{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"401"},{"groupId":"OG001","value":"191"}]}],"title":"Any treatment-emergent AE (TEAE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"223"},{"groupId":"OG001","value":"96"}]}],"title":"Any Grade 3 or higher TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"104"},{"groupId":"OG001","value":"53"}]}],"title":"Any treatment-emergent serious AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"6"}]}],"title":"TEAE leading to death"}],"denoms":[{"counts":[{"groupId":"OG000","value":"404"},{"groupId":"OG001","value":"197"}],"units":"Participants"}],"description":"As determined by assessment of AEs, clinical laboratory tests, and vital signs measurements. AEs were classified by system organ class (SOC) and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA) Version 22.0 or higher; AE severities were classified using Version 4.03 of the (Common Terminology Criteria for Adverse Events) CTCAE criteria.","groups":[{"description":"Tucatinib in combination with capecitabine \\& trastuzumab","id":"OG000","title":"Tuc+Cap+Tra"},{"description":"Placebo in combination with capecitabine \\& trastuzumab","id":"OG001","title":"Pbo+Cap+Tra"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment (tucatinib/placebo, trastuzumab, or capecitabine), with participants allocated to the treatment group associated with the regimen actually received.","reportingStatus":"POSTED","timeFrame":"36.1 months","title":"Incidence of Adverse Events (AEs) at Time of Primary Analysis","type":"SECONDARY","unitOfMeasure":"Participants"}