Table 1.
Summary of AEs by MedDRA SOC.
| AE, n (%) | All-grade AEs, ≥ 20% of total patients | Grade ≥ 3 AEs, ≥ 20% of total patients | SAEs, ≥ 10% of total patients | |||
|---|---|---|---|---|---|---|
| VEN + LDAC (n = 142) | PBO + LDAC (n = 68) | VEN + LDAC (n = 142) | PBO + LDAC (n = 68) | VEN + LDAC (n = 142) | PBO + LDAC (n = 68) | |
| Any | 141 (99) | 67 (99) | 138 (97) | 65 (96) | 95 (67) | 42 (62) |
| Hematologic | 115 (81) | 51 (75) | 111 (78) | 50 (74) | 33 (23) | 16 (24) |
| Neutropenia | 69 (49) | 12 (18) | 69 (49) | 12 (18) | 4 (3) | 0 |
| Thrombocytopenia | 65 (46) | 27 (40) | 65 (46) | 26 (38) | 7 (5) | 2 (3) |
| Febrile neutropenia | 46 (32) | 20 (29) | 46 (32) | 20 (29) | 24 (17) | 12 (18) |
| Anemia | 41 (29) | 15 (22) | 38 (27) | 15 (22) | 4 (3) | 0 |
| Gastrointestinal disorders | 106 (75) | 47 (69) | 19 (13) | 6 (9) | 10 (7) | 1 (1) |
| Nausea | 61 (43) | 21 (31) | 2 (1) | 0 | 0 | 0 |
| Diarrhea | 47 (33) | 12 (18) | 4 (3) | 0 | 1 (1) | 0 |
| Vomiting | 41 (29) | 10 (15) | 1 (1) | 0 | 0 | 0 |
| Constipation | 29 (20) | 22 (32) | 1 (1) | 0 | 0 | 0 |
| Metabolism and nutrition disorders | 87 (61) | 40 (59) | 40 (28) | 22 (32) | 5 (4) | 0 |
| Hypokalemia | 44 (31) | 17 (25) | 17 (12) | 11 (16) | 0 | 0 |
| Decreased appetite | 31 (22) | 13 (19) | 2 (1) | 0 | 1 (1) | 0 |
| Infections | 92 (65) | 41 (60) | 61 (43) | 34 (50) | 53 (37) | 25 (37) |
| Pneumonia | 31 (22) | 11 (16) | 25 (18) | 11 (16) | 20 (14) | 7 (10) |
AE adverse event, LDAC low-dose cytarabine, MedDRA SOC medical dictionary for regulatory activities system organ class, PBO placebo, SAE, serious AE, VEN venetoclax.