Table 3 Most common all-causality treatment-emergent adverse events (≥10% of patients in any arm) by preferred term
From: Encorafenib, cetuximab and chemotherapy in BRAF-mutant colorectal cancer: a randomized phase 3 trial
EC + mFOLFOX6 (n = 231) | SOC (n = 228) | |||
|---|---|---|---|---|
Any grade | Grade ≥3 | Any grade | Grade ≥3 | |
Any adverse event | 230 (99.6) | 181 (78.4) | 223 (97.8) | 149 (65.4) |
Nausea | 118 (51.1) | 6 (2.6) | 110 (48.2) | 7 (3.1) |
Anemia | 84 (36.4) | 25 (10.8) | 52 (22.8) | 8 (3.5) |
Diarrhea | 79 (34.2) | 3 (1.3) | 107 (46.9) | 8 (3.5) |
Neutrophil count decreased | 74 (32.0) | 42 (18.2) | 64 (28.1) | 38 (16.7) |
Decreased appetite | 77 (33.3) | 5 (2.2) | 57 (25.0) | 3 (1.3) |
Vomiting | 77 (33.3) | 8 (3.5) | 48 (21.1) | 5 (2.2) |
Asthenia | 62 (26.8) | 10 (4.3) | 33 (14.5) | 3 (1.3) |
Pyrexia | 60 (26.0) | 4 (1.7) | 31 (13.6) | 1 (0.4) |
Peripheral sensory neuropathy | 57 (24.7) | 13 (5.6) | 49 (21.5) | 5 (2.2) |
Rash | 57 (24.7) | 2 (0.9) | 6 (2.6) | 0 |
Fatigue | 56 (24.2) | 6 (2.6) | 57 (25.0) | 6 (2.6) |
Neuropathy peripheral | 54 (23.4) | 16 (6.9) | 48 (21.1) | 6 (2.6) |
Arthralgia | 51 (22.1) | 2 (0.9) | 8 (3.5) | 0 |
Neutropenia | 51 (22.1) | 34 (14.7) | 51 (22.4) | 21 (9.2) |
Alopecia | 49 (21.2) | 0 | 23 (10.1) | 0 |
Constipation | 47 (20.3) | 1 (0.4) | 44 (19.3) | 1 (0.4) |
Platelet count decreased | 46 (19.9) | 3 (1.3) | 28 (12.3) | 4 (1.8) |
White blood cell count decreased | 42 (18.2) | 13 (5.6) | 32 (14.0) | 8 (3.5) |
Lipase increased | 46 (19.9) | 34 (14.7) | 22 (9.6) | 12 (5.3) |
Weight decreased | 40 (17.3) | 2 (0.9) | 19 (8.3) | 0 |
Skin hyperpigmentation | 39 (16.9) | 0 | 5 (2.2) | 0 |
Abdominal pain | 38 (16.5) | 7 (3.0) | 47 (20.6) | 3 (1.3) |
Dermatitis acneiform | 35 (15.2) | 2 (0.9) | 1 (0.4) | 0 |
Hypokalemia | 30 (13.0) | 4 (1.7) | 22 (9.6) | 7 (3.1) |
Aspartate aminotransferase increased | 29 (12.6) | 2 (0.9) | 25 (11.0) | 3 (1.3) |
Dry skin | 29 (12.6) | 0 | 8 (3.5) | 0 |
Headache | 29 (12.6) | 1 (0.4) | 17 (7.5) | 0 |
Mucosal inflammation | 29 (12.6) | 4 (1.7) | 22 (9.6) | 1 (0.4) |
Paresthesia | 28 (12.1) | 6 (2.6) | 18 (7.9) | 3 (1.3) |
Dysgeusia | 27 (11.7) | 0 | 31 (13.6) | 0 |
Epistaxis | 27 (11.7) | 0 | 28 (12.3) | 0 |
Hypomagnesemia | 27 (11.7) | 2 (0.9) | 9 (3.9) | 1 (0.4) |
Stomatitis | 27 (11.7) | 4 (1.7) | 32 (14.0) | 3 (1.3) |
Alanine aminotransferase increased | 26 (11.3) | 3 (1.3) | 22 (9.6) | 3 (1.3) |
Myalgia | 26 (11.3) | 0 | 9 (3.9) | 0 |
Thrombocytopenia | 26 (11.3) | 0 | 18 (7.9) | 0 |
Neurotoxicity | 25 (10.8) | 11 (4.8) | 18 (7.9) | 0 |
Palmar-plantar erythrodysesthesia syndrome | 25 (10.8) | 3 (1.3) | 18 (7.9) | 2 (0.9) |
Pruritus | 24 (10.4) | 0 | 4 (1.8) | 0 |
Hypoalbuminemia | 23 (10.0) | 1 (0.4) | 13 (5.7) | 0 |
Insomnia | 23 (10.0) | 0 | 13 (5.7) | 0 |
