{ "FullStudy":{ "Rank":217939, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01514864", "OrgStudyIdInfo":{ "OrgStudyId":"CA180-385" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"2011-003128-11", "SecondaryIdType":"EudraCT Number" } ] }, "Organization":{ "OrgFullName":"Bristol-Myers Squibb", "OrgClass":"INDUSTRY" }, "BriefTitle":"Trial of Dasatinib in Patients With Advanced Cancers Harboring DDR2 Mutation or Inactivating B-RAF Mutation", "OfficialTitle":"Phase II Trial of Dasatinib in Subjects With Advanced Cancers Harboring DDR2 Mutation or Inactivating B-RAF Mutation" }, "StatusModule":{ "StatusVerifiedDate":"November 2015", "OverallStatus":"Terminated", "WhyStopped":"Lack of efficacy and slow accrual", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"May 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"July 2014", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"July 2014", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 18, 2012", "StudyFirstSubmitQCDate":"January 20, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 23, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"July 23, 2015", "ResultsFirstSubmitQCDate":"November 2, 2015", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"December 3, 2015", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"November 2, 2015", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"December 3, 2015", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Bristol-Myers Squibb", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to establish whether patients with malignancy harboring a discoidin domain receptor 2 mutation or an inactivating B-RAF mutation will respond to dasatinib." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Carcinoma, Non-small Cell Lung" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Non-Randomized", "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"19", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)", "ArmGroupType":"Experimental", "ArmGroupDescription":"Participants with nonsmall-cell lung cancer (NSCLC) and an inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Dasatinib" ] } },{ "ArmGroupLabel":"Dasatinib, 140 mg (NSCLC With DDR2 Mutation)", "ArmGroupType":"Experimental", "ArmGroupDescription":"Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Dasatinib" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Dasatinib", "InterventionDescription":"Tablet, oral, 140 mg, once daily until unacceptable toxicity or disease progression", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Dasatinib, 140 mg (NSCLC With DDR2 Mutation)", "Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Objective Response Rate (ORR)", "PrimaryOutcomeDescription":"ORR is defined as the percentage of patients with best tumor response of either Partial Response (a 30% or greater decrease in the sum of the longest diameter [LD] of all lesions in reference to the baseline sum LD) or Complete Response (disappearance of clinical and radiologic evidence of target lesions), according to Response Evaluation Criteria in Solid Tumors.", "PrimaryOutcomeTimeFrame":"From enrollment of last patient to 24 months or until all patients have died, whichever occurs first" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Duration of Response (DOR)", "SecondaryOutcomeDescription":"DOR is defined as the time from the first assessment documentation of partial response (PR) or complete response (CR) until the first assessment documentation of disease progression.", "SecondaryOutcomeTimeFrame":"From enrollment of last patient to 24 months or until all patients have died, whichever occurs first" },{ "SecondaryOutcomeMeasure":"Overall Survival", "SecondaryOutcomeDescription":"Overall survival is defined as the time from treatment start date to the date of death. If a patient does not die, survival will be censored on the last date the patient was known to be alive.", "SecondaryOutcomeTimeFrame":"From enrollment of last patient to 24 months or until all patients have died, whichever occurs first" },{ "SecondaryOutcomeMeasure":"Progression-free Survival (PFS) Distribution", "SecondaryOutcomeDescription":"PFS distribution is defined as the percentage of patients with no documentation of disease progression at a specified time point. Confidence interval computed using the Brookmeyer and Crowley method", "SecondaryOutcomeTimeFrame":"From Day 1 of study treatment to Week 12" },{ "SecondaryOutcomeMeasure":"Progression-free Survival (PFS)", "SecondaryOutcomeDescription":"PFS is defined as the time from treatment start date to the earliest evidence of disease progression or death. Patients who die or whose disease does not progress will be censored on the date of their last tumor assessment.", "SecondaryOutcomeTimeFrame":"From Day 1 of study treatment to Week 12" },{ "SecondaryOutcomeMeasure":"Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, and Drug-related AEs Leading to Discontinuation", "SecondaryOutcomeDescription":"AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or unknown relationship to study drug.", "SecondaryOutcomeTimeFrame":"From