{"analyses":[{"ciLowerLimit":"0.452","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.773","groupDescription":"HR was calculated based on the Cox Proportional hazards model. Assuming proportional hazards, a HR less than 1 indicated a reduction in hazard rate in favor of crizotinib.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0002","pValueComment":"Two-sided p-value from the unstratified log rank test was used.","paramType":"Hazard Ratio (HR)","paramValue":"0.591","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.8","upperLimit":"4.2","value":"2.1"},{"groupId":"OG001","lowerLimit":"0.4","upperLimit":"0.7","value":"0.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"166"},{"groupId":"OG001","value":"163"}],"units":"Participants"}],"description":"TTD in pain in chest, dyspnea, or cough from the Quality of Life Questionnaire Core 30 (QLQ-LC13) was a composite endpoint defined as the time from randomization to the earliest time the participant's scale scores showed a 10 point or greater increase after baseline in any of the 3 symptoms. For those who had not shown deterioration, the data was censored at the last date when the participants completed an assessment (QLQ-LC13) for pain, dyspnea, or cough or at last visit date prior to crossover for participants randomized to chemotherapy who subsequently crossed over to crizotinib. A 10-point or higher change in the score was perceived by participants as clinically significant. The transformed score of pain, dyspnea, and cough symptom scales of EORTC QLQ-LC13 (European Organization for the Research and Treatment of Cancer) range from 0 to 100, where higher scores indicate greater symptom severity.","dispersionType":"95% Confidence Interval","groups":[{"description":"Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.","id":"OG000","title":"Crizotinib"},{"description":"Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)\\^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m\\^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg\\*min/mL, approximately 30 min after end of pemetrexed infusion.","id":"OG001","title":"Chemotherapy"}],"paramType":"MEDIAN","populationDescription":"The patient reported outcome (PRO) evaluable population included all participants from the FA population who completed a baseline and at least 1 postbaseline PRO assessment prior to crossover to crizotinib or end of randomized study treatment.","reportingStatus":"POSTED","timeFrame":"From randomization of treatment up to deterioration while on study treatment (up to 35 months)","title":"Time to Deterioration (TTD) in Chest Pain, Dyspnea or Cough","type":"SECONDARY","unitOfMeasure":"months"}