{"analyses":[{"ciLowerLimit":"0.340","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.907","estimateComment":"Hazard ratio, confidence interval and p-value obtained from proportional hazards model stratified by tumour histology (epithelioid vs. biphasic).","groupDescription":"Phase II Part","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.0174","paramType":"Hazard Ratio (HR)","paramValue":"0.555","statisticalMethod":"Proportional hazards mode"},{"ciLowerLimit":"0.79","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.30","estimateComment":"Hazard ratio, confidence interval and p-value obtained from a non-stratified proportional hazards model.","groupDescription":"Phase III part:\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":"0.5430","pValueComment":"one-sided p-value","paramType":"Hazard Ratio (HR)","paramValue":"1.01","statisticalMethod":"Proportional hazards model"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.19","upperLimit":"8.18","value":"5.72"},{"groupId":"OG001","lowerLimit":"5.55","upperLimit":"12.65","value":"9.36"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"44"}],"units":"Participants"}],"title":"Phase II"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.42","upperLimit":"9.00","value":"6.97"},{"groupId":"OG001","lowerLimit":"5.36","upperLimit":"9.07","value":"6.77"}]}],"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":"This outcome measure presents progression-free survival. Disease progression was defined according to the modified Response Evaluation Criteria in Solid Tumours (RECIST) criteria. Progression-free survival time was calculated as the duration from the date of randomization to the date of disease progression or death, whichever occurred first. For patients with known date of progression (or death): PFS (days) = min (date of progression, date of death) - date of randomization + 1 day. For patients without progression or death, PFS was censored at the last imaging date that showed no disease progression: PFS (days, censored) = date of last imaging showing no progression - date randomization + 1 day.","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":"Progression-Free Survival (PFS)","type":"PRIMARY","unitOfMeasure":"Months"}