{"analyses":[{"ciLowerLimit":"0.502","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.755","estimateComment":"If hazard ratio was found to be \\<1 then niraparib can be considered as superior to placebo.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"p-value was calculated based on stratified log-rank test using randomization stratification factors: administration of neoadjuvant chemotherapy, best response to platinum therapy and homologous recombination deficiency (HRD) status.","paramType":"Hazard Ratio (HR)","paramValue":"0.62","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.3","upperLimit":"8.5","value":"8.2"},{"groupId":"OG001","lowerLimit":"11.5","upperLimit":"14.9","value":"13.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"246"},{"groupId":"OG001","value":"487"}],"units":"Participants"}],"description":"Progression free survival was defined as the time from the date of treatment randomization to the date of first documentation of disease progression or death due to any cause in the absence of documented progression, whichever occurs first. It was assessed by the blinded independent central review (BICR). Median and 95% confidence interval (CI) are presented.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \\>=77 kilogram \\[kg\\] and Baseline platelet count \\>=150,000 per microliter \\[μL\\]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \\<77 kg or Baseline platelet count \\<150,000 per μL).","id":"OG000","title":"Placebo"},{"description":"Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \\>=77 kg and Baseline platelet count \\>=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \\<77 kg or Baseline platelet count \\<150,000 per μL).","id":"OG001","title":"Niraparib"}],"paramType":"MEDIAN","populationDescription":"Intent-to-Treat (ITT) population comprised of all participants who were randomized into the study.","reportingStatus":"POSTED","timeFrame":"Up to 34 months","title":"Progression Free Survival","type":"PRIMARY","unitOfMeasure":"Months"}