<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/NCT03042611</url>
  </required_header>
  <id_info>
    <org_study_id>LSK-AM301</org_study_id>
    <nct_id>NCT03042611</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate Rivoceranib Plus Best Supportive Care Compared to Placebo Plus Best Supportive Care in Participants With Gastric Cancer</brief_title>
  <acronym>ANGEL</acronym>
  <official_title>A Prospective, Randomized, Double-Blinded, Placebo-Controlled, Multinational, Multicenter, Parallel-group, Phase III Study to Evaluate the Efficacy and Safety of Apatinib Plus Best Supportive Care (BSC) Compared to Placebo Plus BSC in Patients With Advanced or Metastatic Gastric Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Elevar Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Elevar Therapeutics</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy and safety of rivoceranib plus best&#xD;
      supportive care (BSC) compared to placebo plus BSC in participants with advanced or&#xD;
      metastatic gastric cancer (GC).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 14, 2017</start_date>
  <completion_date type="Actual">September 23, 2020</completion_date>
  <primary_completion_date type="Actual">February 15, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Day 1 (randomization) up to approximately 36 months</time_frame>
    <description>OS was defined as the time from randomization to death. Participants alive or lost to follow-up at the end of study (EOS) were censored.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)</measure>
    <time_frame>Up to approximately 24 months</time_frame>
    <description>PFS was defined as the time from randomization to either documented radiological progression or death from any cause. Participants alive and free of progression at the EOS were censored.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR) Per RECIST 1.1</measure>
    <time_frame>Up to approximately 24 months</time_frame>
    <description>ORR was defined as the percentage of participants in the analysis population with the best overall response of Complete Response (CR: disappearance of all target lesions and reduction in short axis of any nodal target lesions to &lt;10 millimeter [mm]) or a Partial Response (PR: ≥30% decrease in the sum of the longest diameters of the target lesions, taking as a reference the baseline sum diameters) per RECIST 1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate (DCR)</measure>
    <time_frame>Up to approximately 24 months</time_frame>
    <description>DCR was defined as the proportion of participants with a Best Overall Response of CR, PR, or stable disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference the smallest sum diameter while on study) per RECIST 1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Global Health Status/Quality of Life (QoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)</measure>
    <time_frame>Baseline, End of Treatment (EOT) (Up to 24 months)</time_frame>
    <description>EORTC QLQ-C30 is a cancer specific Questionnaire with 30 questions for assessing the health-related QOL of cancer participants. The questionnaire incorporates 5 functional scales, 4 symptom scales, a global QOL scale, and single items for the assessment of additional systems commonly reported by cancer participants. All items are scored on 4-point Likert scales, ranging from 1 ('not at all') to 4 ('very much'), with the exception of 2 items in the global QOL scale which use modified 7-point linear analog scales. A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100. For the functioning scales, a higher score indicated greater functioning and for the symptom scales, a higher score indicated a greater symptom burden.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22) Score</measure>
    <time_frame>Baseline, EOT (Up to 24 months)</time_frame>
    <description>EORTC QLQ-STO22 is a 22-item gastric cancer-specific questionnaire-integrating system for assessing the health-related QOL of gastric cancer participants. Most questions use 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100. For the functioning scales, a higher score indicates greater functioning and for the symptom scales, a higher score indicates a greater symptom burden.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) Score</measure>
    <time_frame>Baseline, EOT (Up to 24 months)</time_frame>
    <description>EQ-5D-5L Questionnaire consists of EQ-5D-5L descriptive system and the visual analogue scale (VAS). The descriptive system comprises the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each dimension has 5 levels. The VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire</measure>
    <time_frame>EOT (Month 24)</time_frame>
    <description>EQ-5D-5L Questionnaire comprises the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each dimension has 5 levels of response.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">460</enrollment>
  <condition>Gastric Cancer</condition>
  <condition>Gastric Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Rivoceranib Plus BSC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive rivoceranib 700 milligrams (mg) orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration is 28 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive matching placebo to rivoceranib orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration is 28 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rivoceranib</intervention_name>
    <description>Oral tablet</description>
    <arm_group_label>Rivoceranib Plus BSC</arm_group_label>
    <other_name>Apatinib</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Oral tablet</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Documented primary diagnosis of histologic- or cytologic-confirmed adenocarcinoma of&#xD;
             the stomach or gastroesophageal junction.&#xD;
&#xD;
          2. Locally advanced unresectable or metastatic disease that has progressed since last&#xD;
             treatment.&#xD;
&#xD;
          3. One or more measurable or nonmeasurable evaluable lesions per Response Evaluation&#xD;
             Criteria in Solid Tumors Version 1.1 (RECIST 1.1).&#xD;
&#xD;
          4. Failure or intolerance to at least 2 prior lines of standard chemotherapies with each&#xD;
             containing one or more of the following agents:&#xD;
&#xD;
               -  fluoropyrimidine (intravenous [IV] 5-fluorouracil [5-FU] capecitabine, or S-1),&#xD;
&#xD;
               -  platinum (cisplatin or oxaliplatin),&#xD;
&#xD;
               -  taxanes (paclitaxel or docetaxel) or epirubicin,&#xD;
&#xD;
               -  irinotecan,&#xD;
&#xD;
               -  trastuzumab in case of human epidermal growth factor receptor 2 (HER2)-positive,&#xD;
&#xD;
               -  ramucirumab&#xD;
&#xD;
               -  nivolumab&#xD;
&#xD;
               -  pembrolizumab&#xD;
&#xD;
          5. Disease progression within 6 months after the last treatment.&#xD;
&#xD;
          6. Adequate bone-marrow, renal and liver function.&#xD;
&#xD;
          7. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.&#xD;
&#xD;
          8. Expected survival of ≥12 weeks, in the opinion of the investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of another malignancy within 2 years prior to randomization except for the&#xD;
             following: Bladder tumors considered superficial such as noninvasive (T1a) and&#xD;
             carcinoma in situ (CIS); Curatively treated cervical CIS; Thyroid papillary cancer&#xD;
             with prior treatment; Carcinoma of the skin without melanomatous features; Prostate&#xD;
             cancer which had been surgically or medically treated and not likely to recur within 2&#xD;
             years.&#xD;
&#xD;
          2. Central nervous system (CNS) metastases as shown by radiology records or clinical&#xD;
