{"analyses":[{"ciLowerLimit":"0.50","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.11","groupIds":["OG000","OG001"],"nonInferiorityComment":"Relative Risk Ratio (ADIPemPlatinum/PlaceboPemPlatinum) is the common relative risk of having a response (CR or PR) based on the Mantel-Haenszel estimator controlling for tumor histology. A relative risk ratio greater than one is favorable to ADIPemPlatinum.","nonInferiorityType":"SUPERIORITY","pValue":"0.9489","paramType":"Risk Ratio (RR)","paramValue":"1.02","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"12"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"87"},{"groupId":"OG001","value":"89"}],"units":"Participants"}],"description":"Objective Response Rate is calculated as the proportion of subjects whose best tumor response from all post-baseline tumor assessments is complete response (CR) or partial response (PR). The best tumor response is the best response recorded from the start of the treatment until the end of treatment taking into account any requirement for confirmation.\n\nTo test Objective Response Rate significance, a Relative Risk Ratio (ADI-PEG 20 / Placebo) was calculated as the common relative risk of having a response (CR or PR) based on the Mantel-Haenszel estimator controlling for tumor histology (biphasic versus sarcomatoid).","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":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"approximately 18 months","title":"Response Rate","type":"PRIMARY","unitOfMeasure":"Participants"}