{"analyses":[{"ciLowerLimit":"5.6","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"19.4","groupDescription":"ORR in all participants of the Global Pembrolizumab + SOC First Course was compared to PFS in all participants of the Global Standard of Care to address the hypothesis (pembrolizumab in combination with trastuzumab plus chemotherapy is superior to trastuzumab plus chemotherapy alone).","groupIds":["OG000","OG001"],"nonInferiorityComment":"The difference in percentage and its 95% confidence interval (CI) were estimated using the Miettinen \\& Nurminen method stratified by geographic region, PD-L1 status (positive vs. negative) at baseline, and chemotherapy regimen (FP or CAPOX).","nonInferiorityType":"SUPERIORITY","pValue":"0.00020","pValueComment":"One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \\> 0.","paramType":"Difference in Percentage","paramValue":"12.6","statisticalMethod":"Stratified Miettinen and Nurminen Method"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"67.6","upperLimit":"77.2","value":"72.6"},{"groupId":"OG001","lowerLimit":"54.7","upperLimit":"65.2","value":"60.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"350"},{"groupId":"OG001","value":"348"}],"units":"Participants"}],"description":"ORR is defined as the percentage of participants who have a Complete Response (\\[CR\\], disappearance of all evidence of disease) or Partial Response (\\[PR\\], regression of measurable disease and no new sites) per RECIST 1.1 as assessed by blinded independent central review (BICR). ORR was determined for first course pembrolizumab in the Global Cohort. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.","id":"OG000","title":"Global Pembrolizumab + Standard of Care First Course"},{"description":"Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.","id":"OG001","title":"Global Standard of Care First Course"}],"paramType":"NUMBER","populationDescription":"All randomized Global Cohort participants in the Pembrolizumab First Course arm and SOC arm were included in this analysis. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.","reportingStatus":"POSTED","timeFrame":"Up to 63 months","title":"Objective Response Rate (ORR) Per RECIST 1.1 Assessed by BICR","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}