Trial Outcomes & Findings for Study of Dabrafenib+Trametinib in the Adjuvant Treatment of Stage III BRAF V600+ Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes (NCT NCT03551626)

NCT ID: NCT03551626

Last Updated: 2025-04-29

Results Overview

The composite rate of pyrexia related events was calculated as the total number of participants experiencing at least one of the three components of the composite endpoint (i.e., grade 3/4 pyrexia, hospitalization due to pyrexia, or permanent treatment discontinuation due to pyrexia), divided by the total number of participants treated in the study and multiplied by 100. Pyrexia is defined as fever ≥ 38 °C. Pyrexia events were graded by the investigator using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Life-threatening) and Grade 5 (Death)

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 552 participants
• Primary outcome timeframe: Baseline up to 12 months
• Results posted on: 2025-04-29

Participant Flow

Patients in this study were enrolled at 103 centers across 23 countries

A total of 748 patients were screened. Of the screened patients, 552 patients were treated.

Participant milestones

Measure	Dabrafenib+Trametinib Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for up to 12 months.
Overall Study STARTED	552
Overall Study COMPLETED	425
Overall Study NOT COMPLETED	127

Reasons for withdrawal

Measure	Dabrafenib+Trametinib Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for up to 12 months.
Overall Study Adverse Event	88
Overall Study Disease relapse	18
Overall Study Withdrawal of informed consent	6
Overall Study Patient decision	5
Overall Study Physician Decision	4
Overall Study Lost to Follow-up	3
Overall Study Pregnancy	1
Overall Study Protocol deviation	1
Overall Study Technical problems	1

Baseline Characteristics

Study of Dabrafenib+Trametinib in the Adjuvant Treatment of Stage III BRAF V600+ Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes

Baseline characteristics by cohort

Measure	Dabrafenib+Trametinib n=552 Participants Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for up to 12 months.
Age, Continuous	53.4 Years STANDARD_DEVIATION 13.09 • n=5 Participants
Sex: Female, Male Female	255 Participants n=5 Participants
Sex: Female, Male Male	297 Participants n=5 Participants
Race/Ethnicity, Customized White	377 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants
Race/Ethnicity, Customized Missing	172 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to 12 months

Population: All subjects who received at least one dose of any study treatment

The composite rate of pyrexia related events was calculated as the total number of participants experiencing at least one of the three components of the composite endpoint (i.e., grade 3/4 pyrexia, hospitalization due to pyrexia, or permanent treatment discontinuation due to pyrexia), divided by the total number of participants treated in the study and multiplied by 100. Pyrexia is defined as fever ≥ 38 °C.

Pyrexia events were graded by the investigator using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Life-threatening) and Grade 5 (Death)

Outcome measures

Measure	Dabrafenib+Trametinib n=552 Participants Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for up to 12 months.
Composite Rate of Pyrexia Related Events	7.6 Percentage of participants Interval 5.5 to 10.1

SECONDARY outcome

Timeframe: At 12 and 24 months

Population: All subjects who received at least one dose of any study treatment

RFS is defined as the time from the date of first dose of the study treatment to the date of the first documented disease recurrence or death due to any cause whichever comes first. Treatment emergent malignancies other than second melanomas were not considered as events.

RFS rate is the estimated percent probability that a patient will remain event-free up to the specified time point. RFS rate was obtained from the Kaplan-Meier survival estimates. RFS was censored if no RFS event was observed before the first to occur between: (i) the analysis cut-off date, and (ii) the date when a new anti-cancer therapy is started. The censoring date was the date of the last adequate tumor assessment prior to data cut-off date/start of new anti-cancer therapy date.

Outcome measures

Measure	Dabrafenib+Trametinib n=552 Participants Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for up to 12 months.
Relapse Free Survival (RFS) Rate 12 months	91.7 Percent probability Interval 89.0 to 93.8
Relapse Free Survival (RFS) Rate 24 months	57.5 Percent probability Interval 48.9 to 65.2

SECONDARY outcome

Timeframe: At 12 and 24 months

Population: All subjects who received at least one dose of any study treatment

OS is defined as the time from date of the first dose of study medication to date of death due to any cause, whichever comes first. If a patient was not known to have died, then OS rate is the estimated probability that a patient will remain event-free up to the specified time point. OS rate was obtained from the Kaplan-Meier survival estimates. OS was censored at the last contact date when the patient was known to be alive (on or before the cut-off date).

