{"analyses":[{"ciLowerLimit":"1.06","ciNumSides":"TWO_SIDED","ciPctValue":"96","ciUpperLimit":"1.22","estimateComment":"GMR was calculated as the ratio of geometric mean (GM) of Cycle 1 AUC0-6 weeks in Arm 1 to that of Arm 2. The associated 96% confidence interval (CI) were calculated using Welch's t test.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Non-inferiority margin is 0.8.","nonInferiorityType":"NON_INFERIORITY","pValue":"<0.00001","paramType":"Geometric Mean Ratio (GMR)","paramValue":"1.14","statisticalComment":"One-sided p-value was calculated using the Welch's t test.","statisticalMethod":"Welch's t test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"40.41","value":"1633.24"},{"groupId":"OG001","spread":"26.23","value":"1437.58"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"245"},{"groupId":"OG001","value":"126"}],"units":"Participants"}],"description":"AUC0-6 weeks was defined as a measure of pembrolizumab exposure that was calculated as the product of serum drug concentration and time from zero to 6 weeks. Blood samples were collected at pre-specified timepoints to determine AUC0-6 weeks. Per protocol, geometric mean AUC0-6 weeks value of pembrolizumab after the first dose of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and after first dose of pembrolizumab in arm 2 was presented.","dispersionType":"Geometric Coefficient of Variation","groups":[{"description":"Participants with treatment-naïve metastatic NSCLC receive 790 mg of Pembrolizumab Formulated With Berahyaluronidase Alfa via subcutaneous (SC) injection on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy.","id":"OG000","title":"Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy"},{"description":"Participants with treatment-naïve metastatic NSCLC receive 400 mg pembrolizumab intravenous (IV) infusion in combination with platinum doublet chemotherapy.","id":"OG001","title":"Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"All randomized participants who received a dose in Cycle 1 with at least 1 valid postdose pharmacokinetic (PK) sample available in Cycle 1 and for whom a model-based assessment of AUC0-6 weeks could be made.","reportingStatus":"POSTED","timeFrame":"Cycle 1: Arm 1: Day 1: Predose and Days 2, 3, 4, 5, 6, 7, 10, 15, 29, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days 4, 15, 29, and 42 postdose (cycle length = 42 days)","title":"Cycle 1: Area Under the Curve From Time 0 to 6 Weeks (AUC0-6 Weeks) of Pembrolizumab After the First Dose","type":"PRIMARY","unitOfMeasure":"μg·day/mL"}