{"analyses":[{"ciLowerLimit":"1.52","ciNumSides":"TWO_SIDED","ciPctValue":"94","ciUpperLimit":"1.84","estimateComment":"GMR was calculated as the ratio of GM of Cycle 3 Ctrough in Arm 1 to that of Arm 2. The associated 94% 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":"GMR","paramValue":"1.67","statisticalComment":"One sided p-value was calculated using Welch's t test.","statisticalMethod":"Welch's t test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"43.29","value":"39.23"},{"groupId":"OG001","spread":"44.23","value":"23.49"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"202"},{"groupId":"OG001","value":"101"}],"units":"Participants"}],"description":"Ctrough was defined as the lowest serum concentration of pembrolizumab reached at steady state. Blood samples were collected at pre-specified timepoints for the determination of Ctrough. Per protocol, geometric mean Ctrough value of pembrolizumab at steady state of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and 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 and Cycle 3 with at least 1 valid postdose PK sample available in Cycle 1 through Cycle 3 and for whom a model-based assessment of Ctrough could be made.","reportingStatus":"POSTED","timeFrame":"Cycle 3: Arm 1: Day 1: Predose and Days 4, 10, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days 4 and 42 postdose (cycle length = 42 days)","title":"Cycle 3: Trough Serum Concentration (Ctrough) of Pembrolizumab at Steady State","type":"PRIMARY","unitOfMeasure":"μg/mL"}