{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"3"}]}],"title":"Tucatinib dose held"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"1"}]}],"title":"Tucatinib dose reduced"},{"categories":[{"measurements":[{"groupId":"OG000","value":"24"},{"comment":"Tucatinib monotherapy arm.","groupId":"OG001","value":"NA"}]}],"title":"Trastuzumab dose held"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"comment":"Tucatinib monotherapy arm.","groupId":"OG001","value":"NA"}]}],"title":"Trastuzumab infusion interrupted (received full dose within 24 hrs)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"comment":"Tucatinib monotherapy arm.","groupId":"OG001","value":"NA"}]}],"title":"Trastuzumab infusion stopped early (full dose not received)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"86"},{"groupId":"OG001","value":"30"}],"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.","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 AEs Resulting in Dose Modification: Interim Analysis","type":"SECONDARY","unitOfMeasure":"Participants"}