{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"7"}]}],"title":"Tucatinib dose held"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"2"}]}],"title":"Tucatinib dose reduced"},{"categories":[{"measurements":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"2"}]}],"title":"Trastuzumab dose held"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"0"}]}],"title":"Trastuzumab infusion interrupted"}],"denoms":[{"counts":[{"groupId":"OG000","value":"86"},{"groupId":"OG001","value":"28"}],"units":"Participants"}],"description":"Dose modification included dose reduction and dose withheld by investigator due to AEs. Dose holds were defined as any instances where planned administration of the study drug was temporarily withheld or interrupted at the direction of the treating physician. Dose reductions of trastuzumab were not allowed; if trastuzumab could not be restarted after being held for a TEAE, it was discontinued. Drug interruption included infusion interrupted (full dose received within 24hrs).","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. 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":"OG001","title":"Tucatinib Post-Crossover (Cohort C)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The safety analysis set included participants who received any amount of study treatment. Data for cohorts A and B was combined as prespecified in SAP.","reportingStatus":"POSTED","timeFrame":"Up to 65.1 months","title":"Number of Participants With AEs Resulting in Dose Modification: Final Analysis","type":"SECONDARY","unitOfMeasure":"Participants"}