<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/NCT01663727</url>
  </required_header>
  <id_info>
    <org_study_id>GO25632</org_study_id>
    <secondary_id>2011-005335-97</secondary_id>
    <nct_id>NCT01663727</nct_id>
  </id_info>
  <brief_title>Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast Cancer</brief_title>
  <official_title>A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      This is a Phase III, randomized, double-blind, placebo-controlled multicenter study to&#xD;
      evaluate the efficacy and safety of bevacizumab administered in combination with paclitaxel&#xD;
      in patients with previously untreated, locally recurrent, or metastatic HER2-negative breast&#xD;
      cancer. Patients will be randomized to one of two treatment arms: bevacizumab or placebo. All&#xD;
      patients will be given an intravenous (IV) infusion of of paclitaxel (90 mg/m2) for 3 weeks&#xD;
      during each 28-day cycle. bevacizumab or placebo (10 mg/kg) will be administered by IV&#xD;
      infusion on Days 1 and 15 of each 28-day cycle. Patients will be treated until disease&#xD;
      progression, unacceptable toxicity or death from any cause occurs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 27, 2012</start_date>
  <completion_date type="Actual">November 21, 2017</completion_date>
  <primary_completion_date type="Actual">November 30, 2014</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Progression or Death in Intent-to-Treat (ITT) Population</measure>
    <time_frame>Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)</time_frame>
    <description>Tumor assessment was performed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator. Disease progression was defined as at least 20 percent (%) increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), unequivocal progression of existing non-target lesions, or presence of new lesions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Progression Free Survival (PFS) in ITT Population</measure>
    <time_frame>Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)</time_frame>
    <description>PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Progression or Death in High Baseline Plasma Vascular Endothelial Growth Factor-A (VEGF-A) ITT Population</measure>
    <time_frame>Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)</time_frame>
    <description>Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PFS in High Baseline Plasma VEGF-A ITT Population</measure>
    <time_frame>Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)</time_frame>
    <description>PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Died - ITT Population</measure>
    <time_frame>From randomization till death or clinical cut-off (up to 244 weeks)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS) - ITT Population</measure>
    <time_frame>From randomization till death or clinical cut-off (up to 244 weeks)</time_frame>
    <description>OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Died - High Baseline Plasma VEGF-A ITT Population</measure>
    <time_frame>From randomization till death or clinical cut-off (up to 244 weeks)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OS - High Baseline Plasma VEGF-A ITT Population</measure>
    <time_frame>From randomization till death or clinical cut-off (up to 244 weeks)</time_frame>
    <description>OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With an Objective Response - ITT Population</measure>
    <time_frame>Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)</time_frame>
    <description>Objective response was defined as having a Complete Response (CR) or Partial Response (PR) according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to &lt;10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Measurable disease was defined by the presence of at least one measurable lesion by clinical measurement, chest x-ray, computed tomography (CT), or magnetic resonance imaging (MRI).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With an Objective Response - High Baseline Plasma VEGF-A ITT Population</measure>
    <time_frame>Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)</time_frame>
    <description>Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to &lt;10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Measurable disease was defined by the presence of at least one measurable lesion by clinical measurement, chest x-ray, CT, or MRI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response - ITT Population</measure>
    <time_frame>Baseline, every 8 weeks until documented disease progression or clinical cut-off (up to 117.7 weeks)</time_frame>
    <description>Duration of response was defined as the time from the initial date of the objective response to documented disease progression or death (whichever occurred first). Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to &lt;10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. Analysis was performed using Kaplan Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response - High Baseline Plasma VEGF-A ITT Population</measure>
    <time_frame>Baseline, every 8 weeks until documented disease progression or clinical cut-off (up to 111.3 weeks)</time_frame>
    <description>Duration of response was defined as the time from the initial date of the objective response to documented disease progression or death (whichever occurred first). Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to &lt;10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. Analysis was performed using Kaplan Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Were Alive at 1 Year - ITT Population</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary: Percentage of Participants Who Were Alive at 1 Year - High Baseline Plasma VEGF-A ITT Population</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">481</enrollment>
  <condition>Metastatic Breast Cancer</condition>
  <arm_group>
    <arm_group_label>A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Paclitaxel + Bevacizumab [Avastin]</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Paclitaxel + Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bevacizumab [Avastin]</intervention_name>
    <description>Intravenous repeating dose</description>
    <arm_group_label>A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>Intravenous repeating dose</description>
    <arm_group_label>A</arm_group_label>
    <arm_group_label>B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Intravenous repeating dose</description>
    <arm_group_label>B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically or cytologically confirmed, HER2-negative adenocarcinoma of the breast,&#xD;
             with measurable or non-measurable locally recurrent or metastatic disease. Locally&#xD;
             recurrent disease must not be amenable to resection with curative intent.&#xD;
&#xD;
          -  ECOG performance status of 0 or 1&#xD;
&#xD;
          -  For women of childbearing potential, use of an acceptable and effective method of&#xD;
             non-hormonal contraception&#xD;
&#xD;
          -  For patients who have received recent radiotherapy, recovery prior to randomization&#xD;
             from any significant acute toxicity, and radiation treatments have to be completed&#xD;
             more than 3 weeks from randomization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Disease-Specific Exclusions:&#xD;
&#xD;
          -  HER2-positive status&#xD;
&#xD;
          -  Prior chemotherapy for locally recurrent or metastatic disease&#xD;
&#xD;
          -  Prior hormonal therapy &lt; 2 weeks prior to randomization&#xD;
&#xD;
          -  Prior adjuvant or neo-adjuvant chemotherapy is allowed, provided its conclusion has&#xD;
             been for at least 12 months prior to randomization&#xD;
&#xD;
          -  Investigational therapy within 28 days of randomization&#xD;
&#xD;
        General Medical Exclusions:&#xD;
&#xD;
          -  Life expectancy of &lt; 12 weeks&#xD;
&#xD;
          -  Inadequate organ function&#xD;
&#xD;
          -  Uncontrolled serious medical or psychiatric illness&#xD;
&#xD;
          -  Active infection requiring intravenous (IV) antibiotics at screening&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  History of other malignancies within 5 years prior to screening, except for tumors&#xD;
             with a negligible risk for metastasis or death&#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>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Cancer Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilshire Oncology Medical Group</name>
      <address>
        <city>Corona</city>
        <state>California</state>
        <zip>92879</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilshire Oncology Medical Group</name>
      <address>
        <city>Glendora</city>
        <state>California</state>
        <zip>91741</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilshire Oncology Medical Group</name>
      <address>
        <city>La Verne</city>
        <state>California</state>
        <zip>91750</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Long Beach Memorial Medical Center; Oncology</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tenet Health System Desert Inc</name>
      <address>
        <city>Palm Springs</city>
        <state>California</state>
        <zip>92262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilshire Oncology Medical Group; Oncology</name>
      <address>
        <city>Pomona</city>
        <state>California</state>
        <zip>91767</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilshire Oncology Medical Group</name>
      <address>
        <city>Rancho Cucamonga</city>
        <state>California</state>
        <zip>91730</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilshire Oncology Medical Group</name>
      <address>
        <city>West Covina</city>
        <state>California</state>
        <zip>91790</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sylvester Comprehensive Cancer Center - Deerfield Beach; Sylvester Cancer Center</name>
      <address>
        <city>Deerfield Beach</city>
        <state>Florida</state>
        <zip>33442</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialists - Broadway</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BRCR Medical Center, Inc.</name>
      <address>
        <city>Plantation</city>
        <state>Florida</state>
        <zip>33322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology Oncology Associates of the Treasure Coast</name>
