{"denoms":[{"counts":[{"groupId":"BG000","value":"350"},{"groupId":"BG001","value":"348"},{"groupId":"BG002","value":"20"},{"groupId":"BG003","value":"20"},{"groupId":"BG004","value":"738"}],"units":"Participants"}],"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. Eligible participants from the Global Cohort Pembrolizumab + Standard of Care who stopped initial course of pembrolizumab due to complete response (CR) or who had stable disease (SD), PR, or CR after completion of 35 cycles of pembrolizumab but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion. Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) for up to 17 additional cycles (approximately 1 year additional treatment).","id":"BG000","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":"BG001","title":"Global Standard of Care"},{"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 SOX chemotherapy.","id":"BG002","title":"Japan Pembrolizumab + Trastuzumab + S-1 Plus Oxaliplatin"},{"description":"Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.","id":"BG003","title":"Japan Trastuzumab + S-1 Plus Oxaliplatin"},{"description":"Total of all reporting groups","id":"BG004","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"11.8","value":"60.4"},{"groupId":"BG001","spread":"10.8","value":"61.7"},{"groupId":"BG002","spread":"12.8","value":"66.1"},{"groupId":"BG003","spread":"6.8","value":"64.1"},{"groupId":"BG004","spread":"11.3","value":"61.2"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"Years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"66"},{"groupId":"BG001","value":"68"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"5"},{"groupId":"BG004","value":"142"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"284"},{"groupId":"BG001","value":"280"},{"groupId":"BG002","value":"17"},{"groupId":"BG003","value":"15"},{"groupId":"BG004","value":"596"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"38"},{"groupId":"BG001","value":"45"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"85"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"309"},{"groupId":"BG001","value":"293"},{"groupId":"BG002","value":"19"},{"groupId":"BG003","value":"19"},{"groupId":"BG004","value":"640"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"13"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"11"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"119"},{"groupId":"BG001","value":"121"},{"groupId":"BG002","value":"20"},{"groupId":"BG003","value":"20"},{"groupId":"BG004","value":"280"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"4"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"218"},{"groupId":"BG001","value":"212"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"430"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"11"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"2"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"113"},{"groupId":"BG001","value":"111"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"224"}]}],"title":"Western Europe/Israel/North America/Australia"},{"categories":[{"measurements":[{"groupId":"BG000","value":"118"},{"groupId":"BG001","value":"119"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"237"}]}],"title":"Asia"},{"categories":[{"measurements":[{"groupId":"BG000","value":"119"},{"groupId":"BG001","value":"118"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"237"}]}],"title":"Rest of the World"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"20"},{"groupId":"BG003","value":"20"},{"groupId":"BG004","value":"40"}]}],"title":"Japan"}],"description":"Per protocol, participants in the Global Cohort were stratified by geographic region using the following categories: Western Europe/Israel/North America/Australia; Asia; and Rest of World. Per protocol, participants in the Japan-specific SOX Cohort were not stratified by geographic region.","paramType":"COUNT_OF_PARTICIPANTS","title":"Geographic Region","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"298"},{"groupId":"BG001","value":"296"},{"groupId":"BG002","value":"16"},{"groupId":"BG003","value":"17"},{"groupId":"BG004","value":"627"}]}],"title":"CPS≥1"},{"categories":[{"measurements":[{"groupId":"BG000","value":"52"},{"groupId":"BG001","value":"52"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"3"},{"groupId":"BG004","value":"111"}]}],"title":"CPS<1"}],"description":"PD-L1 combined positive score (CPS) at baseline was determined by immunohistochemistry (IHC) using an archival tumor sample. The number of participants with CPS\\<1 and CPS≥1 at baseline is presented. Participants with a CPS\\<1 were classified as PD-L1 negative and participants with a CPS≥1 were classified as PD-L1 positive. Per protocol, participants in both the Global Cohort and Japan-specific SOX Cohort were stratified by PD-L1 CPS status at baseline.","paramType":"COUNT_OF_PARTICIPANTS","title":"Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) Status at Baseline","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"53"},{"groupId":"BG001","value":"49"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"102"}]}],"title":"FP (cisplatin plus 5 fluorouracil)"},{"categories":[{"measurements":[{"groupId":"BG000","value":"297"},{"groupId":"BG001","value":"299"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"596"}]}],"title":"CAPOX (capecitabine and oxaliplatin)"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"20"},{"groupId":"BG003","value":"20"},{"groupId":"BG004","value":"40"}]}],"title":"SOX (S-1 plus oxaliplatin)"}],"description":"Per protocol, participants in the Global Cohort were stratified by chemotherapy regimen. Chemotherapy regimen options were FP: cisplatin plus 5-fluorouracil (5-FU) or CAPOX: capecitabine and oxaliplatin. Per protocol, participants in the Japan-specific SOX Cohort were not stratified by chemotherapy regimen.","paramType":"COUNT_OF_PARTICIPANTS","title":"Chemotherapy Regimen","unitOfMeasure":"Participants"}]}