Table 2 Treatment-emergent adverse events (occurring in ≥20% of subjects)
Adverse event, N (%) | Dose escalation (N = 63) | Dose expansion (N = 83) | All (N = 146) | |||
---|---|---|---|---|---|---|
Grades | ||||||
All | ≥3 | All | ≥3 | All | ≥3 | |
Diarrhoea | 45 (71) | 4 (6) | 64 (77) | 6 (7) | 109 (75) | 10 (7) |
Fatigue | 39 (62) | 4 (6) | 44 (53) | 9 (11) | 83 (57) | 13 (9) |
Nausea | 31 (49) | 4 (6) | 42 (51) | 3 (4) | 73 (50) | 7 (5) |
Vomiting | 31 (49) | 2 (3) | 39 (47) | 3 (4) | 70 (48) | 5 (3) |
Dermatitis acneiform | 25 (40) | 6 (10) | 32 (39) | 1 (1) | 57 (39) | 7 (5) |
Maculopapular rash | 24 (38) | 6 (10) | 27 (33) | 6 (7) | 51 (35) | 12 (8) |
Peripheral edema | 26 (41) | 1 (2) | 19 (23) | 0 (0) | 45 (31) | 1 (1) |
Pyrexia | 24 (38) | 0 (0) | 21 (25) | 1 (1) | 45 (31) | 1 (1) |
Decreased appetite | 17 (27) | 0 (0) | 25 (30) | 1 (1) | 42 (29) | 1 (1) |
Stomatitis | 11 (18) | 0 (0) | 23 (28) | 5 (6) | 33 (23) | 5 (3) |
Dyspnoea | 12 (19) | 3 (5) | 17 (21) | 5 (6) | 29 (20) | 8 (6) |