{"analyses":[{"ciLowerLimit":"2.1","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"7.6","estimateComment":"OR calculated using Cochran-Mantel-Haenszel (CMH) method controlling for stratification factors at randomization.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Odds Ratio (OR)","paramValue":"4.0","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"13.3","upperLimit":"23.1","value":"17.8"},{"groupId":"OG001","lowerLimit":"2.8","upperLimit":"8.8","value":"5.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"253"},{"groupId":"OG001","value":"249"}],"units":"Participants"}],"description":"Confirmed objective response rate was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v.1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \\<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The minimum criteria for stable disease (SD) duration are defined as ≥ 5 weeks after the date of randomization. For a response to be considered as confirmed, the subsequent response had to be at least 4 weeks after the initial response. Two-sided 95% exact confidence interval (CI) was computed using the Clopper-Pearson method.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants with rCC/mCC were administered tisotumab vedotin 2.0 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once every 3 weeks (Q3W).","id":"OG000","title":"Tisotumab Vedotin"},{"description":"Participants with rCC/mCC were treated with investigator's choice of chemotherapy which included either topotecan 1 or 1.25 milligram per meter square \\[mg/m\\^2\\] IV on Days 1 to 5, every 21 days or vinorelbine 30 mg/m\\^2 IV on Days 1 and 8, every 21 days or gemcitabine 1000 mg/m\\^2 IV on Days 1 and 8, every 21 days or irinotecan 100 or 125 mg/m\\^2 IV weekly for 28 days, every 42 days or pemetrexed 500 mg/m\\^2 on Day 1, every 21 days.","id":"OG001","title":"Chemotherapy"}],"paramType":"NUMBER","populationDescription":"ITT analysis set included all randomized participants. Participants were included in the treatment group assigned at randomization regardless of any actual treatment received.","reportingStatus":"POSTED","timeFrame":"From the date of randomization until date of confirmed CR or PR (maximum up to 25 months)","title":"Confirmed Objective Response Rate (ORR) as Assessed by Investigator","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}