Table 3.
Any-cause adverse events (grade ≤2 events occurring in ≥10% of patients across cohorts)
| Adverse event, n (%) |
Cohort A (n=76) | Cohort B (n=16) | Cohort C (n=16) | Cohort D (n=17) | Total (N=125) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Grade 1-2 |
Grade 3 |
Grade 4 |
Grade 5 |
Grade 1-2 |
Grade 3 |
Grade 4 |
Grade 5 |
Grade 1-2 |
Grade 3 |
Grade 4 |
Grade 5 |
Grade 1-2 |
Grade 3 |
Grade 4 |
Grade 5 |
Grade 1-2 |
Grade 3 |
Grade 4 |
Grade 5 |
|
| Any | 39 (51) | 30 (39) | 4 (5) | 1 (1)* | 7 (44) | 8 (50) | 1 (6) | 0 | 7 (44) | 8 (50) | 1 (6) | 0 | 9 (53) | 7 (41) | 1 (6) | 0 | 62 (50) | 53 (42) | 7 (6) | 1 (1)* |
| Pyrexia | 42 (55) | 2 (3) | 0 | 0 | 7 (44) | 0 | 0 | 0 | 7 (44) | 1 (6) | 0 | 0 | 7 (41) | 1 (6) | 0 | 0 | 63 (50) | 4 (3) | 0 | 0 |
| Asthenia | 27 (36) | 0 | 0 | 0 | 5 (31) | 0 | 0 | 0 | 2 (13) | 1 (6) | 0 | 0 | 5 (29) | 0 | 0 | 0 | 39 (31) | 1 (1) | 0 | 0 |
| Headache | 26 (34) | 1 (1) | 0 | 0 | 4 (25) | 1 (6) | 0 | 0 | 6 (38) | 0 | 0 | 0 | 7 (41) | 1 (6) | 0 | 0 | 43 (34) | 3 (2) | 0 | 0 |
| Nausea | 23 (30) | 0 | 0 | 0 | 7 (44) | 0 | 0 | 0 | 4 (25) | 0 | 0 | 0 | 6 (35) | 0 | 0 | 0 | 40 (32) | 0 | 0 | 0 |
| Diarrhoea | 22 (29) | 0 | 0 | 0 | 8 (50) | 0 | 0 | 0 | 3 (19) | 0 | 0 | 0 | 7 (41) | 0 | 0 | 0 | 40 (32) | 0 | 0 | 0 |
| Vomiting | 21 (28) | 1 (1) | 0 | 0 | 2 (13) | 0 | 0 | 0 | 2 (13) | 0 | 0 | 0 | 6 (35) | 0 | 0 | 0 | 31 (25) | 1 (1) | 0 | 0 |
| Chills | 16 (21) | 0 | 0 | 0 | 6 (38) | 0 | 0 | 0 | 8 (50) | 0 | 0 | 0 | 5 (29) | 2 (12) | 0 | 0 | 35 (28) | 2 (2) | 0 | 0 |
| Arthralgia | 15 (20) | 0 | 0 | 0 | 3 (19) | 0 | 0 | 0 | 2 (13) | 0 | 0 | 0 | 6 (35) | 0 | 0 | 0 | 26 (21) | 0 | 0 | 0 |
| Myalgia | 13 (17) | 0 | 0 | 0 | 5 (31) | 0 | 0 | 0 | 1 (6) | 1 (6) | 0 | 0 | 5 (29) | 1 (6) | 0 | 0 | 24 (19) | 2 (2) | 0 | 0 |
| Aspartate aminotransferase increase | 11 (14) | 0 | 0 | 0 | 3 (19) | 0 | 0 | 0 | 2 (13) | 0 | 0 | 0 | 3 (18) | 0 | 0 | 0 | 19 (15) | 0 | 0 | 0 |
| Cough | 10 (13) | 0 | 0 | 0 | 2 (13) | 0 | 0 | 0 | 1 (6) | 0 | 0 | 0 | 3 (18) | 0 | 0 | 0 | 16 (13) | 0 | 0 | 0 |
| Oedema peripheral | 10 (13) | 0 | 0 | 0 | 2 (13) | 0 | 0 | 0 | 2 (13) | 0 | 0 | 0 | 3 (18) | 0 | 0 | 0 | 17 (14) | 0 | 0 | 0 |
| Back pain | 9 (12) | 0 | 0 | 0 | 1 (6) | 0 | 0 | 0 | 3 (19) | 0 | 0 | 0 | 2 (12) | 0 | 0 | 0 | 15 (12) | 0 | 0 | 0 |
| Rash | 9 (12) | 0 | 0 | 0 | 6 (38) | 1 (6) | 0 | 0 | 3 (19) | 0 | 0 | 0 | 3 (18) | 0 | 0 | 0 | 21 (17) | 1 (1) | 0 | 0 |
| Constipation | 8 (11) | 0 | 0 | 0 | 2 (13) | 0 | 0 | 0 | 4 (25) | 0 | 0 | 0 | 6 (35) | 0 | 0 | 0 | 20 (16) | 0 | 0 | 0 |
| Decreased appetite | 8 (11) | 0 | 0 | 0 | 4 (25) | 0 | 0 | 0 | 7 (44) | 1 (6) | 0 | 0 | 3 (18) | 0 | 0 | 0 | 22 (18) | 1 (1) | 0 | 0 |
| Pain in extremity | 8 (11) | 0 | 0 | 0 | 3 (19) | 0 | 0 | 0 | 3 (19) | 0 | 0 | 0 | 2 (12) | 0 | 0 | 0 | 16 (13) | 0 | 0 | 0 |
| Dizziness | 5 (7) | 0 | 0 | 0 | 5 (31) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 (18) | 0 | 0 | 0 | 13 (10) | 0 | 0 | 0 |
| Fatigue | 7 (9) | 0 | 0 | 0 | 4 (25) | 0 | 0 | 0 | 7 (44) | 1 (6) | 0 | 0 | 3 (18) | 0 | 0 | 0 | 21 (17) | 1 (1) | 0 | 0 |
| Abdominal pain | 6 (8) | 0 | 0 | 0 | 2 (13) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 (29) | 0 | 0 | 0 | 13 (10) | 0 | 0 | 0 |
| Alanine aminotransferase increased | 7 (9) | 0 | 0 | 0 | 2 (13) | 0 | 0 | 0 | 1 (6) | 0 | 0 | 0 | 2 (12) | 1 (6) | 0 | 0 | 13 (10) | 0 | 0 | 0 |
| Dry skin | 6 (8) | 0 | 0 | 0 | 2 (13) | 0 | 0 | 0 | 3 (19) | 0 | 0 | 0 | 3 (18) | 0 | 0 | 0 | 14 (11) | 0 | 0 | 0 |
Intracranial tumour haemorrhage, considered to be unrelated to study treatment.