enrollment of last patient to 24 months or until all patients have died, whichever occurs first" },{ "SecondaryOutcomeMeasure":"Number of Participants With Laboratory Testing Results That Meet the Criteria for Grade 3 or 4 Abnormality", "SecondaryOutcomeDescription":"Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to adverse event. Laboratory values graded by Common Terminology Criteria for Adverse Events, volume 3. Hemoglobin, Grade 3: <8.0 - 6.5 g/dL, <4.9-4.0 mmol/L, <80-65 g/L. Alkaline phosphatase, Grade 3: >5.0-20.0*upper limit of normal (ULN). Total bilirubin, Grade 3: >3.0-10.0*ULN. Calcium, low, Grade 3: <7.0-6.0 mg/dL, <1.75-1.5 mmol/L.", "SecondaryOutcomeTimeFrame":"From enrollment of last patient to 24 months or until all patients have died, whichever occurs first" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.\n\nInclusion Criteria:\n\nDiagnosis of advanced malignancy, nonsmall-cell lung cancer (NSCLC) only during stage 1 of accrual\n\nNonsynonymous mutation of B-RAF or DDR2, defined as follows:\n\nNSCLC with inactivating B-RAF mutation\nNSCLC with discoidin domain receptor 2 (DDR2) mutation\nMalignancy of other histology with DDR2 mutation or inactivating B-RAF mutation, or NSCLC having a B-RAF mutation that is not functionally characterized\nAt least 1 target lesion per Response Evaluation Criteria in Solid Tumors, vol 1.1, on baseline staging evaluation\nDisease progression after ≥ 1 prior treatment regimen\n\nExclusion Criteria:\n\nPleural or pericardial effusion, Grade >1\nQTcF >470 msec (Grade ≥2) or diagnosed congenital long QT syndrome\nAbsolute granulocyte count <1500/mm^3\nHemoglobin level <10 g/dL\nPlatelet count < 75,000/mm^3\nSerum calcium level 1, despite supplementation\nCreatinine >3*institutional upper limit of normal (ULN)\nTotal bilirubin level >1.5*ULN\nAlanine transaminase level >3*ULN", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Bristol-Myers Squibb", "OverallOfficialAffiliation":"Bristol-Myers Squibb", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"H. Lee Moffitt Cancer & Research Institute", "LocationCity":"Tampa", "LocationState":"Florida", "LocationZip":"33612", "LocationCountry":"United States" },{ "LocationFacility":"Memorial Sloan Kettering Cancer Center", "LocationCity":"New York", "LocationState":"New York", "LocationZip":"10065", "LocationCountry":"United States" },{ "LocationFacility":"Local Institution", "LocationCity":"Barretos", "LocationState":"Sao Paulo", "LocationZip":"14784", "LocationCountry":"Brazil" },{ "LocationFacility":"Local Institution", "LocationCity":"S?o Paulo", "LocationState":"Sao Paulo", "LocationZip":"05403", "LocationCountry":"Brazil" },{ "LocationFacility":"The Ottawa Hospital Cancer Centre", "LocationCity":"Ottawa", "LocationState":"Ontario", "LocationZip":"K1H 8L6", "LocationCountry":"Canada" },{ "LocationFacility":"Local Institution", "LocationCity":"Frankfurt", "LocationZip":"60488", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Heidelberg", "LocationZip":"69120", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Heidelberg", "LocationZip":"69126", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Koeln", "LocationZip":"50924", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Koeln", "LocationZip":"50931", "LocationCountry":"Germany" },{ "LocationFacility":"Local Institution", "LocationCity":"Gdansk", "LocationZip":"80-219", "LocationCountry":"Poland" },{ "LocationFacility":"Local Institution", "LocationCity":"Lodz", "LocationZip":"93-509", "LocationCountry":"Poland" },{ "LocationFacility":"Local Institution", "LocationCity":"Warsaw", "LocationZip":"02-781", "LocationCountry":"Poland" },{ "LocationFacility":"Local Institution", "LocationCity":"Taipei", "LocationZip":"112", "LocationCountry":"Taiwan" },{ "LocationFacility":"Local Institution", "LocationCity":"Cambridge", "LocationState":"Cambridgeshire", "LocationZip":"CB2 2QQ", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Local Institution", "LocationCity":"London", "LocationState":"Greater London", "LocationZip":"SW3 6JJ", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Local Institution", "LocationCity":"Manchester", "LocationState":"Greater Manchester", "LocationZip":"M20 4BX", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Local Institution", "LocationCity":"Edinburgh", "LocationState":"Midlothian", "LocationZip":"EH4 2XU", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Local Institution", "LocationCity":"Sutton", "LocationState":"Surrey", "LocationZip":"SM2 5PT", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Local Institution", "LocationCity":"Gwent", "LocationZip":"NP20 2UB", "LocationCountry":"United Kingdom" } ] } }, "ReferencesModule":{ "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"BMS clinical trial educational resource", "SeeAlsoLinkURL":"http://www.bms.com/studyconnect/Pages/home.aspx" },{ "SeeAlsoLinkLabel":"Investigator Inquiry form", "SeeAlsoLinkURL":"http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"A total of 19 patients were enrolled, and 14 received treatment in 2 cohorts: 9 with nonsmall-cell lung cancer (NSCLC) and an inactivating B-RAF mutation and 5 with NSCLC and a discoidin domain receptor 2 (DDR2) mutation.