{"analyses":[{"ciLowerLimit":"0.76","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.58","estimateComment":"Odds ratio above 1 favours nintedanib.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","otherAnalysisDescription":"Exact 95% CI by Clopper and Pearson.","pValue":"0.3189","pValueComment":"one-sided p-value","paramType":"Odds Ratio (OR)","paramValue":"1.09","statisticalComment":"Odds ratio and one-sided p-value are obtained from an un-adjusted logistic regression model (Nintedanib vs Placebo).","statisticalMethod":"Regression, Logistic"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"36.3","upperLimit":"49.5","value":"42.8"},{"groupId":"OG001","lowerLimit":"38.4","upperLimit":"51.7","value":"45.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"229"},{"groupId":"OG001","value":"229"}],"units":"Participants"}],"description":"Objective response (best overall tumour response of confirmed complete response \\[CR\\] or confirmed partial response \\[PR\\]).\n\nComplete Response: disappearance of all target lesions Partial Response: at least a 30 % decrease in the total tumour measurement of target lesions, taking as reference the baseline total tumour measurement.\n\nPercentage of Patients with confirmed objective response is presented. This endpoint was only evaluated for Phase III part.","dispersionType":"95% Confidence Interval","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":"NUMBER","populationDescription":"Randomised Set: This patient set included all randomized patients.","reportingStatus":"POSTED","timeFrame":"Tumour imaging was to be performed every 6 weeks until disease progression, death or start of subsequent anti-cancer therapy, whichever occurred earlier; up to 54 months","title":"Objective Response According to Modified RECIST- Investigator Assessment","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}