Adverse Events

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BRAFTOVI + cetuximab had a consistently more 
favourable safety profile compared to control arm*12

  • The most common (≥25%) any-grade adverse events (AEs) with BRAFTOVI + cetuximab 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 post-hoc analysis13,a

*Irinotecan based treatment regimen

 
 BRAFTOVI + cetuximab
(n=216)
FOLFIRI + cetuximab
or irinotecan + cetuximab
(n=193)
 Any gradeGrade ≥3bAny gradeGrade ≥3b
Adverse events, % (n)    
Any adverse event98.1% (212)57.4% (124)98.4% (190)64.2% (124)
Diarrhoea38.4% (83)2.8% (6)48.7% (94)10.4% (20)
Nausea38% (82)0.5% (1)43.5% (84)1.6% (3)
Fatigue33.3% (72)4.2% (9)28% (54)4.7% (9)
Decreased   appetite31% (67)1.4% (3)29%(56)3.1%(6)
Acneiform   dermatitis30.1% (65)0.5% (1)39.9% (77)2.6% (5)
Abdominal pain27.8% (60)3.2% (7)28% (54)5.2% (10)
Vomiting27.3% (59)1.4%(3)31.6% (61)3.1%(6)
Asthenia24.1% (52)3.7% (8)27.5% (53)5.2% (10)
Arthralgia22.7% (49)1.4% (3)1.6% (3)0%
Headache19.9% (43)0%2.6% (5)0%
Pyrexia18.5% (40)1.4% (3)14.5% (28)0.5% (1)
Constipation18.1% (39)0%20.2% (39)1% (2)
Melanocytic naevus15.7% (34)0%0%0%
Myalgia15.3% (33)0.5% (1)2.1% (4)0%
Rash14.8% (32)0%14.5% (28)1.6% (3)
Musculoskeletal pain13.4% (29)0%2.6% (5)0%
Dyspnea13% (28)0.9% (2)10.4% (20)3.1% (6)
Back pain13% (28)1.4% (3)14% (27)1% (2)
Dry skin13% (28)0%8.3% (16)0.5% (1)
Pain in  extremity11.6% (25)0%1% (2)0%
Insomnia11.1% (24)0%6.7% (13)0%
Weight decreased11.1% (24)0.5% (1)6.2% (12)0%
Pruritus11.1%(24)0%5.2%(10)0%
Oedema peripheral10.6%(23)0%7.3%(14)0.5%(1)
Abdominal pain upper10.2%(22)0.9%(2)7.8%(15)0.5%(1)
UTI7.9%(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   aminotransferase18.5% (40)1.9% (4)22.3% (43)2.6% (5)
  Bilirubin8.3% (18)2.8% (6)8.8% (17)3.1% (6)
  Creatine kinase

3.7%(8)

0%7.3%(14)0.5%(1)
  Creatinine53.7% (116)3.2% (7)37.8% (73)1% (2)
  Haemoglobin39.4% (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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