{"analyses":[{"ciLowerLimit":"0.46","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.90","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0193","paramType":"Cox Proportional Hazard","paramValue":"0.65","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.78","upperLimit":"7.43","value":"6.24"},{"groupId":"OG001","lowerLimit":"4.14","upperLimit":"5.91","value":"5.65"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"71"}],"units":"Participants"}],"description":"The key secondary endpoint for the phase 3 portion is PFS, which will be analyzed only if the analysis of OS is statistically significant at the final analysis, with alpha level of 0.05 (two-sided) using the same statistical methodologies as applied to OS.","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":"Progression Free Survival","type":"SECONDARY","unitOfMeasure":"months"}