Events occurring in ≥20% of patients in either treatment group
| AE . | GIL + AZA (n = 73) . | AZA (n = 47) . | ||
|---|---|---|---|---|
| All grades . | Grade ≥ 3∗ . | All grades . | Grade ≥ 3∗ . | |
| Overall | 73 (100.0) | 70 (95.9) | 43 (91.5) | 42 (89.4) |
| Pyrexia | 35 (47.9) | 7 (9.6) | 16 (34.0) | 0 |
| Diarrhea | 28 (38.4) | 5 (6.8) | 8 (17.0) | 0 |
| Febrile neutropenia | 26 (35.6) | 26 (35.6) | 10 (21.3) | 9 (19.1) |
| Constipation | 25 (34.2) | 0 | 10 (21.3) | 0 |
| Nausea | 24 (32.9) | 1 (1.4) | 10 (21.3) | 1 (2.1) |
| Anemia | 23 (31.5) | 18 (24.7) | 16 (34.0) | 13 (27.7) |
| Thrombocytopenia | 22 (30.1) | 20 (27.4) | 11 (23.4) | 9 (19.1) |
| Pneumonia | 19 (26.0) | 15 (20.5) | 8 (17.0) | 8 (17.0) |
| Neutropenia | 18 (24.7) | 16 (21.9) | 13 (27.7) | 10 (21.3) |
| Aspartate aminotransferase increased | 18 (24.7) | 4 (5.5) | 3 (6.4) | 0 |
| Vomiting | 18 (24.7) | 2 (2.7) | 8 (17.0) | 0 |
| Asthenia | 17 (23.3) | 5 (6.8) | 7 (14.9) | 0 |
| Edema peripheral | 16 (21.9) | 0 | 5 (10.6) | 0 |
| Hypokalemia | 16 (21.9) | 6 (8.2) | 10 (21.3) | 4 (8.5) |
| Decreased appetite | 15 (20.5) | 3 (4.1) | 7 (14.9) | 1 (2.1) |
| Neutrophil count decreased | 14 (19.2) | 14 (19.2) | 4 (8.5) | 4 (8.5) |
| Platelet count decreased | 14 (19.2) | 13 (17.8) | 9 (19.1) | 9 (19.1) |
| Hyponatremia | 14 (19.2) | 9 (12.3) | 3 (6.4) | 1 (2.1) |
| Sepsis | 4 (5.5) | 4 (5.5) | 5 (10.6) | 5 (10.6) |
| AE . | GIL + AZA (n = 73) . | AZA (n = 47) . | ||
|---|---|---|---|---|
| All grades . | Grade ≥ 3∗ . | All grades . | Grade ≥ 3∗ . | |
| Overall | 73 (100.0) | 70 (95.9) | 43 (91.5) | 42 (89.4) |
| Pyrexia | 35 (47.9) | 7 (9.6) | 16 (34.0) | 0 |
| Diarrhea | 28 (38.4) | 5 (6.8) | 8 (17.0) | 0 |
| Febrile neutropenia | 26 (35.6) | 26 (35.6) | 10 (21.3) | 9 (19.1) |
| Constipation | 25 (34.2) | 0 | 10 (21.3) | 0 |
| Nausea | 24 (32.9) | 1 (1.4) | 10 (21.3) | 1 (2.1) |
| Anemia | 23 (31.5) | 18 (24.7) | 16 (34.0) | 13 (27.7) |
| Thrombocytopenia | 22 (30.1) | 20 (27.4) | 11 (23.4) | 9 (19.1) |
| Pneumonia | 19 (26.0) | 15 (20.5) | 8 (17.0) | 8 (17.0) |
| Neutropenia | 18 (24.7) | 16 (21.9) | 13 (27.7) | 10 (21.3) |
| Aspartate aminotransferase increased | 18 (24.7) | 4 (5.5) | 3 (6.4) | 0 |
| Vomiting | 18 (24.7) | 2 (2.7) | 8 (17.0) | 0 |
| Asthenia | 17 (23.3) | 5 (6.8) | 7 (14.9) | 0 |
| Edema peripheral | 16 (21.9) | 0 | 5 (10.6) | 0 |
| Hypokalemia | 16 (21.9) | 6 (8.2) | 10 (21.3) | 4 (8.5) |
| Decreased appetite | 15 (20.5) | 3 (4.1) | 7 (14.9) | 1 (2.1) |
| Neutrophil count decreased | 14 (19.2) | 14 (19.2) | 4 (8.5) | 4 (8.5) |
| Platelet count decreased | 14 (19.2) | 13 (17.8) | 9 (19.1) | 9 (19.1) |
| Hyponatremia | 14 (19.2) | 9 (12.3) | 3 (6.4) | 1 (2.1) |
| Sepsis | 4 (5.5) | 4 (5.5) | 5 (10.6) | 5 (10.6) |
Including AEs of grade ≥3 severity occurring in at least 10% of patients in either treatment group.