{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"1"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"0"},{"groupId":"OG012","value":"0"},{"groupId":"OG013","value":"0"},{"groupId":"OG014","value":"0"},{"groupId":"OG015","value":"0"},{"groupId":"OG016","value":"0"},{"groupId":"OG017","value":"0"},{"groupId":"OG018","value":"1"},{"groupId":"OG019","value":"0"},{"groupId":"OG020","value":"1"},{"groupId":"OG021","value":"0"},{"groupId":"OG022","value":"1"},{"groupId":"OG023","value":"1"},{"groupId":"OG024","value":"0"},{"groupId":"OG025","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"6"},{"groupId":"OG005","value":"28"},{"groupId":"OG006","value":"27"},{"groupId":"OG007","value":"5"},{"groupId":"OG008","value":"6"},{"groupId":"OG009","value":"11"},{"groupId":"OG010","value":"5"},{"groupId":"OG011","value":"6"},{"groupId":"OG012","value":"6"},{"groupId":"OG013","value":"5"},{"groupId":"OG014","value":"5"},{"groupId":"OG015","value":"5"},{"groupId":"OG016","value":"17"},{"groupId":"OG017","value":"4"},{"groupId":"OG018","value":"9"},{"groupId":"OG019","value":"5"},{"groupId":"OG020","value":"6"},{"groupId":"OG021","value":"11"},{"groupId":"OG022","value":"6"},{"groupId":"OG023","value":"11"},{"groupId":"OG024","value":"5"},{"groupId":"OG025","value":"6"}],"units":"Participants"}],"description":"A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment with single-agent LAG525 or within the first two cycles of treatment with the combination of LAG525 and PDR001. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.","groups":[{"description":"Single-agent LAG525 1 mg/kg Q2W","id":"OG000","title":"Phase 1: LAG525 1 mg/kg Q2W"},{"description":"Single-agent LAG525 3 mg/kg Q2W","id":"OG001","title":"Phase 1: LAG525 3 mg/kg Q2W"},{"description":"Single-agent LAG525 5 mg/kg Q2W","id":"OG002","title":"Phase 1: LAG525 5 mg/kg Q2W"},{"description":"Single-agent LAG525 10 mg/kg Q2W","id":"OG003","title":"Phase 1: LAG525 10 mg/kg Q2W"},{"description":"Single-agent LAG525 15 mg/kg Q2W","id":"OG004","title":"Phase 1: LAG525 15 mg/kg Q2W"},{"description":"Single-agent LAG525 240 mg Q2W","id":"OG005","title":"Phase 1: LAG525 240 mg Q2W"},{"description":"Single-agent LAG525 400 mg Q2W","id":"OG006","title":"Phase 1: LAG525 400 mg Q2W"},{"description":"Single-agent LAG525 3 mg/kg Q4W","id":"OG007","title":"Phase 1: LAG525 3 mg/kg Q4W"},{"description":"Single-agent LAG525 5 mg/kg Q4W","id":"OG008","title":"Phase 1: LAG525 5 mg/kg Q4W"},{"description":"Single-agent LAG525 10 mg/kg Q4W","id":"OG009","title":"Phase 1: LAG525 10 mg/kg Q4W"},{"description":"Single-agent LAG525 400 mg Q4W","id":"OG010","title":"Phase 1: LAG525 400 mg Q4W"},{"description":"Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)","id":"OG011","title":"Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W"},{"description":"Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)","id":"OG012","title":"Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W"},{"description":"Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)","id":"OG013","title":"Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W"},{"description":"Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)","id":"OG014","title":"Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W"},{"description":"Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)","id":"OG015","title":"Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W"},{"description":"Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)","id":"OG016","title":"Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W"},{"description":"Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)","id":"OG017","title":"Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W"},{"description":"Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)","id":"OG018","title":"Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W"},{"description":"Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)","id":"OG019","title":"Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W"},{"description":"Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)","id":"OG020","title":"Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W"},{"description":"Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)","id":"OG021","title":"Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W"},{"description":"Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)","id":"OG022","title":"Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W"},{"description":"Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)","id":"OG023","title":"Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W"},{"description":"Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)","id":"OG024","title":"Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W"},{"description":"Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)","id":"OG025","title":"Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001, and who either completed a minimum exposure requirement or who had a DLT during the first 15 days of treatment (1 cycle) for single-agent LAG525 arms or the first 30 days (2 cycles) for the LAG525 + PDR001 arms.\n\nJapanese patients were analyzed together with the rest of the world (ROW) patients as per protocol.","reportingStatus":"POSTED","timeFrame":"15 days for single-agent LAG525 arms and 30 days for the combination LAG525 + PDR001 arms","title":"Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs)","type":"PRIMARY","unitOfMeasure":"Participants"}