Table 3.
Adverse events, regardless of treatment attribution, occurring in >20% of patients
| ENC + CTX n = 26 | ENC + ALP + CTX n = 28 | |||
|---|---|---|---|---|
| Adverse event, n (%) | All grades | Grade 3/4 | All grades | Grade 3/4 |
| Fatigue | 13 (50.0) | 3 (11.5) | 12 (42.9) | 1 (3.6) |
| Vomiting | 12 (46.2) | 2 (7.7) | 14 (50.0) | 0 |
| Dyspnea | 9 (34.6) | 1 (3.8) | 5 (17.9) | 3 (10.7) |
| Abdominal pain | 8 (30.8) | 3 (11.5) | 7 (25.0) | 1 (3.6) |
| Nausea | 8 (30.8) | 0 | 17 (60.7) | 1 (3.6) |
| Hyperglycemia | 2 (7.7) | 0 | 11 (39.3) | 3 (10.7) |
| Back pain | 7 (26.9) | 1 (3.8) | 3 (10.7) | 1 (3.6) |
| Constipation | 7 (26.9) | 1 (3.8) | 4 (14.3) | 0 |
| Decreased appetite | 7 (26.9) | 0 | 8 (28.6) | 1 (3.6) |
| Hypophosphatasemia | 7 (26.9) | 5 (19.2) | 4 (14.3) | 1 (3.6) |
| Infusion-related | 7 (26.9) | 0 | 1 (3.6) | 0 |
| reaction | ||||
| Weight decreased | 7 (26.9) | 0 | 10 (35.7) | 1 (3.6) |
| Dysphonia | 2 (7.7) | 0 | 7 (25.0) | 0 |
| Melanocytic nevus | 1 (3.8) | 0 | 7 (25.0) | 0 |
| Peripheral edema | 2 (7.7) | 0 | 7 (25.0) | 0 |
| Cough | 6 (23.1) | 0 | 2 (7.1) | 1 (3.6) |
| Headache | 6 (23.1) | 0 | 4 (14.3) | 0 |
| Myalgia | 6 (23.1) | 0 | 4 (14.3) | 0 |
| Pain in extremity | 6 (23.1) | 0 | 2 (7.1) | 0 |
| Stomatitis | 6 (23.1) | 0 | 4 (14.3) | 1 (3.6) |
| Dysgeusia | 1 (3.8) | 0 | 6 (21.4) | 0 |
| Diarrhea | 5 (19.2) | 1 (3.8) | 15 (53.6) | 1 (3.6) |
| Dry skin | 5 (19.2) | 0 | 9 (32.1) | 0 |
| Rash | 5 (19.2) | 0 | 10 (35.7) | 0 |
| Hypomagnesaemia | 4 (15.4) | 0 | 8 (28.6) | 1 (3.6) |
| Dermatitis acneiform | 3 (11.5) | 0 | 8 (28.6) | 1 (3.6) |
| Pyrexia | 3 (11.5) | 0 | 8 (28.6) | 1 (3.6) |
All patients had at least 1 AE. Abbreviations: ENC + ALP + CTX, encorafenib combined with alpelisib and cetuximab; ENC + CTX, encorafenib combined with cetuximab.