             evidence of symptomatic CNS involvement in the last 3 months prior to randomization.&#xD;
&#xD;
          3. Cytotoxic chemotherapy, surgery, immunotherapy, radiotherapy or other targeted&#xD;
             therapies within 3 weeks (4 weeks in cases of ramucirumab, mitomycin C, nitrosourea,&#xD;
             lomustine; 1 week in case of biopsy) prior to randomization (Adjuvant radiotherapy&#xD;
             given to local area for non-curative symptom relief is allowed until 2 weeks before&#xD;
             randomization.).&#xD;
&#xD;
          4. Therapy with clinically significant systemic anticoagulant or antithrombotic agents&#xD;
             within 7 days prior to randomization that may prevent blood clotting and, in the&#xD;
             investigator's opinion, could place the participant at risk.&#xD;
&#xD;
          5. Participants who had therapeutic paracentesis of ascites (&gt;1 Liter [L]) within the 3&#xD;
             months prior to starting study treatment or who, in the opinion of the investigator,&#xD;
             will likely need therapeutic paracentesis of ascites (&gt;1L) within 3 months of starting&#xD;
             study treatment.&#xD;
&#xD;
          6. Previous treatment with rivoceranib.&#xD;
&#xD;
          7. Known hypersensitivity to rivoceranib or components of the formulation.&#xD;
&#xD;
          8. Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9, and&#xD;
             CYP2C19.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Mayo Clinic Phoenix</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Highlands Oncology Group</name>
      <address>
        <city>Rogers</city>
        <state>Arkansas</state>
        <zip>72758</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karmanos Cancer Institute</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Cancer Center</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hudson Valley Cancer Centre</name>
      <address>
        <city>Hawthorne</city>
        <state>New York</state>
        <zip>10532</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Franco-Britannique; Oncologie Médicale</name>
      <address>
        <city>Levallois-Perret</city>
        <zip>92300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Leon-Berard (CLB)</name>
      <address>
        <city>Lyon</city>
        <zip>69008</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Regional du Cancer Montpellier (ICM)</name>
      <address>
        <city>Montpellier</city>
        <zip>34298</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Antoine-Lacassagne</name>
      <address>
        <city>Nice</city>
        <zip>06189</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite - Universitaetsmedizin Berlin - Medizinische Klinik mit Schwerpunkt Haematologie, Onkologie und Tumorimmunologie</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;Institut für Klinisch-Onkologische Forschung (IKF) Krankenhaus Nordwest gGmbH UCT - Universitäres Centrum für Tumorerkrankungen Frankfurt</name>
      <address>
        <city>Frankfurt</city>
        <zip>60488</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facharztzentrum Eppendorf - Haematologisch-Onkologische Praxis Eppendorf (HOPE)</name>
      <address>
        <city>Hamburg</city>
        <zip>20249</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik Marburg, Klinik fur Innere Medizin, Schwerpunkt Haematologie, Onkologie und Immunologie</name>
      <address>
        <city>Marburg</city>
        <zip>35043</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Magna Graecia University- Department of Experimental and Clinical Medicine</name>
      <address>
        <city>Catanzaro</city>
        <zip>88100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>U.O Di Oncologia Ospedale Degli Infermi</name>
      <address>
        <city>Faenza</city>
        <zip>48018</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS-Istituto Nazionale Tumori</name>
      <address>
        <city>Milano</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico di Modena-Azienda Ospedaliero Universitaria di Modena.Oncologia ed Ematologia.</name>
      <address>
        <city>Modena</city>
        <zip>41124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veneto Oncology Institute (IOV-IRCCS), Melanoma &amp; Esophageal Oncology Unit</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale di Piacenza - Oncology and heamatology</name>
      <address>
        <city>Piacenza</city>
        <zip>29121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale &quot;Felice Lotti&quot;</name>
      <address>
        <city>Pontedera</city>
        <zip>56025</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS/Arcispedale Santa Maria Nuova</name>
      <address>
        <city>Reggio Emilia</city>
        <zip>42123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rimini Hospital</name>
      <address>
        <city>Rimini</city>
        <zip>47923</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedali Riuniti di Ancona - SOD Clinica Oncologica</name>
      <address>
        <city>Torrette</city>
        <zip>60126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hyogo Cancer Center</name>
      <address>
        <city>Hyogo</city>
        <state>Akasi-city</state>
        <zip>673-0021</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiba Cancer Center</name>
      <address>
        <city>Chiba</city>
        <state>Chiba City</state>
        <zip>260-8717</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital</name>
      <address>
        <city>Tokyo</city>
        <state>Chuo-ku</state>
        <zip>104-0045</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyushu University Hospital</name>
      <address>
        <city>Fukuoka</city>
        <state>Higashi-ku</state>
        <zip>812-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital East</name>
      <address>
        <city>Chiba</city>
        <state>Kashiwa</state>
        <zip>277-8577</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Marianna University School of Medicine Hospital</name>
      <address>
        <city>Kanagawa</city>
        <state>Kawasaki-shi</state>
        <zip>216-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Cancer Center</name>
      <address>
        <city>Saitama</city>
        <state>Kitaadachi-gun</state>
        <zip>362-0806</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Japan Community Health Care Organization Kyushu Hospital</name>
      <address>
        <city>Fukuoka</city>
        <state>Kitakyushu-shi</state>
        <zip>806-8501</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cancer Institute Hospital of Japanese Foundation For Cancer Research</name>
      <address>
        <city>Tokyo</city>
        <state>Koto-ku</state>
        <zip>135-8550</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Shikoku Cancer Center</name>
      <address>
        <city>Ehime</city>
        <state>Matsuyama</state>
        <zip>791-0280</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saku Central Hospital Advanced Care Center</name>
      <address>
        <city>Nagano</city>
        <state>Saku-shi</state>
        <zip>385-0051</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hokkaido University Hospital</name>
      <address>
        <city>Hokkaido</city>
        <state>Sapporo</state>
        <zip>060-8648</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keio University Hospital</name>
      <address>
        <city>Tokyo</city>
        <state>Shinjuku-ku</state>
        <zip>160-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka University Hospital</name>
      <address>
        <city>Osaka</city>
        <state>Suita</state>
        <zip>565-0871</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aichi Cancer Center Hospital</name>
      <address>
        <city>Nagoya</city>
