{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"11"},{"groupId":"OG003","value":"9"},{"groupId":"OG004","value":"13"},{"groupId":"OG005","value":"8"},{"groupId":"OG006","value":"11"}]}],"title":"TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"6"},{"groupId":"OG006","value":"5"}]}],"title":"Serious TEAE"}],"denoms":[{"counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"11"},{"groupId":"OG003","value":"9"},{"groupId":"OG004","value":"13"},{"groupId":"OG005","value":"8"},{"groupId":"OG006","value":"11"}],"units":"Participants"}],"description":"A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of epacadostat, pembrolizumab, or chemotherapy. Serious adverse event is defined as an event that meets 1 of the following criteria: is fatal or life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability, incapacity, or a substantial disruption of a person's ability to conduct normal life functions, constitutes a congenital anomaly or birth defect,is a medically important event that may jeopardize the participant or may require medical or surgical intervention to prevent 1 of the outcomes listed above.","groups":[{"description":"Epacadostat (Epa) oral twice-daily (BID) continuous daily dosing at the protocol-defined dose in combination with pembrolizumab administered intravenously (IV) in combination with mFOLFOX6 (oxaliplatin IV + leucovorin IV + 5-fluorouracil (5-FU) IV.","id":"OG000","title":"Group A: Epa + Pembrolizumab + mFOLFOX6"},{"description":"Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with nab-paclitaxel IV and gemcitabine IV.","id":"OG001","title":"Group B: Epa + Pembrolizumab + Nab-Paclitaxel and Gemcitabine"},{"description":"Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) in combination with paclitaxel IV and carboplatin IV.","id":"OG002","title":"Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin"},{"description":"Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with pemetrexed IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.","id":"OG003","title":"Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent"},{"description":"Epa (100 mg)oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with cyclophosphamide PO.","id":"OG004","title":"Group E: Epa + Pembrolizumab + Cyclophosphamide"},{"description":"Epa oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab IV in combination with gemcitabine IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.","id":"OG005","title":"Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent"},{"description":"Epa oral BID continuousdaily dosing at the protocol-defined dose in combination with pembrolizumab IV in combination with 5-FU IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.","id":"OG006","title":"Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.","reportingStatus":"POSTED","timeFrame":"Up to 21 months","title":"Phases 1 & 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs","type":"PRIMARY","unitOfMeasure":"Participants"}