{"denoms":[{"counts":[{"groupId":"BG000","value":"43"},{"groupId":"BG001","value":"44"},{"groupId":"BG002","value":"229"},{"groupId":"BG003","value":"229"},{"groupId":"BG004","value":"545"}],"units":"Participants"}],"groups":[{"description":"Phase II part: 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":"BG000","title":"Placebo_Phase II"},{"description":"Phase II part: 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":"BG001","title":"Nintedanib_Phase II"},{"description":"Phase III part: 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":"BG002","title":"Placebo_Phase III"},{"description":"Phase III part: 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":"BG003","title":"Nintedanib_Phase III"},{"description":"Total of all reporting groups","id":"BG004","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"7.6","value":"65.9"},{"groupId":"BG001","spread":"8.6","value":"66.4"},{"groupId":"BG002","spread":"8.9","value":"64.3"},{"groupId":"BG003","spread":"9.5","value":"63.6"},{"groupId":"BG004","spread":"9.1","value":"64.3"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"43"},{"groupId":"BG001","value":"44"},{"groupId":"BG002","value":"229"},{"groupId":"BG003","value":"229"},{"groupId":"BG004","value":"545"}],"units":"Participants"}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"Years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"60"},{"groupId":"BG003","value":"64"},{"groupId":"BG004","value":"142"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"35"},{"groupId":"BG001","value":"34"},{"groupId":"BG002","value":"169"},{"groupId":"BG003","value":"165"},{"groupId":"BG004","value":"403"}],"title":"Male"}],"denoms":[{"counts":[{"groupId":"BG000","value":"43"},{"groupId":"BG001","value":"44"},{"groupId":"BG002","value":"229"},{"groupId":"BG003","value":"229"},{"groupId":"BG004","value":"545"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG004","value":"0"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG004","value":"0"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG004","value":"0"}],"title":"Unknown or Not Reported"}],"denoms":[{"counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Ethnicity data were not collected from any participant","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"14"},{"groupId":"BG003","value":"12"},{"groupId":"BG004","value":"26"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"16"},{"groupId":"BG003","value":"14"},{"groupId":"BG004","value":"30"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"2"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"38"},{"groupId":"BG001","value":"38"},{"groupId":"BG002","value":"180"},{"groupId":"BG003","value":"185"},{"groupId":"BG004","value":"441"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"19"},{"groupId":"BG003","value":"16"},{"groupId":"BG004","value":"46"}],"title":"Unknown or Not Reported"}],"denoms":[{"counts":[{"groupId":"BG000","value":"43"},{"groupId":"BG001","value":"44"},{"groupId":"BG002","value":"229"},{"groupId":"BG003","value":"229"},{"groupId":"BG004","value":"545"}],"units":"Participants"}]}],"description":"Race was only collected where allowed by local law.","paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"}],"populationDescription":"Randomised Set: This patient set included all randomized patients."}