    <description>150 mg tablets administered orally twice daily</description>
    <arm_group_label>Rituximab + Placebo</arm_group_label>
    <arm_group_label>Rituximab + idelalisib</arm_group_label>
    <other_name>GS-1101</other_name>
    <other_name>CAL-101</other_name>
    <other_name>Zydelig®</other_name>
  </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) with absolute lymphocyte count &lt; 5 x 10^9/L at&#xD;
                  the time of diagnosis&#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;
          -  Received previous treatment with rituximab 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>City of Hope Cancer Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Jude Heritage Healthcare</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>UCLA Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</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>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>Middlesex Hospital Cancer Center</name>
      <address>
        <city>Middletown</city>
        <state>Connecticut</state>
        <zip>06457</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgetown University Medical Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialists and Research Institute</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33916</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moffitt Cancer Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</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>Wayne State University</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89169-3321</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</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>MetroHealth Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44109</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>Perelman Center for Advanced Medicine</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prairie Lakes Healthcare System</name>
      <address>
        <city>Watertown</city>
        <state>South Dakota</state>
        <zip>57252</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology, PLLC</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarah Cannon Cancer Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</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>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>Center for Cancer and Blood Disorders, PC</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shenandoah Oncology Associates, PC</name>
      <address>
        <city>Winchester</city>
        <state>Virginia</state>
        <zip>22601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Mason Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Medical Specialties, PLLC</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</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>Haematology and Oncology Clinics of Australia at Chermside</name>
      <address>
        <city>Milton</city>
        <state>Queensland</state>
        <zip>4064</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>Adelaide Cancer Centre</name>
      <address>
        <city>Kurralta Park</city>
        <zip>SA 5037</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fiona Stanley Hospital</name>
      <address>
        <city>Murdoch</city>
        <zip>6150</zip>
        <country>Australia</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>University Hospital of Bordeaux</name>
      <address>
        <city>Pessac</city>
        <state>Aquitaine</state>
        <zip>33604</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 Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez</name>
      <address>
        <city>Lille cedex</city>
        <state>NORD Pas-de-calais</state>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Brest</name>
      <address>
        <city>Brest</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 de Versailles</name>
      <address>
        <city>Le Chesnay</city>
        <zip>78157</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>Hôpital Hôtel-Dieu</name>
      <address>
        <city>Nantes cedex 1</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Lyon Sud</name>
      <address>
        <city>Pierre Bénite Cedex</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Poitiers Hôpital de la Milétrie</name>
      <address>
        <city>Poitiers Cedex</city>
        <zip>86000</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>78052</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gemeinschaftspraxis Dres. Söling Und Siehl</name>
      <address>
        <city>Kassel</city>
        <state>Hessen</state>
        <zip>34119</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Debreceni Egyetem Orvos-és Egészségtudományi Centrum</name>
      <address>
        <city>Debrecen</city>
        <state>Hajdu-bihar</state>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Somogy Megyei Kaposi Mór Oktató Kórház</name>
      <address>
        <city>Kaposvár</city>
        <state>Somogy</state>
        <zip>7400</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Markusovszky Egyetemi Oktatókórház</name>
      <address>
        <city>Szombathely</city>
        <state>VAS</state>
        <zip>9700</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Semmelweis Egyetem</name>
      <address>
        <city>Budapest</city>
        <zip>1083</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Országos Onkológiai Intézet</name>
      <address>
        <city>Budapest</city>
        <zip>1122</zip>
        <country>Hungary</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>Rabin Medical Center</name>
      <address>
        <city>Petach Tikva</city>
        <zip>49100</zip>
        <country>Israel</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>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>61100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro di Riferimento Oncologico di Aviano</name>
      <address>
        <city>Pordenone</city>
        <zip>33081</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>Nagoya City University Hospital</name>
      <address>
        <city>Nagoya City</city>
        <state>Aichi</state>
        <zip>467-8681</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Nagoya Medical Center</name>
      <address>
        <city>Nagoya-shi</city>
        <state>Aichi</state>
        <zip>4600001</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aichi Cancer Center Hospital</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <zip>464-8681</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Kyushu Cancer Center</name>
      <address>
        <city>Minami Ku</city>
        <state>Fukuoka</state>
        <zip>811-1395</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kobe City Medical Center General Hospital</name>
      <address>
        <city>Kobe-city</city>
        <state>Hyogo</state>
        <zip>650-0047</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokai University Hospital</name>
      <address>
        <city>Isehara-shi</city>
        <state>Kanagawa</state>
        <zip>259-1193</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Kumamoto Medical Center</name>
      <address>
        <city>Chuo-ku</city>
        <state>Kumamoto</state>
        <zip>860-0008</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tohoku University Hospital</name>
      <address>
        <city>Sendai</city>
        <state>Miyagi</state>
        <zip>9808574</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Okayama University Hospital</name>
      <address>
        <city>Okayama-city</city>
        <state>Okayama</state>
        <zip>700-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka City University Hospital</name>
      <address>
        <city>Osaka-shi</city>
        <state>Osaka</state>
        <zip>545-8586</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital</name>
      <address>
