{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"6"}]}],"title":"On study drug (total)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"4"}]}],"title":"On study drug: Due to AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"3"}]}],"title":"On study drug: Due to AE poss related"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}]}],"title":"On study drug: Due to study disease"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"6"}]}],"title":"Within 30 Days of Discontinuation (disc) (total)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"4"}]}],"title":"Within 30 Days of Disc: Due to AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}]}],"title":"Within 30 Days of Disc: Due to AE poss related"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"2"}]}],"title":"Within 30 Days of Disc: Due to study disease"}],"denoms":[{"counts":[{"groupId":"OG000","value":"283"},{"groupId":"OG001","value":"272"}],"units":"Participants"}],"description":"The number of deaths that occurred while on study drug, the number of deaths due to adverse events (AEs) while on study drug, and the number of deaths due to the study disease (that is, disease progression) while on study drug are presented. In addition, the number of deaths within 30 days of treatment discontinuation, the number of deaths due to AEs within 30 days of treatment discontinuation, and the number of deaths due to study disease within 30 days of treatment discontinuation are presented. For both the deaths due to AEs that occurred on study and for deaths due to AEs that occurred within 30 days of treatment discontinuation, the causality (events assess as possibly related \\[poss related\\] to study drug per investigator judgement) is also presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","groups":[{"description":"Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (\"Concurrent Phase\") for three 21-day cycles, followed by a 3-5 week \"Recovery Period,\" then treated with consolidation chemotherapy with pemetrexed (\"Consolidation Phase\") for up to four 21-day cycles\n\nConcurrent Phase:\n\nPemetrexed: 500 mg/m\\^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m\\^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.\n\nConsolidation Phase:\n\nPemetrexed: 500 mg/m\\^2, IV on Day 1 of each 21-day cycle up to 4 cycles","id":"OG000","title":"Arm A: Pemetrexed + Cisplatin and TRT"},{"description":"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (\"Concurrent Phase\") for two 28-day cycles, followed by a 3-5 week \"Recovery Period,\" then received consolidation treatment with cytotoxic chemotherapy of choice (\"Consolidation Phase\") for up to 2 cycles\n\nConcurrent Phase:\n\nEtoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m\\^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m\\^2, IV on Days1, 8, 29, and 36\n\nConsolidation Phase options:\n\nOption 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m\\^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m\\^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m\\^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22","id":"OG001","title":"Arm B: Etoposide + Cisplatin and TRT"}],"paramType":"NUMBER","populationDescription":"All randomized participants who received at least one dose of study drug.","reportingStatus":"POSTED","timeFrame":"Baseline through 30 Days Post Study","title":"Adverse Events: The Number of Deaths Per Treatment Group","type":"OTHER_PRE_SPECIFIED","unitOfMeasure":"participants"}