{"analyses":[{"ciLowerLimit":"0.95","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.66","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.1063","paramType":"Hazard Ratio (HR)","paramValue":"1.25","statisticalMethod":"Log Rank","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.6","upperLimit":"13.0","value":"9.3"},{"groupId":"OG001","lowerLimit":"6.1","upperLimit":"9.4","value":"6.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"165"},{"groupId":"OG001","value":"158"}],"units":"Participants"}],"description":"TOI is defined as the sum of the scores of the PW, FWB, and LCS of the FACT-L instrument. Trial Outcome Index measures the physical functioning of participants. Time to deterioration in TOI is defined as time from randomization until the earlier of a clinically meaningful decline from baseline in TOI or death on study. The clinically meaningful decline used to determine deterioration in TOI was ≥6- point decline from baseline. Kaplan-Meier estimates were used for analysis.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received either pemetrexed 500 mg/m\\^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m\\^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.","id":"OG000","title":"Comparator"},{"description":"Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.","id":"OG001","title":"Erlotinib"}],"paramType":"MEDIAN","populationDescription":"FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.","reportingStatus":"POSTED","timeFrame":"Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months","title":"Time to Deterioration in the TOI","type":"SECONDARY","unitOfMeasure":"weeks"}