{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"150"},{"groupId":"OG001","value":"136"},{"groupId":"OG002","value":"11"},{"groupId":"OG003","value":"11"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"350"},{"groupId":"OG001","value":"346"},{"groupId":"OG002","value":"20"},{"groupId":"OG003","value":"20"}],"units":"Participants"}],"description":"An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who discontinued study treatment due to an AE is reported for each treatment arm. Per statistical analysis plan, data from the second course of pembrolizumab was not included in the safety analysis.","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"},{"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":"OG002","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":"OG003","title":"Japan Trastuzumab + S-1 Plus Oxaliplatin"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All randomized participants in the Global Cohort Pembrolizumab and SOC arms who received at least 1 dose of treatment, and all participants in the Japan-specific SOX Cohort who received at least 1 dose of treatment were included in this analysis. Per statistical analysis plan, data from the second course of pembrolizumab was not included in the safety analysis.","reportingStatus":"POSTED","timeFrame":"Up to 63 months","title":"Number of Participants Who Discontinued Study Treatment Due to AEs","type":"SECONDARY","unitOfMeasure":"Participants"}