{"analyses":[{"ciLowerLimit":"-2.51","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.60","groupDescription":"This is the analysis for QLQ-LC13 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":"0.7254","paramType":"Mean Difference (Net)","paramValue":"0.55","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-8.06","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-1.03","groupDescription":"This is the analysis for QLQ-LC13 Coughing. 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":"0.0115","paramType":"Mean Difference (Net)","paramValue":"-4.55","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-0.75","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.99","groupDescription":"This is the analysis for QLQ-LC13 Haemoptysis. 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":"0.7824","paramType":"Mean Difference (Net)","paramValue":"0.12","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-1.04","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.36","groupDescription":"This is the analysis for QLQ-LC13 Sore Mouth. 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":"0.2988","paramType":"Mean Difference (Net)","paramValue":"1.16","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-3.79","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.76","groupDescription":"This is the analysis for QLQ-LC13 Dysphagia. 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":"0.1916","paramType":"Mean Difference (Net)","paramValue":"-1.51","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"0.59","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"10.15","groupDescription":"This is the analysis for QLQ-LC13 Peripheral Neuropathy. 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":"0.0279","paramType":"Mean Difference (Net)","paramValue":"5.37","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-3.89","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.49","groupDescription":"This is the analysis for QLQ-LC13 Alopecia. 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":"0.9162","paramType":"Mean Difference (Net)","paramValue":"-0.20","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-2.96","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.90","groupDescription":"This is the analysis for QLQ-LC13 Pain in Chest. 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":"0.6698","paramType":"Mean Difference (Net)","paramValue":"-0.53","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-3.13","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"4.04","groupDescription":"This is the analysis for QLQ-LC13 Pain in Arm or Shoulder. 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":"0.8035","paramType":"Mean Difference (Net)","paramValue":"0.45","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-0.82","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"7.55","groupDescription":"This is the analysis for QLQ-LC13 Pain in Other Parts. 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":"0.1143","paramType":"Mean Difference (Net)","paramValue":"3.36","statisticalMethod":"Mixed Models Analysis"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-6.55","upperLimit":"-2.17","value":"-4.36"},{"groupId":"OG001","lowerLimit":"-7.34","upperLimit":"-2.47","value":"-4.90"}]}],"title":"Dyspnoea"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-23.71","upperLimit":"-18.70","value":"-21.21"},{"groupId":"OG001","lowerLimit":"-19.48","upperLimit":"-13.84","value":"-16.66"}]}],"title":"Coughing"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-3.12","upperLimit":"-1.94","value":"-2.53"},{"groupId":"OG001","lowerLimit":"-3.34","upperLimit":"-1.97","value":"-2.65"}]}],"title":"Haemoptysis"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-0.98","upperLimit":"2.10","value":"0.56"},{"groupId":"OG001","lowerLimit":"-2.39","upperLimit":"1.19","value":"-0.60"}]}],"title":"Sore Mouth"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-2.95","upperLimit":"0.25","value":"-1.35"},{"groupId":"OG001","lowerLimit":"-1.68","upperLimit":"2.00","value":"0.16"}]}],"title":"Dysphagia"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.21","upperLimit":"14.91","value":"11.56"},{"groupId":"OG001","lowerLimit":"2.39","upperLimit":"10.00","value":"6.20"}]}],"title":"Peripheral Neuropathy"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-0.97","upperLimit":"4.20","value":"1.61"},{"groupId":"OG001","lowerLimit":"-1.08","upperLimit":"4.70","value":"1.81"}]}],"title":"Alopecia"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-11.27","upperLimit":"-7.80","value":"-9.54"},{"groupId":"OG001","lowerLimit":"-10.97","upperLimit":"-7.05","value":"-9.01"}]}],"title":"Pain in Chest"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-9.43","upperLimit":"-4.43","value":"-6.93"},{"groupId":"OG001","lowerLimit":"-10.24","upperLimit":"-4.52","value":"-7.38"}]}],"title":"Pain in Arm or Shoulder"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-5.28","upperLimit":"0.66","value":"-2.31"},{"groupId":"OG001","lowerLimit":"-8.97","upperLimit":"-2.38","value":"-5.67"}]}],"title":"Pain in Other Parts"}],"denoms":[{"counts":[{"groupId":"OG000","value":"146"},{"groupId":"OG001","value":"139"}],"units":"Participants"}],"description":"The EORTC QLQ LC13 consists of 13 questions and includes 1 multi-item scale and 9 single items assessing symptoms (dyspnea, cough, haemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and pain medication use. The scale scores rang from 0 to 100, with higher scores indicating higher (\"worse\") level 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 Lung Cancer Symptoms as Assessed by the EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13) During Overall Treatment","type":"SECONDARY","unitOfMeasure":"Units on a scale"}