{"analyses":[{"ciLowerLimit":"0.55","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.93","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0234","paramType":"Cox Proportional Hazard","paramValue":"0.71","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.85","upperLimit":"11.79","value":"9.30"},{"groupId":"OG001","lowerLimit":"6.14","upperLimit":"9.53","value":"7.66"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"108"},{"groupId":"OG001","value":"116"}],"units":"Participants"}],"description":"Overall survival is defined as the time from randomization until death. In the event that no death was documented prior to study termination or analysis cutoff, OS was censored at the last known date the subject was known to be alive, either through completion of on-study visits or through survival follow-up contact.\n\nThe treatment effect on OS was evaluated using the stratified log-rank test (stratified by tumor histology).\n\nThe Kaplan-Meier curves were also plotted. A Cox proportional hazard model with an adjustment for tumor histology (biphasic vs sarcomatoid) was used to compute the estimated hazard ratio and two-sided 95% CI. The treatment effect on OS was evaluated using the stratified log-rank test (stratified by tumor histology). The significance level to be used in the OS analysis at the final analysis was based on α = 0.04999 (two-sided).","dispersionType":"95% Confidence Interval","groups":[{"description":"Dose: 36 mg/m2 given weekly Route of Administration: Intramuscular (IM) Duration : Course of Study\n\nIn Combination With:\n\nPemetrexed Dose: 500 mg/m2 every 3 weeks Route of Administration: Intravenous Cisplatin Dose: 75 mg/m2 every 3 weeks Route of Administration: Intravenous Carboplatin Dose: AUC 5 mg/mL/min every 3 weeks Route of Administration: Intravenous\n\nADI-PEG 20 plus Pem Platinum: Investigational Drug in combination approved standard of care treatment for this indication\n\nADI-PEG 20 plus Pem Platinum: Investigational Drug in combination approved standard of care treatment for this indication","id":"OG000","title":"Drug: ADI-PEG 20 Plus Pem Platinum"},{"description":"Dose: 36 mg/m2 given weekly Route of Administration: Intramuscular (IM) Duration : Course of Study\n\nIn Combination With:\n\nPemetrexed Dose: 500 mg/m2 every 3 weeks Route of Administration: Intravenous Cisplatin Dose: 75 mg/m2 every 3 weeks Carboplatin Dose: AUC 5 mg/mL/min every 3 weeks Route of Administration: Intravenous\n\nPlacebo plus Pem Platinum: Placebo in combination approved standard of care treatment for this indication\n\nPlacebo plus Pem Platinum: Placebo in combination approved standard of care treatment for this indication","id":"OG001","title":"Drug: Placebo Plus Pem Platinum"}],"paramType":"MEDIAN","reportingStatus":"POSTED","timeFrame":"18 months","title":"Overall Survival","type":"PRIMARY","unitOfMeasure":"months"}