      <address>
        <city>Port Saint Lucie</city>
        <state>Florida</state>
        <zip>34952</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northeast Georgia Cancer Care LLC</name>
      <address>
        <city>Athens</city>
        <state>Georgia</state>
        <zip>30607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peachtree Hematology &amp; Oncology Consultants, Pc</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30318</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Foundation Hospital; Dr. Eron's Office</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96819</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IU Cancer Pavilion</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greater Baltimore Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maryland Oncology Hematology, P.A.</name>
      <address>
        <city>Columbia</city>
        <state>Maryland</state>
        <zip>21044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lahey Clinic Inc. - PARENT ACCOUNT</name>
      <address>
        <city>Burlington</city>
        <state>Massachusetts</state>
        <zip>01805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Jones Clinic, PC</name>
      <address>
        <city>New Albany</city>
        <state>Mississippi</state>
        <zip>38652</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Missouri Cancer Associates</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University; Center for Adv Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</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>ProMedica Hickman Cancer Center at Flower Hospital; Hickman Cancer Center</name>
      <address>
        <city>Sylvania</city>
        <state>Ohio</state>
        <zip>43560</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Toledo; Dept. of Medicine</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Cancer Specialists - Leesburg</name>
      <address>
        <city>Leesburg</city>
        <state>Pennsylvania</state>
        <zip>20176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pennsylvania Oncology Hematology Associates, Inc.; PA Oncology &amp; Hematology</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina; Division of Hematology-Oncology</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCRI-Tennessee Oncology</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology-Medical City Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology, P.A. - Dallas Presbyterian</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology, P.A. - Fort Worth</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology- Southwest Fort Worth</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ of Texas Medical Branch</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology, P.A. - Garland</name>
      <address>
        <city>Garland</city>
        <state>Texas</state>
        <zip>77060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Care Centers of S Texas</name>
      <address>
        <city>Kerrville</city>
        <state>Texas</state>
        <zip>78028</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology- Longview Cancer Center</name>
      <address>
        <city>Longview</city>
        <state>Texas</state>
        <zip>75601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology, P.A. - McAllen; South Texas Cancer Center-McAllen</name>
      <address>
        <city>McAllen</city>
        <state>Texas</state>
        <zip>78503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology Plano West</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Care Centers of South Texas</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Care Centers of South Texas</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78217</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CancerCare Centers of South Texas</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology, P.A. - Tyler</name>
      <address>
        <city>The Woodlands</city>
        <state>Texas</state>
        <zip>77060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology, P.A.</name>
      <address>
        <city>The Woodlands</city>
        <state>Texas</state>
        <zip>77060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Cancer Specialists - Alexandria</name>
      <address>
        <city>Alexandria</city>
        <state>Virginia</state>
        <zip>22304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fairfax Northern Virginia Hematology-Oncology PC</name>
      <address>
        <city>Arlington</city>
        <state>Virginia</state>
        <zip>22205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellmonth Physician Services</name>
      <address>
        <city>Bristol</city>
        <state>Virginia</state>
        <zip>24201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Oncology Associates - Chesapeake</name>
      <address>
        <city>Chesapeake</city>
        <state>Virginia</state>
        <zip>23320</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncology &amp; Hematology Associates of SW Va Inc. - Market Street</name>
      <address>
        <city>Christiansburg</city>
        <state>Virginia</state>
        <zip>24073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Cancer Specialists, PC</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology Oncology Associates of Fredericksburg, Inc.</name>
      <address>
        <city>Fredericksburg</city>
        <state>Virginia</state>
        <zip>22408</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Cancer Specialists - Gainsville</name>
      <address>
        <city>Gainesville</city>
        <state>Virginia</state>
        <zip>20155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Oncology Associates - Hampton</name>
      <address>
        <city>Hampton</city>
        <state>Virginia</state>
        <zip>23666</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncology and Hematology Assoc. of SW VA, Inc. - Low Moor</name>
      <address>
        <city>Low Moor</city>
        <state>Virginia</state>
        <zip>24457</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Oncology Associates - New Port News</name>
      <address>
        <city>Newport News</city>
        <state>Virginia</state>
        <zip>23606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Oncology Associates</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncology &amp; Hematolgy Associates of SW Va Inc. - Roanoke</name>
      <address>
        <city>Roanoke</city>
        <state>Virginia</state>
        <zip>24014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncology and Hematology Assoc. of SW VA, Inc.</name>
      <address>
        <city>Salem</city>
        <state>Virginia</state>
        <zip>77060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Oncology Associates - Virginia Beach</name>
      <address>
        <city>Virginia Beach</city>
        <state>Virginia</state>
        <zip>23456</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncology and Hematology Assoc. of SW VA, Inc. - Wytheville</name>
      <address>
        <city>Wytheville</city>
        <state>Virginia</state>
        <zip>24382</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Medical Specialties, PLLC; Research Department</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Virginia University; Endocrinology</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Britanico de Buenos Aires</name>
      <address>
        <city>Ciudad Autonoma Buenos Aires</city>
        <zip>C1284AEB</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Oncologico Riojano Integral (CORI)</name>
      <address>
        <city>La Rioja</city>
        <zip>F5300COE</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Investigacion Pergamino SA</name>
      <address>
        <city>Pergamino</city>
        <zip>B2700CPM</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Investigaciones Clínicas Quilmes</name>
      <address>
        <city>Quilmes</city>
        <zip>1878</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanatorio Parque S.A.</name>
      <address>
        <city>Rosario, Santa FE</city>
        <zip>S2000DSV</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Provincial del Centenario</name>
      <address>
        <city>Rosario</city>
        <zip>2000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto CAICI</name>
      <address>
        <city>Rosario</city>
        <zip>S2000CVB</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Oncología de Rosario</name>
      <address>
        <city>Rosario</city>
        <zip>S2000KZE</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ISIS Clinica Especializada</name>
      <address>
        <city>Santa Fe</city>
        <zip>03000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ KLINA</name>
      <address>
        <city>Brasschaat</city>
        <zip>2930</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Brussel</name>
      <address>
        <city>Brussel</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Antwerpen</name>
      <address>
        <city>Edegem</city>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GHdC Site Saint-Joseph</name>
      <address>
        <city>Gilly (Charleroi)</city>
        <zip>6000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Ambroise Paré; Hematology and Oncology Department</name>
      <address>
        <city>Mons</city>
        <zip>7000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica de Tratamento e Pesquisa Oncologica - Oncotek</name>
      <address>
        <city>Brasilia</city>
        <state>DF</state>
        <zip>70390-055</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia</name>
      <address>
        <city>Passo Fundo</city>
        <state>RS</state>
        <zip>99010-260</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Sao Lucas - PUCRS; Pesquisa Clinica</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90110-270</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica de Oncologia de Porto Alegre - CliniOnco</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90430-090</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Nossa Senhora da Conceicao</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>91350-200</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Pesquisas Oncologicas - CEPON</name>
      <address>
        <city>Florianopolis</city>
        <state>SC</state>
        <zip>88034-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica de Neoplasias Litoral</name>
      <address>
