{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"Temperature >=38 degree C"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"0"}]}],"title":"Oxygen saturation <88%"},{"categories":[{"measurements":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"27"}]}],"title":"SBP >= 120 mmHg or DBP >= 80 mmHg"},{"categories":[{"measurements":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"13"}]}],"title":"SBP >= 140 mmHg or DBP >= 90 mmHg"},{"categories":[{"measurements":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"4"}]}],"title":"SBP >= 160 mmHg or DBP >= 100 mmHg"},{"categories":[{"measurements":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"5"}]}],"title":"Heart rate > 100 bpm"},{"categories":[{"measurements":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"23"}]}],"title":"Maximum decrease from baseline in weight (kg)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"86"},{"groupId":"OG001","value":"28"}],"units":"Participants"}],"description":"Vital signs included temperature, oxygen saturation, systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate and weight. Vital signs were considered clinically significant: temperature: \\>= 38 degree Celsius (C); oxygen saturation less than (\\<)88%; SBP \\>=120 millimeters of mercury (mmHg) or DBP \\>=80 mmHg; SBP \\>=140 mmHg or DBP \\>=90 mmHg; SBP \\>=160 mmHg or DBP \\>=100 mmHg and heart rate \\>100 beats per minute (bpm) and maximum decrease from baseline in weight in kilograms (kg).","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 Clinically Significant Vital Signs: Final Analysis","type":"SECONDARY","unitOfMeasure":"Participants"}