{"analyses":[{"ciLowerLimit":"1.14","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"8.16","groupDescription":"This is the analysis for QLQ-C30 Global QOL. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0096","paramType":"Mean Difference (Net)","paramValue":"4.65","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-1.01","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"5.05","groupDescription":"This is the analysis for QLQ-C30 Physical Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.1897","paramType":"Mean Difference (Net)","paramValue":"2.02","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-1.87","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"6.04","groupDescription":"This is the analysis for QLQ-C30 Role Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.2999","paramType":"Mean Difference (Net)","paramValue":"2.09","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-0.06","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"5.22","groupDescription":"This is the analysis for QLQ-C30 Emotional Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0553","paramType":"Mean Difference (Net)","paramValue":"2.58","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-6.47","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.12","groupDescription":"This is the analysis for QLQ-C30 Cognitive Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0588","paramType":"Mean Difference (Net)","paramValue":"-3.18","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-1.30","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"5.85","groupDescription":"This is the analysis for QLQ-C30 Social Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.2118","paramType":"Mean Difference (Net)","paramValue":"2.27","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-9.42","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-1.92","groupDescription":"This is the analysis for QLQ-C30 Fatigue. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0032","paramType":"Mean Difference (Net)","paramValue":"-5.67","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-9.86","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-5.86","groupDescription":"This is the analysis for QLQ-C30 Nausea and Vomiting. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Mean Difference (Net)","paramValue":"-7.86","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-2.49","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"4.82","groupDescription":"This is the analysis for QLQ-C30 Pain. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.5310","paramType":"Mean Difference (Net)","paramValue":"1.16","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-1.98","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"5.43","groupDescription":"This is the analysis for QLQ-C30 Dyspnoea. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.3602","paramType":"Mean Difference (Net)","paramValue":"1.72","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-11.25","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-4.64","groupDescription":"This is the analysis for QLQ-C30 Insomnia. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Mean Difference (Net)","paramValue":"-7.95","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-11.80","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-6.62","groupDescription":"This is the analysis for QLQ-C30 Appetite Loss. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Mean Difference (Net)","paramValue":"-9.21","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-9.07","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-0.79","groupDescription":"This is the analysis for QLQ-C30 Constipation. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0198","paramType":"Mean Difference (Net)","paramValue":"-4.93","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-15.49","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-8.58","groupDescription":"This is the analysis for QLQ-C30 Diarrhea. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Mean Difference (Net)","paramValue":"-12.03","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-4.90","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.82","groupDescription":"This is the analysis for QLQ-C30 Financial Difficulties. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.5947","paramType":"Mean Difference (Net)","paramValue":"-1.04","statisticalMethod":"Mixed Models Analysis"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.09","upperLimit":"11.11","value":"8.60"},{"groupId":"OG001","lowerLimit":"1.15","upperLimit":"6.76","value":"3.95"}]}],"title":"Global QOL"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.67","upperLimit":"7.01","value":"4.84"},{"groupId":"OG001","lowerLimit":"0.42","upperLimit":"5.22","value":"2.82"}]}],"title":"Physical Functioning"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.05","upperLimit":"9.68","value":"6.86"},{"groupId":"OG001","lowerLimit":"1.61","upperLimit":"7.95","value":"4.78"}]}],"title":"Role Functioning"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.88","upperLimit":"10.67","value":"8.77"},{"groupId":"OG001","lowerLimit":"4.09","upperLimit":"8.30","value":"6.20"}]}],"title":"Emotional Functioning"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-6.56","upperLimit":"-1.84","value":"-4.20"},{"groupId":"OG001","lowerLimit":"-3.64","upperLimit":"1.60","value":"-1.02"}]}],"title":"Cognitive Functioning"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.48","upperLimit":"9.52","value":"7.00"},{"groupId":"OG001","lowerLimit":"1.87","upperLimit":"7.57","value":"4.72"}]}],"title":"Social Functioning"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-12.61","upperLimit":"-7.26","value":"-9.93"},{"groupId":"OG001","lowerLimit":"-7.28","upperLimit":"-1.25","value":"-4.26"}]}],"title":"Fatigue"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-5.79","upperLimit":"-2.90","value":"-4.35"},{"groupId":"OG001","lowerLimit":"1.89","upperLimit":"5.14","value":"3.51"}]}],"title":"Nausea and Vomiting"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-7.17","upperLimit":"-2.02","value":"-4.60"},{"groupId":"OG001","lowerLimit":"-8.67","upperLimit":"-2.85","value":"-5.76"}]}],"title":"Pain"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-9.66","upperLimit":"-4.39","value":"-7.02"},{"groupId":"OG001","lowerLimit":"-11.76","upperLimit":"-5.74","value":"-8.75"}]}],"title":"Dyspnoea"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-19.71","upperLimit":"-14.96","value":"-17.34"},{"groupId":"OG001","lowerLimit":"-12.07","upperLimit":"-6.71","value":"-9.39"}]}],"title":"Insomnia"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-15.00","upperLimit":"-11.30","value":"-13.15"},{"groupId":"OG001","lowerLimit":"-6.01","upperLimit":"-1.88","value":"-3.95"}]}],"title":"Appetite Loss"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-5.33","upperLimit":"0.54","value":"-2.40"},{"groupId":"OG001","lowerLimit":"-0.83","upperLimit":"5.90","value":"2.53"}]}],"title":"Constipation"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-3.42","upperLimit":"1.59","value":"-0.92"},{"groupId":"OG001","lowerLimit":"8.33","upperLimit":"13.91","value":"11.12"}]}],"title":"Diarrhea"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-9.52","upperLimit":"-4.05","value":"-6.79"},{"groupId":"OG001","lowerLimit":"-8.80","upperLimit":"-2.68","value":"-5.74"}]}],"title":"Financial Difficulties"}],"denoms":[{"counts":[{"groupId":"OG000","value":"148"},{"groupId":"OG001","value":"140"}],"units":"Participants"}],"description":"The EORTC QLQ C30 consists of 30 questions and includes 5 functional scales (physical, role, cognitive, emotional, and social); a global health status/global quality of life scale; 3 symptom scales (fatigue, pain, nausea and vomiting); and 6 single items that assess additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and financial impact. All scales and single item measures range in score from 0 to 100. Higher scores on the functional scales represent higher levels of functioning. Higher scores on the global health status/quality of life scale represent higher health status/quality of life. Higher scores on symptom scales/items represent a greater presence of symptoms.","dispersionType":"95% Confidence Interval","groups":[{"description":"Lorlatinib monotherapy at the recommended Phase 2 dose of 100 mg, was administered orally once daily (QD) at approximately the same time of the day on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.","id":"OG000","title":"Lorlatinib"},{"description":"Crizotinib monotherapy at the registered dose of 250 mg, was administered orally twice daily (BID) at approximately the same time in the morning and evening (12 hours apart) on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.","id":"OG001","title":"Crizotinib"}],"paramType":"MEAN","populationDescription":"Participants from the FA population who completed a baseline (last patient-reported outcome (PRO) assessment prior to the first dose of study treatment) and at least 1 post-baseline PRO assessment.","reportingStatus":"POSTED","timeFrame":"From Baseline up to Cycle 38 Day 1","title":"Change From Baseline in Global Quality of Life (QOL), Functional Scales and Symptoms Scales as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) During Overall Treatment","type":"SECONDARY","unitOfMeasure":"Units on a scale"}