{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"12.35","value":"4.78"},{"groupId":"OG001","spread":"9.47","value":"12.20"},{"groupId":"OG002","spread":"17.32","value":"19.81"},{"groupId":"OG003","spread":"18.48","value":"34.67"},{"groupId":"OG004","spread":"21.10","value":"23.12"},{"groupId":"OG005","spread":"39.20","value":"35.42"},{"groupId":"OG006","spread":"22.08","value":"32.30"},{"groupId":"OG007","spread":"10.31","value":"55.53"},{"groupId":"OG008","spread":"34.1","value":"29.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"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"},{"groupId":"OG008","value":"167"}],"units":"Participants"}],"title":"Tisotumab Vedotin: Cycle 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"27.65","value":"3.85"},{"groupId":"OG001","spread":"11.51","value":"12.51"},{"groupId":"OG002","spread":"5.14","value":"20.25"},{"groupId":"OG003","spread":"7.11","value":"32.38"},{"groupId":"OG004","spread":"24.97","value":"21.84"},{"groupId":"OG005","spread":"30.39","value":"35.92"},{"groupId":"OG006","spread":"0.32","value":"44.30"},{"groupId":"OG007","spread":"26.37","value":"48.79"},{"groupId":"OG008","spread":"41.2","value":"26.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"2"},{"groupId":"OG007","value":"3"},{"groupId":"OG008","value":"146"}],"units":"Participants"}],"title":"Tisotumab Vedotin: Cycle 2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"13.00","value":"4.90"},{"groupId":"OG001","spread":"8.31","value":"11.84"},{"groupId":"OG002","spread":"11.64","value":"17.98"},{"groupId":"OG003","spread":"10.14","value":"29.30"},{"groupId":"OG004","spread":"25.16","value":"23.55"},{"groupId":"OG005","spread":"37.42","value":"30.57"},{"groupId":"OG006","spread":"21.77","value":"38.78"},{"groupId":"OG007","spread":"12.77","value":"58.02"},{"groupId":"OG008","spread":"31.1","value":"39.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"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"},{"groupId":"OG008","value":"168"}],"units":"Participants"}],"title":"Total HuMax-TF: Cycle 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.83","value":"3.96"},{"groupId":"OG001","spread":"8.83","value":"11.54"},{"groupId":"OG002","spread":"1.57","value":"16.90"},{"groupId":"OG003","spread":"8.13","value":"31.33"},{"groupId":"OG004","spread":"21.03","value":"22.11"},{"groupId":"OG005","spread":"42.96","value":"37.71"},{"groupId":"OG006","spread":"6.67","value":"43.40"},{"groupId":"OG007","spread":"19.75","value":"53.67"},{"groupId":"OG008","spread":"33.3","value":"38.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"2"},{"groupId":"OG007","value":"3"},{"groupId":"OG008","value":"146"}],"units":"Participants"}],"title":"Total HuMax-TF: Cycle 2"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"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"},{"groupId":"OG008","value":"168"}],"units":"Participants"}],"description":"PK parameters in plasma were determined based on non-compartmental methods and calculated separately for Cycle 1 and Cycle 2 in each part of the study.","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"},{"description":"PK was only planned to be analyzed per the dose level received, not per cancer type. So the PK data is pooled for all participants in the dose expansion part of the study","id":"OG008","title":"Dose Expansion Part: Pharmacokinetics (PK) Analysis Set"}],"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 and Expansion Part: Maximum Observed Plasma Concentration (Cmax) of Tisotumab Vedotin and Total HuMax-TF","type":"SECONDARY","unitOfMeasure":"ug/mL"}