{"analyses":[{"ciLowerLimit":"0.61","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.87","estimateComment":"Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status, and chemotherapy regimen with small strata collapsed.","groupDescription":"PFS 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 hazard ratio (HR) and its 95% confidence interval (CI) were estimated using a stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status (positive vs. negative) at baseline, and chemotherapy regimen (FP or CAPOX).","nonInferiorityType":"SUPERIORITY","pValue":"0.0002","paramType":"Hazard Ratio (HR)","paramValue":"0.73","statisticalComment":"One-sided p-value based on log-rank test stratified by geographic region, PD-L1 status, and chemotherapy regimen with small strata collapsed.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.6","upperLimit":"12.2","value":"10.0"},{"groupId":"OG001","lowerLimit":"7.0","upperLimit":"8.5","value":"8.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"350"},{"groupId":"OG001","value":"348"}],"units":"Participants"}],"description":"PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. PFS 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"}],"paramType":"MEDIAN","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 46 months","title":"Progression Free Survival (PFS) Per RECIST 1.1 Assessed by BICR","type":"PRIMARY","unitOfMeasure":"Months"}