Outcome measures

Measure	Dabrafenib+Trametinib n=552 Participants Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for up to 12 months.
Overall Survival (OS) Rate 12 months	99.1 Percent probability Interval 97.8 to 99.6
Overall Survival (OS) Rate 24 months	92.6 Percent probability Interval 90.0 to 94.5

SECONDARY outcome

Timeframe: Baseline up to 12 months

Population: All subjects who received at least one dose of any study treatment

Percentage of patients who experienced pyrexia and required intervention including hospitalizations, concomitant medications, and study treatment modifications (dose reductions, permanent discontinuations and/or interruptions) due to pyrexia. Pyrexia is defined as fever ≥ 38 °C

Outcome measures

Measure	Dabrafenib+Trametinib n=552 Participants Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for up to 12 months.
Percentage of Participants Who Required Management of Pyrexia Hospitalizations due to pyrexia	24 Participants
Percentage of Participants Who Required Management of Pyrexia Concomitant medications due to pyrexia	210 Participants
Percentage of Participants Who Required Management of Pyrexia Permanent discontinuation of dabrafenib and trametinib (both drugs together) due to pyrexia	13 Participants
Percentage of Participants Who Required Management of Pyrexia Reduction of dabrafenib and trametinib (both drugs together) due to pyrexia	29 Participants
Percentage of Participants Who Required Management of Pyrexia Interruption of dabrafenib and trametinib (both drugs together) due to pyrexia	339 Participants

SECONDARY outcome

Timeframe: Baseline up to 12 months

Population: All subjects who received at least one dose of any study treatment

Percentage of participants who permanently discontinued treatment due to any AE during treatment. An AE is any untoward medical occurrence (e.g., any unfavorable and unintended sign, symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study.

Outcome measures

Measure	Dabrafenib+Trametinib n=552 Participants Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for up to 12 months.
Percentage of Participants Who Permanently Discontinued Treatment Due to Any Adverse Event (AE)	87 Participants

SECONDARY outcome

Timeframe: Baseline up to 24 months

Population: All subjects who received at least one dose of any study treatment. Number analyzed represents participants with data available at the specified data points

The FACT-M is a questionnaire that assesses participant health-related quality of life. It includes a melanoma specific (FACT-M MS) subscale that consists in 16 items related to signs, symptoms, physical/social activities most relevant to participants with advanced-stage melanoma. Each item ranges from 0 (not at all) to 4 (very much). FACT-M MS score ranges from 0 to 64, with higher score indicating better quality of life. If a patient discontinued the study treatment at Month 1 or Month 2, then the follow-up assessments started at Month 3 follow-up and continued until Month 24 follow-up or at withdrawal, lost to follow-up, death, or end of study. If a patient discontinued the study treatment from Month 3 through Month 5, the follow-up assessments started at Month 6 follow-up. If a patient discontinued from Month 6 through Month 11, the follow-up assessments started from Month 12 follow-up. For patients who completed treatment, the follow-up assessments started from Month 15 follow-up

