{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"3"}],"units":"Participants"}],"description":"A SAE is defined as an AE that met one or more of the following criteria/outcomes which were classified as serious:\n\nRequired inpatient hospitalization or prolongation of existing hospitalization. Resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions.\n\nWas a congenital anomaly/birth defect. Medically important determined by the investigator. Resulted in death. Was life-threatening.","groups":[{"description":"Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials \\[RP2D\\] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).","id":"OG000","title":"Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian"},{"description":"Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials \\[RP2D\\] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).","id":"OG001","title":"Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical"},{"description":"Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).","id":"OG002","title":"Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian"},{"description":"Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).","id":"OG003","title":"Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical"},{"description":"Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.","id":"OG004","title":"Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian"},{"description":"Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.","id":"OG005","title":"Part 2: Cohort Expansion: Cohort 6 1q3w Cervical"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"Baseline to end of trial (Part 2), up to 36 weeks","title":"Part 2: Number of Participants Reporting One or More Serious Adverse Events (SAE)","type":"PRIMARY","unitOfMeasure":"Participants"}