Table 3. Grade 3 and higher adverse events for all cycles in evaluable patients in the dose escalation phase.
Patient cohort | 1 | 2 | 3 | Total |
---|---|---|---|---|
Guadecitabine dose | 20 mg/m2, day 1-5 | 20 mg/m2, day 1-5 + G-CSF | 30 mg/m2, day 1-5 + G-CSF | |
n | 4 | 8 | 5 | 17 |
Patients that experienced at least one AE graded 3 or above | 4 (100%) | 8 (100%) | 5 (100%) | 17 (100%) |
Blood and lymphatic system disorders | ||||
Anaemia | 1 (25.0%) | 2 (25.0%) | 2 (40.0%) | 5 (29.4%) |
Febrile neutropenia | 1 (25.0%) | 1 (12.5%) | 0 (0.0%) | 2 (11.8%) |
Neutropenia | 3 (75.0%) | 5 (62.5%) | 5 (100.0%) | 13 (76.5%) |
Leucopenia | 1 (25.0%) | 1 (12.5%) | 3 (60.0%) | 5 (29.4%) |
Pancytopenia | 0 (0.0%) | 1 (12.5%) | 0 (0.0%) | 1 (5.9%) |
Thrombocytopenia | 4 (100.0%) | 4 (50.0%) | 3 (60.0%) | 11 (64.7%) |
Ear and labyrinth disorders | ||||
Hypoacusis | 1 (25.0%) | 0 (0.0%) | 0 (0.0%) | 1 (5.9%) |
Tinnitus | 0 (0.0%) | 0 (0.0%) | 1 (20.0%) | 1 (5.9%) |
Gastrointestinal disorders | ||||
Diarrhoea | 0 (0.0%) | 0 (0.0%) | 1 (20.0%) | 1 (5.9%) |
Melaena | 0 (0.0%) | 1 (12.5%) | 0 (0.0%) | 1 (5.9%) |
Nausea | 1 (25.0%) | 1 (12.5%) | 0 (0.0%) | 2 (11.8%) |
Vomiting | 0 (0.0%) | 1 (12.5%) | 0 (0.0%) | 1 (5.9%) |
General disorders and administration site conditions | ||||
Fatigue | 1 (25.0%) | 0 (0.0%) | 0 (0.0%) | 1 (5.9%) |
Pyrexia | 0 (0.0%) | 0 (0.0%) | 1 (20.0%) | 1 (5.9%) |
Infections and infestations | ||||
Corona virus infection | 0 (0.0%) | 1 (12.5%) | 0 (0.0%) | 1 (5.9%) |
Infection | 0 (0.0%) | 0 (0.0%) | 1 (20.0%) | 1 (5.9%) |
Pneumonia | 0 (0.0%) | 1 (12.5%) | 0 (0.0%) | 1 (5.9%) |
Tooth Infection | 0 (0.0%) | 0 (0.0%) | 1 (20.0%) | 1 (5.9%) |
Urinary Tract Infection | 0 (0.0%) | 1 (12.5%) | 0 (0.0%) | 1 (5.9%) |
Metabolism and nutrition disorders | ||||
Dehydration | 0 (0.0%) | 1 (12.5%) | 0 (0.0%) | 1 (5.9%) |
Hypokalaemia | 0 (0.0%) | 0 (0.0%) | 1 (20.0%) | 1 (5.9%) |
Hypomagnesaemia | 0 (0.0%) | 0 (0.0%) | 1 (20.0%) | 1 (5.9%) |
Hyponatraemia | 1 (25.0%) | 0 (0.0%) | 0 (0.0%) | 1 (5.9%) |
Renal and urinary disorders | ||||
Ureteric Obstruction | 0 (0.0%) | 1 (12.5%) | 0 (0.0%) | 1 (5.9%) |
Vascular disorders | ||||
Embolism | 1 (25.0%) | 1 (12.5%) | 0 (0.0%) | 2 (11.8%) |
Peripheral Ischaemia | 0 (0.0%) | 0 (0.0%) | 1 (20.0%) | 1 (5.9%) |