{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"43"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"12"},{"groupId":"OG004","value":"42"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"55"},{"groupId":"OG007","value":"9"}]}],"title":"Any AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"42"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"12"},{"groupId":"OG004","value":"37"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"52"},{"groupId":"OG007","value":"7"}]}],"title":"AEs related to study treatment"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"13"},{"groupId":"OG007","value":"1"}]}],"title":"AEs leading to permanent discontinuation of any study treatment"},{"categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"18"},{"groupId":"OG005","value":"2"},{"groupId":"OG006","value":"29"},{"groupId":"OG007","value":"5"}]}],"title":"AEs leading to dose reduction"},{"categories":[{"measurements":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"24"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"18"},{"groupId":"OG005","value":"2"},{"groupId":"OG006","value":"40"},{"groupId":"OG007","value":"6"}]}],"title":"AEs leading to dose interruption/delay"},{"categories":[{"measurements":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"17"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"16"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"32"},{"groupId":"OG007","value":"4"}]}],"title":"Any SAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"7"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"19"},{"groupId":"OG007","value":"3"}]}],"title":"SAEs related to study treatment"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"3"},{"groupId":"OG007","value":"0"}]}],"title":"Fatal SAEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"43"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"13"},{"groupId":"OG004","value":"45"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"55"},{"groupId":"OG007","value":"10"}],"units":"Participants"}],"description":"The distribution of adverse events (AE) was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs) and Serious Adverse Event (TESAEs) through the monitoring of relevant clinical and laboratory safety parameters.","groups":[{"description":"All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.","id":"OG000","title":"Anaplastic Thyroid Cancer (ATC)"},{"description":"All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.","id":"OG001","title":"Biliary Tract Cancer (BTC)"},{"description":"All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.","id":"OG002","title":"Gastrointestinal Stromal Tumor (GIST)"},{"description":"All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.","id":"OG003","title":"Low Grade (WHO G1/G2) Glioma (LGG)"},{"description":"All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.","id":"OG004","title":"High Grade (WHO G3/G4) Glioma (HGG)"},{"description":"All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.","id":"OG005","title":"Adenocarcinoma of the Small Intestine (ASI)"},{"description":"All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.","id":"OG006","title":"Hairy Cell Leukemia (HCL)"},{"description":"All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.","id":"OG007","title":"Multiple Myeloma (MM)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All-treated Subjects (ATS) population - Primary and expansion cohort combined","reportingStatus":"POSTED","timeFrame":"From study treatment start date till 30 days safety follow-up, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)","title":"Number of Participants With Adverse Events (AEs)","type":"SECONDARY","unitOfMeasure":"Participants"}