        <city>Itajai</city>
        <state>SC</state>
        <zip>88301-220</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital das Clinicas - FMUSP Ribeirao Preto</name>
      <address>
        <city>Ribeirao Preto</city>
        <state>SP</state>
        <zip>14048-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universidade Federal de Sao Paulo - UNIFESP</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>22793-080</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT Dr. Tota Venkova AD</name>
      <address>
        <city>Gabrovo</city>
        <zip>5300</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SHATOD Haskovo EOOD</name>
      <address>
        <city>Haskovo</city>
        <zip>6300</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complex Oncological Center - Plovdiv, EOOD</name>
      <address>
        <city>Plovdiv</city>
        <zip>4004</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complex Oncological Center - Shumen, EOOD; Department of Chemotherapy</name>
      <address>
        <city>Shumen</city>
        <zip>9700</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SHATOD - Sofia District, EOOD</name>
      <address>
        <city>Sofia</city>
        <zip>1233</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT Serdika, EOOD</name>
      <address>
        <city>Sofia</city>
        <zip>1303</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT Tsaritsa Yoanna - ISUL, EAD</name>
      <address>
        <city>Sofia</city>
        <zip>1527</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SHATOD - Sofia City, EOOD</name>
      <address>
        <city>Sofia</city>
        <zip>1784</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SHATOD Dr. Marko Antonov Markov-Varna, EOOD</name>
      <address>
        <city>Varna</city>
        <zip>9010</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>COC - Veliko Tarnovo</name>
      <address>
        <city>Veliko Tarnovo</city>
        <zip>5000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Estudios Oncologicos de Santiago (CEOS) Oncologia</name>
      <address>
        <city>Santiago</city>
        <zip>7500921</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacion Arturo Lopez Perez</name>
      <address>
        <city>Santiago</city>
        <zip>7500921</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Nacional del Cancer</name>
      <address>
        <city>Santiago</city>
        <zip>8380000</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Oncologico Ltda.</name>
      <address>
        <city>Viña del Mar</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Studienzentrum Aschaffenburg</name>
      <address>
        <city>Aschaffenburg</city>
        <zip>63739</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Johannes Hospital; Klinik fuer innere Medizin II, Onkologie, Haematologie</name>
      <address>
        <city>Dortmund</city>
        <zip>44137</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilhelm-Anton-Hospital gGmbH</name>
      <address>
        <city>Goch</city>
        <zip>47574</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Elisabeth-Krankenhaus</name>
      <address>
        <city>Köln</city>
        <zip>50935</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Ulm</name>
      <address>
        <city>Ulm</city>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera A. Cardarelli</name>
      <address>
        <city>Napoli</city>
        <state>Campania</state>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale degli Infermi</name>
      <address>
        <city>Rimini</city>
        <state>Emilia-Romagna</state>
        <zip>47923</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Mater Salutis</name>
      <address>
        <city>Legnago (VR)</city>
        <state>Lombardia</state>
        <zip>37045</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Raffaele</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Salvatore Maugeri IRCCS</name>
      <address>
        <city>Pavia</city>
        <state>Lombardia</state>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Casa Sollievo Della Sofferenza IRCCS</name>
      <address>
        <city>San Giovanni Rotondo</city>
        <state>Puglia</state>
        <zip>71013</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Versilia</name>
      <address>
        <city>Lido Di Camaiore</city>
        <state>Toscana</state>
        <zip>55043</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHO Shikoku Cancer Center; Dept of Respiratory Medicine</name>
      <address>
        <city>Ehime</city>
        <zip>791-0280</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHO Kyushu Cancer Center</name>
      <address>
        <city>Fukuoka</city>
        <zip>811-1395</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gifu University Hospital</name>
      <address>
        <city>Gifu</city>
        <zip>501-1194</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hiroshima University Hospital</name>
      <address>
        <city>Hiroshima</city>
        <zip>734-8551</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hyogo College of Medicine Hospital</name>
      <address>
        <city>Hyogo</city>
        <zip>663-8501</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iwate Medical University Hospital</name>
      <address>
        <city>Iwate</city>
        <zip>020-8505</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hakuaikai Sagara Hospital</name>
      <address>
        <city>Kagoshima</city>
        <zip>892-0833</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokai University Hospital</name>
      <address>
        <city>Kanagawa</city>
        <zip>259-1193</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kumamoto University Hospital</name>
      <address>
        <city>Kumamoto</city>
        <zip>860-8556</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kumamoto City Hospital</name>
      <address>
        <city>Kumamoto</city>
        <zip>862-8505</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tohoku University Hospital</name>
      <address>
        <city>Miyagi</city>
        <zip>980-8574</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Niigata Cancer Center Hospital</name>
      <address>
        <city>Niigata</city>
        <zip>951-8566</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHO Osaka National Hospital</name>
      <address>
        <city>Osaka</city>
        <zip>540-0006</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka International Cancer Institute</name>
      <address>
        <city>Osaka</city>
        <zip>541-8567</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kindai University Hospital</name>
      <address>
        <city>Osaka</city>
        <zip>589-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHO Hokkaido Cancer Center</name>
      <address>
        <city>Sapporo-shi</city>
        <zip>003-0804</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shizuoka General Hospital</name>
      <address>
        <city>Shizuoka-shi</city>
        <zip>420-8527</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toranomon Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>105-8470</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Juntendo University Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>113-8431</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>113-8677</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Centre</name>
      <address>
        <city>Gyeonggi-do</city>
        <zip>10408</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Gyeonggi-do</city>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital, Yonsei University Health System; Pharmacy</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center.</name>
      <address>
        <city>Seoul</city>
        <zip>138-736</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>6351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hemato Oncologico Panama</name>
      <address>
        <city>Panama</city>
        <zip>0832</zip>
        <country>Panama</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Research Centre</name>
      <address>
        <city>Panama</city>
        <country>Panama</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institutul Oncologic &quot;Prof. Dr. Al. Trestioreanu&quot;</name>
      <address>
        <city>Bucuresti</city>
        <zip>022328</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca; Radioterapie I - Oncologie</name>
      <address>
        <city>Cluj-Napoca</city>
        <zip>400015</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medisprof SRL</name>
      <address>
        <city>Cluj-Napoca</city>
        <zip>400058</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncomed SRL</name>
      <address>
        <city>Timisoara</city>
        <zip>300239</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CTPI Chernihiv Regional Oncological Dispensary</name>
      <address>
        <city>Chernihiv</city>
        <zip>14029</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SHI Republican Clinical Oncological Dispensary of HM RT</name>
      <address>
        <city>Kazan</city>
        <zip>420029</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Clinical Oncology Dispensary</name>
      <address>
        <city>Krasnodar</city>
        <zip>350040</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FSBSI &quot;Russian Oncological Scientific Center n.a. N.N. Blokhin&quot;</name>
      <address>
        <city>Moscow</city>
        <zip>115478</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Clinical Oncology Dispensary</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>197022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SBEIHPE SSMU n.a. I.P.Pavlov of MOH and SD of RF</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>197101</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FBI &quot;Scientific Research Institute of Oncology n. a. N. N. Petrov&quot;</name>
      <address>
        <city>Saint-Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samara Regional Oncology Dispensary</name>
      <address>
        <city>Samara</city>
        <zip>443031</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Non-state Healthcare Institution &quot;Road Clinical Hospital of JSC Russian Railways&quot;</name>
      <address>
        <city>St. Petersburg</city>
        <zip>195271</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital; Oncotherapy Dept</name>
      <address>
        <city>Bloemfontein</city>
