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. Author manuscript; available in PMC: 2020 Feb 1.
Published in final edited form as: Invest New Drugs. 2018 Jul 28;37(1):147–158. doi: 10.1007/s10637-018-0646-1

Table 2.

Summary of treatment emergent adverse events experienced by at least 10% of subjects, irrespective of causality

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