        <zip>464-8681</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hallym University Sacred Heart Hospital</name>
      <address>
        <city>Anyang-si</city>
        <state>Gyeonggi-do</state>
        <zip>14069</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center</name>
      <address>
        <city>Goyang-si</city>
        <state>Gyeonggi-do</state>
        <zip>10408</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ajou University Hospital</name>
      <address>
        <city>Suwon-si</city>
        <state>Gyonggi-do</state>
        <zip>16499</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inje University Haeundae Paik Hospital</name>
      <address>
        <city>Busan</city>
        <zip>48108</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dong-A University Hospital</name>
      <address>
        <city>Busan</city>
        <zip>49201</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pusan National University Hospital</name>
      <address>
        <city>Busan</city>
        <zip>49241</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chungbuk National University Medical Center</name>
      <address>
        <city>Chuncheon</city>
        <zip>41404</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chungbuk National University Hospital</name>
      <address>
        <city>Chungbuk</city>
        <zip>54907</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyungpook National University Medical Center</name>
      <address>
        <city>Daegu</city>
        <zip>41404</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keimyung University Dongsan Medical Center</name>
      <address>
        <city>Daegu</city>
        <zip>41931</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yeungnam University Medical Center</name>
      <address>
        <city>Daegu</city>
        <zip>42415</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chungnam National University Hospital</name>
      <address>
        <city>Daejeon</city>
        <zip>35015</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>Gachon University Gil Medical Center</name>
      <address>
        <city>Incheon</city>
        <zip>21555</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University Anam Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>02841</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severence Hospital, Yonsei University Health System</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Health Service (VHS) Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05368</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASAN Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gangnam Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>06273</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University Guro Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>08308</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ulsan University Hospital</name>
      <address>
        <city>Ulsan</city>
        <zip>44033</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Uniwersytecki w Krakowie, Odział Kliniczny Onkologii</name>
      <address>
        <city>Kraków</city>
        <zip>31-501</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie, Klinika Gastroenterologii Onkologicznej</name>
      <address>
        <city>Warszawa</city>
        <zip>02-781</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Constantin Hospital (TEO HEALTH SA)</name>
      <address>
        <city>Brasov</city>
        <zip>500091</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institutul Oncologic &quot;Prof. Dr. Ion Chiricuta&quot; Cluj-Napoca, Sectia de Radioterapie I</name>
      <address>
        <city>Cluj-Napoca</city>
        <zip>400015</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>S.C. Medisprof S.R.L.</name>
      <address>
        <city>Cluj-Napoca</city>
        <zip>400058</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrul de Oncologie &quot;Sf. Nectarie&quot;, Sectia de Oncologie Medicala</name>
      <address>
        <city>Craiova</city>
        <zip>200347</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budgetary Healthcare Institution of Arkhangelsk Region &quot;Arkhangelsk Clinical Oncology Dispensary&quot;</name>
      <address>
        <city>Arkhangelsk</city>
        <zip>163045</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Healthcare Institution &quot;Kursk Regional Clinical Oncology Dispensary&quot;</name>
      <address>
        <city>Kursk</city>
        <zip>305035</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omsk regional clinical oncology center</name>
      <address>
        <city>Omsk</city>
        <zip>644013</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Budgetary Healthcare Institution of Orel Region &quot;Orel Oncology Dispensary&quot;</name>
      <address>
        <city>Oryol</city>
        <zip>302020</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budgetary Healthcare Institution of Stavropol Territory &quot;Pyatigorsk Oncology Dispensary&quot;</name>
      <address>
        <city>Pyatigorsk</city>
        <zip>357502</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ogarev Mordovia State University</name>
      <address>
        <city>Saransk</city>
        <zip>430032</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal State Budgetary Educational Institution of Higher Education &quot;Academician I.P. Pavlov First St. Petersburg State Medical University&quot; of the Ministry of Heaithcare of the Russian Federation</name>
      <address>
        <city>St. Petersburg</city>
        <zip>197022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budgetary Healthcare Institution &quot;Republican Clinical Oncology Dispensary&quot;</name>
      <address>
        <city>Ufa</city>
        <zip>450054</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <state>Beitou Dist</state>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital - Linko Branch</name>
      <address>
        <city>Taoyuan</city>
        <state>Kuei Shan Hsiang</state>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chi Mei Medical Center - LiouYing Branch</name>
      <address>
        <city>Tainan</city>
        <state>Liuying DIst</state>
        <zip>736</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital - Kaohsiung Branch</name>
      <address>
        <city>Kaohsiung</city>
        <state>Niaosong Dist</state>
        <zip>83301</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaohsiung Medical University Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <state>Sanmin Dist</state>
        <zip>80708</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China Medical University Hospital</name>
      <address>
        <city>Taichung</city>
        <state>Taichung City</state>
        <zip>40447</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National CHeng Kung University Hospital</name>
      <address>
        <city>Tainan</city>
        <state>Tainan City</state>
        <zip>70403</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <state>Zhongzheng Dist</state>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dnipropetrovsk Medical Academy, Department of Oncology</name>
      <address>
        <city>Dnipro</city>
        <zip>49102</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Communal Institution &quot;Ivano-Frankivsk Regional Oncological Center&quot;</name>
      <address>
        <city>Ivano-Frankivsk</city>
        <zip>76000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Communal Institution &quot;Kharkiv Regional Clinical Oncology Center &quot;, Chemotherapy department #1, Medical Academy of Postgraduate Education, Oncology and Pediatric Oncology</name>
      <address>
        <city>Kharkiv</city>
        <zip>61070</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kherson Regional Oncological Dispensary</name>
      <address>
        <city>Kherson</city>