        <zip>9301</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cape Town Oncology Trials</name>
      <address>
        <city>Cape Town</city>
        <zip>7570</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopelands Cancer Centre Durban</name>
      <address>
        <city>Durban</city>
        <zip>4091</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mary Potter Oncology Centre</name>
      <address>
        <city>Groenkloof</city>
        <zip>0181</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopelands Cancer Centre</name>
      <address>
        <city>Hilton</city>
        <zip>3245</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancercare</name>
      <address>
        <city>Port Elizabeth</city>
        <zip>6045</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pretoria; Department of Medical Oncology</name>
      <address>
        <city>Pretoria</city>
        <zip>0002</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CI Cherkasy Regional Oncological Dispensary of Cherkasy RC RC of Clinical Oncology</name>
      <address>
        <city>Cherkassy</city>
        <zip>18009</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CI Dnipropetrovsk CMCH 4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU</name>
      <address>
        <city>Dnipropetrovsk</city>
        <zip>49102</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CCTPI Donetsk Regional Antitumor Center</name>
      <address>
        <city>Donetsk</city>
        <zip>83092</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyiv Сity Clinical Oncological Center</name>
      <address>
        <city>Kyiv</city>
        <zip>03115</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical and Prophylactic Institution Volyn Regional Oncological Dispensary</name>
      <address>
        <city>Lutsk</city>
        <zip>63000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lviv State Oncological Regional Treatment and Diagnostic Center</name>
      <address>
        <city>Lviv</city>
        <zip>79031</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RCI Sumy Regional Clinical Oncological Dispensary</name>
      <address>
        <city>Sumy</city>
        <zip>40005</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CCCH City Oncological Center SHEI Uzhgorod NU</name>
      <address>
        <city>Uzhgorod</city>
        <zip>88000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Velindre Cancer Centre</name>
      <address>
        <city>Cardiff</city>
        <zip>CF14 2TL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western General Hospital</name>
      <address>
        <city>Edinburgh</city>
        <zip>EH4 2XU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Devon and Exeter Hospital (Wonford)</name>
      <address>
        <city>Exeter</city>
        <zip>EX2 5DW</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>Peterborough City Hospital</name>
      <address>
        <city>Peterborough</city>
        <zip>PE3 9GZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Derriford Hospital; Clinical Neurology Research Group</name>
      <address>
        <city>Plymouth</city>
        <zip>PL6 8BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Bulgaria</country>
    <country>Chile</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Panama</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>South Africa</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Slovakia</country>
    <country>Vietnam</country>
  </removed_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 9, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <results_first_submitted>January 12, 2016</results_first_submitted>
  <results_first_submitted_qc>January 12, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 10, 2016</results_first_posted>
  <last_update_submitted>January 7, 2019</last_update_submitted>
  <last_update_submitted_qc>January 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Bevacizumab</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Paclitaxel+Placebo</title>
          <description>Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.</description>
        </group>
        <group group_id="P2">
          <title>Paclitaxel+ Bevacizumab</title>
          <description>Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="242"/>
                <participants group_id="P2" count="239"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="242"/>
                <participants group_id="P2" count="238"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="161"/>
                <participants group_id="P2" count="155"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Terminated</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by subject and Adverse Event.</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal prior to dosing.</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent-to-treat (ITT) population: All participants randomized to study treatment irrespective of whether the assigned treatment was actually received.</population>
      <group_list>
        <group group_id="B1">
          <title>Paclitaxel+Placebo</title>
          <description>Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.</description>
        </group>
        <group group_id="B2">
          <title>Paclitaxel+ Bevacizumab</title>
          <description>Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.</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="242"/>
            <count group_id="B2" value="239"/>
            <count group_id="B3" value="481"/>
          </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="54.7" spread="10.7"/>
                    <measurement group_id="B2" value="55.8" spread="11.5"/>
                    <measurement group_id="B3" value="55.3" spread="11.1"/>
                  </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="237"/>
                    <measurement group_id="B2" value="236"/>
                    <measurement group_id="B3" value="473"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Progression or Death in Intent-to-Treat (ITT) Population</title>
        <description>Tumor assessment was performed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator. Disease progression was defined as at least 20 percent (%) increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), unequivocal progression of existing non-target lesions, or presence of new lesions.</description>
        <time_frame>Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)</time_frame>
        <population>ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Paclitaxel+Placebo</title>
            <description>Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.</description>
          </group>
          <group group_id="O2">
            <title>Paclitaxel+ Bevacizumab</title>
            <description>Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Progression or Death in Intent-to-Treat (ITT) Population</title>
          <description>Tumor assessment was performed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator. Disease progression was defined as at least 20 percent (%) increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), unequivocal progression of existing non-target lesions, or presence of new lesions.</description>
          <population>ITT population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="242"/>
                <count group_id="O2" value="239"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.4"/>
                    <measurement group_id="O2" value="63.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Progression Free Survival (PFS) in ITT Population</title>
        <description>PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method.</description>
        <time_frame>Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)</time_frame>
        <population>ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Paclitaxel+Placebo</title>
            <description>Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.</description>
          </group>
          <group group_id="O2">
            <title>Paclitaxel+ Bevacizumab</title>
            <description>Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival (PFS) in ITT Population</title>
          <description>PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method.</description>
          <population>ITT population.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="242"/>
                <count group_id="O2" value="239"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.8" lower_limit="7.4" upper_limit="9.3"/>
                    <measurement group_id="O2" value="11.0" lower_limit="9.5" upper_limit="12.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Stratified analysis: Stratification factors were plasma VEGF-A level (low/high), prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0007</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.68</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.51</ci_lower_limit>
            <ci_upper_limit>0.91</ci_upper_limit>
            <estimate_desc>Hazards ratio was estimated by Cox regression.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Unstratified Analysis.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0046</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.73</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.55</ci_lower_limit>
            <ci_upper_limit>0.97</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A stratified multivariate Cox regression model, including treatment, VEGF-A level, and interaction between treatment and VEGF-A level (low, high) as factors was used to estimate the interaction p-value of the treatment with VEGF-A level for PFS. Analysis for the interaction of treatment effect with the plasma VEGF-A levels was a secondary objective.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.4619</p_value>
            <method>Wald Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Died - ITT Population</title>
        <time_frame>From randomization till death or clinical cut-off (up to 244 weeks)</time_frame>
        <population>ITT Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Paclitaxel+Placebo</title>
            <description>Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.</description>
          </group>
          <group group_id="O2">
            <title>Paclitaxel+ Bevacizumab</title>
            <description>Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Died - ITT Population</title>
