{ "FullStudy":{ "Rank":217590, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01519414", "OrgStudyIdInfo":{ "OrgStudyId":"NCI-2012-00237" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"NCI-2012-00237", "SecondaryIdType":"Registry Identifier", "SecondaryIdDomain":"CTRP (Clinical Trial Reporting Program)" },{ "SecondaryId":"CDR0000721410" },{ "SecondaryId":"OSU11132" },{ "SecondaryId":"OSU-11132" },{ "SecondaryId":"OSU 11132", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"Ohio State University Comprehensive Cancer Center" },{ "SecondaryId":"8986", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"CTEP" },{ "SecondaryId":"N01CM00070", "SecondaryIdType":"U.S. NIH Grant/Contract", "SecondaryIdLink":"https://projectreporter.nih.gov/reporterapi.cfm?PROJECTNUM=N01CM00070&Fy=all" },{ "SecondaryId":"N01CM00071", "SecondaryIdType":"U.S. NIH Grant/Contract", "SecondaryIdLink":"https://projectreporter.nih.gov/reporterapi.cfm?PROJECTNUM=N01CM00071&Fy=all" },{ "SecondaryId":"N01CM00100", "SecondaryIdType":"U.S. NIH Grant/Contract", "SecondaryIdLink":"https://projectreporter.nih.gov/reporterapi.cfm?PROJECTNUM=N01CM00100&Fy=all" },{ "SecondaryId":"N01CM62207", "SecondaryIdType":"U.S. NIH Grant/Contract", "SecondaryIdLink":"https://projectreporter.nih.gov/reporterapi.cfm?PROJECTNUM=N01CM62207&Fy=all" },{ "SecondaryId":"P30CA016058", "SecondaryIdType":"U.S. NIH Grant/Contract", "SecondaryIdLink":"https://projectreporter.nih.gov/reporterapi.cfm?PROJECTNUM=P30CA016058&Fy=all" },{ "SecondaryId":"U01CA062491", "SecondaryIdType":"U.S. NIH Grant/Contract", "SecondaryIdLink":"https://projectreporter.nih.gov/reporterapi.cfm?PROJECTNUM=U01CA062491&Fy=all" } ] }, "Organization":{ "OrgFullName":"National Cancer Institute (NCI)", "OrgClass":"NIH" }, "BriefTitle":"Tivantinib in Treating Patients With Metastatic Prostate Cancer", "OfficialTitle":"A Randomized, Double-Blind, Placebo-Controlled Phase II Study of ARQ 197 (Tivantinib) in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate Resistant Prostate Cancer" }, "StatusModule":{ "StatusVerifiedDate":"August 2018", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 11, 2012", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"August 18, 2015", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"August 18, 2015", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 25, 2012", "StudyFirstSubmitQCDate":"January 25, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 27, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"October 11, 2017", "ResultsFirstSubmitQCDate":"August 13, 2018", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"September 12, 2018", "ResultsFirstPostDateType":"Actual" }, "LastUpdateSubmitDate":"August 13, 2018", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"September 12, 2018", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"National Cancer Institute (NCI)", "LeadSponsorClass":"NIH" } }, "OversightModule":{}, "DescriptionModule":{ "BriefSummary":"This randomized phase II trial studies how well tivantinib works compared to placebo in treating patients with metastatic prostate cancer. Tivantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.", "DetailedDescription":"PRIMARY OBJECTIVES:\n\nI. To determine progression-free survival (PFS) in men with minimally symptomatic or asymptomatic metastatic, castrate-resistant, chemotherapy-naïve prostate cancer treated with ARQ 197 (tivantinib).\n\nSECONDARY OBJECTIVES:\n\nI. To determine the prostate-specific antigen (PSA) response rate at 12 weeks in men with metastatic, castrate-resistant, chemotherapy-naïve prostate cancer treated with ARQ 197.\n\nII. To determine the radiographic response rate at 12 weeks based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria on computed tomography (CT) scans and stability of bone lesions on bone scan in castrate-resistant, chemotherapy-naïve prostate cancer treated with ARQ 197.\n\nIII. To determine the proportion of patients who are progression-free at 12 weeks.\n\nIV. To assess safety and tolerability in patients treated with ARQ 197 using the National Institute of Cancer (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grading of toxicities.\n\nTERTIARY OBJECTIVES:\n\nI. Evaluate markers of bone turnover. (Exploratory)\n\nOUTLINE: Patients are randomized to 1 of 2 treatment arms.\n\nArm I: Patients receive tivantinib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\nArm II: Patients receive placebo PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.\n\nAfter completion of study treatment, patients are followed up every 3 months for 6 months." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Hormone-Resistant Prostate Cancer", "Prostate Adenocarcinoma", "Recurrent Prostate Carcinoma", "Stage IV Prostate Cancer" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Crossover Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Double", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"78", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Arm I (tivantinib)", "ArmGroupType":"Experimental", "ArmGroupDescription":"Patients receive tivantinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: Laboratory Biomarker Analysis", "Drug: Tivantinib" ] } },{ "ArmGroupLabel":"Arm II (placebo)", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"Patients receive placebo PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: Laboratory Biomarker Analysis", "Other: Placebo" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Other", "InterventionName":"Laboratory Biomarker Analysis", "InterventionDescription":"Optional correlative studies", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Arm I (tivantinib)", "Arm II (placebo)" ] } },{ "InterventionType":"Other", "InterventionName":"Placebo", "InterventionDescription":"Given