{"analyses":[{"ciLowerLimit":"0.433","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.412","estimateComment":"Hazard ratio, confidence interval and p-value obtained from proportional hazards model stratified by tumour histology (epithelioid vs. biphasic).","groupDescription":"Phase II","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.4132","paramType":"Hazard Ratio (HR)","paramValue":"0.782","statisticalMethod":"Proportional hazards mode"},{"ciLowerLimit":"0.79","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.58","estimateComment":"Hazard ratio, confidence interval and p-value obtained from a non-stratified proportional hazards model.","groupDescription":"Phase III:\n\nA Cox proportional hazards model was fitted to estimate hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) for the comparison of treatment arms (Nintedanib vs Placebo).\n\nIf the hazard ratio is below 1 then it favours nintedanib.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.7306","pValueComment":"one-sided p-value","paramType":"Hazard Ratio (HR)","paramValue":"1.12","statisticalMethod":"Proportional hazards model"}],"classes":[{"categories":[{"measurements":[{"comment":"The 75th percentile was not reached because of insufficient number of patients with OS event thus not calculated.","groupId":"OG000","lowerLimit":"10.41","upperLimit":"NA","value":"14.46"},{"comment":"The 75th percentile was not reached because of insufficient number of patients with OS event thus not calculated.","groupId":"OG001","lowerLimit":"10.91","upperLimit":"NA","value":"18.30"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"44"}],"units":"Participants"}],"title":"Phase II"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"9.66","upperLimit":"19.29","value":"16.07"},{"groupId":"OG001","lowerLimit":"9.13","upperLimit":"18.69","value":"14.36"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"229"},{"groupId":"OG001","value":"229"}],"units":"Participants"}],"title":"Phase III"}],"denoms":[{"counts":[{"groupId":"OG000","value":"272"},{"groupId":"OG001","value":"273"}],"units":"Participants"}],"description":"Overall survival was defined as the duration of time from randomization to time of death.\n\nThis is the key secondary endpoint of the trial.","dispersionType":"Inter-Quartile Range","groups":[{"description":"Nintedanib matching Placebo 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of placebo could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.","id":"OG000","title":"Placebo"},{"description":"Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of Nintedanib could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.","id":"OG001","title":"Nintedanib"}],"paramType":"MEDIAN","populationDescription":"Randomised Set: This patient set included all randomized patients.","reportingStatus":"POSTED","timeFrame":"From randomization until the earliest of disease progression, death or (Phase II: cut-off date of 4-March-2016; up to 889 days) (Phase III: cut-off date of 16-March-2018; up to 31 months)","title":"Overall Survival (OS)","type":"SECONDARY","unitOfMeasure":"Months"}