        <zip>73035</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Institution Kryvyi Rig Oncology Dispensary&quot;, Chemotherapy Department</name>
      <address>
        <city>Kryvyi Rih</city>
        <zip>50048</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Institution &quot;Kyiv City Clinical Oncological Center&quot;</name>
      <address>
        <city>Kyiv</city>
        <zip>03115</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Communal Institution &quot;Transcarpathian Regional Clinical Oncological Center&quot;</name>
      <address>
        <city>Uzhhorod</city>
        <zip>88014</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Communal Institution &quot;Vinnytsia Regional Clinical Oncology Dispensary&quot;</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21029</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State institution &quot;Zaporizhzhia Medical Academy of Postgraduate Education MOH Ukraine&quot;, Department of oncology based on Municipal Institution &quot;Zaporizhzhia Regional Clinical Oncology Dispensary&quot; Zaporizhzhia Regional Assembly</name>
      <address>
        <city>Zaporizhzhia</city>
        <zip>69040</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Marsden Hospital London</name>
      <address>
        <city>London</city>
        <zip>SW3 6JJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Christie NHS Foundation Trust</name>
      <address>
        <city>Manchester</city>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Marsden Hospital Surrey</name>
      <address>
        <city>Sutton</city>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Taiwan</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <results_first_submitted>May 9, 2022</results_first_submitted>
  <results_first_submitted_qc>June 15, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">July 8, 2022</results_first_posted>
  <last_update_submitted>June 15, 2022</last_update_submitted>
  <last_update_submitted_qc>June 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gastric Cancer</keyword>
  <keyword>Gastric Adenocarcinoma</keyword>
  <keyword>Gastro-esophageal Cancer</keyword>
  <keyword>Gastro-esophageal Junction Cancer</keyword>
  <keyword>Stomach Cancer</keyword>
  <keyword>Tumor</keyword>
  <keyword>Oncology</keyword>
  <keyword>Antiangiogenesis</keyword>
  <keyword>Metastatic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apatinib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 16, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT03042611/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 1, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT03042611/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Participants were randomized to receive either rivoceranib +best supportive care (BSC) or placebo +BSC for approximately 24 months. Participants who benefited from rivoceranib were permitted to continue rivoceranib during an extension period of the study, up to approximately 36 months. Participants in the extension period were followed for survival status only. Only participants whose reason for study discontinuation was death are included. See the AE module for All-Cause Mortality Deaths.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Rivoceranib Plus Best Supportive Care (BSC)</title>
          <description>Participants received rivoceranib 700 milligrams (mg) orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days.</description>
        </group>
        <group group_id="P2">
          <title>Placebo Plus BSC</title>
          <description>Participants received matching placebo to rivoceranib orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days.</description>
        </group>
        <group group_id="P3">
          <title>Extension Phase: Rivoceranib Plus BSC</title>
          <description>Participants received rivoceranib 700 mg orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days.</description>
        </group>
        <group group_id="P4">
          <title>Extension Phase: Placebo Plus BSC</title>
          <description>Participants received matching placebo to rivoceranib orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Core Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="308"/>
                <participants group_id="P2" count="152"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="307"/>
                <participants group_id="P2" count="151"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
                <participants group_id="P2" count="28"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="256"/>
                <participants group_id="P2" count="124"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="232"/>
                <participants group_id="P2" count="110"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Closed</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Extension Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="52"/>
                <participants group_id="P4" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="52"/>
                <participants group_id="P4" count="28"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="34"/>
                <participants group_id="P4" count="16"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Closed</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="17"/>
                <participants group_id="P4" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The Intent to Treat (ITT) set consists of data from all participants who were randomized. In the ITT set, participants were included in the group to which they were randomized.</population>
      <group_list>
        <group group_id="B1">
          <title>Rivoceranib Plus Best Supportive Care (BSC)</title>
          <description>Participants received rivoceranib 700 milligrams (mg) orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days.</description>
        </group>
        <group group_id="B2">
          <title>Placebo Plus BSC</title>
          <description>Participants received matching placebo to rivoceranib orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days.</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="308"/>
            <count group_id="B2" value="152"/>
            <count group_id="B3" value="460"/>
          </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="60.03" spread="11.11"/>
                    <measurement group_id="B2" value="59.96" spread="10.63"/>
                    <measurement group_id="B3" value="60.01" spread="10.94"/>
                  </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="67"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="107"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="241"/>
                    <measurement group_id="B2" value="112"/>
                    <measurement group_id="B3" value="353"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="303"/>
                    <measurement group_id="B2" value="152"/>
                    <measurement group_id="B3" value="455"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="207"/>
                    <measurement group_id="B2" value="105"/>
                    <measurement group_id="B3" value="312"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="146"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Survival (OS)</title>
        <description>OS was defined as the time from randomization to death. Participants alive or lost to follow-up at the end of study (EOS) were censored.</description>
        <time_frame>Day 1 (randomization) up to approximately 36 months</time_frame>
        <population>The ITT set for the OS final analysis consisted of data from all participants who were randomized, including participants who were still in OS follow-up at the time of primary analysis. In the ITT set, participants were included in the group to which they were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivoceranib Plus Best Supportive Care (BSC)</title>
