{"classes":[{"categories":[{"measurements":[{"groupId":"OG011","spread":"8.24","value":"9.71"},{"groupId":"OG012","spread":"4.81","value":"10.2"},{"groupId":"OG013","spread":"3.38","value":"12.5"},{"groupId":"OG014","spread":"8.72","value":"20.7"},{"groupId":"OG015","spread":"47","value":"30.8"},{"groupId":"OG016","spread":"13.8","value":"22.8"},{"groupId":"OG017","spread":"4.78","value":"14.8"},{"groupId":"OG018","spread":"5","value":"11.8"},{"groupId":"OG019","spread":"3.72","value":"14"},{"groupId":"OG020","spread":"10.2","value":"15.1"},{"groupId":"OG021","spread":"8.41","value":"20.4"},{"groupId":"OG022","spread":"7.18","value":"18.7"},{"groupId":"OG023","spread":"10","value":"20.4"},{"groupId":"OG024","spread":"5.48","value":"14.6"},{"groupId":"OG025","spread":"2.76","value":"17.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"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":"0"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"4"},{"groupId":"OG012","value":"6"},{"groupId":"OG013","value":"6"},{"groupId":"OG014","value":"5"},{"groupId":"OG015","value":"6"},{"groupId":"OG016","value":"16"},{"groupId":"OG017","value":"5"},{"groupId":"OG018","value":"11"},{"groupId":"OG019","value":"7"},{"groupId":"OG020","value":"4"},{"groupId":"OG021","value":"10"},{"groupId":"OG022","value":"6"},{"groupId":"OG023","value":"11"},{"groupId":"OG024","value":"6"},{"groupId":"OG025","value":"6"}],"units":"Participants"}],"title":"Cycle 1, ROW patients"},{"categories":[{"measurements":[{"groupId":"OG011","spread":"9.4","value":"21.4"},{"groupId":"OG012","spread":"7.13","value":"22.3"},{"groupId":"OG013","spread":"10.3","value":"12.4"},{"groupId":"OG014","spread":"5.03","value":"17.8"},{"groupId":"OG015","spread":"36.8","value":"44.4"},{"groupId":"OG016","spread":"19.4","value":"27.7"},{"groupId":"OG017","spread":"4.25","value":"27.4"},{"groupId":"OG018","spread":"5.64","value":"17.4"},{"groupId":"OG019","spread":"12.4","value":"20.8"},{"groupId":"OG020","value":"22.4"},{"groupId":"OG021","spread":"4.22","value":"21.9"},{"groupId":"OG022","spread":"12.5","value":"32.8"},{"groupId":"OG023","spread":"10.2","value":"16.7"},{"groupId":"OG024","spread":"5.64","value":"16.1"},{"groupId":"OG025","spread":"6.75","value":"24.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"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":"0"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"3"},{"groupId":"OG012","value":"5"},{"groupId":"OG013","value":"3"},{"groupId":"OG014","value":"2"},{"groupId":"OG015","value":"3"},{"groupId":"OG016","value":"12"},{"groupId":"OG017","value":"3"},{"groupId":"OG018","value":"6"},{"groupId":"OG019","value":"3"},{"groupId":"OG020","value":"1"},{"groupId":"OG021","value":"3"},{"groupId":"OG022","value":"2"},{"groupId":"OG023","value":"7"},{"groupId":"OG024","value":"4"},{"groupId":"OG025","value":"5"}],"units":"Participants"}],"title":"Cycle 3, ROW patients"}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"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":"0"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"6"},{"groupId":"OG012","value":"6"},{"groupId":"OG013","value":"6"},{"groupId":"OG014","value":"5"},{"groupId":"OG015","value":"6"},{"groupId":"OG016","value":"20"},{"groupId":"OG017","value":"5"},{"groupId":"OG018","value":"11"},{"groupId":"OG019","value":"7"},{"groupId":"OG020","value":"4"},{"groupId":"OG021","value":"10"},{"groupId":"OG022","value":"6"},{"groupId":"OG023","value":"11"},{"groupId":"OG024","value":"6"},{"groupId":"OG025","value":"6"}],"units":"Participants"}],"description":"Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Elimination half-life (T1/2) values were calculated as 0.693/terminal elimination rate constant.\n\nJapanese patients were not treated with PDR001 and therefore the PK parameters of this study drug are not applicable.","dispersionType":"Standard Deviation","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":"MEAN","populationDescription":"All patients in phase 1 who received at least one full or partial dose of PDR001 and who had at least one serum sample providing evaluable PK data.","reportingStatus":"POSTED","timeFrame":"pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).","title":"Phase 1: Terminal Elimination Half-life (T1/2) of PDR001","type":"SECONDARY","unitOfMeasure":"day"}