{ "FullStudy":{ "Rank":218099, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01512745", "OrgStudyIdInfo":{ "OrgStudyId":"HENGRUI 20101208" }, "Organization":{ "OrgFullName":"Jiangsu HengRui Medicine Co., Ltd.", "OrgClass":"INDUSTRY" }, "BriefTitle":"Phase III Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer", "OfficialTitle":"A Randomized, Double Blinded, Placebo Controlled Multicenter Phase III Study of Apatinib Mesylate Tablets in the Treatment of Advanced or Metastatic Gastric Cancer" }, "StatusModule":{ "StatusVerifiedDate":"April 2015", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"May 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"May 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 13, 2012", "StudyFirstSubmitQCDate":"January 15, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 19, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"August 6, 2015", "ResultsFirstSubmitQCDate":"May 8, 2016", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"June 15, 2016", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"August 30, 2016", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"October 17, 2016", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Jiangsu HengRui Medicine Co., Ltd.", "LeadSponsorClass":"INDUSTRY" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Fudan University", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"The 81 Hospital of PLA", "CollaboratorClass":"UNKNOWN" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. The investigators' phase I study has shown that the drug's toxicity is manageable and the maximum tolerable daily dose is 850 mg. The purpose of this study is to determine whether apatinib can improve progression free survival or overall survival compared with placebo in patients with metastatic gastric carcinoma who failed two lines of chemotherapy." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Advanced or Metastatic Gastric Cancer" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Quadruple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"267", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"apatinib", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: apatinib" ] } },{ "ArmGroupLabel":"placebo", "ArmGroupType":"Placebo Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: placebo" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"apatinib", "InterventionDescription":"apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "apatinib" ] } },{ "InterventionType":"Drug", "InterventionName":"placebo", "InterventionDescription":"placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "placebo" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Progression Free Survival(PFS)", "PrimaryOutcomeDescription":"Progression free survival of All the Evaluable Participants.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of diameters of target lesions, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).", "PrimaryOutcomeTimeFrame":"30 months" },{ "PrimaryOutcomeMeasure":"Overall Survival(OS)", "PrimaryOutcomeDescription":"Overall Survival of the Participants", "PrimaryOutcomeTimeFrame":"30 months" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Disease Control Rate(DCR)", "SecondaryOutcomeDescription":"Disease control is defined as the proportion of patients who had a best response rating of complete response, partial response, or stable disease, and lasted at least 4 weeks.", "SecondaryOutcomeTimeFrame":"30 months" },{ "SecondaryOutcomeMeasure":"Objective Response Rate(ORR)", "SecondaryOutcomeDescription":"Objective Response Rate is defined as the proportion of patients with complete response(CR) or partial response(PR)", "SecondaryOutcomeTimeFrame":"30 months" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With Adverse Events", "SecondaryOutcomeTimeFrame":"30 months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\n≥ 18 and ≤ 70 years of age\nHistological confirmed advanced or metastatic adenocarcinoma of the stomach\nHave failed for at least 2 lines of chemotherapy\nLife expectancy of at least 12 weeks.\nEastern Cooperative Oncology Group Performance Status of 0 or 1 within 1 week before randomization.\nAt least one measurable lesion beyond stomach (larger than 10 mm in diameter by spiral CT scan)\nDuration from the last therapy is more than 6 weeks for nitroso or mitomycin\nMore than 4 weeks for operation or radiotherapy\nMore than 4 weeks for cytotoxic agents or growth inhibitors\nAdequate hepatic, renal, heart, and hematologic functions (HB ≥ 90g/L,platelets > 80 ×10 E+9/L, neutrophil > 1.5 × 10 E+9/L, serum creatinine ≤ 1× upper limit of normal(ULN), bilirubin < 1.25× ULN, and serum transaminase ≤ 2.5× ULN).\n\nExclusion Criteria:\n\nPregnant or lactating women\nHistory of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg).\nAny factors that influence the usage of oral administration; Evidence of Central Nerves System(CNS) metastasis\nIntercurrence with one of the following: coronary artery disease, arrhythmia ,heart failure and proteinuria ≥ (+)\nInternational Normalize Ratio (INR) > 1.5 and activated partial thromboplastin time（APPT） > 1.5 × ULN\nAbuse of alcohol or drugs\nCertain possibility of gastric or intestine hemorrhage\nLess than 4 weeks from the last clinical trial\nPrior VEGFR inhibitor treatment\nDisability of serious uncontrolled intercurrence infection Objective evidence of previous or current pulmonary fibrosis history, interstitial pneumonia, Pneumoconiosis, radiation pneumonitis, drug-related pneumonia, Pulmonary function damaged seriously etc.