            <description>Participants received rivoceranib 700 mg orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Plus BSC</title>
            <description>Participants received matching placebo to rivoceranib orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>OS was defined as the time from randomization to death. Participants alive or lost to follow-up at the end of study (EOS) were censored.</description>
          <population>The ITT set for the OS final analysis consisted of data from all participants who were randomized, including participants who were still in OS follow-up at the time of primary analysis. In the ITT set, participants were included in the group to which they were randomized.</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="308"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.82" lower_limit="5.26" upper_limit="6.47"/>
                    <measurement group_id="O2" value="5.13" lower_limit="4.47" upper_limit="6.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)</title>
        <description>PFS was defined as the time from randomization to either documented radiological progression or death from any cause. Participants alive and free of progression at the EOS were censored.</description>
        <time_frame>Up to approximately 24 months</time_frame>
        <population>The ITT set consisted of data from all participants who were randomized. In the ITT set, participants were included in the group to which they were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivoceranib Plus Best Supportive Care (BSC)</title>
            <description>Participants received rivoceranib 700 mg orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Plus BSC</title>
            <description>Participants received matching placebo to rivoceranib orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)</title>
          <description>PFS was defined as the time from randomization to either documented radiological progression or death from any cause. Participants alive and free of progression at the EOS were censored.</description>
          <population>The ITT set consisted of data from all participants who were randomized. In the ITT set, participants were included in the group to which they were randomized.</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="308"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.83" lower_limit="2.07" upper_limit="3.52"/>
                    <measurement group_id="O2" value="1.77" lower_limit="1.71" upper_limit="1.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Objective Response Rate (ORR) Per RECIST 1.1</title>
        <description>ORR was defined as the percentage of participants in the analysis population with the best overall response of Complete Response (CR: disappearance of all target lesions and reduction in short axis of any nodal target lesions to &lt;10 millimeter [mm]) or a Partial Response (PR: ≥30% decrease in the sum of the longest diameters of the target lesions, taking as a reference the baseline sum diameters) per RECIST 1.1.</description>
        <time_frame>Up to approximately 24 months</time_frame>
        <population>The ITT set consisted of data from all participants who were randomized. In the ITT set, participants were included in the group to which they were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivoceranib Plus Best Supportive Care (BSC)</title>
            <description>Participants received rivoceranib 700 mg orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Plus BSC</title>
            <description>Participants received matching placebo to rivoceranib orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate (ORR) Per RECIST 1.1</title>
          <description>ORR was defined as the percentage of participants in the analysis population with the best overall response of Complete Response (CR: disappearance of all target lesions and reduction in short axis of any nodal target lesions to &lt;10 millimeter [mm]) or a Partial Response (PR: ≥30% decrease in the sum of the longest diameters of the target lesions, taking as a reference the baseline sum diameters) per RECIST 1.1.</description>
          <population>The ITT set consisted of data from all participants who were randomized. In the ITT set, participants were included in the group to which they were randomized.</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="308"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5" lower_limit="3.74" upper_limit="9.25"/>
                    <measurement group_id="O2" value="1.3" lower_limit="0.16" upper_limit="4.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease Control Rate (DCR)</title>
        <description>DCR was defined as the proportion of participants with a Best Overall Response of CR, PR, or stable disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference the smallest sum diameter while on study) per RECIST 1.1.</description>
        <time_frame>Up to approximately 24 months</time_frame>
        <population>The ITT set consisted of data from all participants who were randomized. In the ITT set, participants were included in the group to which they were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivoceranib Plus Best Supportive Care (BSC)</title>
            <description>Participants received rivoceranib 700 mg orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Plus BSC</title>
            <description>Participants received matching placebo to rivoceranib orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Control Rate (DCR)</title>
          <description>DCR was defined as the proportion of participants with a Best Overall Response of CR, PR, or stable disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference the smallest sum diameter while on study) per RECIST 1.1.</description>
          <population>The ITT set consisted of data from all participants who were randomized. In the ITT set, participants were included in the group to which they were randomized.</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="308"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.3" lower_limit="34.78" upper_limit="45.74"/>
                    <measurement group_id="O2" value="13.2" lower_limit="7.78" upper_limit="18.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Global Health Status/Quality of Life (QoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)</title>
        <description>EORTC QLQ-C30 is a cancer specific Questionnaire with 30 questions for assessing the health-related QOL of cancer participants. The questionnaire incorporates 5 functional scales, 4 symptom scales, a global QOL scale, and single items for the assessment of additional systems commonly reported by cancer participants. All items are scored on 4-point Likert scales, ranging from 1 ('not at all') to 4 ('very much'), with the exception of 2 items in the global QOL scale which use modified 7-point linear analog scales. A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100. For the functioning scales, a higher score indicated greater functioning and for the symptom scales, a higher score indicated a greater symptom burden.</description>
        <time_frame>Baseline, End of Treatment (EOT) (Up to 24 months)</time_frame>
        <population>The ITT set consisted of data from all participants who were randomized. In the ITT set, participants were included in the group to which they were randomized. Overall number of participants indicates total number of participants with evaluable data.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivoceranib Plus Best Supportive Care (BSC)</title>
            <description>Participants received rivoceranib 700 mg orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Plus BSC</title>