PO", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Arm II (placebo)" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "placebo therapy", "PLCB", "sham therapy" ] } },{ "InterventionType":"Drug", "InterventionName":"Tivantinib", "InterventionDescription":"Given PO", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Arm I (tivantinib)" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "ARQ 197", "ARQ-197", "c-Met Inhibitor ARQ 197" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Progression-free Survival (PFS) Based on the RECIST Criteria", "PrimaryOutcomeDescription":"The progression-free survival distributions between the two arms will be compared using log-rank tests. Progression-free survival curves will be constructed using the Kaplan-Meier product limit method, and additional analyses will be done using the Cox proportional hazards model.", "PrimaryOutcomeTimeFrame":"Time from study entry to the date of documented progression and/or death, assessed up to 6 months" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Changes in PSA Levels", "SecondaryOutcomeDescription":"Evaluated and patterns graphically explored through waterfall plots.", "SecondaryOutcomeTimeFrame":"Baseline to 12 weeks" },{ "SecondaryOutcomeMeasure":"Proportion of Patients Who Respond", "SecondaryOutcomeDescription":"An assumed binomial distribution used. Summarized with their corresponding 95% binomial confidence intervals and compared in an exploratory manner between the two treatment arms. Dichotomized outcomes of response will be descriptively summarized and graphically evaluated using bar graphs.", "SecondaryOutcomeTimeFrame":"At 12 weeks" },{ "SecondaryOutcomeMeasure":"PSA Response Rate", "SecondaryOutcomeDescription":"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", "SecondaryOutcomeTimeFrame":"up to 12 weeks" },{ "SecondaryOutcomeMeasure":"Incidence of Adverse Events Graded as 3, 4, or 5 Per NCI CTCAE Version 4.0", "SecondaryOutcomeDescription":"Fisher's exact tests will be used to quantitatively compare the incidence of severe as well as specific toxicities of interest between the treatment arms and graphically assessed differences in maximum grades observed for toxicities between the arms.", "SecondaryOutcomeTimeFrame":"Up to 1 year" } ] }, "OtherOutcomeList":{ "OtherOutcome":[ { "OtherOutcomeMeasure":"Radiographic Response Rate Based on RECIST Criteria", "OtherOutcomeDescription":"Summarized with their corresponding 95% binomial confidence intervals and compared in an exploratory manner between the two treatment arms. Dichotomized outcomes of response will be descriptively summarized and graphically evaluated using bar graphs.", "OtherOutcomeTimeFrame":"Up to 12 weeks" },{ "OtherOutcomeMeasure":"Change in Bone Specific Alkaline Phosphatase (BSAP) in Serum", "OtherOutcomeDescription":"BSAP will first be descriptively summarized by treatment group and also evaluated using graphical analyses to assess potential patterns over time and see if changes in bone resorption differ between those who are progression-free at 12 weeks vs. not after treatment with tivantinib. The potential impact of early changes in these markers on PFS using Cox regression models will be also explored.", "OtherOutcomeTimeFrame":"Baseline to up to 6 months" },{ "OtherOutcomeMeasure":"Change in Markers of Bone Turnover in Urine", "OtherOutcomeDescription":"NTx and CTX will first be descriptively summarized by treatment group and also evaluated using graphical analyses to assess potential patterns over time and see if changes in bone resorption differ between those who are progression-free at 12 weeks vs. not after treatment with tivantinib. The potential impact of early changes in these markers on PFS using Cox regression models will be also explored.", "OtherOutcomeTimeFrame":"Baseline to up to 6 months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nPatients must have histologically documented adenocarcinoma of the prostate with progressive systemic disease (either rising PSA or progression of disease on CT scan or magnetic resonance imaging [MRI] or bone scan) despite castrate levels of testosterone due to orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist or antagonist; castrate levels of testosterone must be maintained throughout the study\nEvidence of metastatic disease on CT or bone imaging\n\nPatients must have demonstrated evidence of progressive disease since the most recent change in therapy; progressive disease is defined as any one of the following (measurable disease, bone scan, or PSA progression):\n\nMeasurable disease progression: objective evidence of increase > 20% in the sum of the longest diameters (LD) of target lesions from the time of maximal regression or the appearance of one or more new lesions\nBone scan progression: appearance of two or more new lesions on bone scan attributable to prostate cancer will constitute progression\nPSA progression: two successive rises from baseline PSA separated at least by one week with the last value >= 2 ng/mL\nAsymptomatic or minimally symptomatic from prostate cancer - no symptoms attributed to prostate cancer greater than grade I using NCI CTCAE version 4.0 grading of toxicities\nSecondary hormonal therapies (e.g., abiraterone acetate, flutamide, estrogen) must be discontinued for at least 4 weeks prior to study enrollment unless the duration of the therapy was less than 8 weeks and there was no demonstrated decrease in PSA\nSecondary hormonal therapies with bicalutamide or nilutamide must be discontinued for 6 weeks unless duration of therapy was less than 8 weeks and there was no demonstrated PSA decrease\nPrior abiraterone (or investigational anti-androgen) use is allowed; these too