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Safety illustration

SAFETY

Explore COLUMBUS study design and patients characteristics

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Choose a treatment with a favourable safety profile3,6

Less than 1 in 5 patients discontinued due adverse events (AE)3

Adverse events occuring in ≥10% of patients in the BRAFTOVI® + MEKTOVI® arma,3

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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%

 

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

GO TO SUPPORT AND RESOURCES 

  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%

 

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

GO TO SUPPORT AND RESOURCES 

  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%

 

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

GO TO SUPPORT AND RESOURCES 

  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%

 

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

GO TO SUPPORT AND RESOURCES 

  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%

 

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

GO TO SUPPORT AND RESOURCES 

  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%

 

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

GO TO SUPPORT AND RESOURCES 

  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%

 

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

GO TO SUPPORT AND RESOURCES 

  BRAFTOVI® + MEKTOVI® (n=192) Vemurafenib (n=186)
  All grades Grade 3/4 All grades Grade 3/4
Blurred visiona 16% 0% 2% 0%
Nasopharyngitisb 14% 0% 11% 0%
Coughc 13% 1% 9% 1%
Insomniad 10% 0% 8% 0%

 

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

GO TO SUPPORT AND RESOURCES 

aEye disorders. bInfections and infestations. cRespiratory disorders. dPsychiatric disorders. 

In the BRAFTOVI® + MEKTOVI® arma : 
 

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Pyrexia

Pyrexia: Dose adjustments or interruptions were uncommon, occurring in 6% of patients

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Retine

Ocular toxicity: Discontinuation occurred in only one patient

Some sites adopted amendment 6 prior to the data cut-off of September 2020. Following the adoption date, only Grade ≥3 and all serious AEs are recorded at those sites. AE, adverse event; ALT, alanine transaminase. aAdapted from Dummer et al. 2022.3  

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.

GO TO SUPPORT AND RESOURCES 

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 European Summary 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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