{"classes":[{"categories":[{"measurements":[{"comment":"Upper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.","groupId":"OG000","lowerLimit":"17.2","upperLimit":"NA","value":"25.5"},{"comment":"Median TTD and Upper Limit for the 95% confidence interval were not estimated due to the small number of participants with events at data cut off.","groupId":"OG001","lowerLimit":"29.6","upperLimit":"NA","value":"NA"}]}],"title":"Median TTD for Physical Functioning Scale (months)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.9","upperLimit":"22.8","value":"13.1"},{"comment":"Upper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.","groupId":"OG001","lowerLimit":"18.2","upperLimit":"NA","value":"21.9"}]}],"title":"Median TTD for Role Functioning Scale (months)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"10.1","upperLimit":"21.5","value":"15.7"},{"groupId":"OG001","lowerLimit":"15.4","upperLimit":"25.5","value":"20.0"}]}],"title":"Median TTD for Cognitive Functioning Scale (months)"},{"categories":[{"measurements":[{"comment":"Upper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.","groupId":"OG000","lowerLimit":"25.2","upperLimit":"NA","value":"29.6"},{"comment":"Median TTD, Lower Limit and Upper Limit for the 95% confidence interval were not estimated due to the small number of participants with events at data cut off.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"Median TTD for Emotional Functioning Scale (months)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.7","upperLimit":"27.8","value":"19.3"},{"comment":"Upper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.","groupId":"OG001","lowerLimit":"20.6","upperLimit":"NA","value":"28.4"}]}],"title":"Median TTD for Social Functioning Scale (months)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.6","upperLimit":"11.8","value":"5.9"},{"groupId":"OG001","lowerLimit":"13.8","upperLimit":"28.4","value":"20.0"}]}],"title":"Median TTD for Fatigue Symptom Scale (months)"},{"categories":[{"measurements":[{"comment":"Upper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.","groupId":"OG000","lowerLimit":"21.5","upperLimit":"NA","value":"28.0"},{"comment":"Upper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.","groupId":"OG001","lowerLimit":"20.0","upperLimit":"NA","value":"24.6"}]}],"title":"Median TTD for Pain Symptom Scale (months)"},{"categories":[{"measurements":[{"comment":"Upper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.","groupId":"OG000","lowerLimit":"13.2","upperLimit":"NA","value":"20.5"},{"comment":"Upper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.","groupId":"OG001","lowerLimit":"23.4","upperLimit":"NA","value":"30.5"}]}],"title":"Median TTD for Nausea/Vomiting Symptom Scale (months)"},{"categories":[{"measurements":[{"comment":"Median TTD and Upper Limit for the 95% confidence interval were not estimated due to the small number of participants with events at data cut off.","groupId":"OG000","lowerLimit":"25.8","upperLimit":"NA","value":"NA"},{"comment":"Median TTD and Upper Limit for the 95% confidence interval were not estimated due to the small number of participants with events at data cut off.","groupId":"OG001","lowerLimit":"21.9","upperLimit":"NA","value":"NA"}]}],"title":"Median TTD for Dyspnea Symptom Item (months)"},{"categories":[{"measurements":[{"comment":"Median TTD and Upper Limit for the 95% confidence interval were not estimated due to the small number of participants with events at data cut off.","groupId":"OG000","lowerLimit":"27.7","upperLimit":"NA","value":"NA"},{"comment":"Median TTD and Upper Limit for the 95% confidence interval were not estimated due to the small number of participants with events at data cut off.","groupId":"OG001","lowerLimit":"23.4","upperLimit":"NA","value":"NA"}]}],"title":"Median TTD for Insomnia Symptom Item (months)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.1","upperLimit":"23.0","value":"10.1"},{"comment":"Upper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.","groupId":"OG001","lowerLimit":"21.0","upperLimit":"NA","value":"28.4"}]}],"title":"Median TTD for Appetite Loss Symptom Item (months)"},{"categories":[{"measurements":[{"comment":"Upper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.","groupId":"OG000","lowerLimit":"15.9","upperLimit":"NA","value":"21.7"},{"comment":"Median TTD and Upper Limit for the 95% confidence interval were not estimated due to the small number of participants with events at data cut off.","groupId":"OG001","lowerLimit":"23.8","upperLimit":"NA","value":"NA"}]}],"title":"Median TTD for Constipation Symptom Item (months)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.4","upperLimit":"11.9","value":"7.8"},{"groupId":"OG001","lowerLimit":"4.6","upperLimit":"16.9","value":"7.7"}]}],"title":"Median TTD for Diarrhea Symptom Item (months)"},{"categories":[{"measurements":[{"comment":"Upper Limit for the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.","groupId":"OG000","lowerLimit":"20.1","upperLimit":"NA","value":"25.8"},{"comment":"Median TTD and Upper Limit for the 95% confidence interval were not estimated due to the small number of participants with events at data cut off.","groupId":"OG001","lowerLimit":"24.6","upperLimit":"NA","value":"NA"}]}],"title":"Median TTD for Global Health Status/Quality of Life (months)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"279"},{"groupId":"OG001","value":"278"}],"units":"Participants"}],"description":"The EORTC QLQ-C30 consists of 30 questions that are combined to produce 3 symptom scales (fatigue, pain, and nausea/vomiting), 5 individual symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea), 5 functional scales (physical, role, cognitive, emotional, and social), and a global measure of health status/QoL. Scores range from 0-100 after a linear transformation.\n\nTime to deterioration (TTD) is defined as the time from randomization until the date of the first clinically meaningful worsening (a change in the score from baseline of ≥10) that is confirmed at a subsequent assessment or death in the absence of a clinically meaningful symptom, function, or global health status/QoL worsening, regardless of whether the patient withdraws from study treatment or receives another anticancer therapy prior to symptom, function or GHS/QoL deterioration. The median TTD was calculated using the Kaplan-Meier method.","dispersionType":"95% Confidence Interval","groups":[{"description":"Osimertinib (AZD9291) 80 mg in combination with pemetrexed (500 mg/m2) plus either cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21-day cycles for 4 cycles, followed by Osimertinib (AZD9291) 80 mg QD with Pemetrexed maintenance (500 mg/m2) Q3W","id":"OG000","title":"Randomized: AZD9291 + Chemo"},{"description":"Osimertinib (AZD9291) 80mg QD.","id":"OG001","title":"Randomized: AZD9291"}],"paramType":"MEDIAN","populationDescription":"Full Analysis Set, includes all randomized participants.","reportingStatus":"POSTED","timeFrame":"Up to approximately 33 months after the first patient is randomized.","title":"Median Time to Deterioration in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Items (EORTC QLQ-C30) (Randomized Component)","type":"SECONDARY","unitOfMeasure":"Months"}