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)", "FlowGroupDescription":"Participants with nonsmall-cell lung cancer (NSCLC) and an inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Dasatinib, 140 mg (NSCLC With DDR2 Mutation)", "FlowGroupDescription":"Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"9" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"5" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementComment":"Study was terminated; no patients completed study treatment", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"9" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"5" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Disease progression", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"7" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"5" } ] } },{ "FlowDropWithdrawType":"Study drug toxicity", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"All participants who received at least 1 dose of study drug", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)", "BaselineGroupDescription":"Participants with nonsmall-cell lung cancer (NSCLC) and an inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred" },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Dasatinib, 140 mg (NSCLC With DDR2 Mutation)", "BaselineGroupDescription":"Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred" },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"9" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"5" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"14" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Categorical", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"<=18 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Between 18 and 65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"6" } ] } },{ "BaselineCategoryTitle":">=65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"8" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Median", "BaselineMeasureDispersionType":"Full Range", "BaselineMeasureUnitOfMeasure":"Years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"67.0", "BaselineMeasurementLowerLimit":"51.0", "BaselineMeasurementUpperLimit":"75.0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"63.0", "BaselineMeasurementLowerLimit":"50.0", "BaselineMeasurementUpperLimit":"73.0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"66.5", "BaselineMeasurementLowerLimit":"50.0", "BaselineMeasurementUpperLimit":"75.0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"6" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"8" } ] } } ] } } ] } },{ "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":"1" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1" } ] } },{ "BaselineCategoryTitle":"Asian", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } },{ "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":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1" } ] } },{ "BaselineCategoryTitle":"White", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"12" } ] } },{ "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":"Race/Ethnicity, Customized", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Hispanic/Latino", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1" } ] } } ] } },{ "BaselineClassTitle":"Not Hispanic/Latino", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"10" } ] } } ] } },{ "BaselineClassTitle":"Not reported", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"3" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Time from cancer diagnosis to start of study therapy", "BaselineMeasureParamType":"Median", "BaselineMeasureDispersionType":"Full Range", "BaselineMeasureUnitOfMeasure":"Months", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"14.4", "BaselineMeasurementLowerLimit":"6.2", "BaselineMeasurementUpperLimit":"21.7" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"8.5", "BaselineMeasurementLowerLimit":"1.5", "BaselineMeasurementUpperLimit":"51.6" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"12.1", "BaselineMeasurementLowerLimit":"1.5", "BaselineMeasurementUpperLimit":"51.6" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Tumor Type", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Nonsmall-cell lung carcinoma", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"9" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"14" } ] } } ] } },{ "BaselineClassTitle":"Other", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Nonsmall-cell lung carcinoma histology", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Adenocarcinoma", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"8" } ] } } ] } },{ "BaselineClassTitle":"Bronco-alveolar carcinoma", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1" } ] } } ] } },{ "BaselineClassTitle":"Large cell carcinoma", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1" } ] } } ] } },{ "BaselineClassTitle":"Squamous cell carcinoma", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"4" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Histopathologic