{"classes":[{"categories":[{"measurements":[{"groupId":"OG001","spread":"11.84","value":"68.40"},{"groupId":"OG002","spread":"14.54","value":"70.80"},{"groupId":"OG003","spread":"16.87","value":"63.46"},{"groupId":"OG004","spread":"12.38","value":"86.10"},{"groupId":"OG005","spread":"35.60","value":"81.13"},{"groupId":"OG006","spread":"21.62","value":"92.04"},{"groupId":"OG007","spread":"18.07","value":"61.46"}]}],"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":"9.53","value":"76.69"},{"groupId":"OG002","spread":"7.99","value":"69.74"},{"groupId":"OG003","spread":"6.03","value":"62.61"},{"groupId":"OG004","spread":"20.82","value":"99.20"},{"groupId":"OG005","spread":"42.93","value":"70.21"},{"groupId":"OG006","spread":"4.19","value":"74.82"},{"groupId":"OG007","spread":"5.79","value":"72.74"}]}],"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":"1.61","value":"51.55"},{"groupId":"OG002","spread":"17.79","value":"60.27"},{"groupId":"OG003","spread":"8.65","value":"57.38"},{"groupId":"OG004","spread":"10.74","value":"77.55"},{"groupId":"OG005","spread":"50.61","value":"67.26"},{"groupId":"OG006","spread":"30.52","value":"68.69"},{"groupId":"OG007","spread":"7.20","value":"50.69"}]}],"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":"10.80","value":"55.75"},{"groupId":"OG002","spread":"8.90","value":"57.13"},{"groupId":"OG003","spread":"12.66","value":"58.48"},{"groupId":"OG004","spread":"22.85","value":"84.98"},{"groupId":"OG005","spread":"36.02","value":"50.62"},{"groupId":"OG006","spread":"17.48","value":"60.40"},{"groupId":"OG007","spread":"12.31","value":"58.10"}]}],"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":"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 planned to be collected for the volume of distribution 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: Volume of Distribution of Tisotumab Vedotin and Total HuMax-TF","type":"SECONDARY","unitOfMeasure":"mL/kg"}