{"analyses":[{"groupDescription":"Pneumonitis","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"1.0000","statisticalComment":"Two-sided significance level = 0.05","statisticalMethod":"Fisher Exact"},{"groupDescription":"Fibrosis","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.2736","statisticalComment":"Two-sided significance level = 0.05","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.6","upperLimit":"17.8","value":"5.3"},{"groupId":"OG001","lowerLimit":"2.3","upperLimit":"15.5","value":"6.9"}]}],"title":"Pneumonitis"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.6","upperLimit":"17.8","value":"5.3"},{"groupId":"OG001","lowerLimit":"0.0","upperLimit":"7.5","value":"1.4"}]}],"title":"Fibrosis"}],"denoms":[{"counts":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"72"}],"units":"Participants"}],"description":"RILT is defined as clinical radiation pneumonitis and clinical fibrosis. Grading is defined in the protocol as follows (grade 3 and higher):\n\n* Clinical pneumonitis:\n\n  * Grade 3: Severe cough, unresponsive to narcotic antitussive agent and /or dyspnea at rest, with radiographic evidence of acute pneumonitis, and requiring oxygen (intermittent or continuous) for treatment;\n  * Grade 4: Radiation pneumonitis causes respiratory insufficiency, requiring assisted ventilation;\n  * Grade 5: Radiation pneumonitis directly contributes to the cause of the death;\n* Clinical fibrosis:\n\n  * Grade 3: Radiographic evidence of radiation fibrosis causing dyspnea at rest, interfering with activities of daily living, and home oxygen indicated;\n  * Grade 4: Radiation fibrosis causes respiratory insufficiency, requiring assisted ventilation;\n  * Grade 5: Radiation fibrosis directly contributes to the cause of the death.","dispersionType":"95% Confidence Interval","groups":[{"description":"60 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel.","id":"OG000","title":"Standard Radiation Therapy"},{"description":"A maximum of 80.4 Gy radiation therapy in 30 once daily fractions concurrent with weekly carboplatin and paclitaxel. Radiation therapy dose is individualized for final 9 fractions based on imaging results from PET/CT scan between fractions 18 and 19.","id":"OG001","title":"Adaptive Radiation Therapy"}],"paramType":"NUMBER","populationDescription":"Eligible participants with RILT data.","reportingStatus":"POSTED","timeFrame":"From randomization to last follow-up: weekly during treatment, then 1, 3, 6, 9, 12, 18, 24, 30, 36, 48, and 60 months after end of protocol treatment, then annually. Maximum follow-up at time of reporting was 7.3 years.","title":"Percentage of Participants With Grade 3+ Radiation-induced Lung Toxicity [RILT] at Any Time (NRG)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}