{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"82"},{"groupId":"OG001","value":"176"}]}],"title":"Participants with Treatment Emergent Adverse Events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"89"}]}],"title":"Participants with Serious Treatment Emergent AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"5"}]}],"title":"Participants with Fatal Treatment Emergent AEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"83"},{"groupId":"OG001","value":"176"}],"units":"Participants"}],"description":"An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and up to 100 days after last dose of study drug. Adverse events of grade 5 which result in death are called as fatal AEs.","groups":[{"description":"Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 and participants with melanoma I/O-relapsed and melanoma I/O-refractory enrolled in this arm received epacadostat 100 mg BID in combination with nivolumab 480 mg IV infusion Q4W on Days 1 and Day 29 of each 8-week cycle.","id":"OG000","title":"Phase 2: Epacadostat 100 mg + Nivolumab 240/480 mg"},{"description":"Participants with select solid tumor types received epacadostat 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.","id":"OG001","title":"Phase 2: Epacadostat 300 mg + Nivolumab 240 mg"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The Phase 2 Safety population includes all participants enrolled in the study who received at least 1 dose of study drug.","reportingStatus":"POSTED","timeFrame":"up to approximately 35 months","title":"Phase 2: Safety and Tolerability Measured by the Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and Fatal Treatment Emergent AEs","type":"SECONDARY","unitOfMeasure":"Participants"}