            <description>Participants received matching placebo to rivoceranib orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Global Health Status/Quality of Life (QoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)</title>
          <description>EORTC QLQ-C30 is a cancer specific Questionnaire with 30 questions for assessing the health-related QOL of cancer participants. The questionnaire incorporates 5 functional scales, 4 symptom scales, a global QOL scale, and single items for the assessment of additional systems commonly reported by cancer participants. All items are scored on 4-point Likert scales, ranging from 1 ('not at all') to 4 ('very much'), with the exception of 2 items in the global QOL scale which use modified 7-point linear analog scales. A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100. For the functioning scales, a higher score indicated greater functioning and for the symptom scales, a higher score indicated a greater symptom burden.</description>
          <population>The ITT set consisted of data from all participants who were randomized. In the ITT set, participants were included in the group to which they were randomized. Overall number of participants indicates total number of participants with evaluable data.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="207"/>
                <count group_id="O2" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.51" spread="22.72"/>
                    <measurement group_id="O2" value="-18.01" spread="26.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22) Score</title>
        <description>EORTC QLQ-STO22 is a 22-item gastric cancer-specific questionnaire-integrating system for assessing the health-related QOL of gastric cancer participants. Most questions use 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100. For the functioning scales, a higher score indicates greater functioning and for the symptom scales, a higher score indicates a greater symptom burden.</description>
        <time_frame>Baseline, EOT (Up to 24 months)</time_frame>
        <population>The ITT set consisted of data from all participants who were randomized. In the ITT set, participants were included in the group to which they were randomized. Overall number of participants indicates total at baseline, number of participants analyzed indicates number of participants with evaluable data.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivoceranib Plus Best Supportive Care (BSC)</title>
            <description>Participants received rivoceranib 700 mg orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Plus BSC</title>
            <description>Participants received matching placebo to rivoceranib orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22) Score</title>
          <description>EORTC QLQ-STO22 is a 22-item gastric cancer-specific questionnaire-integrating system for assessing the health-related QOL of gastric cancer participants. Most questions use 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100. For the functioning scales, a higher score indicates greater functioning and for the symptom scales, a higher score indicates a greater symptom burden.</description>
          <population>The ITT set consisted of data from all participants who were randomized. In the ITT set, participants were included in the group to which they were randomized. Overall number of participants indicates total at baseline, number of participants analyzed indicates number of participants with evaluable data.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="207"/>
                <count group_id="O2" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Body Image</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="205"/>
                    <count group_id="O2" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.71" spread="29.95"/>
                    <measurement group_id="O2" value="9.43" spread="35.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dyspnea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="207"/>
                    <count group_id="O2" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.64" spread="26.34"/>
                    <measurement group_id="O2" value="16.50" spread="24.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="207"/>
                    <count group_id="O2" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.72" spread="23.96"/>
                    <measurement group_id="O2" value="13.75" spread="21.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reflux Symptoms</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="207"/>
                    <count group_id="O2" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.46" spread="24.80"/>
                    <measurement group_id="O2" value="8.31" spread="21.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eating Restrictions</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="207"/>
                    <count group_id="O2" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.12" spread="26.45"/>
                    <measurement group_id="O2" value="17.76" spread="22.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="207"/>
                    <count group_id="O2" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.69" spread="23.64"/>
                    <measurement group_id="O2" value="10.55" spread="26.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dry Mouth</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="207"/>
                    <count group_id="O2" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.77" spread="33.22"/>
                    <measurement group_id="O2" value="11.56" spread="29.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Taste</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="207"/>
                    <count group_id="O2" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.30" spread="32.46"/>
                    <measurement group_id="O2" value="14.48" spread="30.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hair Loss</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="206"/>
                    <count group_id="O2" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.37" spread="33.71"/>
                    <measurement group_id="O2" value="-18.69" spread="30.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) Score</title>
        <description>EQ-5D-5L Questionnaire consists of EQ-5D-5L descriptive system and the visual analogue scale (VAS). The descriptive system comprises the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each dimension has 5 levels. The VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.</description>
        <time_frame>Baseline, EOT (Up to 24 months)</time_frame>
        <population>The ITT set consisted of data from all participants who were randomized. In the ITT set, participants were included in the group to which they were randomized. Overall number of participants indicates total number of participants with evaluable data.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivoceranib Plus Best Supportive Care (BSC)</title>
            <description>Participants received rivoceranib 700 mg orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Plus BSC</title>
            <description>Participants received matching placebo to rivoceranib orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) Score</title>
          <description>EQ-5D-5L Questionnaire consists of EQ-5D-5L descriptive system and the visual analogue scale (VAS). The descriptive system comprises the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each dimension has 5 levels. The VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.</description>
          <population>The ITT set consisted of data from all participants who were randomized. In the ITT set, participants were included in the group to which they were randomized. Overall number of participants indicates total number of participants with evaluable data.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="207"/>