Grade", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"G2-moderately differentiated", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"4" } ] } } ] } },{ "BaselineClassTitle":"G3-poorly differentiated", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"2" } ] } } ] } },{ "BaselineClassTitle":"GX-grade cannot be assessed", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"8" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status", "BaselineMeasureDescription":"ECOG is a 6-item scale used to assess disease progression, daily functioning, and appropriate treatment and prognosis. Performance status is scored on a scale ranging from 0-5, with (best score) 0=fully active and able to carry on all predisease performance without restriction and (worst score) 5=death.", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"ECOG score 0", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"2" } ] } } ] } },{ "BaselineClassTitle":"ECOG score 1", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"9" } ] } } ] } },{ "BaselineClassTitle":"ECOG score 2", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"3" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Number of Index Lesions", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"1", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"3" } ] } } ] } },{ "BaselineClassTitle":"2", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"2" } ] } } ] } },{ "BaselineClassTitle":"3", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"5" } ] } } ] } },{ "BaselineClassTitle":"4", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"4" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Objective Response Rate (ORR)", "OutcomeMeasureDescription":"ORR is defined as the percentage of patients with best tumor response of either Partial Response (a 30% or greater decrease in the sum of the longest diameter [LD] of all lesions in reference to the baseline sum LD) or Complete Response (disappearance of clinical and radiologic evidence of target lesions), according to Response Evaluation Criteria in Solid Tumors.", "OutcomeMeasurePopulationDescription":"All participants who received at least 1 dose of study drug. Because no patients had a response of CR or PR, ORR could not be calculated.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureTimeFrame":"From enrollment of last patient to 24 months or until all patients have died, whichever occurs first", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)", "OutcomeGroupDescription":"Participants with nonsmall-cell lung cancer (NSCLC) with inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Dasatinib, 140 mg (NSCLC With DDR2 Mutation)", "OutcomeGroupDescription":"Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"0" } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Duration of Response (DOR)", "OutcomeMeasureDescription":"DOR is defined as the time from the first assessment documentation of partial response (PR) or complete response (CR) until the first assessment documentation of disease progression.", "OutcomeMeasurePopulationDescription":"All participants who received at least 1 dose of study drug. Because no patients had a response of CR or PR, DOR could not be calculated.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureTimeFrame":"From enrollment of last patient to 24 months or until all patients have died, whichever occurs first", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)", "OutcomeGroupDescription":"Participants with nonsmall-cell lung cancer (NSCLC) and an inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Dasatinib, 140 mg (NSCLC With DDR2 Mutation)", "OutcomeGroupDescription":"Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"0" } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Overall Survival", "OutcomeMeasureDescription":"Overall survival is defined as the time from treatment start date to the date of death. If a patient does not die, survival will be censored on the last date the patient was known to be alive.", "OutcomeMeasurePopulationDescription":"All participants who received treatment", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"90% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"Months", "OutcomeMeasureTimeFrame":"From enrollment of last patient to 24 months or until all patients have died, whichever occurs first", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)", "OutcomeGroupDescription":"Participants with nonsmall-cell lung cancer (NSCLC) with inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Dasatinib, 140 mg (NSCLC With DDR2 Mutation)", "OutcomeGroupDescription":"Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"9" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"5" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.06", "OutcomeMeasurementLowerLimit":"0.76", "OutcomeMeasurementUpperLimit":"6.47" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4.21", "OutcomeMeasurementLowerLimit":"0.82", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"The upper limit Confidence Interval cannot be