Table 2.
TEAEs | Part 1/Cohort 1 (N = 3) | Part 1/Cohort 2 (N = 3) | Part 1/Cohort 3 (N = 3) | Part 1/Cohort 4 (N = 3) | Part 1/Cohort 5 (N = 3) | Part 2/ 24 mg/kg (N = 21) | All Parts at 24 mg/kg (N = 24) | Total (N = 36) |
---|---|---|---|---|---|---|---|---|
All TEAEs | 3 (100.0%) | 3 (100.0%) | 3 (100.0%) | 3 (100.0%) | 3 (100.0%) | 20 (95.2%) | 23 (95.8%) | 35 (97.2%) |
Fatigue | 1 (33.3%) | 0 | 0 | 1 (33.3%) | 1 (33.3%) | 8 (38.1%) | 9 (37.5%) | 11 (30.6%) |
Decreased appetite | 2 (66.7%) | 0 | 1 (33.3%) | 0 | 0 | 5 (23.8%) | 5 (20.8%) | 8 (22.2%) |
Nausea | 1 (33.3%) | 1 (33.3%) | 0 | 1 (33.3%) | 0 | 5 (23.8%) | 5 (20.8%) | 8 (22.2%) |
Anaemia | 1 (33.3%) | 1 (33.3%) | 0 | 1 (33.3%) | 1 (33.3%) | 2 (9.5%) | 3 (12.5%) | 6 (16.7%) |
Abdominal distension | 1 (33.3%) | 0 | 0 | 0 | 0 | 5 (23.8%) | 5 (20.8%) | 6 (16.7%) |
Vomiting | 1 (33.3%) | 0 | 0 | 1 (33.3%) | 1 (33.3%) | 3 (14.3%) | 4 (16.7%) | 6 (16.7%) |
Diarrhoea | 0 | 1 (33.3%) | 0 | 0 | 0 | 4 (19.0%) | 4 (16.7%) | 5 (13.9%) |
Rash | 2 (66.7%) | 0 | 0 | 0 | 0 | 3 (14.3%) | 3 (12.5%) | 5 (13.9%) |
Pyrexia | 1 (33.3%) | 0 | 1 (33.3%) | 0 | 0 | 3 (14.3%) | 3 (12.5%) | 5 (13.9%) |
Abdominal pain | 0 | 1 (33.3%) | 0 | 0 | 0 | 3 (14.3%) | 3 (12.5%) | 4 (11.1%) |
Constipation | 0 | 1 (33.3%) | 1 (33.3%) | 0 | 0 | 2 (9.5%) | 2 (8.3%) | 4 (11.1%) |
Back pain | 0 | 1 (33.3%) | 0 | 0 | 1 (33.3%) | 2 (9.5%) | 3 (12.5%) | 4 (11.1%) |
Musculoskeletal pain | 1 (33.3%) | 1 (33.3%) | 0 | 1 (33.3%) | 0 | 1 (4.8%) | 1 (4.2%) | 4 (11.1%) |
Dyspnoea exertional | 0 | 0 | 0 | 1 (33.3%) | 0 | 3 (14.3%) | 3 (12.5%) | 4 (11.1%) |
Pruritus | 2 (66.7%) | 0 | 0 | 0 | 0 | 2 (9.5%) | 2 (8.3%) | 4 (11.1%) |
n (%) is shown