{"analyses":[{"ciLowerLimit":"0.40","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.55","estimateComment":"Odds ratio above 1 favours nintedanib.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.7512","pValueComment":"one-sided p-value","paramType":"Odds Ratio (OR)","paramValue":"0.79","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":"88.4","upperLimit":"95.6","value":"92.6"},{"groupId":"OG001","lowerLimit":"86.3","upperLimit":"94.2","value":"90.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"229"},{"groupId":"OG001","value":"229"}],"units":"Participants"}],"description":"Disease control (best overall response of confirmed CR or PR, or Stable Disease (SD) that lasted ≥36 days) according to modified RECIST.\n\nPercentage of Patients with Disease control 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":"Disease Control According to Modified RECIST- Investigator Assessment","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}