{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"82"},{"groupId":"OG001","value":"54"},{"groupId":"OG002","value":"36"},{"groupId":"OG003","value":"20"}]}],"title":"Treatment Emergent Adverse Events (TAEs)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"38"},{"groupId":"OG002","value":"24"},{"groupId":"OG003","value":"9"}]}],"title":"Treatment Emergent Serious Adverse Events (TESAEs)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"title":"Deaths due to AE causally related to treatment"}],"denoms":[{"counts":[{"groupId":"OG000","value":"84"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"36"},{"groupId":"OG003","value":"20"}],"units":"Participants"}],"description":"The distribution of adverse events (AE) was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.","groups":[{"description":"Participants with or without prior systemic anti-cancer therapy received Dabrafenib 150 mg BID until disease progression, death, or unacceptable adverse event(s) (AEs) or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.","id":"OG000","title":"Cohort A (Dabrafenib Monotherapy): Dabrafenib Monotherapy 150mg BID"},{"description":"Participants who had received 1-3 prior lines of systemic anti-cancer therapies for advanced stage/metastatic disease received Dabrafenib 150 mg BID and Trametinib 2 mg once daily (OD). Treatment continued until disease progression, death, or unacceptable AEs or investigator discretion to discontinue.","id":"OG001","title":"Cohort B - Double Combination (Dabrafenib+Trametinib) mBRAF V600E: DAB 150MG BID, TRA 2mG QD"},{"description":"Participants who had not received any prior systemic anti-cancer for metastatic disease therapies were given Dabrafenib 150 mg BID and Trametinib 2 mg OD. Treatment continued until disease progression, death, or unacceptable AEs or at investigator discretion to discontinue.","id":"OG002","title":"Cohort C - Double Combination (Dabrafenib+Trametinib) Naive mBRAF V600E: DAB 150MG BID, TRA 2mG QD"},{"description":"Crossover - Double Combination (Dabrafenib+Trametinib): Participants received Dabrafenib 150 mg BID in combination with Trametinib 2 mg once daily and continued treatment until disease progression, death, or unacceptable adverse event.","id":"OG003","title":"Crossover - Double Combination (Dabrafenib+Trametinib): DAB 150MG BID, TRA 2mG QD"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All Treated Population (ATP)","reportingStatus":"POSTED","timeFrame":"From study treatment start date till 30 days safety follow-up, assessed up to approximately 81 months","title":"Number of Participants With Treatment Emergent Adverse Events","type":"SECONDARY","unitOfMeasure":"Participants"}