{"classes":[{"categories":[{"measurements":[{"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"}]}],"title":"TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"2"},{"groupId":"OG006","value":"2"},{"groupId":"OG007","value":"4"}]}],"title":"Serious TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"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"}]}],"title":"Infusion-Related TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"2"},{"groupId":"OG007","value":"4"}]}],"title":"CTCAE Grade >=3 TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"3"},{"groupId":"OG007","value":"6"}]}],"title":"TEAEs Related to Study Drug"}],"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"}],"units":"Participants"}],"description":"Evaluation of treatment-emergent adverse events (TEAEs) includes number of participants with at least one:\n\nTEAE Serious TEAE Infusion-related TEAE Common Terminology Criteria for Adverse Events (CTCAE) grade \\>=3 Treatment-related TEAE\n\nA CTCAE TEAE was determined using the CTCAE grading systems based on National Cancer Institute (NCI)-CTCAE version 4.03 assessed by the investigator per the below definitions.\n\nGrade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living.\n\nGrade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.","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":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the dose escalation part.","title":"Dose Escalation Part: Evaluation of Treatment-Emergent Adverse Events","type":"PRIMARY","unitOfMeasure":"Participants"}