{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"15"}]}],"title":"Heart rate, Decrease to <60 bpm"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"37"}]}],"title":"Heart rate, Change to normal or no change"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"26"}]}],"title":"Heart rate, Increase to >100 bpm"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"8"}]}],"title":"SBP, Increase to G3 or G4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"4"}]}],"title":"DBP, Increase to G3 or G4"}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"23"},{"groupId":"OG002","value":"27"},{"groupId":"OG003","value":"78"}],"units":"Participants"}],"description":"Blood pressure and heart rate were summarized according to NCI CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to G3 or G4 occurred. Blood pressure measurement included systolic blood pressure (SBP, millimeters of mercury \\[mmHg\\]) and diastolic BP (DBP). Heart rate is the measure of heart beats per minute (bpm). Changes in heart rate, either decrease to \\<60 bpm, change to normal or no change, or increase to \\>100 bpm are presented.","groups":[{"description":"Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.","id":"OG000","title":"Part B: Dabrafenib 75 mg + Trametinib 1 mg"},{"description":"Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.","id":"OG001","title":"Part B: Dabrafenib 150 mg + Trametinib 1 mg"},{"description":"Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.","id":"OG002","title":"Part B: Dabrafenib 150 mg + Trametinib 1.5 mg"},{"description":"Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.","id":"OG003","title":"Part B: Dabrafenib 150 mg + Trametinib 2 mg"}],"paramType":"NUMBER","populationDescription":"ATP Population","reportingStatus":"POSTED","timeFrame":"From Baseline (Day 1) until Follow-up visit (up to approximately 8 years)","title":"Part B: Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure","type":"PRIMARY","unitOfMeasure":"Participants"}