{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"101"}]}],"title":"Any TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"44"}]}],"title":"Any TESAE"}],"denoms":[{"counts":[{"groupId":"OG000","value":"101"}],"units":"Participants"}],"description":"An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE is defined as an AE that meets one of the following criteria: fatal or life-threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; medically significant (an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above \\[medical and scientific judgment must be exercised in deciding whether an AE is \"medically important\"\\]); required inpatient hospitalization or prolongation of existing hospitalization. A TEAE is defined as an AE occurring or worsening between the first dose of tisotumab vedotin and 30 days after the last dose received.","groups":[{"description":"Participants received IV tisotumab vedotin 2.0 mg/kg Q3W until radiographic disease progression verified by the IRC, unacceptable AEs requiring drug discontinuation, withdrawal of consent, lost to follow up or death, whichever occurred first.","id":"OG000","title":"Tisotumab Vedotin"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"FAS included all participants who received at least 1 dose of tisotumab vedotin.","reportingStatus":"POSTED","timeFrame":"From Day 1 through 30 days after the last dose of study drug (approximately 49 months)","title":"Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)","type":"SECONDARY","unitOfMeasure":"Participants"}