Table 4. Grade 3 and higher adverse events for all cycles in the dose expansion phase.
Characteristic | GC + guadecitabine | GC | Total |
---|---|---|---|
n | 10 | 10 | 20 |
Patients that experienced at least one AE graded 3 or above | 8 (80.0%) | 7 (70.0%) | 15 (75.0%) |
Blood and lymphatic system disorders | |||
Febrile neutropenia | 1 (10.0%) | 0 (0.0%) | 1 (5.0%) |
Neutropenia | 4 (40.0%) | 5 (50.0%) | 9 (45.0%) |
Leukopenia | 1 (10.0%) | 0 (0.0%) | 1 (5.0%) |
Thrombocytopenia | 4 (40.0%) | 3 (30.0%) | 7 (35.0%) |
General disorders | |||
Pyrexia | 1 (10.0%) | 1 (10.0%) | 2 (10.0%) |
Infections and infestations | |||
Urinary tract infection | 1 (10.0%) | 1 (10.0%) | 2 (10.0%) |
Respiratory, thoracic and mediastinal disorders | |||
Pulmonary embolism | 1 (10.0%) | 1 (10.0%) | 2 (10.0%) |
Skin and subcutaneous tissue disorders | |||
Rash | 1 (10.0%) | 1 (10.0%) | 2 (10.0%) |
GC, gemcitabine and guadecitabine; AE, adverse event