{"denoms":[{"counts":[{"groupId":"OG000","value":"0"}],"units":"Participants"}],"description":"AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs). TEAE Grades will be evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.","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: Number of Participants With Grade 3 or Higher TEAEs","type":"SECONDARY"}