          <population>ITT Population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="242"/>
                <count group_id="O2" value="239"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.9"/>
                    <measurement group_id="O2" value="64.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS) - ITT Population</title>
        <description>OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method.</description>
        <time_frame>From randomization till death or clinical cut-off (up to 244 weeks)</time_frame>
        <population>ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Paclitaxel+Placebo</title>
            <description>Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.</description>
          </group>
          <group group_id="O2">
            <title>Paclitaxel+ Bevacizumab</title>
            <description>Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS) - ITT Population</title>
          <description>OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method.</description>
          <population>ITT population.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="242"/>
                <count group_id="O2" value="239"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.8" lower_limit="21.8" upper_limit="30.2"/>
                    <measurement group_id="O2" value="28.8" lower_limit="22.8" upper_limit="32.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Stratified analysis: Stratified analysis: Stratification factors were plasma VEGF-A level (low/high), prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.5877</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.75</ci_lower_limit>
            <ci_upper_limit>1.18</ci_upper_limit>
            <estimate_desc>Hazards ratio was estimated by Cox regression.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Unstratified analysis.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.8004</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.97</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.78</ci_lower_limit>
            <ci_upper_limit>1.21</ci_upper_limit>
            <estimate_desc>Hazards ratio was estimated by Cox regression.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Died - High Baseline Plasma VEGF-A ITT Population</title>
        <time_frame>From randomization till death or clinical cut-off (up to 244 weeks)</time_frame>
        <population>High Baseline Plasma VEGF-A ITT Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Paclitaxel+Placebo</title>
            <description>Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.</description>
          </group>
          <group group_id="O2">
            <title>Paclitaxel+ Bevacizumab</title>
            <description>Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Died - High Baseline Plasma VEGF-A ITT Population</title>
          <population>High Baseline Plasma VEGF-A ITT Population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.2"/>
                    <measurement group_id="O2" value="71.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>OS - High Baseline Plasma VEGF-A ITT Population</title>
        <description>OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method.</description>
        <time_frame>From randomization till death or clinical cut-off (up to 244 weeks)</time_frame>
        <population>High Baseline Plasma VEGF-A ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Paclitaxel+Placebo</title>
            <description>Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.</description>
          </group>
          <group group_id="O2">
            <title>Paclitaxel+ Bevacizumab</title>
            <description>Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.</description>
          </group>
        </group_list>
        <measure>
          <title>OS - High Baseline Plasma VEGF-A ITT Population</title>
          <description>OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method.</description>
          <population>High Baseline Plasma VEGF-A ITT population.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.4" lower_limit="16.5" upper_limit="25.0"/>
                    <measurement group_id="O2" value="22.8" lower_limit="18.2" upper_limit="31.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Stratified analysis: Stratification factors were prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.2745</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.63</ci_lower_limit>
            <ci_upper_limit>1.14</ci_upper_limit>
            <estimate_desc>Hazards ratio was estimated by Cox regression.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Unstratified analysis.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.3616</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.87</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.65</ci_lower_limit>
            <ci_upper_limit>1.17</ci_upper_limit>
            <estimate_desc>Hazards ratio was estimated by Cox regression.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With an Objective Response - ITT Population</title>
        <description>Objective response was defined as having a Complete Response (CR) or Partial Response (PR) according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to &lt;10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Measurable disease was defined by the presence of at least one measurable lesion by clinical measurement, chest x-ray, computed tomography (CT), or magnetic resonance imaging (MRI).</description>
        <time_frame>Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)</time_frame>
        <population>Number of participants analyzed=participants from ITT population with measurable disease at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Paclitaxel+Placebo</title>
            <description>Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.</description>
          </group>
          <group group_id="O2">
            <title>Paclitaxel+ Bevacizumab</title>
            <description>Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With an Objective Response - ITT Population</title>
          <description>Objective response was defined as having a Complete Response (CR) or Partial Response (PR) according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to &lt;10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Measurable disease was defined by the presence of at least one measurable lesion by clinical measurement, chest x-ray, computed tomography (CT), or magnetic resonance imaging (MRI).</description>
          <population>Number of participants analyzed=participants from ITT population with measurable disease at baseline.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="214"/>
                <count group_id="O2" value="202"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.2" lower_limit="26.87" upper_limit="39.49"/>
                    <measurement group_id="O2" value="54.0" lower_limit="47.09" upper_limit="60.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Fisher</method>
            <param_type>Difference in Response Rates</param_type>
            <param_value>20.78</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>11.45</ci_lower_limit>
            <ci_upper_limit>30.11</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Progression or Death in High Baseline Plasma Vascular Endothelial Growth Factor-A (VEGF-A) ITT Population</title>
        <description>Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions.</description>
        <time_frame>Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)</time_frame>
        <population>High baseline plasma VEGF-A ITT population: All participants randomized to study treatment with high baseline plasma VEGF-A levels (VEGF-A levels greater than or equal to 5.05 picograms per milliliter), irrespective of whether the assigned treatment was actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>Paclitaxel+Placebo</title>
            <description>Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.</description>
          </group>
          <group group_id="O2">
            <title>Paclitaxel+ Bevacizumab</title>
            <description>Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Progression or Death in High Baseline Plasma Vascular Endothelial Growth Factor-A (VEGF-A) ITT Population</title>
          <description>Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions.</description>
          <population>High baseline plasma VEGF-A ITT population: All participants randomized to study treatment with high baseline plasma VEGF-A levels (VEGF-A levels greater than or equal to 5.05 picograms per milliliter), irrespective of whether the assigned treatment was actually received.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.0"/>
                    <measurement group_id="O2" value="70.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>PFS in High Baseline Plasma VEGF-A ITT Population</title>
        <description>PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method.</description>
        <time_frame>Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)</time_frame>
        <population>High baseline plasma VEGF-A ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Paclitaxel+Placebo</title>
            <description>Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.</description>
          </group>
          <group group_id="O2">
            <title>Paclitaxel+ Bevacizumab</title>
            <description>Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.</description>
          </group>
        </group_list>
        <measure>
          <title>PFS in High Baseline Plasma VEGF-A ITT Population</title>
          <description>PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method.</description>
          <population>High baseline plasma VEGF-A ITT population.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.3" lower_limit="5.6" upper_limit="8.7"/>
                    <measurement group_id="O2" value="9.6" lower_limit="9.0" upper_limit="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Stratified analysis: Stratification factors were prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0038</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.64</param_value>
            <ci_percent>96</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.47</ci_lower_limit>
            <ci_upper_limit>0.88</ci_upper_limit>
            <estimate_desc>Hazards ratio was estimated by Cox regression.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Unstratified analysis.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0101</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.68</param_value>