estimated" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Progression-free Survival (PFS) Distribution", "OutcomeMeasureDescription":"PFS distribution is defined as the percentage of patients with no documentation of disease progression at a specified time point. Confidence interval computed using the Brookmeyer and Crowley method", "OutcomeMeasurePopulationDescription":"All participants who received at least 1 dose of study drug", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"90% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"From Day 1 of study treatment to Week 12", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)", "OutcomeGroupDescription":"Participants with nonsmall-cell lung cancer (NSCLC) with inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Dasatinib, 140 mg (NSCLC With DDR2 Mutation)", "OutcomeGroupDescription":"Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"9" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"5" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.41", "OutcomeMeasurementLowerLimit":"0.72", "OutcomeMeasurementUpperLimit":"1.87" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.38", "OutcomeMeasurementLowerLimit":"0.59", "OutcomeMeasurementUpperLimit":"2.96" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Progression-free Survival (PFS)", "OutcomeMeasureDescription":"PFS is defined as the time from treatment start date to the earliest evidence of disease progression or death. Patients who die or whose disease does not progress will be censored on the date of their last tumor assessment.", "OutcomeMeasurePopulationDescription":"All participants who received at least 1 dose of study drug", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"90% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"Months", "OutcomeMeasureTimeFrame":"From Day 1 of study treatment to Week 12", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)", "OutcomeGroupDescription":"Participants with nonsmall-cell lung cancer (NSCLC) with inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Dasatinib, 140 mg (NSCLC With DDR2 Mutation)", "OutcomeGroupDescription":"Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"9" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"5" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.41", "OutcomeMeasurementLowerLimit":"0.72", "OutcomeMeasurementUpperLimit":"1.87" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.38", "OutcomeMeasurementLowerLimit":"0.59", "OutcomeMeasurementUpperLimit":"2.96" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, and Drug-related AEs Leading to Discontinuation", "OutcomeMeasureDescription":"AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or unknown relationship to study drug.", "OutcomeMeasurePopulationDescription":"All participants who received at least 1 dose of study drug", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"From enrollment of last patient to 24 months or until all patients have died, whichever occurs first", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)", "OutcomeGroupDescription":"Participants with nonsmall-cell lung cancer (NSCLC) with inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Dasatinib, 140 mg (NSCLC With DDR2 Mutation)", "OutcomeGroupDescription":"Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"9" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"5" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Death", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4" } ] } } ] } },{ "OutcomeClassTitle":"Death within 30 days of last treatment", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"SAEs", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4" } ] } } ] } },{ "OutcomeClassTitle":"Drug-related SAEs", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"AEs leading to discontinuation", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"Drug-related AEs leading to discontinuation", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Drug-related AEs", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Participants With Laboratory Testing Results That Meet the Criteria for Grade 3 or 4 Abnormality", "OutcomeMeasureDescription":"Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to adverse event. Laboratory values graded by Common Terminology Criteria for Adverse Events, volume 3. Hemoglobin, Grade 3: <8.0 - 6.5 g/dL, <4.9-4.0 mmol/L, <80-65 g/L. Alkaline phosphatase, Grade 3: >5.0-20.0*upper limit of normal (ULN). Total bilirubin, Grade 3: >3.0-10.0*ULN. Calcium, low, Grade 3: <7.0-6.0 mg/dL, <1.75-1.5 mmol/L.", "OutcomeMeasurePopulationDescription":"All participants who received study drug.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"From enrollment of last patient to 24 months or until all patients have died, whichever occurs first", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Dasatinib, 140 mg", "OutcomeGroupDescription":"Participants with nonsmall-cell lung cancer (NSCLC) received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred. Data from both arms were combined for safety reporting, because the safety profile of dasatinib should not have be affected by the type of mutation in the tumor. In addition, pooling the data from both arms increased the robustness of the data set." