{"analyses":[{"ciLowerLimit":"0.47","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.88","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0078","paramType":"Cox Proportional Hazard","paramValue":"0.64","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.85","upperLimit":"12.91","value":"9.82"},{"groupId":"OG001","lowerLimit":"5.88","upperLimit":"9.46","value":"7.49"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"78"},{"groupId":"OG001","value":"91"}],"units":"Participants"}],"description":"The primary analysis of OS Phase 3 was performed at the interim analysis. This was performed once 50% of the planned OS events for phase 3 have occurred (ie, 169 of the 338 planned OS events). This interim analysis will evaluate OS in the ITT population in an unblinded manner. The OS data at the second interim analysis will be analyzed to support the following decisions:\n\nFutility stopping: Terminate the study due to futility at the interim analysis. Sample size re-estimation: Increase the target number of OS events after the second interim analysis.. The treatment effect on OS will be evaluated using the stratified log-rank test (stratified by tumor histology).","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","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","id":"OG001","title":"Drug: Placebo Plus Pem Platinum"}],"paramType":"MEDIAN","reportingStatus":"POSTED","timeFrame":"Approximately 18 months","title":"Overall Survival Phase 3 Interim Analysis","type":"PRIMARY","unitOfMeasure":"months"}