Adverse Event

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BRAFTOVI + cetuximab had a consistently more
favourable safety profile compared to control arm12

  • The most common (≥25%) any-grade adverse events (AEs) were nausea, diarrhoea, fatigue, acneiform dermatitis, abdominal pain, vomiting and decreased appetite13
  • Very common (≥10%) any-grade AEs and selected laboratory abnormalities observed with BRAFTOVI + cetuximab reported in BEACON CRC per updated analysis13,a

Very common (≥10%) any-grade AEs and selected laboratory abnormalities observed with BRAFTOVI + cetuximab reported in BEACON CRC per updated analysis13,a
  BRAFTOVI + cetuximab
(n=216)
FOLFIRI + cetuximab
or irinotecan + cetuximab
(n=193)
  Any grade Grade ≥3b Any grade Grade ≥3b
Adverse events, % (n)        
Any adverse event 98.1% (212) 57.4% (124) 98.4% (190) 64.2% (124)
Diarrhoea 38.4% (83) 2.8% (6) 48.7% (94) 10.4% (20)
Nausea 38% (82) 0.5% (1) 43.5% (84) 1.6% (3)
Fatigue 33.3% (72) 4.2% (9) 28% (54) 4.7% (9)
Decreased   appetite 31% (67) 1.4% (3) 29%(56) 3.1%(6)
Acneiform   dermatitis 30.1% (65) 0.5% (1) 39.9% (77) 2.6% (5)
Abdominal pain 27.8% (60) 3.2% (7) 28% (54) 5.2% (10)
Vomiting 27.3% (59) 1.4%(3) 31.6% (61) 3.1%(6)
Asthenia 24.1% (52) 3.7% (8) 27.5% (53) 5.2% (10)
Arthralgia 22.7% (49) 1.4% (3) 1.6% (3) 0%
Headache 19.9% (43) 0% 2.6% (5) 0%
Pyrexia 18.5% (40) 1.4% (3) 14.5% (28) 0.5% (1)
Constipation 18.1% (39) 0% 20.2% (39) 1% (2)
Melanocytic naevus 15.7% (34) 0% 0% 0%
Myalgia 15.3% (33) 0.5% (1) 2.1% (4) 0%
Rash 14.8% (32) 0% 14.5% (28) 1.6% (3)
Musculoskeletal pain 13.4% (29) 0% 2.6% (5) 0%
Dyspnea 13% (28) 0.9% (2) 10.4% (20) 3.1% (6)
Back pain 13% (28) 1.4% (3) 14% (27) 1% (2)
Dry skin 13% (28) 0% 8.3% (16) 0.5% (1)
Pain in  extremity 11.6% (25) 0% 1% (2) 0%
Insomnia 11.1% (24) 0% 6.7% (13) 0%
Weight decreased 11.1% (24) 0.5% (1) 6.2% (12) 0%
Pruritus 11.1%(24) 0% 5.2%(10) 0%
Oedema peripheral 10.6%(23) 0% 7.3%(14) 0.5%(1)
Abdominal pain upper 10.2%(22) 0.9%(2) 7.8%(15) 0.5%(1)
UTI 7.9%(17) 2.3%(5) 3.1%(6) 1%(2)
Laboratory abnormalities, % (n)        
  Alanine aminotransferase  19% (41) 0.5% (1) 29.5% (57) 4.1% (8)
  Aspartate   aminotransferase 18.5% (40) 1.9% (4) 22.3% (43) 2.6% (5)
  Bilirubin 8.3% (18) 2.8% (6) 8.8% (17) 3.1% (6)
  Creatine kinase

3.7%(8)

0% 7.3%(14) 0.5%(1)
  Creatinine 53.7% (116) 3.2% (7) 37.8% (73) 1% (2)
  Haemoglobin 39.4% (85) 5.6% (12) 46.1% (89) 5.2% (10)

aGrades per National Cancer Institute CTCAE v4.03.
bIncludes grade ≥3 AEs in more than 2% of patients in the BRAFTOVI + binimetinib + cetuximab arm or the BRAFTOVI + cetuximab arm.

AE, adverse event; CTCAE, Common Terminology Criteria for Adverse Events; mCRC, metastatic colorectal cancer; UTI, urinary tract infection.

BEACON CRC safety data on this page are from the updated analysis (data cut-off August 2019) and were published in the Journal Clinical Oncology in January 2021.

Download the Therapy Management Guide for more information on dosing and adverse reactions.

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