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"70 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Jin Li, MD, PHD", "OverallOfficialAffiliation":"Fudan University", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Shukui Qin, MD", "OverallOfficialAffiliation":"The 81 Hospital of PLA", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"The 81 Hosiptal of PLA", "LocationCity":"Nanjing", "LocationState":"Jiangsu", "LocationCountry":"China" },{ "LocationFacility":"Fudan University cancer hospital", "LocationCity":"Shanghai", "LocationState":"Shanghai", "LocationCountry":"China" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Apatinib", "FlowGroupDescription":"apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Placebo", "FlowGroupDescription":"placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"176" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"91" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"136" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"71" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"40" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"20" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Adverse Event", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"22" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"3" } ] } },{ "FlowDropWithdrawType":"Death", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"9" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"13" } ] } },{ "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"2" } ] } },{ "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"4" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Lack of Efficacy", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"2" } ] } },{ "FlowDropWithdrawType":"Protocol Violation", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"5 participants in the apatinib group and 1 in the placebo group withdrew from the study before receiving the assigned treatments.As a result,267 randomly assigned participants were included in Full Analysis Set （FAS），with 176 assigned to the apatinib group and 91 assigned to the placeo group.", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Apatinib", "BaselineGroupDescription":"apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent" },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Placebo", "BaselineGroupDescription":"placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent" },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"176" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"91" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"267" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"55.01", "BaselineMeasurementSpread":"9.92" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"56.08", "BaselineMeasurementSpread":"9.74" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"55.37", "BaselineMeasurementSpread":"9.81" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"44" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"22" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"66" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"132" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"69" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"201" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Progression Free Survival(PFS)", "OutcomeMeasureDescription":"Progression free survival of All the Evaluable Participants.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of diameters of target lesions, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"month", "OutcomeMeasureTimeFrame":"30 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Apatinib", "OutcomeGroupDescription":"apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"176" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"91" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.6", "OutcomeMeasurementLowerLimit":"2.0", "OutcomeMeasurementUpperLimit":"2.9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.8", "OutcomeMeasurementLowerLimit":"1.4", "OutcomeMeasurementUpperLimit":"1.9" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Overall Survival(OS)", "OutcomeMeasureDescription":"Overall Survival of the Participants", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"month", "OutcomeMeasureTimeFrame":"30 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Apatinib", "OutcomeGroupDescription":"apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"176" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"91" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6.5", "OutcomeMeasurementLowerLimit":"4.8", "OutcomeMeasurementUpperLimit":"7.6" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4.7", "OutcomeMeasurementLowerLimit":"3.6", "OutcomeMeasurementUpperLimit":"5.4" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Disease Control Rate(DCR)", "OutcomeMeasureDescription":"Disease control is defined as the proportion of patients who had a best response rating of complete response, partial response, or stable disease, and lasted at least 4 weeks.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"30 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Apatinib", "OutcomeGroupDescription":"apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"176" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"91" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"42.05" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8.79" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Objective Response Rate(ORR)", "OutcomeMeasureDescription":"Objective Response Rate is defined as the proportion of patients with complete response(CR) or partial response(PR)", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"30 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Apatinib", "OutcomeGroupDescription":"apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"176" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"91" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.84" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.00" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With Adverse Events", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"30 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Apatinib", "OutcomeGroupDescription":"apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"176" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"91" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"98.30" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"90.11" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Apatinib", "EventGroupDescription":"apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent", "EventGroupSeriousNumAffected":"6", "EventGroupSeriousNumAtRisk":"176", "EventGroupOtherNumAffected":"173", "EventGroupOtherNumAtRisk":"176" },{ "EventGroupId":"EG001", "EventGroupTitle":"Placebo", "EventGroupDescription":"placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent", "EventGroupSeriousNumAffected":"6", "EventGroupSeriousNumAtRisk":"91", "EventGroupOtherNumAffected":"82", "EventGroupOtherNumAtRisk":"91" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Abdominal pain", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"176" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"91" } ] } },{ "SeriousEventTerm":"Gastrointestinal bleeding", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"5", "SeriousEventStatsNumAffected":"5", "SeriousEventStatsNumAtRisk":"176" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"5", "SeriousEventStatsNumAffected":"5", "SeriousEventStatsNumAtRisk":"91" } ] } } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"proteinuria", "OtherEventOrganSystem":"Renal and urinary disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"84", "OtherEventStatsNumAffected":"84", "OtherEventStatsNumAtRisk":"176" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"15", "OtherEventStatsNumAffected":"15", "OtherEventStatsNumAtRisk":"91" } ] } },{ "OtherEventTerm":"hypertension", "OtherEventOrganSystem":"Vascular disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"62", "OtherEventStatsNumAffected":"62", "OtherEventStatsNumAtRisk":"176" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"5", "OtherEventStatsNumAffected":"5", "OtherEventStatsNumAtRisk":"91" } ] } },{ "OtherEventTerm":"hand-foot syndrome", "OtherEventOrganSystem":"Skin and subcutaneous tissue disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"49", "OtherEventStatsNumAffected":"49", "OtherEventStatsNumAtRisk":"176" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"2", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"91" } ] } },{ "OtherEventTerm":"elevated transaminase", "OtherEventOrganSystem":"Hepatobiliary disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"49", "OtherEventStatsNumAffected":"49", "OtherEventStatsNumAtRisk":"176" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"20", "OtherEventStatsNumAffected":"20", "OtherEventStatsNumAtRisk":"91" } ] } },{ "OtherEventTerm":"hyperbilirubinemia", "OtherEventOrganSystem":"Hepatobiliary disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"43", "OtherEventStatsNumAffected":"43", "OtherEventStatsNumAtRisk":"176" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"13", "OtherEventStatsNumAffected":"13", "OtherEventStatsNumAtRisk":"91" } ] } },{ "OtherEventTerm":"bleeding", "OtherEventOrganSystem":"Blood and lymphatic system disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"35", "OtherEventStatsNumAffected":"35", "OtherEventStatsNumAtRisk":"176" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"22", "OtherEventStatsNumAffected":"22", "OtherEventStatsNumAtRisk":"91" } ] } },{ "OtherEventTerm":"fatigue", "OtherEventOrganSystem":"General disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"36", "OtherEventStatsNumAffected":"36", "OtherEventStatsNumAtRisk":"176" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"13", "OtherEventStatsNumAffected":"13", "OtherEventStatsNumAtRisk":"91" } ] } },{ "OtherEventTerm":"ALP increased", "OtherEventOrganSystem":"Hepatobiliary disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"35", "OtherEventStatsNumAffected":"35", "OtherEventStatsNumAtRisk":"176" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"14", "OtherEventStatsNumAffected":"14", "OtherEventStatsNumAtRisk":"91" } ] } },{ "OtherEventTerm":"elevated GGT", "OtherEventOrganSystem":"Hepatobiliary disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"29", "OtherEventStatsNumAffected":"29", "OtherEventStatsNumAtRisk":"176" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"15", "OtherEventStatsNumAffected":"15", "OtherEventStatsNumAtRisk":"91" } ] } },{ "OtherEventTerm":"abdominal pain", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"28", "OtherEventStatsNumAffected":"28", "OtherEventStatsNumAtRisk":"176" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"16", "OtherEventStatsNumAffected":"16", "OtherEventStatsNumAtRisk":"91" } ] } },{ "OtherEventTerm":"decreased appetite", "OtherEventOrganSystem":"Metabolism and nutrition disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"26", "OtherEventStatsNumAffected":"26", "OtherEventStatsNumAtRisk":"176" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"8", "OtherEventStatsNumAffected":"8", "OtherEventStatsNumAtRisk":"91" } ] } },{ "OtherEventTerm":"hypoproteinemia", "OtherEventOrganSystem":"Metabolism and nutrition disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"23", "OtherEventStatsNumAffected":"23", "OtherEventStatsNumAtRisk":"176" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"8", "OtherEventStatsNumAffected":"8", "OtherEventStatsNumAtRisk":"91" } ] } },{ "OtherEventTerm":"diarrhea", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"20", "OtherEventStatsNumAffected":"20", "OtherEventStatsNumAtRisk":"176" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"3", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"91" } ] } },{ "OtherEventTerm":"elevated LDH", "OtherEventOrganSystem":"Investigations", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"18", "OtherEventStatsNumAffected":"18", "OtherEventStatsNumAtRisk":"176" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"12", "OtherEventStatsNumAffected":"12", "OtherEventStatsNumAtRisk":"91" } ] } },{ "OtherEventTerm":"leukopenia", "OtherEventOrganSystem":"Blood and lymphatic system disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"71", "OtherEventStatsNumAffected":"71", "OtherEventStatsNumAtRisk":"176" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"8", "OtherEventStatsNumAffected":"8", "OtherEventStatsNumAtRisk":"91" } ] } },{ "OtherEventTerm":"neutropenia", "OtherEventOrganSystem":"Blood and lymphatic system disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"66", "OtherEventStatsNumAffected":"66", "OtherEventStatsNumAtRisk":"176" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"9", "OtherEventStatsNumAffected":"9", "OtherEventStatsNumAtRisk":"91" } ] } },{ "OtherEventTerm":"anemia", "OtherEventOrganSystem":"Blood and lymphatic system disorders", 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