{"classes":[{"categories":[{"measurements":[{"groupId":"OG001","spread":"7.81","value":"15.57"},{"groupId":"OG002","spread":"15.70","value":"25.77"},{"groupId":"OG003","spread":"10.99","value":"46.68"},{"groupId":"OG004","spread":"20.93","value":"33.95"},{"groupId":"OG005","spread":"48.61","value":"63.88"},{"groupId":"OG006","spread":"30.88","value":"53.47"},{"groupId":"OG007","spread":"8.68","value":"105.84"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"3"},{"groupId":"OG007","value":"6"}],"units":"Participants"}],"title":"Tisotumab Vedotin: Cycle 1"},{"categories":[{"measurements":[{"groupId":"OG001","spread":"4.98","value":"14.52"},{"groupId":"OG002","spread":"6.44","value":"26.12"},{"groupId":"OG003","spread":"9.98","value":"46.59"},{"groupId":"OG004","spread":"26.43","value":"30.56"},{"groupId":"OG005","spread":"24.03","value":"80.59"},{"groupId":"OG006","spread":"19.06","value":"64.10"},{"groupId":"OG007","spread":"11.04","value":"88.95"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"2"},{"groupId":"OG006","value":"2"},{"groupId":"OG007","value":"3"}],"units":"Participants"}],"title":"Tisotumab Vedotin: Cycle 2"},{"categories":[{"measurements":[{"groupId":"OG001","spread":"0.20","value":"23.75"},{"groupId":"OG002","spread":"16.39","value":"37.02"},{"groupId":"OG003","spread":"13.26","value":"69.96"},{"groupId":"OG004","spread":"35.67","value":"48.19"},{"groupId":"OG005","spread":"52.74","value":"90.08"},{"groupId":"OG006","spread":"30.45","value":"93.29"},{"groupId":"OG007","spread":"12.70","value":"157.81"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"3"},{"groupId":"OG007","value":"2"}],"units":"Participants"}],"title":"Total HuMax-TF: Cycle 1"},{"categories":[{"measurements":[{"groupId":"OG001","spread":"9.95","value":"23.01"},{"groupId":"OG002","spread":"6.37","value":"37.08"},{"groupId":"OG003","spread":"14.25","value":"67.93"},{"groupId":"OG004","spread":"30.31","value":"43.41"},{"groupId":"OG005","spread":"12.41","value":"136.08"},{"groupId":"OG006","spread":"26.45","value":"98.59"},{"groupId":"OG007","spread":"9.42","value":"145.82"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"2"},{"groupId":"OG006","value":"2"},{"groupId":"OG007","value":"3"}],"units":"Participants"}],"title":"Total HuMax-TF: Cycle 2"}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"3"},{"groupId":"OG007","value":"6"}],"units":"Participants"}],"description":"PK parameters in plasma were determined based on non compartmental methods and calculated separately for Cycle 1 and Cycle 2. AUC0-inf was only analyzed in the dose escalation part of the study. Data was not planned to be collected for the AUC0-inf of tisotumab vedotin and total HuMax-TF for the dose expansion part.","dispersionType":"Geometric Coefficient of Variation","groups":[{"description":"Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.","id":"OG000","title":"Dose Escalation Part: 0.3 mg/kg"},{"description":"Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.","id":"OG001","title":"Dose Escalation Part: 0.6 mg/kg"},{"description":"Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.","id":"OG002","title":"Dose Escalation Part: 0.9 mg/kg"},{"description":"Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.","id":"OG003","title":"Dose Escalation Part: 1.2 mg/kg"},{"description":"Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.","id":"OG004","title":"Dose Escalation Part: 1.5 mg/kg"},{"description":"Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.","id":"OG005","title":"Dose Escalation Part: 1.8 mg/kg"},{"description":"Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.","id":"OG006","title":"Dose Escalation Part: 2.0 mg/kg"},{"description":"Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.","id":"OG007","title":"Dose Escalation Part: 2.2 mg/kg"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"PK analysis set: all participants who had been exposed to tisotumab vedotin and had at least 1 PK assessment after first dose.","reportingStatus":"POSTED","timeFrame":"Before infusion, Day 1 (pre-dose) and 0.25 to 336 hours post-dose of Cycle 1 and Cycle 2 (each cycle was 21 days)","title":"Dose Escalation Part: Area Under the Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Tisotumab Vedotin and Total HuMax-TF","type":"SECONDARY","unitOfMeasure":"day*ug/mL"}