will need to be discontinued at least 4 weeks prior to study enrollment\nPSA prior to treatment must be >= 2 ng/ml\nCastrate testosterone level (< 50 ng/dL)\nEastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)\nNo prior chemotherapy unless utilized in neoadjuvant/adjuvant setting and must have completed > 6 months prior to enrollment\nFour weeks since major surgery or radiation therapy\nAbsolute neutrophil count >= 1,500/mcL\nPlatelets >= 100,000/mcL\nTotal bilirubin within normal institutional limits\nAspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.0 X institutional upper limit of normal\nCreatinine within normal institutional limits OR creatinine clearance >= 40 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal\nPatients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment\nMen and any female partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation and for additional 2 months after finishing therapy; should a patient's sexual partner become pregnant or suspect she is pregnant while patient is participating in this study, he should inform the treating physician immediately\nBisphosphonate or denosumab therapy is permitted provided patients began therapy prior to registration and that they continue them as per the manufacturer's guidelines and/or per institutional practice; patients not taking ongoing bisphosphonate or denosumab therapy will not be permitted to start such therapy until they have completed 12 weeks of study treatment\nPatients must be able to swallow pills to participate in the study\n\nExclusion Criteria:\n\nPatients who have radiotherapy within 4 weeks or chemotherapy prior to entering the study or those who have not recovered (resolution to grade 1) from adverse events due to agents administered more than 4 weeks earlier; neoadjuvant/adjuvant chemotherapy for local disease is allowed if greater than 6 months have elapsed\nPrevious hepatocyte growth factor receptor (C-MET) inhibitor treatment (either monoclonal antibody to C-MET or human growth factor [HGF] or small molecule inhibitory to C-MET)\nHistory of allergic reactions attributed to compounds of similar chemical or biologic composition ARQ 197\nCaution should be used with patients receiving inhibitors of cytochrome P450 family 2, subfamily C, polypeptide 19 (CYP2C19) and strong inhibitors of cytochrome P450 family 3, subfamily A, polypeptide4 (CYP3A4); additional hematologic testing will be advised if the medication cannot be substituted\nUncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or known psychiatric illness/social situations that would limit compliance with study requirements\nKnown brain metastasis\nCurrent, recent (within 4 weeks of the first study drug administration), or concurrent planned participation in another investigational therapeutic study\nPatients with a \"currently active\" second malignancy other than non-melanoma skin cancers are not to be registered; patients are not considered to have a \"currently active\" malignancy if they have completed therapy and are now considered to be at less than 30% risk for relapse (by their physician)\nPatients may continue on a daily multi-vitamin and calcium/vitamin D supplements; all other herbal, alternative, and food supplements (i.e., PC-SPES, Saw Palmetto, St. John wort, etc.) must be discontinued before registration\nNew York Heart Association (NYHA) class III or greater congestive heart failure\nHistory of myocardial infarction or unstable angina within 6 months prior to initial treatment\nHistory of severely impaired lung function\nBaseline electrocardiogram (ECG) abnormalities including first degree (PR interval > 210 ms), second degree, or third degree heart block (exception: patients with pacemakers may be enrolled); QRS prolongation or bundle branch block (QRS >= 120 ms), or QT prolongation (per institutional standard of care: Fridericia corrected QT interval [QTcF] or Bazett corrected QT interval [QTcB] >= 470 ms); other ECG abnormalities will need consideration by the treating investigator and enrollment is up to his/her discretion\nPresence of non-healing wound, active ulcer, or untreated bone fracture\nKnown diabetics that have poorly controlled diabetes mellitus (glycated hemoglobin [HbA1c] >= 8.0%) or fasting glucose level >= 189 mg/dL (diabetic patient); patients may be potentially eligible once anti-diabetic agent(s) are either added or titrated to control their diabetes mellitus\nActive liver disease (AST or ALT >= 2.0 times the upper limit of normal [ULN] or total bilirubin >= institutional ULN) or gallbladder disease; patients with known liver cirrhosis or severe hepatic impairment (Child-Pugh Class C) will also be excluded\nA known history of human immunodeficiency virus (HIV) seropositivity\nImpairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of ARQ 197 (e.g., uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or significant small bowel resection)\nPatients with an active bleeding diathesis", "HealthyVolunteers":"No", "Gender":"Male", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"J. Monk", "OverallOfficialAffiliation":"Ohio State University Comprehensive Cancer Center", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"MedStar Georgetown University Hospital", "LocationCity":"Washington", "LocationState":"District of Columbia", "LocationZip":"20007", "LocationCountry":"United States" },{ "LocationFacility":"Moffitt Cancer Center", "LocationCity":"Tampa", "LocationState":"Florida", "LocationZip":"33612", "LocationCountry":"United States" },{ "LocationFacility":"Northwestern University", "LocationCity":"Chicago", "LocationState":"Illinois", "LocationZip":"60611", "LocationCountry":"United States" },{ "LocationFacility":"Michael Reese