{"denoms":[{"counts":[{"groupId":"OG000","value":"0"}],"units":"Participants"}],"description":"An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE therefore could have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was either reported for the first time or the worsening of a pre-existing event after the first dose of either study drug until 104 days after the last dose of study treatment or the start of new anticancer therapy.","groups":[{"description":"Participants received INCB099280 400 milligrams (mg) twice daily (BID) and axitinib 5 mg BID in consecutive 21-day cycles for up to 2 years as long as they were receiving benefit and did not meet any criteria for study withdrawal.","id":"OG000","title":"INCB099280 400 mg BID Plus Axitinib 5 mg BID"}],"populationDescription":"Safety Population. Enrollment in this study was closed during Part 1 following the sponsor's decision to discontinue the INCB099280 development program for strategic reasons. There were no safety concerns that contributed to the decision. Part 2 of the study was not conducted.","reportingStatus":"POSTED","timeFrame":"up to 2 years","title":"Part 2: Number of Participants With TEAEs Leading to a Dosing Modification (Treatment Interruption, Dose Reduction, and Permanent Discontinuation of Either Study Drug)","type":"SECONDARY"}