Table 2 Grade 3 and grade 4 treatment-emergent adverse events (TEAEs) reported in treated patients fully assessable for all study endpoints, as assessed by the Common Terminology Criteria for Adverse Events, version 4.0
| Â | Decitabine+ Chemotherapy | Chemotherapy only | ||
|---|---|---|---|---|
Adverse event | Grade 3 n (%) | Grade 4 n (%) | Grade 3 n (%) | Grade 4 n (%) |
Any Grade 3 or Grade 4 TEAEs | 7 (87.5) | 7 (87.5) | 7 (77.8) | 7 (77.8) |
Blood and lymphatic system disorders | ||||
 Anemia | 6 (75.0) | 2 (25.0) | 4 (44.4) | 1 (11.1) |
 Febrile neutropenia | 1 (12.5) | 0 | 4 (44.4) | 0 |
 Other: Neutropenia | 1 (12.3) | 3 (37.5) | 1 (11.1) | 1 (11.1) |
 Other: Thrombocytopenia | 4 (50.0) | 4 (50.0) | 0 | 2 (22.2) |
Gastrointestinal disorders | ||||
 Colitis | 2 (25.0) | 0 | 2 (25.0) | 0 |
Investigations | ||||
 Neutrophil count decreased | 0 | 0 | 1 (11.1) | 3 (33.3) |
 Platelet count decreased | 0 | 1 (12.5) | 2 (22.2) | 3 (33.3) |
 White blood cell count decreased | 6 (75.0) | 6 (75.0) | 3 (33.3) | 5 (55.6) |
Metabolism and nutrition disorders | ||||
 Decreased appetite | 3 (37.5) | 0 | 0 | 0 |
 Hypokalemia | 3 (37.5) | 0 | 1 (11.1) | 0 |
 Hypophosphatemia | 2 (25.0) | 0 | 0 | 0 |