                <count group_id="O2" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.48" spread="19.11"/>
                    <measurement group_id="O2" value="-15.36" spread="21.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire</title>
        <description>EQ-5D-5L Questionnaire comprises the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each dimension has 5 levels of response.</description>
        <time_frame>EOT (Month 24)</time_frame>
        <population>The ITT set consisted of data from all participants who were randomized. In the ITT set, participants were included in the group to which they were randomized. Overall number of participants indicates total at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivoceranib Plus Best Supportive Care (BSC)</title>
            <description>Participants received rivoceranib 700 mg orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Plus BSC</title>
            <description>Participants received matching placebo to rivoceranib orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire</title>
          <description>EQ-5D-5L Questionnaire comprises the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each dimension has 5 levels of response.</description>
          <population>The ITT set consisted of data from all participants who were randomized. In the ITT set, participants were included in the group to which they were randomized. Overall number of participants indicates total at baseline.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="308"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mobility: No problems</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mobility: Slight problems</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mobility: Moderate problems</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mobility: Severe problems</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mobility: Unable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mobility: Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Self Care: No problems</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Self Care: Slight problems</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Self Care: Moderate problems</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Self Care: Severe problems</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Self Care: Unable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Self Care: Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Usual Activities: No problems</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Usual Activities: Slight problems</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Usual Activities: Moderate problems</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Usual Activities: Severe problems</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Usual Activities: Unable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Usual Activities: Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain/Discomfort: No pain or discomfort</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain/Discomfort: Slight pain or discomfort</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain/Discomfort: Moderate pain or discomfort</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain/Discomfort: Severe pain or discomfort</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain/Discomfort: Extreme pain or discomfort</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain/Discomfort: Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety/Depression: Not anxious or depressed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety/Depression: Slightly anxious or depressed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety/Depression: Moderately anxious or depressed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety/Depression: Severely anxious or depressed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety/Depression: Extremely anxious or depressed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety/Depression: Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to approximately 36 months</time_frame>
      <desc>The Safety set consisted of data from all participants in the ITT set who received at least 1 dose of rivoceranib or placebo. In the Safety set, participants were included in the group based on the treatment that was received. Safety data was analyzed by the Safety set which includes participants who were alive and on treatment or in OS follow-up. All-Cause Mortality includes deaths that led to study discontinuation and deaths that occurred during safety follow up.</desc>
      <group_list>
        <group group_id="E1">
          <title>Rivoceranib Plus Best Supportive Care (BSC)</title>
          <description>Participants received rivoceranib 700 mg orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days.</description>
        </group>
        <group group_id="E2">
          <title>Placebo Plus BSC</title>
          <description>Participants received matching placebo to rivoceranib orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 21.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="283" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="134" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="149" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="66" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Disseminated intravascular coagulation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Cardiac ventricular thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Ventricular fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Gastric haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Obstruction gastric</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Subileus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Gastric perforation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Gastric stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Large intestine perforation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Mechanical ileus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Acute abdomen</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Intestinal infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Ileus paralytic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Large intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Malignant dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Oesophageal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Oesophageal perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Oesophageal stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Volvulus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Disease progression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Localised oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Bile duct obstruction</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Hepatic failure</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Jaundice cholestatic</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Biliary dilatation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Hepatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Jaundice</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Bile duct stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Cholangitis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Liver disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Biliary sepsis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Biliary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Endophthalmitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Escherichia sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Oesophageal candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Urethritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Subdural haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Intestinal anastomosis complication</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Radiation mucositis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Hypernatraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Cachexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Hypophagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Spinal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Tumour haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Cancer pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Gastric cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Posterior reversible encephalopathy syndrome</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Spinal cord compression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device malfunction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Delusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Nephropathy toxic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Central venous catheter removal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 21.