{"analyses":[{"ciLowerLimit":"0.442","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.106","estimateComment":"If hazard ratio was found to be \\<1 then niraparib can be considered as superior to placebo.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.1238","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 HRD status.","paramType":"Hazard Ratio (HR)","paramValue":"0.70","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"NA indicates median and 95% CI (upper limit) could not be derived, as \\<50% of participants experienced the event within the treatment arm.","groupId":"OG000","lowerLimit":"25.0","upperLimit":"NA","value":"NA"},{"comment":"NA indicates 95% CI (upper limit) could not be derived, as \\<75% of participants experienced the event within the treatment arm.","groupId":"OG001","lowerLimit":"30.3","upperLimit":"NA","value":"30.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"246"},{"groupId":"OG001","value":"487"}],"units":"Participants"}],"description":"Overall survival was defined as the time from the date of randomization to the date of death by any cause. Median and 95% CI are presented for overall survival interim analysis.","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":"ITT Population","reportingStatus":"POSTED","timeFrame":"Up to 34 months","title":"Overall Survival","type":"SECONDARY","unitOfMeasure":"Months"}