Adverse Events
Image
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
| 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) |
Download the Therapy Management Guide for more information on dosing and adverse reactions.
Download the file
Thank you for the interest you give to our publications. Before accessing to our document, please tell us more about you.