        <city>Chuo-ku</city>
        <state>Tokyo</state>
        <zip>1040045</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cancer Institute Hospital of JFCR</name>
      <address>
        <city>Koto-ku</city>
        <state>Tokyo</state>
        <zip>135-8550</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toranomon Hospital</name>
      <address>
        <city>Minato-ku</city>
        <state>Tokyo</state>
        <zip>1058470</zip>
        <country>Japan</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>138-876</zip>
        <country>Korea, Republic of</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>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>Centrum Onkologii i Hipertermii</name>
      <address>
        <city>Warszawa</city>
        <zip>02-781</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Geral de Santo António do Centro Hospitalar do Porto</name>
      <address>
        <city>Porto</city>
        <zip>4099-001</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institutul Clinic Fundeni</name>
      <address>
        <city>Bucuresti</city>
        <zip>022328</zip>
        <country>Romania</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>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>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>410 028</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Singapore General Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>169608</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Centre Singapore</name>
      <address>
        <city>Singapore</city>
        <zip>169610</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gleneagles Medical Centre</name>
      <address>
        <city>Singapore</city>
        <zip>258500</zip>
        <country>Singapore</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>Skånes Universitetssjukhus, Malmö</name>
      <address>
        <city>Malmö</city>
        <zip>205 02</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital (CGMH)</name>
      <address>
        <city>Kaohsiung</city>
        <zip>83301</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tri-Service General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>11490</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barts and The London NHS Trust</name>
      <address>
        <city>London</city>
        <state>England</state>
        <zip>EC1A 7BE</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>Sunderland Royal Infirmary</name>
      <address>
        <city>Sunderland</city>
        <zip>SR4 7TP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Singapore</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Taiwan</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Bulgaria</country>
    <country>Czech Republic</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>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>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>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 16 January 2013. The last study visit occurred on 18 May 2016.</recruitment_details>
      <pre_assignment_details>385 participants were screened.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Idelalisib + Rituximab</title>
          <description>Idelalisib (Zydelig®) 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions</description>
        </group>
        <group group_id="P2">
          <title>Placebo + Rituximab</title>
          <description>Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 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="198"/>
                <participants group_id="P2" count="97"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="156"/>
                <participants group_id="P2" count="69"/>
              </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="105"/>
                <participants group_id="P2" count="55"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Initiation of Other Anti-Cancer Therapy</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>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 + Rituximab</title>
          <description>Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions</description>
        </group>
        <group group_id="B2">
          <title>Placebo + Rituximab</title>
          <description>Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 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="198"/>
            <count group_id="B2" value="97"/>
            <count group_id="B3" value="295"/>
          </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="64" spread="11.4"/>
                    <measurement group_id="B2" value="67" spread="11.4"/>
                    <measurement group_id="B3" value="65" spread="11.4"/>
                  </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="99"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="147"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="99"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="148"/>
                  </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="35"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="123"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="177"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Permitted</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="51"/>
                  </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="12"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="150"/>
                    <measurement group_id="B2" value="75"/>
                    <measurement group_id="B3" value="225"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown or Not Reported</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="55"/>
                  </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="7"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Singapore</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Romania</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hungary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Portugal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Czech Republic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sweden</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>Taiwan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Korea, Republic of</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>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Israel</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Progression Free Survival</title>
        <description>Progression-free survival (PFS) is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphoma (iNHL) disease progression or death from any cause. 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 + Rituximab</title>
            <description>Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Rituximab</title>
            <description>Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival</title>
          <description>Progression-free survival (PFS) is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphoma (iNHL) disease progression or death from any cause. 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>Overall Response Rate</title>
        <description>Overall Response Rate (ORR) is defined as the proportion of participants who achieve a complete response or partial response (or very good partial response or minor response 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 + Rituximab</title>
            <description>Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Rituximab</title>
            <description>Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Response Rate</title>
          <description>Overall Response Rate (ORR) is defined as the proportion of participants who achieve a complete response or partial response (or very good partial response or minor response 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 + Rituximab</title>
