{"denoms":[{"counts":[{"groupId":"OG000","value":"0"}],"units":"Participants"}],"description":"ORR is defined as the percentage of participants who achieve confirmed partial response (cPR) or confirmed complete response (cCR) (determined by the investigator) during the study in the response-evaluable population. ORR will be assessed as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Complete response (CR): defined as disappearance of all target and non- target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than \\<10 mm. Partial response (PR): defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. cPR or cCR is defined as a PR or CR that is confirmed with additional imaging 6 weeks after initial response.","groups":[{"description":"Participants were planned to receive TAK-500 at recommended doses based on dose escalation cohorts. No participants were enrolled in the expansion phase due to early termination of the study before initiating this phase.","id":"OG000","title":"Dose Expansion: TAK-500"}],"populationDescription":"Due to early study termination, Dose Expansion Phase was not initiated and hence, no data was collected for this outcome measure.","reportingStatus":"POSTED","timeFrame":"Up to approximately 32.8 months","title":"Dose Expansion: Overall Response Rate (ORR)","type":"PRIMARY"}