{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"82"},{"groupId":"OG001","value":"28"}]}],"title":"Any TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"22"}]}],"title":"Tucatinib-related TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"58"},{"comment":"Tucatinib monotherapy arm.","groupId":"OG001","value":"NA"}]}],"title":"Trastuzumab-related TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"8"}]}],"title":"Any grade 3-5 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"comment":"Tucatinib monotherapy arm.","groupId":"OG001","value":"NA"}]}],"title":"Trastuzumab-related grade 3-5 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"2"}]}],"title":"Tucatinib-related grade 3-5 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"3"}]}],"title":"Any Treatment-Emergent Serious AE (TESAE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"}]}],"title":"Tucatinib-related TESAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"comment":"Tucatinib monotherapy arm.","groupId":"OG001","value":"NA"}]}],"title":"Trastuzumab-related TESAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"TEAE leading to death"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"0"}]}],"title":"Discontinuation of any study treatment due to TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"0"}]}],"title":"Discontinuation of tucatinib due to TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}]}],"title":"Discontinuation of tucatinib due to tucatinib-related TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"comment":"Tucatinib monotherapy arm.","groupId":"OG001","value":"NA"}]}],"title":"Discontinuation of trastuzumab due to TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"comment":"Tucatinib monotherapy arm.","groupId":"OG001","value":"NA"}]}],"title":"Discontinuation of trastuzumab due to trastuzumab-related TEAE"}],"denoms":[{"counts":[{"groupId":"OG000","value":"86"},{"groupId":"OG001","value":"30"}],"units":"Participants"}],"description":"AE: Any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Treatment emergent AEs (TEAEs): Events that were new or worsened on or after receiving the first dose of study treatment (tucatinib or trastuzumab) and up through 30 days after the last dose of study treatment (tucatinib or trastuzumab). Serious AE (SAE): An event that at any dose led to death; life-threatening; required inpatient hospitalization/prolongation of existing hospitalization; persistent/significant disability/incapacity; congenital anomaly/birth defect/ important medical event. Treatment related AEs, SAEs, deaths also included. Relatedness was judged by investigator According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03: Grade(G) 3=severe AE, G4=life-threatening, urgent intervention indicated, G5=death related to AE.","groups":[{"description":"Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.","id":"OG000","title":"Tucatinib+Trastuzumab (Cohorts A+B)"},{"description":"Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Participants who did not respond to monotherapy were given the option to receive tucatinib and trastuzumab based on radiographic progression (as determined by investigator assessment using RECIST v1.1), or if they had not achieved a PR or CR by the week 12 assessment.","id":"OG001","title":"Tucatinib Pre-Crossover (Cohort C)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The safety analysis set included participants who received any amount of study treatment. Data for cohort A and B was combined as prespecified in SAP.","reportingStatus":"POSTED","timeFrame":"Up to 49.3 months","title":"Number of Participants With Adverse Events (AEs): Interim Analysis","type":"SECONDARY","unitOfMeasure":"Participants"}