{"analyses":[{"ciLowerLimit":"-0.58","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"5.02","groupIds":["OG000","OG001"],"nonInferiorityComment":"Based on a constrained longitudinal data analysis (cLDA) model with the scores as the response variable with covariates for treatment by visit interaction and stratification factors (Stage (II versus III), TPS (\\>=50% versus \\<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).","nonInferiorityType":"OTHER","pValue":"0.1197","paramType":"Difference in Least Square Means","paramValue":"2.22","statisticalMethod":"t-test, 2 sided"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-3.67","upperLimit":"0.63","value":"-1.52"},{"groupId":"OG001","lowerLimit":"-5.96","upperLimit":"-1.52","value":"-3.74"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"395"},{"groupId":"OG001","value":"397"}],"units":"Participants"}],"description":"Change from baseline in GHS/QoL score using the EORTC QLQ-C30 will be determined. The EORTC QLQ-C30 is the most widely used cancer-specific, health-related QoL instrument comprised of 30 individual items arranged as both multi-item scales and individual items. Specifically, these items are divided into 5 functional scales (15 items total), 3 symptom scales (7 items total), 6 individual items, and a GHS/QoL scale composed of 2 items: GHS and QoL. The GHS/QoL score measured here refers to only the composite score calculated for the GHS/QoL scale. Both items on the GHS/QoL scale are scored from 1 (very poor GHS/QoL) to 7 (excellent GHS/QoL) and scores for both items are averaged and a linear transformation applied to standardize the overall GHS/QoL score from 0 to 100, with higher overall scores indicating higher GHS/QoL.","dispersionType":"95% Confidence Interval","groups":[{"description":"Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of pembrolizumab \\[200 mg, intravenous (IV); given on cycle day 1\\] in combination with platinum doublet neoadjuvant chemotherapy (NAC), consisting of cisplatin \\[75 mg/m\\^2, IV; given on cycle day 1\\] and either Gemcitabine \\[1000 mg/m\\^2, IV; given on cycle days 1 and 8\\] or Pemetrexed \\[500 mg/m\\^2, IV; given on cycle day 1\\].\n\nAdjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of pembrolizumab \\[200 mg, IV; given on cycle day 1\\].","id":"OG000","title":"NAC + Neoadjuvant/Adjuvant Pembrolizumab"},{"description":"Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of placebo \\[normal saline, IV; given on cycle day 1\\] in combination with platinum doublet NAC, consisting of cisplatin \\[75 mg/m\\^2, IV; given on cycle day 1\\] and either Gemcitabine \\[1000 mg/m\\^2, IV; given on cycle days 1 and 8\\] or Pemetrexed \\[500 mg/m\\^2, IV; given on cycle day 1\\].\n\nAdjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of placebo \\[normal saline, IV; given on cycle day 1\\].","id":"OG001","title":"NAC + Neoadjuvant/Adjuvant Placebo"}],"paramType":"LEAST_SQUARES_MEAN","populationDescription":"All randomized participants who received at least one dose of study treatment and have at least one EORTC-QLQ-C30 Item 30 assessment data available.","reportingStatus":"POSTED","timeFrame":"Baseline (cycle 1 in neoadjuvant phase) and adjuvant week 10 (up to Study Week 30)","title":"Change From Baseline in Adjuvant Phase in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) Score","type":"SECONDARY","unitOfMeasure":"Sore on a scale"}