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"14" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Hemoglobin, Grade 3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"Alkaline phosphatase, Grade 3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"Total bilirubin, Grade 3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"Calcium, low, Grade 3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Dasatinib, 140 mg", "EventGroupDescription":"Participants with nonsmall-cell lung cancer received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred. Data from both arms were combined for safety reporting, because the safety profile of dasatinib should not have be affected by the type of mutation in the tumor. In addition, pooling the data from both arms increased the robustness of the data set.", "EventGroupSeriousNumAffected":"11", "EventGroupSeriousNumAtRisk":"14", "EventGroupOtherNumAffected":"13", "EventGroupOtherNumAtRisk":"14" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Non-small cell lung cancer", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA 17.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"14" } ] } },{ "SeriousEventTerm":"Diverticular perforation", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 17.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"14" } ] } },{ "SeriousEventTerm":"Lung infection", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 17.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"14" } ] } },{ "SeriousEventTerm":"Pleural effusion", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"MedDRA 17.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"14" } ] } },{ "SeriousEventTerm":"Cholangitis", "SeriousEventOrganSystem":"Hepatobiliary disorders", "SeriousEventSourceVocabulary":"MedDRA 17.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"14" } ] } },{ "SeriousEventTerm":"Lower respiratory tract infection", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 17.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"14" } ] } },{ "SeriousEventTerm":"Angina pectoris", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 17.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"14" } ] } },{ "SeriousEventTerm":"Atrial fibrillation", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 17.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"14" } ] } },{ "SeriousEventTerm":"General physical health deterioration", "SeriousEventOrganSystem":"General disorders", "SeriousEventSourceVocabulary":"MedDRA 17.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"14" } ] } },{ "SeriousEventTerm":"Groin pain", "SeriousEventOrganSystem":"Musculoskeletal and connective tissue disorders", "SeriousEventSourceVocabulary":"MedDRA 17.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"14" } ] } },{ "SeriousEventTerm":"Angina unstable", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 17.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"14" } ] } },{ "SeriousEventTerm":"Haemoglobin decreased", "SeriousEventOrganSystem":"Investigations", "SeriousEventSourceVocabulary":"MedDRA 17.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"14" } ] } },{ "SeriousEventTerm":"Hypercalcaemia", "SeriousEventOrganSystem":"Metabolism and nutrition disorders", "SeriousEventSourceVocabulary":"MedDRA 17.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"14" } ] } },{ "SeriousEventTerm":"Lipase increased", "SeriousEventOrganSystem":"Investigations", "SeriousEventSourceVocabulary":"MedDRA 17.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"14" } ] } },{ "SeriousEventTerm":"Neoplasm malignant", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA 17.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"14" } ] } },{ "SeriousEventTerm":"Gastrointestinal haemorrhage", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 17.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"14" } ] } },{ "SeriousEventTerm":"Malignant neoplasm progression", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA 17.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"4", "SeriousEventStatsNumAtRisk":"14" } ] } },{ "SeriousEventTerm":"Musculoskeletal chest pain", "SeriousEventOrganSystem":"Musculoskeletal and connective tissue disorders", "SeriousEventSourceVocabulary":"MedDRA 17.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"14" } ] } },{ "SeriousEventTerm":"Pain", "SeriousEventOrganSystem":"General disorders", "SeriousEventSourceVocabulary":"MedDRA 17.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"14" } ] } },{ "SeriousEventTerm":"Panic reaction", "SeriousEventOrganSystem":"Psychiatric disorders", "SeriousEventSourceVocabulary":"MedDRA 17.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"14" } ] } },{ "SeriousEventTerm":"Dyspnoea", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"MedDRA 17.0", "SeriousEventAssessmentType":"Systematic Assessment", 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