{"analyses":[{"ciLowerLimit":"0.62","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.00","groupDescription":"TTD in GHS/QoL combined score was compared between all participants of the pembro combo arm and the chemo arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\\<10 vs. CPS≥10) at baseline.","groupIds":["OG000","OG002"],"nonInferiorityType":"OTHER","pValueComment":"No formal hypothesis testing was performed.","paramType":"Hazard Ratio (HR)","paramValue":"0.78"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.9","upperLimit":"10.3","value":"8.0"},{"groupId":"OG002","lowerLimit":"2.8","upperLimit":"8.2","value":"4.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"314"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"311"}],"units":"Participants"}],"description":"EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to the GHS question \"How would you rate your overall health during the past week?\" (Item 29) and the QoL question \"How would you rate your overall quality of life during the past week?\" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. TTD in GHS/QoL was defined as the time from first dose date to the first onset of a ≥10 point decrease from baseline in GHS/QoL combined score without confirmation. Per protocol, TTD in GHS/QoL combined score was compared between the pembro combo arm and chemo arm. TTD in GHS/QoL combined score was compared separately between the pembro arm and chemo arm and is presented later in the record.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m\\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m\\^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m\\^2 IV on Day 1 and Day 8 of each 3-week cycle.","id":"OG000","title":"Pembrolizumab + ST Chemotherapy (Pembro Combo)"},{"description":"Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.","id":"OG001","title":"Pembrolizumab (Pembro)"},{"description":"Participants received ST chemotherapy with EITHER cisplatin 70 mg/m\\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m\\^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m\\^2 IV on Day 1 and Day 8 of each 3-week cycle.","id":"OG002","title":"ST Chemotherapy (Chemo)"}],"paramType":"MEDIAN","populationDescription":"All participants in the ITT population randomized to the pembro combo arm and chemo arm who received at least 1 dose of study drug and who had an EORTC-QLQ-C30 assessment at baseline were included in the analysis. Per protocol, the pembro arm was compared to the chemo arm separately and is not included in this analysis.","reportingStatus":"POSTED","timeFrame":"Baseline up to approximately 25 months","title":"Pembro Combo vs Chemo: Time to Deterioration (TTD) in the EORTC-QLQ-C30 GHS/QoL (Items 29 and 30) Combined Score","type":"SECONDARY","unitOfMeasure":"Months"}