Outcome measures

Measure	Dabrafenib+Trametinib n=552 Participants Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for up to 12 months.
Change From Baseline in Subject-reported Quality of Life (QoL) Assessed by Functional Assessment Cancer Therapy - Melanoma Subscale Score (FACT-M MS) Month 1	-2.46 Score on a scale Standard Deviation 5.488
Change From Baseline in Subject-reported Quality of Life (QoL) Assessed by Functional Assessment Cancer Therapy - Melanoma Subscale Score (FACT-M MS) Month 2	-2.42 Score on a scale Standard Deviation 4.892
Change From Baseline in Subject-reported Quality of Life (QoL) Assessed by Functional Assessment Cancer Therapy - Melanoma Subscale Score (FACT-M MS) Month 3	-2.26 Score on a scale Standard Deviation 4.789
Change From Baseline in Subject-reported Quality of Life (QoL) Assessed by Functional Assessment Cancer Therapy - Melanoma Subscale Score (FACT-M MS) Month 4	-2.34 Score on a scale Standard Deviation 5.297
Change From Baseline in Subject-reported Quality of Life (QoL) Assessed by Functional Assessment Cancer Therapy - Melanoma Subscale Score (FACT-M MS) Month 5	-2.03 Score on a scale Standard Deviation 5.278
Change From Baseline in Subject-reported Quality of Life (QoL) Assessed by Functional Assessment Cancer Therapy - Melanoma Subscale Score (FACT-M MS) Month 6	-2.19 Score on a scale Standard Deviation 5.494
Change From Baseline in Subject-reported Quality of Life (QoL) Assessed by Functional Assessment Cancer Therapy - Melanoma Subscale Score (FACT-M MS) Month 7	-2.39 Score on a scale Standard Deviation 5.873
Change From Baseline in Subject-reported Quality of Life (QoL) Assessed by Functional Assessment Cancer Therapy - Melanoma Subscale Score (FACT-M MS) Month 8	-2.32 Score on a scale Standard Deviation 5.609
Change From Baseline in Subject-reported Quality of Life (QoL) Assessed by Functional Assessment Cancer Therapy - Melanoma Subscale Score (FACT-M MS) Month 9	-2.06 Score on a scale Standard Deviation 5.534
Change From Baseline in Subject-reported Quality of Life (QoL) Assessed by Functional Assessment Cancer Therapy - Melanoma Subscale Score (FACT-M MS) Month 10	-2.15 Score on a scale Standard Deviation 5.743
Change From Baseline in Subject-reported Quality of Life (QoL) Assessed by Functional Assessment Cancer Therapy - Melanoma Subscale Score (FACT-M MS) Month 11	-2.05 Score on a scale Standard Deviation 5.578
Change From Baseline in Subject-reported Quality of Life (QoL) Assessed by Functional Assessment Cancer Therapy - Melanoma Subscale Score (FACT-M MS) Month 12	-1.96 Score on a scale Standard Deviation 5.757
Change From Baseline in Subject-reported Quality of Life (QoL) Assessed by Functional Assessment Cancer Therapy - Melanoma Subscale Score (FACT-M MS) End of treatment	-3.36 Score on a scale Standard Deviation 5.944
Change From Baseline in Subject-reported Quality of Life (QoL) Assessed by Functional Assessment Cancer Therapy - Melanoma Subscale Score (FACT-M MS) Follow-up Month 3	2.43 Score on a scale Standard Deviation 4.685
Change From Baseline in Subject-reported Quality of Life (QoL) Assessed by Functional Assessment Cancer Therapy - Melanoma Subscale Score (FACT-M MS) Follow-up Month 6	-0.33 Score on a scale Standard Deviation 4.915
Change From Baseline in Subject-reported Quality of Life (QoL) Assessed by Functional Assessment Cancer Therapy - Melanoma Subscale Score (FACT-M MS) Follow-up Month 12	-1.71 Score on a scale Standard Deviation 5.671
Change From Baseline in Subject-reported Quality of Life (QoL) Assessed by Functional Assessment Cancer Therapy - Melanoma Subscale Score (FACT-M MS) Follow-up Month 15	-0.60 Score on a scale Standard Deviation 6.018
Change From Baseline in Subject-reported Quality of Life (QoL) Assessed by Functional Assessment Cancer Therapy - Melanoma Subscale Score (FACT-M MS) Follow-up Month 18	-0.09 Score on a scale Standard Deviation 4.948
Change From Baseline in Subject-reported Quality of Life (QoL) Assessed by Functional Assessment Cancer Therapy - Melanoma Subscale Score (FACT-M MS) Follow-up Month 24	-0.75 Score on a scale Standard Deviation 5.406

POST_HOC outcome

Timeframe: On-treatment: from first study treatment to 30 days after last dose of study treatment, up to 13 months. Post-treatment: From day 31 after last study treatment up to approximately 39 months

Population: All subjects who received at least one dose of any study treatment.

On-treatment deaths were collected from date of first administration of study treatment to 30 days after date of last administration of any study treatment (dabrafenib or trametinib).

