{"analyses":[{"ciLowerLimit":"0.65","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.85","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.7423","paramType":"Hazard Ratio (HR)","paramValue":"1.09","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Upper limit of 95% confidence interval (CI) was not estimable due to insufficient number of participants with events.","groupId":"OG000","lowerLimit":"39.8","upperLimit":"NA","value":"39.8"},{"comment":"Median and upper limit of 95% CI were not estimable due to insufficient number of participants with events.","groupId":"OG001","lowerLimit":"29.6","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"113"},{"groupId":"OG001","value":"110"}],"units":"Participants"}],"description":"OS was defined as the time from randomization to death from any cause. K-M method was used to estimate median OS. 95% CI for median was computed using the method of Brookmeyer and Crowley.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received platinum-containing anticancer treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating investigator based on NSCLC histology. Participants with NSCLC of non-squamous histology received carboplatin + pemetrexed or cisplatin + pemetrexed or pembrolizumab + carboplatin + pemetrexed or pembrolizumab + cisplatin + pemetrexed. Participants with NSCLC of squamous histology received carboplatin or cisplatin + gemcitabine or carboplatin + paclitaxel/nab-paclitaxel + pembrolizumab until PD or for up to a maximum of 2 years.","id":"OG000","title":"Arm A: Treatment Period- SOC"},{"description":"Participants received pralsetinib, 400 mg, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity, non-compliance, withdrawal of consent, closure of the study by the sponsor, or death, whichever occurred first (cycle length=21 days).","id":"OG001","title":"Arm B: Treatment Period- Pralsetinib"}],"paramType":"MEDIAN","populationDescription":"ITT population included all randomized participants whether or not the assigned study treatment was received. As specified in the protocol, assessment of this outcome measure was limited to Arms A and B, as the objective was to compare pralsetinib with SOC platinum-containing anticancer treatment regimens.","reportingStatus":"POSTED","timeFrame":"From randomization to death (up to approximately 50 months)","title":"Arm A vs Arm B: Overall Survival (OS)","type":"SECONDARY","unitOfMeasure":"months"}