Table 3 TEAEs occurring in ≥15% patients (safety analysis set).
TEAE, n (%) | Cohort A N = 42 | Cohort A2 N = 26 | Cohort B1 N = 16 | Cohort C N = 13 | ||||
|---|---|---|---|---|---|---|---|---|
Any grade AEs occurring | Grade 3/4 | Any grade | Grade 3/4 | Any grade | Grade 3/4 | Any grade | Grade 3/4 | |
Nausea | 28 (66.7) | 3 (7.1) | 12 (46.2) | 1 (3.8) | 7 (43.6) | 1 (6.3) | 6 (46.2) | 0 (0.0) |
Fatigue | 20 (47.6) | 3 (7.1) | 15 (57.7) | 1 (3.8) | 12 (75.0) | 2 (12.5) | 3 (23.1) | 1 (7.7) |
Vomiting | 19 (45.2) | 3 (7.1) | 10 (38.5) | 1 (3.8) | 2 (12.5) | 1 (6.3) | 8 (61.5) | 0 (0.0) |
Increased AST | 14 (33.3) | 6 (14.3) | 11 (42.3) | 6 (23.1) | 3 (18.8) | 1 (14.3) | 11 (84.6) | 3 (23.1) |
Increased ALT | 13 (31.0) | 6 (14.3) | 11 (42.3) | 5 (19.2) | 5 (31.3) | 1 (14.3) | 10 (76.9) | 3 (23.1) |
Constipation | 12 (28.6) | 0 (0.0) | 7 (26.9) | 0 (0.0) | 2 (12.5) | 0 (0.0) | 2 (15.4) | 0 (0.0) |
Increased blood bilirubin | 11 (26.2) | 10 (23.8) | 12 (46.2) | 8 (30.8) | 1 (6.3) | 0 (0.0) | 8 (61.5) | 5 (38.5) |
Headache | 9 (21.4) | 0 (0.0) | 2 (7.7) | 0 (0.0) | 2 (12.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Pyrexia | 8 (19.0) | 1 (2.4) | 9 (34.6) | 1 (3.8) | 1 (6.3) | 0 (0.0) | 3 (23.1) | 0 (0.0) |
Abdominal pain | 7 (16.7) | 2 (4.8) | 3 (11.5) | 1 (3.8) | 1 (6.3) | 0 (0.0) | 2 (15.4) | 1 (7.7) |
Diarrhoea | 7 (16.7) | 0 (0.0) | 10 (38.5) | 0 (0.0) | 2 (12.5) | 1 (6.3) | 2 (15.4) | 0 (0.0) |
Hyperbilirubinemia | 6 (14.3) | 4 (9.5) | 4 (15.4) | 2 (7.7) | 3 (18.8) | 2 (12.5) | 0 (0.0) | 0 (0.0) |
Decreased appetite | 6 (14.3) | 0 (0.0) | 6 (23.1) | 0 (0.0) | 3 (18.8) | 0 (0.0) | 2 (15.4) | 0 (0.0) |
Dehydration | 5 (11.9) | 1 (2.4) | 5 (19.2) | 0 (0.0) | 0 (0.0) | NR | 0 (0.0) | 0 (0.0) |
Dyspnoea | 5 (11.9) | 0 (0.0) | 6 (23.1) | 0 (0.0) | 2 (12.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Anaemia | 4 (9.5) | 0 (0.0) | 9 (34.6) | 3 (11.5) | 8 (50.0) | 5 (31.3) | 8 (61.5) | 6 (46.2) |
Neutropenia | 1 (2.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 9 (56.3) | 7 (43.8) | 0 (0.0) | 0 (0.0) |
Thrombocytopenia | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 10 (62.5) | 6 (37.5) | 1 (7.7) | 1 (7.7) |
Disease progression | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (15.4) | 2 (15.4) |
Peripheral oedema | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (6.3) | 0 (0.0) | 2 (15.4) | 0 (0.0) |
Jaundice | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (15.4) | 0 (0.0) |
Urinary tract infection | 0 (0.0) | 0 (0.0) | 3 (11.5) | 1 (3.8) | 1 (6.3) | 0 (0.0) | 3 (23.1) | 0 (0.0) |
Hypokalaemia | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (18.8) | 1 (6.3) | 0 (0.0) | 0 (0.0) |
Hypomagnesaemia | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 4 (25.0) | 1 (6.3) | 0 (0.0) | 0 (0.0) |
