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SAFETY

Explore COLUMBUS study design and patients characteristics

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Choose a treatment with a favourable safety profile4,9

Adverse events (AE) occuring in ≥10% of patients in the BRAFTOVI® + MEKTOVI® arma,b,c,d

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  BRAFTOVI® + MEKTOVI® (n=192) Vemurafenib (n=186)
  All grades Grade 3/4 All grades Grade 3/4
Total 98% 70% 100% 66%

a Cut-off date: September 2020. b Adapted from Dummer et al. 2022.4 c Organ classes were defined according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.9 d Some sites adopted amendment 6 prior to the data cut-off of September 15, 2020. Following the adoption date, only grade ≥3 AEs and all serious AEs are recorded at those sites.4 

AE, adverse event

  BRAFTOVI® + MEKTOVI® (n=192) Vemurafenib (n=186)
  All grades Grade 3/4 All grades Grade 3/4
Nausea 44% 2% 35% 2%
Diarrhoea 39% 3% 34% 3%
Vomiting 33% 3% 16% 1%
Constipation 26% 0% 7% 1%
Abdominal pain 19% 4% 8% 1%
Upper abdominal pain 13% 1% 11% 1%
Decreased appetite 10% 0% 19% 1%

a Cut-off date: September 2020. b Adapted from Dummer et al. 2022.4 c Organ classes were defined according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.9 d Some sites adopted amendment 6 prior to the data cut-off of September 15, 2020. Following the adoption date, only grade ≥3 AEs and all serious AEs are recorded at those sites.4 

AE, adverse event; GI, gastrointestinal.

  BRAFTOVI® + MEKTOVI® (n=192) Vemurafenib (n=186)
  All grades Grade 3/4 All grades Grade 3/4
Fatigue 30% 2% 31% 2%
Headache 27% 2% 20% 1%
Asthenia 22% 2% 19% 4%
Pyrexia 21% 4% 29% 0%
Dizziness 17% 2% 4% 0%
Peripheral oedema 13% 2% 11% 1%

a Cut-off date: September 2020. b Adapted from Dummer et al. 2022.4 c Organ classes were defined according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.9 d Some sites adopted amendment 6 prior to the data cut-off of September 15, 2020. Following the adoption date, only grade ≥3 AEs and all serious AEs are recorded at those sites.4 

AE, adverse event.

  BRAFTOVI® + MEKTOVI® (n=192) Vemurafenib (n=186)
  All grades Grade 3/4 All grades Grade 3/4
Rash 20% 2% 37% 7%
Dry skin 17% 0% 23% 0%
Hyperkeratosis 15% 1% 29% 0%
Alopecia 15% 0% 38% 0%
Pruritus 14% 1% 22% 1%

a Cut-off date: September 2020. b Adapted from Dummer et al. 2022.4 c Organ classes were defined according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.9 d Some sites adopted amendment 6 prior to the data cut-off of September 15, 2020. Following the adoption date, only grade ≥3 AEs and all serious AEs are recorded at those sites.4 

AE, adverse event.

  BRAFTOVI® + MEKTOVI® (n=192) Vemurafenib (n=186)
  All grades Grade 3/4 All grades Grade 3/4
Arthralgia 33% 1% 47% 6%
Myalgia 16% 0% 18% 1%
Back pain 16% 1% 7% 2%
Muscle spasms 14% 1% 2% 1%
Pain in extremity 13% 1% 15% 1%

a Cut-off date: September 2020. b Adapted from Dummer et al. 2022.4 c Organ classes were defined according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.9 d Some sites adopted amendment 6 prior to the data cut-off of September 15, 2020. Following the adoption date, only grade ≥3 AEs and all serious AEs are recorded at those sites.4 

AE, adverse event.

  BRAFTOVI® + MEKTOVI® (n=192) Vemurafenib (n=186)
  All grades Grade 3/4 All grades Grade 3/4
Anaemia 19% 6% 10% 3%
Hypertension 17% 7% 13% 4%

a Cut-off date: September 2020. b Adapted from Dummer et al. 2022.4 c Organ classes were defined according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.9 d Some sites adopted amendment 6 prior to the data cut-off of September 15, 2020. Following the adoption date, only grade ≥3 AEs and all serious AEs are recorded at those sites.4 

AE, adverse event.

  BRAFTOVI® + MEKTOVI® (n=192) Vemurafenib (n=186)
  All grades Grade 3/4 All grades Grade 3/4
Increased blood creatine phosphokinase  27% 8% 2% 0%
Increased gamma-glutamyl transferase 16% 9% 11% 3%
Increased ALT 11% 5% 8% 2%

a Cut-off date: September 2020. b Adapted from Dummer et al. 2022.4 c Organ classes were defined according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.9 d Some sites adopted amendment 6 prior to the data cut-off of September 15, 2020. Following the adoption date, only grade ≥3 AEs and all serious AEs are recorded at those sites.4 

AE, adverse event; ALT, alanine transaminase.

  BRAFTOVI® + MEKTOVI® (n=192) Vemurafenib (n=186)
  All grades Grade 3/4 All grades Grade 3/4
Blurred visione 16% 0% 2% 0%
Nasopharyngitisf 14% 0% 11% 0%
Coughg 13% 1% 9% 1%
Insomniah 10% 0% 8% 0%

a Cut-off date: September 2020. b Adapted from Dummer et al. 2022.4 c Organ classes were defined according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.9 d Some sites adopted amendment 6 prior to the data cut-off of September 15, 2020. Following the adoption date, only grade ≥3 AEs and all serious AEs are recorded at those sites.4 e Eye disorders. f Infections and infestations. g Respiratory disorders. h Psychiatric disorders. 

AE, adverse event.

Patient monitoring is recommended prior, during and after the treatment. For more information on safety, explore our Therapy Management Guide, on the Support and Resources page.

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For complete information, please refer to the Summaries of Product Characteristics.

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IMPORTANT: the information on this website is based on the EU Summaries of Product Characteristics. Prescribing Information and indication may vary per country. You must refer to your country prescribing information. Please be aware we do not take responsibility for accessing such information which may not comply with the regulation or usage in your country.

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