            <description>Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Rituximab</title>
            <description>Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 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>Complete Response Rate</title>
        <description>Complete response rate is defined as the proportion of participants who achieve a complete response. Complete 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 + Rituximab</title>
            <description>Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Rituximab</title>
            <description>Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions</description>
          </group>
        </group_list>
        <measure>
          <title>Complete Response Rate</title>
          <description>Complete response rate is defined as the proportion of participants who achieve a complete response. Complete 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</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 + Rituximab</title>
            <description>Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Rituximab</title>
            <description>Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival</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 27 months plus 30 days</time_frame>
      <desc>Safety Analysis Set</desc>
      <group_list>
        <group group_id="E1">
          <title>Idelalisib + Rituximab</title>
          <description>Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions</description>
        </group>
        <group group_id="E2">
          <title>Placebo + Rituximab</title>
          <description>Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 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="103" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="95"/>
              </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="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Colitis ulcerative</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Incarcerated inguinal hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Salivary gland disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Salivary gland enlargement</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </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="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Drug-induced liver injury</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Hepatic failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Jaundice</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Eczema herpeticum</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Fungaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Herpes zoster meningomyelitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Infective exacerbation of chronic obstructive airways disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Metapneumovirus infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Neutropenic sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Otitis externa</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Pneumocystis jirovecii pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Skin bacterial infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Staphylococcal bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Clavicle fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Subdural haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Blood lactate dehydrogenase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Cachexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast cancer recurrent</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Glioblastoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Major depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </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="5" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bronchitis chronic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Lung disorder</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </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="189" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="83" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="88" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="50" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="41" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="50" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="95"/>
              </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="36" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="95"/>
              </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="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="56" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </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="26" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="95"/>
              </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="9" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="95"/>
              </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="28" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="95"/>
              </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/NCT01732913
org study id: GS-US-313-0124
nct id: NCT01732913
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 effect of the addition of idelalisib
      to 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
description: Progression-free survival (PFS) is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphoma (iNHL) disease progression or death from any cause. PFS was to be assessed by an independent review committee (IRC).
measure: Overall Response Rate
description: Overall Response Rate (ORR) is defined as the proportion of participants who achieve a complete response or partial response (or very good partial response or minor response 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: Complete Response Rate
description: Complete response rate is defined as the proportion of participants who achieve a complete response. Complete response rate was to be assessed by an IRC.
measure: Overall Survival
description: Overall survival is defined as the interval from randomization to death from any cause.
arm group label: Rituximab + idelalisib
arm group type: Experimental
description: Participants will receive rituximab + idelalisib.
arm group label: Rituximab + Placebo
arm group type: Placebo Comparator
description: Participants will receive rituximab + placebo. Following confirmation of iNHL disease progression by the independent review committee and unblinding, participants may be eligible to receive open-label idelalisib 150 mg twice daily.
intervention type: Drug
intervention name: Placebo
description: Tablets administered orally twice daily
arm group label: Rituximab + Placebo
intervention type: Drug
intervention name: Rituximab
description: 375 mg/m^2 administered intravenously weekly for 4 weeks, then every 8 weeks (up to a total of 8 infusions)
arm group label: Rituximab + Placebo
arm group label: Rituximab + idelalisib
other name: Rituxan®
other name: MabThera®
intervention type: Drug
intervention name: Idelalisib
description: 150 mg tablets administered orally twice daily
arm group label: Rituximab + Placebo
arm group label: Rituximab + idelalisib
other name: GS-1101
other name: CAL-101
other name: Zydelig®
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: Czechia
country: France
country: Germany
country: Hungary
country: Israel
country: Italy
country: Japan
country: Korea, Republic of
country: Poland
country: Portugal
country: Romania
country: Russian Federation
country: Singapore
country: Spain
country: Sweden
country: Taiwan
country: United Kingdom
country: United States
country: Bulgaria
country: Czech Republic
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, Non-Hodgkin
mesh term: Rituximab
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: 