{"classes":[{"categories":[{"measurements":[{"groupId":"OG001","spread":"7.79","value":"1.61"},{"groupId":"OG002","spread":"15.23","value":"1.46"},{"groupId":"OG003","spread":"11.60","value":"1.07"},{"groupId":"OG004","spread":"20.59","value":"1.84"},{"groupId":"OG005","spread":"60.05","value":"1.17"},{"groupId":"OG006","spread":"34.12","value":"1.56"},{"groupId":"OG007","spread":"8.93","value":"0.87"}]}],"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":"5"}],"units":"Participants"}],"title":"Tisotumab Vedotin: Cycle 1"},{"categories":[{"measurements":[{"groupId":"OG001","spread":"4.98","value":"1.72"},{"groupId":"OG002","spread":"6.32","value":"1.44"},{"groupId":"OG003","spread":"10.45","value":"1.07"},{"groupId":"OG004","spread":"26.80","value":"2.05"},{"groupId":"OG005","spread":"24.03","value":"0.93"},{"groupId":"OG006","spread":"19.06","value":"1.30"},{"groupId":"OG007","spread":"11.34","value":"1.03"}]}],"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":"Tisotumab Vedotin: Cycle 2"},{"categories":[{"measurements":[{"groupId":"OG001","spread":"0.20","value":"1.02"},{"groupId":"OG002","spread":"16.90","value":"0.98"},{"groupId":"OG003","spread":"12.61","value":"0.69"},{"groupId":"OG004","spread":"31.29","value":"1.26"},{"groupId":"OG005","spread":"69.72","value":"0.81"},{"groupId":"OG006","spread":"33.85","value":"0.87"},{"groupId":"OG007","spread":"14.13","value":"0.56"}]}],"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":"5"}],"units":"Participants"}],"title":"Total HuMax-TF: Cycle 1"},{"categories":[{"measurements":[{"groupId":"OG001","spread":"9.95","value":"1.05"},{"groupId":"OG002","spread":"6.52","value":"0.98"},{"groupId":"OG003","spread":"13.41","value":"0.71"},{"groupId":"OG004","spread":"31.39","value":"1.40"},{"groupId":"OG005","spread":"12.41","value":"0.53"},{"groupId":"OG006","spread":"26.45","value":"0.82"},{"groupId":"OG007","spread":"9.72","value":"0.61"}]}],"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":"5"}],"units":"Participants"}],"description":"Pharmacokinetic (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. Data was not collected to report or calculate clearance for the expansion phase.","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: Clearance of Tisotumab Vedotin and Total HuMax-TF","type":"SECONDARY","unitOfMeasure":"mL/hr/kg"}