Post-treatment follow-up deaths were collected after the on-treatment period. All deaths refer to the sum of on-treatment and post-treatment follow-up deaths

Outcome measures

Measure	Dabrafenib+Trametinib n=552 Participants Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for up to 12 months.
All Collected Deaths On-treatment deaths	1 Participants
All Collected Deaths Post-treatment follow-up deaths	47 Participants
All Collected Deaths All deaths	48 Participants

Adverse Events

Dabrafenib+Trametinib (On-treatment)

Serious events: 121 serious events

Other events: 526 other events

Deaths: 1 deaths

Dabrafenib+Trametinib (Post-treatment Follow-up)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 47 deaths

Serious adverse events

Measure	Dabrafenib+Trametinib (On-treatment) n=552 participants at risk AEs during on-treatment period (up to 30 days post-treatment)	Dabrafenib+Trametinib (Post-treatment Follow-up) Deaths collected in the post-treatment follow-up period (starting from day 31 post- treatment). No AEs were collected during this period
Blood and lymphatic system disorders Febrile neutropenia	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Blood and lymphatic system disorders Lymphadenopathy	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Blood and lymphatic system disorders Neutropenia	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Cardiac disorders Atrial fibrillation	0.54% 3/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Cardiac disorders Left ventricular dysfunction	0.36% 2/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Cardiac disorders Angina pectoris	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Cardiac disorders Cardiac failure	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Eye disorders Detachment of retinal pigment epithelium	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Eye disorders Retinal vein occlusion	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Eye disorders Scleritis	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Eye disorders Uveitis	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Gastrointestinal disorders Abdominal discomfort	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Gastrointestinal disorders Abdominal pain	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Gastrointestinal disorders Abdominal pain upper	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Gastrointestinal disorders Diarrhoea	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Gastrointestinal disorders Haematemesis	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Gastrointestinal disorders Nausea	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Gastrointestinal disorders Pancreatitis acute	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Gastrointestinal disorders Vomiting	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
General disorders Pyrexia	5.1% 28/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
General disorders Influenza like illness	0.54% 3/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
General disorders Chills	0.36% 2/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
General disorders Chest pain	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
General disorders Fatigue	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
General disorders Granuloma	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
General disorders Hyperthermia	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Hepatobiliary disorders Cholestasis	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Hepatobiliary disorders Hepatotoxicity	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Hepatobiliary disorders Hypertransaminasaemia	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Infections and infestations Cellulitis	0.91% 5/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Infections and infestations Erysipelas	0.54% 3/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Infections and infestations Pneumonia legionella	0.36% 2/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Infections and infestations Appendicitis	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Infections and infestations Bacterial infection	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Infections and infestations Complicated appendicitis	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Infections and infestations Groin infection	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Infections and infestations Infection	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Infections and infestations Lower respiratory tract infection	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Infections and infestations Peritonitis	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Infections and infestations Pneumonia	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Infections and infestations Pneumonia aspiration	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Infections and infestations Prostate infection	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Infections and infestations Sepsis	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Infections and infestations Soft tissue infection	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Infections and infestations Systemic candida	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Injury, poisoning and procedural complications Seroma	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Investigations Ejection fraction decreased	3.4% 19/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Investigations Alanine aminotransferase increased	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Investigations Aspartate aminotransferase increased	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Investigations General physical condition abnormal	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Investigations Hepatic enzyme increased	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Investigations Lipase increased	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Investigations Lymphocyte morphology abnormal	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Investigations Neutrophil count decreased	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Metabolism and nutrition disorders Hypokalaemia	0.36% 2/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Metabolism and nutrition disorders Hypophosphataemia	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Musculoskeletal and connective tissue disorders Arthralgia	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.72% 4/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Nervous system disorders Cerebrovascular accident	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Nervous system disorders Focal dyscognitive seizures	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Nervous system disorders Headache	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Nervous system disorders Loss of consciousness	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Nervous system disorders Multiple sclerosis	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Nervous system disorders Polyneuropathy	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Nervous system disorders Presyncope	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Nervous system disorders Radicular pain	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Psychiatric disorders Major depression	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Renal and urinary disorders Nephrolithiasis	0.36% 2/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Renal and urinary disorders Haematuria	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Renal and urinary disorders Renal colic	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Renal and urinary disorders Renal failure	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Renal and urinary disorders Urinary retention	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Reproductive system and breast disorders Ovarian cyst	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.54% 3/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Skin and subcutaneous tissue disorders Rash	0.36% 2/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Skin and subcutaneous tissue disorders Erythema multiforme	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Skin and subcutaneous tissue disorders Erythema nodosum	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Skin and subcutaneous tissue disorders Panniculitis	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Skin and subcutaneous tissue disorders Skin mass	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Skin and subcutaneous tissue disorders Skin ulcer	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Skin and subcutaneous tissue disorders Vasculitic rash	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Vascular disorders Lymphoedema	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Vascular disorders Venous thrombosis	0.18% 1/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.