Hospital", "LocationCity":"Chicago", "LocationState":"Illinois", "LocationZip":"60616", "LocationCountry":"United States" },{ "LocationFacility":"University of Chicago Comprehensive Cancer Center", "LocationCity":"Chicago", "LocationState":"Illinois", "LocationZip":"60637", "LocationCountry":"United States" },{ "LocationFacility":"Decatur Memorial Hospital", "LocationCity":"Decatur", "LocationState":"Illinois", "LocationZip":"62526", "LocationCountry":"United States" },{ "LocationFacility":"NorthShore University HealthSystem-Evanston Hospital", "LocationCity":"Evanston", "LocationState":"Illinois", "LocationZip":"60201", "LocationCountry":"United States" },{ "LocationFacility":"Ingalls Memorial Hospital", "LocationCity":"Harvey", "LocationState":"Illinois", "LocationZip":"60426", "LocationCountry":"United States" },{ "LocationFacility":"Illinois CancerCare-Peoria", "LocationCity":"Peoria", "LocationState":"Illinois", "LocationZip":"61615", "LocationCountry":"United States" },{ "LocationFacility":"Southern Illinois University School of Medicine", "LocationCity":"Springfield", "LocationState":"Illinois", "LocationZip":"62702", "LocationCountry":"United States" },{ "LocationFacility":"Fort Wayne Medical Oncology and Hematology Inc - Jefferson Boulevard", "LocationCity":"Fort Wayne", "LocationState":"Indiana", "LocationZip":"46804", "LocationCountry":"United States" },{ "LocationFacility":"Indiana University/Melvin and Bren Simon Cancer Center", "LocationCity":"Indianapolis", "LocationState":"Indiana", "LocationZip":"46202", "LocationCountry":"United States" },{ "LocationFacility":"University of Maryland/Greenebaum Cancer Center", "LocationCity":"Baltimore", "LocationState":"Maryland", "LocationZip":"21201", "LocationCountry":"United States" },{ "LocationFacility":"University of Maryland Saint Joseph Medical Center", "LocationCity":"Towson", "LocationState":"Maryland", "LocationZip":"21204", "LocationCountry":"United States" },{ "LocationFacility":"Mercy Hospital Saint Louis", "LocationCity":"Saint Louis", "LocationState":"Missouri", "LocationZip":"63141", "LocationCountry":"United States" },{ "LocationFacility":"Roswell Park Cancer Institute", "LocationCity":"Buffalo", "LocationState":"New York", "LocationZip":"14263", "LocationCountry":"United States" },{ "LocationFacility":"Case Western Reserve University", "LocationCity":"Cleveland", "LocationState":"Ohio", "LocationZip":"44106", "LocationCountry":"United States" },{ "LocationFacility":"Cleveland Clinic Foundation", "LocationCity":"Cleveland", "LocationState":"Ohio", "LocationZip":"44195", "LocationCountry":"United States" },{ "LocationFacility":"Ohio State University Comprehensive Cancer Center", "LocationCity":"Columbus", "LocationState":"Ohio", "LocationZip":"43210", "LocationCountry":"United States" },{ "LocationFacility":"University of Wisconsin Hospital and Clinics", "LocationCity":"Madison", "LocationState":"Wisconsin", "LocationZip":"53792", "LocationCountry":"United States" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Arm I (Tivantinib)", "FlowGroupDescription":"Patients receive tivantinib 360 mg (3 * 120 mg tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Arm II (Placebo)", "FlowGroupDescription":"Patients receive matched placebo (3 tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I." },{ "FlowGroupId":"FG002", "FlowGroupTitle":"Crossover From Placebo to Tivantinib", "FlowGroupDescription":"Patients who were originally assigned to placebo and experience disease progression will be allowed to crossover and take ARQ 197. The treatment plan, duration of therapy, criteria for progression and follow-up will be the same as described above for men originally assigned to ARQ 197." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Pre Cross-over", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"52" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"26" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"52" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"26" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" } ] } } ] } },{ "FlowPeriodTitle":"Post Cross-over", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"52" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"14" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"12" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"52" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"14" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"12" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Arm I (Tivantinib)", "BaselineGroupDescription":"Patients receive tivantinib 360 mg (3 * 120 mg tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Arm II (Placebo)", "BaselineGroupDescription":"Patients receive matched placebo (3 tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"52" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"26" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"78" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Median", "BaselineMeasureDispersionType":"Full Range", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"67", "BaselineMeasurementLowerLimit":"43", "BaselineMeasurementUpperLimit":"84" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"66.5", "BaselineMeasurementLowerLimit":"48", "BaselineMeasurementUpperLimit":"85" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"67", "BaselineMeasurementLowerLimit":"43", "BaselineMeasurementUpperLimit":"85" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"52" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"26" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"78" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Race (NIH/OMB)", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"American Indian or Alaska Native", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Asian", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1" } ] } },{ "BaselineCategoryTitle":"Native Hawaiian or Other Pacific Islander", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Black or African American", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"8" } ] } },{ "BaselineCategoryTitle":"White", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"49" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"20" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"69" } ] } },{ "BaselineCategoryTitle":"More than one race", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Unknown or Not Reported", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"patients", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"United States", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"52" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"26" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"78" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Progression-free Survival (PFS) Based on the RECIST Criteria", "OutcomeMeasureDescription":"The progression-free survival distributions between the two arms will be compared using log-rank tests. Progression-free survival curves will be constructed using the Kaplan-Meier product limit method, and additional analyses will be done using the Cox proportional hazards model.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"months", "OutcomeMeasureTimeFrame":"Time from study entry to the date of documented progression and/or death, assessed up to 6 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Arm I (Tivantinib)", "OutcomeGroupDescription":"Patients receive tivantinib 360 mg (3 * 120 mg tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Arm II (Placebo)", "OutcomeGroupDescription":"Patients receive matched placebo (3 tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"52" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"26" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5.5", "OutcomeMeasurementLowerLimit":"3.2", "OutcomeMeasurementUpperLimit":"8.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3.7", "OutcomeMeasurementLowerLimit":"2.7", "OutcomeMeasurementUpperLimit":"5.4" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.02", "OutcomeAnalysisStatisticalMethod":"Log Rank" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Changes in PSA Levels", "OutcomeMeasureDescription":"Evaluated and patterns graphically explored through waterfall plots.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"Full Range", "OutcomeMeasureUnitOfMeasure":"percentage change from baseline", "OutcomeMeasureTimeFrame":"Baseline to 12 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Arm I (Tivantinib)", "OutcomeGroupDescription":"Patients receive tivantinib 360 mg (3 * 120 mg tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Arm II (Placebo)", "OutcomeGroupDescription":"Patients receive matched placebo (3 tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"52" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"26" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"140.1", "OutcomeMeasurementLowerLimit":"-9.0", "OutcomeMeasurementUpperLimit":"5768.1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"301.5", "OutcomeMeasurementLowerLimit":"-3.3", "OutcomeMeasurementUpperLimit":"3254.4" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Proportion of Patients Who Respond", "OutcomeMeasureDescription":"An assumed binomial distribution used. Summarized with their corresponding 95% binomial confidence intervals and compared in an exploratory manner between the two treatment arms. Dichotomized outcomes of response will be descriptively summarized and graphically evaluated using bar graphs.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of patients", "OutcomeMeasureTimeFrame":"At 12 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Arm I (Tivantinib)", "OutcomeGroupDescription":"Arm I: Patients receive tivantinib 360 mg (3 * 120 mg tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Arm II (Placebo)", "OutcomeGroupDescription":"Patients receive placebo PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Crossover From Placebo to Tivantinib", "OutcomeGroupDescription":"Patients who were originally assigned to placebo and experience disease progression will be allowed to crossover and take ARQ 197. The treatment plan, duration of therapy, criteria for progression and follow-up will be the same as described above for men originally assigned to ARQ 197." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"52" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"26" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"12" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.9", "OutcomeMeasurementLowerLimit":"0.05", "OutcomeMeasurementUpperLimit":"10.26" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"8.3", "OutcomeMeasurementLowerLimit":"0.2", "OutcomeMeasurementUpperLimit":"38.5" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"PSA Response Rate", "OutcomeMeasureDescription":"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of patients", "OutcomeMeasureTimeFrame":"up to 12 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Arm I (Tivantinib)", "OutcomeGroupDescription":"Patients receive tivantinib 360 mg (3 * 120 mg tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Arm II (Placebo)", "OutcomeGroupDescription":"Patients receive matched placebo (3 tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Crossover From Placebo to Tivantinib", "OutcomeGroupDescription":"Patients who were originally assigned to placebo and experience disease progression will be allowed to crossover and take ARQ 197. The treatment plan, duration of therapy, criteria for progression and follow-up will be the same as described above for men originally assigned to ARQ 197." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"52" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"26" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"12" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.9", "OutcomeMeasurementLowerLimit":"0.05", "OutcomeMeasurementUpperLimit":"10.26" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"8.3", "OutcomeMeasurementLowerLimit":"0.2", "OutcomeMeasurementUpperLimit":"38.5" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Incidence of Adverse Events Graded as 3, 4, or 5 Per NCI CTCAE Version 4.0", "OutcomeMeasureDescription":"Fisher's exact tests will be used to quantitatively compare the incidence of severe as well as specific toxicities of interest between the treatment arms and graphically assessed differences in maximum grades observed for toxicities between the arms.", "OutcomeMeasurePopulationDescription":"Adverse events graded as 3, 4 or 5 per NCI CTCAE version 4 (regardless of attribution)", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"patients", "OutcomeMeasureTimeFrame":"Up to 1 year", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Arm I (Tivantinib)", "OutcomeGroupDescription":"Patients receive tivantinib 360 mg (3 * 120 mg tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Arm II (Placebo)", "OutcomeGroupDescription":"Patients receive matched placebo (3 tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Crossover From Placebo to Tivantinib", "OutcomeGroupDescription":"Patients who were originally assigned to placebo and experience disease progression will be allowed to crossover and take ARQ 197. The treatment plan, duration of therapy, criteria for progression and follow-up will be the same as described above for men originally assigned to ARQ 197." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"52" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"26" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"12" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Acute coronary syndrome", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Alkaline phosphatase increased", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"Anemia", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"Back pain", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"Confusion", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Cataract", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Death NOS", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"Dehydration", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"Dizziness", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Duodenal ulcer", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Dyspnea", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Enterocolitis infectious", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Fall", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Fatigue", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Febrile neutropenia", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Gait disturbance", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Generalized muscle weakness", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypertension", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypokalemia", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hyponatremia", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypotension", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypoxia", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Infections and infestations - Other, specify", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Lymph gland infection", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Lymphocyte count decreased", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"Musculoskeletal and connective tissue disorder - O", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Neoplasms benign, malignant and unspecified (incl", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Nervous system disorders - Other, specify", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Neutrophil count decreased", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"Platelet count decreased", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Pleural effusion", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"Productive cough", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"Sinus bradycardia", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Sinus tachycardia", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Syncope", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Thromboembolic event", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Tumor pain", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Upper respiratory infection", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Urinary tract obstruction", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"White blood cell decreased", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Other Pre-specified", "OutcomeMeasureTitle":"Radiographic Response Rate Based on RECIST Criteria", "OutcomeMeasureDescription":"Summarized with their corresponding 95% binomial confidence intervals and compared in an exploratory manner between the two treatment arms. Dichotomized outcomes of response will be descriptively summarized and graphically evaluated using bar graphs.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of patients", "OutcomeMeasureTimeFrame":"Up to 12 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Arm I (Tivantinib)", "OutcomeGroupDescription":"Arm I: Patients receive tivantinib 360 mg (3 * 120 mg tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Arm II (Placebo)", "OutcomeGroupDescription":"Arm II: Patients receive matched placebo (3 tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Crossover From Placebo to Tivantinib", "OutcomeGroupDescription":"Patients who were originally assigned to placebo and experience disease progression will be allowed to crossover and take ARQ 197. The treatment plan, duration of therapy, criteria for progression and follow-up will be the same as described above for men originally assigned to ARQ 197." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"52" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"26" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"12" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.9", "OutcomeMeasurementLowerLimit":"0.05", "OutcomeMeasurementUpperLimit":"10.26" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"8.3", "OutcomeMeasurementLowerLimit":"0.2", "OutcomeMeasurementUpperLimit":"38.5" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Other Pre-specified", "OutcomeMeasureTitle":"Change in Bone Specific Alkaline Phosphatase (BSAP) in Serum", "OutcomeMeasureDescription":"BSAP will first be descriptively summarized by treatment group and also evaluated using graphical analyses to assess potential patterns over time and see if changes in bone resorption differ between those who are progression-free at 12 weeks vs. not after treatment with tivantinib. The potential impact of early changes in these markers on PFS using Cox regression models will be also explored.", "OutcomeMeasureReportingStatus":"Not Posted", "OutcomeMeasureTimeFrame":"Baseline to up to 6 months", "OutcomeMeasureDenomUnitsSelected":"Participants" },{ "OutcomeMeasureType":"Other Pre-specified", "OutcomeMeasureTitle":"Change in Markers of Bone Turnover in Urine", "OutcomeMeasureDescription":"NTx and CTX will first be descriptively summarized by treatment group and also evaluated using graphical analyses to assess potential patterns over time and see if changes in bone resorption differ between those who are progression-free at 12 weeks vs. not after treatment with tivantinib. The potential impact of early changes in these markers on PFS using Cox regression models will be also explored.", "OutcomeMeasureReportingStatus":"Not Posted", "OutcomeMeasureTimeFrame":"Baseline to up to 6 months", "OutcomeMeasureDenomUnitsSelected":"Participants" } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventsDescription":"The National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Arm I (Tivantinib)", "EventGroupDescription":"Patients receive tivantinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.", "EventGroupDeathsNumAffected":"7", "EventGroupDeathsNumAtRisk":"52", "EventGroupSeriousNumAffected":"19", "EventGroupSeriousNumAtRisk":"52", "EventGroupOtherNumAffected":"52", "EventGroupOtherNumAtRisk":"52" },{ "EventGroupId":"EG001", "EventGroupTitle":"Arm II (Placebo)", "EventGroupDescription":"Patients receive placebo PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.", "EventGroupDeathsNumAffected":"4", "EventGroupDeathsNumAtRisk":"26", "EventGroupSeriousNumAffected":"22", "EventGroupSeriousNumAtRisk":"26", "EventGroupOtherNumAffected":"26", "EventGroupOtherNumAtRisk":"26" },{ "EventGroupId":"EG002", "EventGroupTitle":"Crossover From Placebo to Tivantinib", "EventGroupDescription":"Patients who were originally assigned to placebo and experience disease progression will be allowed to crossover and take ARQ 197. The treatment plan, duration of therapy, criteria for progression and follow-up will be the same as described above for men originally assigned to ARQ 197.", "EventGroupDeathsNumAffected":"0", "EventGroupDeathsNumAtRisk":"12", "EventGroupSeriousNumAffected":"5", "EventGroupSeriousNumAtRisk":"12", "EventGroupOtherNumAffected":"12", "EventGroupOtherNumAtRisk":"12" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Anemia", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventSourceVocabulary":"CTCAE version 400", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"52" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"12" } ] } },{ "SeriousEventTerm":"Acute coronary syndrome", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"CTCAE version 400", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"52" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"12" } ] } },{ "SeriousEventTerm":"Sinus bradycardia", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"CTCAE version 400", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"52" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"12" } ] } },{ "SeriousEventTerm":"Sinus tachycardia", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"CTCAE version 400", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"52" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"12" } ] } },{ "SeriousEventTerm":"Abdominal pain", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"CTCAE version 400", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"52" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"12" } ] } },{ "SeriousEventTerm":"Constipation", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"CTCAE version 400", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"52" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"12" } ] } },{ "SeriousEventTerm":"Diarrhea", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"CTCAE version 400", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"52" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"12" } ] } },{ "SeriousEventTerm":"Duodenal ulcer", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"CTCAE version 400", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"52" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"12" } ] } },{ "SeriousEventTerm":"Nausea", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"CTCAE version 400", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"52" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"12" } ] } },{ "SeriousEventTerm":"Death NOS", "SeriousEventOrganSystem":"General disorders", "SeriousEventSourceVocabulary":"CTCAE version 400", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"52" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"12" } ] } },{ "SeriousEventTerm":"Edema limbs", "SeriousEventOrganSystem":"General disorders", "SeriousEventSourceVocabulary":"CTCAE version 400", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"52" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"12" } ] } },{ "SeriousEventTerm":"Fatigue", "SeriousEventOrganSystem":"General disorders", "SeriousEventSourceVocabulary":"CTCAE version 400", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"52" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"12" } ] } },{ "SeriousEventTerm":"Fever", "SeriousEventOrganSystem":"General disorders", "SeriousEventSourceVocabulary":"CTCAE version 400", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"52" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"12" } ] } },{ "SeriousEventTerm":"Gait disturbance", "SeriousEventOrganSystem":"General disorders", "SeriousEventSourceVocabulary":"CTCAE version 400", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"52" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"12" } ] } },{ "SeriousEventTerm":"Enterocolitis infectious", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"CTCAE version 400", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"52" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"12" } ] } },{ "SeriousEventTerm":"Infections and infestations - Other, specify", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"CTCAE version 400", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"52" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"12" } ] } },{ "SeriousEventTerm":"Upper respiratory infection", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"CTCAE version 400", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"52" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"12" } ] } },{ "SeriousEventTerm":"Fall", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventSourceVocabulary":"CTCAE version 400", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"52" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"12" } ] } },{ "SeriousEventTerm":"Anorexia", "SeriousEventOrganSystem":"Metabolism and nutrition disorders", "SeriousEventSourceVocabulary":"CTCAE version 400", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"52" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"12" } ] } },{ "SeriousEventTerm":"Dehydration", "SeriousEventOrganSystem":"Metabolism and nutrition disorders", "SeriousEventSourceVocabulary":"CTCAE version 400", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"52" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"12" } ] } },{ "SeriousEventTerm":"Generalized muscle weakness", "SeriousEventOrganSystem":"Musculoskeletal and connective tissue disorders", "SeriousEventSourceVocabulary":"CTCAE version 400", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"52" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"12" } ] } },{ "SeriousEventTerm":"Musculoskeletal and connective tissue disorder - Other, specify", "SeriousEventOrganSystem":"Musculoskeletal and connective tissue disorders", "SeriousEventSourceVocabulary":"CTCAE version 400", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"52" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"12" } ] } },{ "SeriousEventTerm":"Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"CTCAE version 400", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"52" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"12" } ] } },{ "SeriousEventTerm":"Tumor pain", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"CTCAE version 400", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"52" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"12" } ] } },{ "SeriousEventTerm":"Dizziness", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"CTCAE version 400", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"52" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"12" } ] } },{ "SeriousEventTerm":"Nervous system disorders - Other, specify", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"CTCAE version 400", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"52" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"12" } ] } },{ "SeriousEventTerm":"Seizure", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"CTCAE version 400", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"52" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"12" } ] } },{ "SeriousEventTerm":"Stroke", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"CTCAE version 400", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"52" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"12" } ] } },{ "SeriousEventTerm":"Syncope", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"CTCAE version 400", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"52" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"12" } ] } },{ "SeriousEventTerm":"Confusion", "SeriousEventOrganSystem":"Psychiatric disorders", "SeriousEventSourceVocabulary":"CTCAE version 400", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"52" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"12" } ] } },{ "SeriousEventTerm":"Urinary tract obstruction", "SeriousEventOrganSystem":"Renal and urinary disorders", "SeriousEventSourceVocabulary":"CTCAE version 400", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"52" },{ 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