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="299" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="140" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="64" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="41" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="78" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="92" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="72" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="34" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="69" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="53" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="51" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="83" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="77" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="71" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="69" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="64" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="43" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="46" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="132" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="45" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="41" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="90" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" subjects_affected="44" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Palmar-plantar erythrodysaesthesia syndrome</sub_title>
                <counts group_id="E1" subjects_affected="81" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="106" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="151"/>
              </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>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Elevar Clinical Trials</name_or_title>
      <organization>Elevar Therapeutics, Inc</organization>
      <phone>(801) 303-7440</phone>
      <email>info-clinicalstudy@elevartherapeutics.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/NCT03042611
org study id: LSK-AM301
nct id: NCT03042611
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the efficacy and safety of rivoceranib plus best
      supportive care (BSC) compared to placebo plus BSC in participants with advanced or
      metastatic gastric cancer (GC).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Overall Survival (OS)
time frame: Day 1 (randomization) up to approximately 36 months
description: OS was defined as the time from randomization to death. Participants alive or lost to follow-up at the end of study (EOS) were censored.
measure: Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
time frame: Up to approximately 24 months
description: PFS was defined as the time from randomization to either documented radiological progression or death from any cause. Participants alive and free of progression at the EOS were censored.
measure: Objective Response Rate (ORR) Per RECIST 1.1
time frame: Up to approximately 24 months
description: ORR was defined as the percentage of participants in the analysis population with the best overall response of Complete Response (CR: disappearance of all target lesions and reduction in short axis of any nodal target lesions to <10 millimeter [mm]) or a Partial Response (PR: ≥30% decrease in the sum of the longest diameters of the target lesions, taking as a reference the baseline sum diameters) per RECIST 1.1.
measure: Disease Control Rate (DCR)
time frame: Up to approximately 24 months
description: DCR was defined as the proportion of participants with a Best Overall Response of CR, PR, or stable disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference the smallest sum diameter while on study) per RECIST 1.1.
measure: Change From Baseline in Global Health Status/Quality of Life (QoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
time frame: Baseline, End of Treatment (EOT) (Up to 24 months)
description: EORTC QLQ-C30 is a cancer specific Questionnaire with 30 questions for assessing the health-related QOL of cancer participants. The questionnaire incorporates 5 functional scales, 4 symptom scales, a global QOL scale, and single items for the assessment of additional systems commonly reported by cancer participants. All items are scored on 4-point Likert scales, ranging from 1 ('not at all') to 4 ('very much'), with the exception of 2 items in the global QOL scale which use modified 7-point linear analog scales. A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100. For the functioning scales, a higher score indicated greater functioning and for the symptom scales, a higher score indicated a greater symptom burden.
measure: Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22) Score
time frame: Baseline, EOT (Up to 24 months)
description: EORTC QLQ-STO22 is a 22-item gastric cancer-specific questionnaire-integrating system for assessing the health-related QOL of gastric cancer participants. Most questions use 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100. For the functioning scales, a higher score indicates greater functioning and for the symptom scales, a higher score indicates a greater symptom burden.
measure: Change From Baseline in EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) Score
time frame: Baseline, EOT (Up to 24 months)
description: EQ-5D-5L Questionnaire consists of EQ-5D-5L descriptive system and the visual analogue scale (VAS). The descriptive system comprises the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each dimension has 5 levels. The VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
measure: Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire
time frame: EOT (Month 24)
description: EQ-5D-5L Questionnaire comprises the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each dimension has 5 levels of response.
arm group label: Rivoceranib Plus BSC
arm group type: Experimental
description: Participants will receive rivoceranib 700 milligrams (mg) orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration is 28 days.
arm group label: Placebo
arm group type: Experimental
description: Participants will receive matching placebo to rivoceranib orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration is 28 days.
intervention type: Drug
intervention name: Rivoceranib
description: Oral tablet
arm group label: Rivoceranib Plus BSC
other name: Apatinib
intervention type: Drug
intervention name: Placebo
description: Oral tablet
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: France
country: Germany
country: Italy
country: Japan
country: Korea, Republic of
country: Poland
country: Romania
country: Russian Federation
country: Taiwan
country: Ukraine
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Stomach Neoplasms
mesh term: Apatinib
sharing ipd: No
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