Treatment-emergent AEs during cycles 1 and 2, and the entire phase 2 study regardless of relation to study treatment
| Preferred term, n (%) . | IV decitabine cycle 1 or 2 (n = 75) . | Oral cedazuridine/decitabine cycle 1 or 2 (n =78) . | All oral cedazuridine/decitabine cycles (n = 78) . |
|---|---|---|---|
| Patients with ≥1 TEAE | 69 (92) | 72 (92) | 75 (96) |
| Most common TEAEs (≥20% of patients) | |||
| Neutropenia | 22 (29) | 17 (22) | 36 (46) |
| Thrombocytopenia | 24 (32) | 23 (29) | 34 (44) |
| Fatigue | 10 (13) | 15 (19) | 26 (33) |
| Febrile neutropenia | 12 (16) | 9 (12) | 23 (29) |
| Nausea | 11 (15) | 13 (17) | 22 (28) |
| Diarrhea | 9 (12) | 10 (13) | 22 (28) |
| Leukopenia | 9 (12) | 10 (13) | 21 (27) |
| Dizziness | 8 (11) | 9 (12) | 20 (26) |
| Anemia | 11 (15) | 10 (13) | 19 (24) |
| Constipation | 12 (16) | 14 (18) | 19 (24) |
| Dyspnea | 2 (3) | 12 (15) | 19 (24) |
| Patients with grade ≥3 TEAEs | 44 (59) | 45 (58) | 65 (83) |
| Most common grade ≥3 TEAEs (≥10% of patients) | |||
| Neutropenia | 20 (27) | 16 (21) | 36 (46) |
| Thrombocytopenia | 21 (28) | 18 (23) | 30 (38) |
| Febrile neutropenia | 12 (16) | 9 (12) | 23 (29) |
| Leukopenia | 8 (11) | 7 (9) | 19 (24) |
| Anemia | 9 (12) | 9 (12) | 17 (22) |
| Pneumonia | 5 (7) | 7 (9) | 10 (13) |
| Sepsis | 1 (1) | 4 (5) | 8 (10) |
| Preferred term, n (%) . | IV decitabine cycle 1 or 2 (n = 75) . | Oral cedazuridine/decitabine cycle 1 or 2 (n =78) . | All oral cedazuridine/decitabine cycles (n = 78) . |
|---|---|---|---|
| Patients with ≥1 TEAE | 69 (92) | 72 (92) | 75 (96) |
| Most common TEAEs (≥20% of patients) | |||
| Neutropenia | 22 (29) | 17 (22) | 36 (46) |
| Thrombocytopenia | 24 (32) | 23 (29) | 34 (44) |
| Fatigue | 10 (13) | 15 (19) | 26 (33) |
| Febrile neutropenia | 12 (16) | 9 (12) | 23 (29) |
| Nausea | 11 (15) | 13 (17) | 22 (28) |
| Diarrhea | 9 (12) | 10 (13) | 22 (28) |
| Leukopenia | 9 (12) | 10 (13) | 21 (27) |
| Dizziness | 8 (11) | 9 (12) | 20 (26) |
| Anemia | 11 (15) | 10 (13) | 19 (24) |
| Constipation | 12 (16) | 14 (18) | 19 (24) |
| Dyspnea | 2 (3) | 12 (15) | 19 (24) |
| Patients with grade ≥3 TEAEs | 44 (59) | 45 (58) | 65 (83) |
| Most common grade ≥3 TEAEs (≥10% of patients) | |||
| Neutropenia | 20 (27) | 16 (21) | 36 (46) |
| Thrombocytopenia | 21 (28) | 18 (23) | 30 (38) |
| Febrile neutropenia | 12 (16) | 9 (12) | 23 (29) |
| Leukopenia | 8 (11) | 7 (9) | 19 (24) |
| Anemia | 9 (12) | 9 (12) | 17 (22) |
| Pneumonia | 5 (7) | 7 (9) | 10 (13) |
| Sepsis | 1 (1) | 4 (5) | 8 (10) |
TEAEs were coded using Medical Dictionary for Regulatory Activities, version 21.0, and are presented in decreasing incidence for entire phase 2 study; patients received IV decitabine or oral cedazuridine/decitabine in cycles 1 and 2, and then received oral cedazuridine/decitabine in all subsequent cycles.
TEAE, treatment-emergent adverse events.