Other adverse events

Measure	Dabrafenib+Trametinib (On-treatment) n=552 participants at risk AEs during on-treatment period (up to 30 days post-treatment)	Dabrafenib+Trametinib (Post-treatment Follow-up) Deaths collected in the post-treatment follow-up period (starting from day 31 post- treatment). No AEs were collected during this period
Blood and lymphatic system disorders Neutropenia	8.0% 44/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Gastrointestinal disorders Abdominal pain	8.0% 44/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Gastrointestinal disorders Abdominal pain upper	5.4% 30/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Gastrointestinal disorders Constipation	8.3% 46/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Gastrointestinal disorders Diarrhoea	27.0% 149/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Gastrointestinal disorders Nausea	23.2% 128/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Gastrointestinal disorders Vomiting	15.2% 84/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
General disorders Chills	26.4% 146/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
General disorders Fatigue	25.7% 142/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
General disorders Influenza like illness	11.8% 65/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
General disorders Oedema peripheral	12.0% 66/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
General disorders Pain	5.1% 28/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
General disorders Asthenia	23.7% 131/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
General disorders Pyrexia	67.8% 374/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Investigations Alanine aminotransferase increased	13.6% 75/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Investigations Amylase increased	6.3% 35/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Investigations Aspartate aminotransferase increased	13.4% 74/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Investigations Blood alkaline phosphatase increased	6.7% 37/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Investigations Blood creatine phosphokinase increased	30.4% 168/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Investigations Lipase increased	13.0% 72/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Metabolism and nutrition disorders Decreased appetite	6.9% 38/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Metabolism and nutrition disorders Hyperglycaemia	5.6% 31/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Metabolism and nutrition disorders Hypophosphataemia	6.9% 38/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Musculoskeletal and connective tissue disorders Arthralgia	21.0% 116/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Musculoskeletal and connective tissue disorders Back pain	7.1% 39/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Musculoskeletal and connective tissue disorders Muscle spasms	7.6% 42/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Musculoskeletal and connective tissue disorders Myalgia	15.4% 85/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Musculoskeletal and connective tissue disorders Pain in extremity	8.7% 48/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Nervous system disorders Dizziness	5.6% 31/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Nervous system disorders Headache	31.5% 174/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Cough	14.3% 79/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.5% 36/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.3% 29/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Skin and subcutaneous tissue disorders Dry skin	6.0% 33/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Skin and subcutaneous tissue disorders Erythema	6.9% 38/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Skin and subcutaneous tissue disorders Pruritus	5.3% 29/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Skin and subcutaneous tissue disorders Rash	21.0% 116/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.
Vascular disorders Hypertension	7.4% 41/552 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.	— 0/0 • Adverse events were collected from date of first administration of study treatment to 30 days after date of last actual administration of any study treatment (dabrafenib or trametinib), up to approximately 13 months. Deahs were collected in the post-treatment follow-up period from 31 days after last dose of study treatment until the end of the study, up to approximately 39 months Any sign or symptom that occurs during the study treatment plus the 30 days post treatment (on-treatment period). Deaths in the post treatment follow-up are not considered Adverse Events. The total number at risk in the post-treatment period includes patients that entered the post-treatment follow-up period.

Additional Information

Study director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: Novartis.email@novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER