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. Author manuscript; available in PMC: 2021 Jul 12.
Published in final edited form as: Clin Cancer Res. 2021 Jan 20;27(7):1882–1892. doi: 10.1158/1078-0432.CCR-20-3946

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%)