Table 2 Summary of adverse events of any grade occurring in >2 patients in the total BID dose-escalation cohort (N = 45).
BID dose-escalation cohort | |||||||||
|---|---|---|---|---|---|---|---|---|---|
2.5 mg (n = 4) | 5.0 mg (n = 3) | 10 mg (n = 3) | 20 mg (n = 3) | 40 mg (n = 6) | 60 mg (n = 11) | 80 mg (n = 10) | 120 mg (n = 5) | Total (N = 45) | |
Nausea | 3 (75.0) | 0 (0.0) | 1 (33.3) | 2 (66.7) | 5 (83.3) | 6 (54.5) | 8 (80.0) | 4 (80.0) | 29 (64.4) |
Vomiting | 1 (25.0) | 0 (0.0) | 1 (33.3) | 2 (66.7) | 5 (83.3) | 4 (36.4) | 2 (20.0) | 1 (20.0) | 16 (35.6) |
Fatigue | 1 (25.0) | 1 (33.3) | 0 (0.0) | 3 (100.0) | 2 (33.3) | 2 (18.2) | 4 (40.0) | 2 (40.0) | 15 (33.3) |
Anaemia | 1 (25.0) | 0 (0.0) | 1 (33.3) | 0 (0.0) | 2 (33.3) | 4 (36.4) | 4 (40.0) | 3 (60.0) | 15 (33.3) |
Diarrhoea | 0 (0.0) | 1 (33.3) | 1 (33.3) | 2 (66.7) | 2 (33.3) | 4 (36.4) | 1 (10.0) | 2 (40.0) | 13 (28.9) |
Abdominal pain | 1 (25.0) | 0 (0.0) | 1 (33.3) | 2 (66.7) | 0 (0.0) | 3 (27.3) | 2 (20.0) | 0 (0.0) | 9 (20.0) |
Constipation | 1 (25.0) | 0 (0.0) | 1 (33.3) | 0 (0.0) | 1 (16.7) | 1 (9.1) | 4 (40.0) | 0 (0.0) | 8 (17.8) |
Upper respiratory tract infection | 1 (25.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 1 (9.1) | 5 (50.0) | 0 (0.0) | 8 (17.8) |
Urinary tract infection | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (33.3) | 0 (0.0) | 3 (27.3) | 2 (20.0) | 2 (40.0) | 8 (17.8) |
Neutropenia | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (33.3) | 0 (0.0) | 3 (30.0) | 1 (20.0) | 6 (13.3) |
Ascites | 1 (25.0) | 0 (0.0) | 2 (66.7) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 1 (10.0) | 0 (0.0) | 5 (11.1) |
Decreased appetite | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (9.1) | 2 (20.0) | 2 (40.0) | 5 (11.1) |
Hypomagnesemia | 0 (0.0) | 0 (0.0) | 1 (33.3) | 1 (33.3) | 0 (0.0) | 0 (0.0) | 2 (20.0) | 0 (0.0) | 4 (8.9) |
Pyrexia | 1 (25.0) | 0 (0.0) | 1 (33.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (10.0) | 1 (20.0) | 4 (8.9) |
Headache | 0 (0.0) | 1 (33.3) | 0 (0.0) | 1 (33.3) | 2 (33.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 4 (8.9) |
Back pain | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (33.3) | 1 (9.1) | 0 (0.0) | 1 (20.0) | 4 (8.9) |
Muscle spasms | 1 (25.0) | 1 (33.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (9.1) | 1 (10.0) | 0 (0.0) | 4 (8.9) |
Cough | 0 (0.0) | 0 (0.0) | 1 (33.3) | 0 (0.0) | 0 (0.0) | 1 (9.1) | 1 (10.0) | 1 (20.0) | 4 (8.9) |
Pleural effusion | 0 (0.0) | 1 (33.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (18.2) | 0 (0.0) | 1 (20.0) | 4 (8.9) |
Dyspnoea | 0 (0.0) | 0 (0.0) | 1 (33.3) | 1 (33.3) | 0 (0.0) | 1 (9.1) | 0 (0.0) | 0 (0.0) | 3 (6.7) |
Pain in extremity | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (33.3) | 0 (0.0) | 1 (9.1) | 0 (0.0) | 1 (20.0) | 3 (6.7) |
Non-cardiac chest pain | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (9.1) | 1 (10.0) | 1 (20.0) | 3 (6.7) |
Peripheral sensory neuropathy | 0 (0.0) | 1 (33.3) | 0 (0.0) | 1 (33.3) | 0 (0.0) | 1 (9.1) | 0 (0.0) | 0 (0.0) | 3 (6.7) |
Hypoalbuminemia | 1 (25.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (18.2) | 0 (0.0) | 0 (0.0) | 3 (6.7) |
Hypophosphatemia | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 1 (9.1) | 0 (0.0) | 1 (20.0) | 3 (6.7) |
Increased AST | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 1 (9.1) | 0 (0.0) | 1 (20.0) | 3 (6.7) |
