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
| 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.
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