            <ci_percent>96</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.50</ci_lower_limit>
            <ci_upper_limit>0.93</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With an Objective Response - High Baseline Plasma VEGF-A ITT Population</title>
        <description>Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to &lt;10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Measurable disease was defined by the presence of at least one measurable lesion by clinical measurement, chest x-ray, CT, or MRI.</description>
        <time_frame>Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)</time_frame>
        <population>Number of participants analyzed=participants from high baseline plasma VEGF-A ITT population with measurable disease at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Paclitaxel+Placebo</title>
            <description>Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.</description>
          </group>
          <group group_id="O2">
            <title>Paclitaxel+ Bevacizumab</title>
            <description>Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With an Objective Response - High Baseline Plasma VEGF-A ITT Population</title>
          <description>Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to &lt;10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Measurable disease was defined by the presence of at least one measurable lesion by clinical measurement, chest x-ray, CT, or MRI.</description>
          <population>Number of participants analyzed=participants from high baseline plasma VEGF-A ITT population with measurable disease at baseline.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="116"/>
                <count group_id="O2" value="105"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.8" lower_limit="24.22" upper_limit="41.30"/>
                    <measurement group_id="O2" value="54.3" lower_limit="44.76" upper_limit="63.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0017</p_value>
            <method>Fisher</method>
            <param_type>Difference in Response Rates</param_type>
            <param_value>21.53</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>8.73</ci_lower_limit>
            <ci_upper_limit>34.32</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response - ITT Population</title>
        <description>Duration of response was defined as the time from the initial date of the objective response to documented disease progression or death (whichever occurred first). Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to &lt;10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. Analysis was performed using Kaplan Meier method.</description>
        <time_frame>Baseline, every 8 weeks until documented disease progression or clinical cut-off (up to 117.7 weeks)</time_frame>
        <population>Number of participants analyzed=participants from ITT population who had an objective response.</population>
        <group_list>
          <group group_id="O1">
            <title>Paclitaxel+Placebo</title>
            <description>Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.</description>
          </group>
          <group group_id="O2">
            <title>Paclitaxel+ Bevacizumab</title>
            <description>Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response - ITT Population</title>
          <description>Duration of response was defined as the time from the initial date of the objective response to documented disease progression or death (whichever occurred first). Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to &lt;10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. Analysis was performed using Kaplan Meier method.</description>
          <population>Number of participants analyzed=participants from ITT population who had an objective response.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.2" lower_limit="7.4" upper_limit="11.5"/>
                    <measurement group_id="O2" value="9.5" lower_limit="7.8" upper_limit="12.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Stratified analysis: Stratification factors were plasma VEGF-A level (low/high), prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.2737</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.54</ci_lower_limit>
            <ci_upper_limit>1.19</ci_upper_limit>
            <estimate_desc>Hazards ratio was estimated by Cox regression.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Unstratified analysis.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.2959</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.56</ci_lower_limit>
            <ci_upper_limit>1.19</ci_upper_limit>
            <estimate_desc>Hazards ratio was estimated by Cox regression.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response - High Baseline Plasma VEGF-A ITT Population</title>
        <description>Duration of response was defined as the time from the initial date of the objective response to documented disease progression or death (whichever occurred first). Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to &lt;10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. Analysis was performed using Kaplan Meier method.</description>
        <time_frame>Baseline, every 8 weeks until documented disease progression or clinical cut-off (up to 111.3 weeks)</time_frame>
        <population>Number of participants analyzed=participants from high baseline plasma VEGF-A ITT population who had an objective response.</population>
        <group_list>
          <group group_id="O1">
            <title>Paclitaxel+Placebo</title>
            <description>Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.</description>
          </group>
          <group group_id="O2">
            <title>Paclitaxel+ Bevacizumab</title>
            <description>Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response - High Baseline Plasma VEGF-A ITT Population</title>
          <description>Duration of response was defined as the time from the initial date of the objective response to documented disease progression or death (whichever occurred first). Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to &lt;10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. Analysis was performed using Kaplan Meier method.</description>
          <population>Number of participants analyzed=participants from high baseline plasma VEGF-A ITT population who had an objective response.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.2" lower_limit="5.6" upper_limit="9.5"/>
                    <measurement group_id="O2" value="8.1" lower_limit="7.1" upper_limit="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Stratified analysis: Stratification factors were prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1783</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.70</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.41</ci_lower_limit>
            <ci_upper_limit>1.18</ci_upper_limit>
            <estimate_desc>Hazards ratio was estimated by Cox regression.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Unstratified analysis.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.2429</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.74</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.45</ci_lower_limit>
            <ci_upper_limit>1.22</ci_upper_limit>
            <estimate_desc>Hazards ratio was estimated by Cox regression.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Were Alive at 1 Year - ITT Population</title>
        <time_frame>1 year</time_frame>
        <population>ITT Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Paclitaxel+Placebo</title>
            <description>Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.</description>
          </group>
          <group group_id="O2">
            <title>Paclitaxel+ Bevacizumab</title>
            <description>Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Were Alive at 1 Year - ITT Population</title>
          <population>ITT Population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="242"/>
                <count group_id="O2" value="239"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.94"/>
                    <measurement group_id="O2" value="82.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Secondary: Percentage of Participants Who Were Alive at 1 Year - High Baseline Plasma VEGF-A ITT Population</title>
        <time_frame>1 year</time_frame>
        <population>High Baseline Plasma VEGF-A ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Paclitaxel+Placebo</title>
            <description>Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.</description>
          </group>
          <group group_id="O2">
            <title>Paclitaxel+ Bevacizumab</title>
            <description>Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.</description>
          </group>
        </group_list>
        <measure>
          <title>Secondary: Percentage of Participants Who Were Alive at 1 Year - High Baseline Plasma VEGF-A ITT Population</title>
          <population>High Baseline Plasma VEGF-A ITT Population</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.27"/>
                    <measurement group_id="O2" value="80.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)</time_frame>
      <desc>Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).</desc>
      <group_list>
        <group group_id="E1">
          <title>Paclitaxel+Placebo</title>
          <description>Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.</description>
        </group>
        <group group_id="E2">
          <title>Paclitaxel+ Bevacizumab</title>
          <description>Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (17.1)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="162" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="161" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="45" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="66" subjects_at_risk="238"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="233"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Left ventricular dysfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>ACUTE CORONARY SYNDROME</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>CARDIAC FAILURE CONGESTIVE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Optic nerve disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Visual acuity reduced</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>CATARACT</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="233"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Duodenal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Gastric ulcer haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Gastric varices haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="233"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="238"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>CATHETER SITE ERYTHEMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="238"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile duct obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Gallbladder pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Hepatic failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>ANAPHYLACTIC REACTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal wall abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Abscess limb</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="6" subjects_affected="4" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Cholecystitis infective</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Colonic abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="233"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Device related sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Pharyngotonsillitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="233"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Pneumonia necrotising</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Sepsis syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Wound infection bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>VIRAL INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>CATHETER SITE INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>KLEBSIELLA SEPSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>SOFT TISSUE INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>URINARY TRACT INFECTION BACTERIAL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>ROAD TRAFFIC ACCIDENT</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>STERNAL FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>WOUND DEHISCENCE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Urine output decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>HYPOKALAEMIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>HYPONATRAEMIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>LACTIC ACIDOSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Osteonecrosis of jaw</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Cancer pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Gastric cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral ischaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Dementia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Speech disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Spinal cord compression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="238"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Cystitis haemorrhagic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bronchospasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain of skin</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Skin haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Embolism venous</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Superior vena cava syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Venous thrombosis limb</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>ARTERIAL THROMBOSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="238"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (17.1)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="225" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="230" subjects_at_risk="238"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="82" subjects_affected="39" subjects_at_risk="233"/>
                <counts group_id="E2" events="63" subjects_affected="39" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="42" subjects_affected="14" subjects_at_risk="233"/>
                <counts group_id="E2" events="41" subjects_affected="17" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="124" subjects_affected="50" subjects_at_risk="233"/>
                <counts group_id="E2" events="254" subjects_affected="77" subjects_at_risk="238"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="30" subjects_affected="17" subjects_at_risk="233"/>
                <counts group_id="E2" events="27" subjects_affected="20" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="14" subjects_affected="13" subjects_at_risk="233"/>
                <counts group_id="E2" events="16" subjects_affected="13" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="70" subjects_affected="50" subjects_at_risk="233"/>
                <counts group_id="E2" events="108" subjects_affected="67" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="128" subjects_affected="72" subjects_at_risk="233"/>
                <counts group_id="E2" events="189" subjects_affected="88" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="20" subjects_affected="16" subjects_at_risk="233"/>
                <counts group_id="E2" events="40" subjects_affected="23" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="205" subjects_affected="75" subjects_at_risk="233"/>
                <counts group_id="E2" events="310" subjects_affected="99" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="35" subjects_affected="26" subjects_at_risk="233"/>
                <counts group_id="E2" events="75" subjects_affected="42" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="233"/>
                <counts group_id="E2" events="16" subjects_affected="15" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="63" subjects_affected="36" subjects_at_risk="233"/>
                <counts group_id="E2" events="96" subjects_affected="47" subjects_at_risk="238"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="50" subjects_affected="36" subjects_at_risk="233"/>
                <counts group_id="E2" events="62" subjects_affected="32" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="123" subjects_affected="74" subjects_at_risk="233"/>
                <counts group_id="E2" events="156" subjects_affected="88" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="57" subjects_affected="42" subjects_at_risk="233"/>
                <counts group_id="E2" events="56" subjects_affected="41" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="37" subjects_affected="28" subjects_at_risk="233"/>
                <counts group_id="E2" events="59" subjects_affected="34" subjects_at_risk="238"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="233"/>
                <counts group_id="E2" events="14" subjects_affected="11" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="65" subjects_affected="36" subjects_at_risk="233"/>
                <counts group_id="E2" events="54" subjects_affected="24" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Paronychia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="233"/>
                <counts group_id="E2" events="13" subjects_affected="13" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="14" subjects_affected="11" subjects_at_risk="233"/>
                <counts group_id="E2" events="26" subjects_affected="25" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="22" subjects_affected="16" subjects_at_risk="233"/>
                <counts group_id="E2" events="47" subjects_affected="35" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>SINUSITIS</sub_title>
                <counts group_id="E1" events="12" subjects_affected="8" subjects_at_risk="233"/>
                <counts group_id="E2" events="15" subjects_affected="12" subjects_at_risk="238"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="21" subjects_affected="17" subjects_at_risk="233"/>
                <counts group_id="E2" events="37" subjects_affected="21" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="19" subjects_affected="16" subjects_at_risk="233"/>
                <counts group_id="E2" events="32" subjects_affected="21" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="100" subjects_affected="20" subjects_at_risk="233"/>
                <counts group_id="E2" events="56" subjects_affected="15" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="84" subjects_affected="16" subjects_at_risk="233"/>
                <counts group_id="E2" events="87" subjects_affected="21" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>WEIGHT DECREASED</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="233"/>
                <counts group_id="E2" events="13" subjects_affected="12" subjects_at_risk="238"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="65" subjects_affected="42" subjects_at_risk="233"/>
                <counts group_id="E2" events="91" subjects_affected="55" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="13" subjects_affected="10" subjects_at_risk="233"/>
                <counts group_id="E2" events="22" subjects_affected="15" subjects_at_risk="238"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="86" subjects_affected="53" subjects_at_risk="233"/>
                <counts group_id="E2" events="91" subjects_affected="53" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="42" subjects_affected="31" subjects_at_risk="233"/>
                <counts group_id="E2" events="32" subjects_affected="26" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" events="32" subjects_affected="20" subjects_at_risk="233"/>
                <counts group_id="E2" events="17" subjects_affected="11" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="60" subjects_affected="28" subjects_at_risk="233"/>
                <counts group_id="E2" events="83" subjects_affected="43" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="23" subjects_affected="21" subjects_at_risk="233"/>
                <counts group_id="E2" events="32" subjects_affected="23" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>NECK PAIN</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="233"/>
                <counts group_id="E2" events="13" subjects_affected="12" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>MUSCULOSKELETAL PAIN</sub_title>
                <counts group_id="E1" events="8" subjects_affected="5" subjects_at_risk="233"/>
                <counts group_id="E2" events="14" subjects_affected="12" subjects_at_risk="238"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="25" subjects_affected="24" subjects_at_risk="233"/>
