{"analyses":[{"groupIds":["OG000"],"nonInferiorityComment":"The statistical hypotheses was tested to address ORR \\<= 11% vs. ORR \\> 11%.","nonInferiorityType":"OTHER","pValue":"0.0002","statisticalMethod":"one-sided exact test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"15.9","upperLimit":"33.3","value":"23.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"101"}],"units":"Participants"}],"description":"The confirmed OR is defined as best overall response of confirmed complete response (CR) or confirmed partial response (PR) based upon RECIST v1.1, assessed by the IRC. The CR is disappearance of all target and non-target lesions and no new lesions. A confirmed CR is 2 CRs (CR-CR sequence) that were separated by at least 4 weeks with no evidence of progression in-between. The PR is ≥ 30% decrease in the sum of diameters of target lesions (compared to baseline) and no unequivocal progression of existing non-target lesions and no new lesion. A confirmed PR is PR-PR sequence or PR-CR sequence that were separated by at least 4 weeks. The intermediate missing (Not Evaluable \\[NE\\]) scan evaluations between response scan and confirmation scan were allowed, eg, PR-NE-PR and PR-NE-NE-PR was considered PR confirmed (a repeat scan not earlier than 4 weeks after initial scan documenting response). 95% CI was calculated using the Clopper-Pearson method.","dispersionType":"95% Confidence Interval","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":"NUMBER","populationDescription":"FAS included all participants who received at least 1 dose of tisotumab vedotin.","reportingStatus":"POSTED","timeFrame":"From Day 1 through IRC verified disease progression, initiation of new anticancer therapy, study withdrawal, or death, whichever occurred first (approximately 20 months)","title":"Percentage of Participants With Confirmed Objective Response (OR) as Assessed by the Independent Review Committee (IRC)","type":"PRIMARY","unitOfMeasure":"Percentage of Participants"}