Adverse events
| Adverse event∗ . | All patients N = 50 . | Arm A: ENA + AZA n = 27 . | Arm B: ENA n = 23 . | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Grade 1/2 . | Grade 3/4 . | Total (%) . | Grade 1/2 . | Grade 3/4 . | Total (%) . | Grade 1/2 . | Grade 3/4 . | Total (%) . | |
| Neutropenia | 1 | 19 | 20 (40) | — | 17 | 17 (63) | 1 | 2 | 3 (13) |
| Nausea | 17 | 1 | 18 (36) | 14 | 1 | 15 (56) | 3 | — | 3 (13) |
| Constipation | 16 | 0 | 16 (32) | 15 | — | 15 (56) | 1 | — | 1 (4) |
| Fatigue | 11 | 2 | 13 (26) | 3 | 1 | 4 (15) | 8 | 1 | 9 (39) |
| Thrombocytopenia | 0 | 11 | 11 (22) | — | 11 | 11 (40) | — | — | — |
| Differentiation syndrome | 3 | 5 | 8 (16) | 2 | 1 | 3 (11) | 1 | 4 | 5 (22) |
| Hyperbilirubinemia | 3 | 4 | 7 (14) | 1 | 4 | 5 (19) | 2 | — | 2 (9) |
| Anemia | 2 | 3 | 5 (10) | 1 | 3 | 4 (15) | 1 | — | 1 (4) |
| Leukopenia | 0 | 4 | 4 (8) | — | 4 | 4 (15) | — | — | — |
| Rash | 4 | 0 | 4 (8) | 1 | — | 1 (4) | 3 | — | 3 (13) |
| Vomiting | 3 | 1 | 4 (8) | 3 | 1 | 4 (15) | — | — | — |
| Diarrhea | 2 | 1 | 3 (6) | 2 | 1 | 3 (11) | — | — | — |
| Elevated alkaline phosphatase | 3 | 0 | 3 (6) | 2 | — | 2 (7) | 1 | — | 1 (4) |
| Elevated LFT | 2 | 1 | 3 (6) | 1 | — | 1 (4) | 1 | 1 | 2 (9) |
| Febrile neutropenia | 0 | 3 | 3 (6) | — | 3 | 3 (11) | — | — | — |
| Anorexia | 2 | 0 | 2 (4) | 2 | — | 2 (7) | — | — | — |
| Bruising | 2 | 0 | 2 (4) | 2 | — | 2 (7) | — | — | — |
| Dysgeusia | 2 | 0 | 2 (4) | 1 | — | 1 (4) | 1 | — | 1 (4) |
| Dermatitis | 2 | 0 | 2 (4) | 2 | — | 2 (7) | — | — | — |
| Weight loss | 2 | 0 | 2 (4) | 1 | — | 1 (4) | 1 | — | 1 (4) |
| Adverse event∗ . | All patients N = 50 . | Arm A: ENA + AZA n = 27 . | Arm B: ENA n = 23 . | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Grade 1/2 . | Grade 3/4 . | Total (%) . | Grade 1/2 . | Grade 3/4 . | Total (%) . | Grade 1/2 . | Grade 3/4 . | Total (%) . | |
| Neutropenia | 1 | 19 | 20 (40) | — | 17 | 17 (63) | 1 | 2 | 3 (13) |
| Nausea | 17 | 1 | 18 (36) | 14 | 1 | 15 (56) | 3 | — | 3 (13) |
| Constipation | 16 | 0 | 16 (32) | 15 | — | 15 (56) | 1 | — | 1 (4) |
| Fatigue | 11 | 2 | 13 (26) | 3 | 1 | 4 (15) | 8 | 1 | 9 (39) |
| Thrombocytopenia | 0 | 11 | 11 (22) | — | 11 | 11 (40) | — | — | — |
| Differentiation syndrome | 3 | 5 | 8 (16) | 2 | 1 | 3 (11) | 1 | 4 | 5 (22) |
| Hyperbilirubinemia | 3 | 4 | 7 (14) | 1 | 4 | 5 (19) | 2 | — | 2 (9) |
| Anemia | 2 | 3 | 5 (10) | 1 | 3 | 4 (15) | 1 | — | 1 (4) |
| Leukopenia | 0 | 4 | 4 (8) | — | 4 | 4 (15) | — | — | — |
| Rash | 4 | 0 | 4 (8) | 1 | — | 1 (4) | 3 | — | 3 (13) |
| Vomiting | 3 | 1 | 4 (8) | 3 | 1 | 4 (15) | — | — | — |
| Diarrhea | 2 | 1 | 3 (6) | 2 | 1 | 3 (11) | — | — | — |
| Elevated alkaline phosphatase | 3 | 0 | 3 (6) | 2 | — | 2 (7) | 1 | — | 1 (4) |
| Elevated LFT | 2 | 1 | 3 (6) | 1 | — | 1 (4) | 1 | 1 | 2 (9) |
| Febrile neutropenia | 0 | 3 | 3 (6) | — | 3 | 3 (11) | — | — | — |
| Anorexia | 2 | 0 | 2 (4) | 2 | — | 2 (7) | — | — | — |
| Bruising | 2 | 0 | 2 (4) | 2 | — | 2 (7) | — | — | — |
| Dysgeusia | 2 | 0 | 2 (4) | 1 | — | 1 (4) | 1 | — | 1 (4) |
| Dermatitis | 2 | 0 | 2 (4) | 2 | — | 2 (7) | — | — | — |
| Weight loss | 2 | 0 | 2 (4) | 1 | — | 1 (4) | 1 | — | 1 (4) |
LFT, liver function test.
Values are presented as n or n (%).