                <counts group_id="E2" events="33" subjects_affected="28" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="24" subjects_affected="22" subjects_at_risk="233"/>
                <counts group_id="E2" events="43" subjects_affected="33" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="71" subjects_affected="44" subjects_at_risk="233"/>
                <counts group_id="E2" events="85" subjects_affected="51" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" events="67" subjects_affected="50" subjects_at_risk="233"/>
                <counts group_id="E2" events="72" subjects_affected="47" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="21" subjects_affected="17" subjects_at_risk="233"/>
                <counts group_id="E2" events="14" subjects_affected="12" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" events="107" subjects_affected="84" subjects_at_risk="233"/>
                <counts group_id="E2" events="129" subjects_affected="92" subjects_at_risk="238"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="15" subjects_affected="15" subjects_at_risk="233"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="24" subjects_affected="20" subjects_at_risk="233"/>
                <counts group_id="E2" events="46" subjects_affected="35" subjects_at_risk="238"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" events="33" subjects_affected="26" subjects_at_risk="233"/>
                <counts group_id="E2" events="53" subjects_affected="32" subjects_at_risk="238"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="38" subjects_affected="30" subjects_at_risk="233"/>
                <counts group_id="E2" events="59" subjects_affected="43" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="233"/>
                <counts group_id="E2" events="24" subjects_affected="19" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="33" subjects_affected="30" subjects_at_risk="233"/>
                <counts group_id="E2" events="41" subjects_affected="33" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="77" subjects_affected="48" subjects_at_risk="233"/>
                <counts group_id="E2" events="158" subjects_affected="97" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="15" subjects_affected="14" subjects_at_risk="233"/>
                <counts group_id="E2" events="23" subjects_affected="18" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="233"/>
                <counts group_id="E2" events="26" subjects_affected="20" subjects_at_risk="238"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="159" subjects_affected="145" subjects_at_risk="233"/>
                <counts group_id="E2" events="149" subjects_affected="140" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="233"/>
                <counts group_id="E2" events="20" subjects_affected="18" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Nail discolouration</sub_title>
                <counts group_id="E1" events="18" subjects_affected="18" subjects_at_risk="233"/>
                <counts group_id="E2" events="37" subjects_affected="33" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Nail disorder</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="233"/>
                <counts group_id="E2" events="14" subjects_affected="13" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Onychomadesis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="233"/>
                <counts group_id="E2" events="17" subjects_affected="15" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Pruritis</sub_title>
                <counts group_id="E1" events="12" subjects_affected="10" subjects_at_risk="233"/>
                <counts group_id="E2" events="17" subjects_affected="15" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="36" subjects_affected="31" subjects_at_risk="233"/>
                <counts group_id="E2" events="113" subjects_affected="58" subjects_at_risk="238"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="30" subjects_affected="10" subjects_at_risk="233"/>
                <counts group_id="E2" events="17" subjects_affected="15" subjects_at_risk="238"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="83" subjects_affected="30" subjects_at_risk="233"/>
                <counts group_id="E2" events="109" subjects_affected="73" subjects_at_risk="238"/>
              </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>The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Communications</name_or_title>
      <organization>Hoffmann-LaRoche</organization>
      <phone>800 821-8590</phone>
      <email>genentech@druginfo.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/NCT01663727
org study id: GO25632
secondary id: 2011-005335-97
nct id: NCT01663727
lead sponsor: 
This is a Phase III, randomized, double-blind, placebo-controlled multicenter study to
      evaluate the efficacy and safety of bevacizumab administered in combination with paclitaxel
      in patients with previously untreated, locally recurrent, or metastatic HER2-negative breast
      cancer. Patients will be randomized to one of two treatment arms: bevacizumab or placebo. All
      patients will be given an intravenous (IV) infusion of of paclitaxel (90 mg/m2) for 3 weeks
      during each 28-day cycle. bevacizumab or placebo (10 mg/kg) will be administered by IV
      infusion on Days 1 and 15 of each 28-day cycle. Patients will be treated until disease
      progression, unacceptable toxicity or death from any cause occurs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percentage of Participants With Progression or Death in Intent-to-Treat (ITT) Population
time frame: Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)
description: Tumor assessment was performed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator. Disease progression was defined as at least 20 percent (%) increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), unequivocal progression of existing non-target lesions, or presence of new lesions.
measure: Progression Free Survival (PFS) in ITT Population
time frame: Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)
description: PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method.
measure: Percentage of Participants With Progression or Death in High Baseline Plasma Vascular Endothelial Growth Factor-A (VEGF-A) ITT Population
time frame: Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)
description: Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions.
measure: PFS in High Baseline Plasma VEGF-A ITT Population
time frame: Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)
description: PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method.
measure: Percentage of Participants Who Died - ITT Population
time frame: From randomization till death or clinical cut-off (up to 244 weeks)
measure: Overall Survival (OS) - ITT Population
time frame: From randomization till death or clinical cut-off (up to 244 weeks)
description: OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method.
measure: Percentage of Participants Who Died - High Baseline Plasma VEGF-A ITT Population
time frame: From randomization till death or clinical cut-off (up to 244 weeks)
measure: OS - High Baseline Plasma VEGF-A ITT Population
time frame: From randomization till death or clinical cut-off (up to 244 weeks)
description: OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method.
measure: Percentage of Participants With an Objective Response - ITT Population
time frame: Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)
description: Objective response was defined as having a Complete Response (CR) or Partial Response (PR) according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Measurable disease was defined by the presence of at least one measurable lesion by clinical measurement, chest x-ray, computed tomography (CT), or magnetic resonance imaging (MRI).
measure: Percentage of Participants With an Objective Response - High Baseline Plasma VEGF-A ITT Population
time frame: Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)
description: Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Measurable disease was defined by the presence of at least one measurable lesion by clinical measurement, chest x-ray, CT, or MRI.
measure: Duration of Response - ITT Population
time frame: Baseline, every 8 weeks until documented disease progression or clinical cut-off (up to 117.7 weeks)
description: Duration of response was defined as the time from the initial date of the objective response to documented disease progression or death (whichever occurred first). Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. Analysis was performed using Kaplan Meier method.
measure: Duration of Response - High Baseline Plasma VEGF-A ITT Population
time frame: Baseline, every 8 weeks until documented disease progression or clinical cut-off (up to 111.3 weeks)
description: Duration of response was defined as the time from the initial date of the objective response to documented disease progression or death (whichever occurred first). Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. Analysis was performed using Kaplan Meier method.
measure: Percentage of Participants Who Were Alive at 1 Year - ITT Population
time frame: 1 year
measure: Secondary: Percentage of Participants Who Were Alive at 1 Year - High Baseline Plasma VEGF-A ITT Population
time frame: 1 year
arm group label: A
arm group type: Experimental
description: Paclitaxel + Bevacizumab [Avastin]
arm group label: B
arm group type: Experimental
description: Paclitaxel + Placebo
intervention type: Drug
intervention name: Bevacizumab [Avastin]
description: Intravenous repeating dose
arm group label: A
intervention type: Drug
intervention name: Paclitaxel
description: Intravenous repeating dose
arm group label: A
arm group label: B
intervention type: Drug
intervention name: Placebo
description: Intravenous repeating dose
arm group label: B
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
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country: Argentina
country: Belgium
country: Brazil
country: Bulgaria
country: Chile
country: Germany
country: Italy
country: Japan
country: Korea, Republic of
country: Panama
country: Romania
country: Russian Federation
country: South Africa
country: Ukraine
country: United Kingdom
country: United States
country: Slovakia
country: Vietnam
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Paclitaxel
mesh term: Bevacizumab
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