Table 2.
Treatment-emergent adverse events of any grade occurring in more than 25% of patients
| Adverse event (N = 145) | Venetoclax 400 mg (n = 60) | Venetoclax 800 mg (n = 74) | Venetoclax 1200 mg (n = 11) | Total (N = 145) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DEC (n = 31) | AZA (n = 29) | DEC (n = 37) | AZA (n = 37) | DEC (n = 5) | AZA (n = 6) | |||||||||
| Any grade | Gr3/4 | Any grade | Gr3/4 | Any grade | Gr3/4 | Any grade | Gr3/4 | Any grade | Gr3/4 | Any grade | Gr3/4 | Any grade | Gr3/4 | |
| Any event, n (%) | 31 (100) | 24 (77) | 29 (100) | 25 (86) | 37 (100) | 34 (92) | 37 (100) | 30 (81) | 5 (100) | 4 (80) | 6 (100) | 5 (83) | 145 (100) | 122 (84) |
| Nausea | 17 (55) | 0 | 18 (62) | 1 (3) | 23 (62) | 1 (3) | 23 (62) | 0 | 4 (80) | 0 | 3 (50) | 0 | 88 (61) | 2 (1) |
| Diarrhea | 13 (42) | 2 (6) | 15 (52) | 1 (3) | 22 (60) | 2 (5) | 18 (49) | 2 (5) | 4 (80) | 0 | 4 (67) | 0 | 76 (52) | 7 (5) |
| Constipation | 14 (45) | 0 | 17 (59) | 2 (7) | 15 (41) | 0 | 18 (49) | 0 | 2 (40) | 0 | 4 (67) | 0 | 70 (48) | 2 (1) |
| Febrile neutropenia | 19 (61) | 19 (61) | 11 (38) | 11 (38) | 15 (41) | 15 (41) | 13 (35) | 13 (35) | 2 (40) | 2 (40) | 3 (50) | 3 (50) | 63 (43) | 63 (43) |
| Fatigue | 12 (39) | 3 (10) | 10 (34) | 0 | 13 (35) | 3 (8) | 13 (35) | 1 (3) | 4 (80) | 1 (20) | 2 (33) | 0 | 54 (37) | 8 (6) |
| Hypokalemia | 10 (32) | 4 (13) | 5 (17) | 2 (7) | 17 (46) | 5 (14) | 11 (30) | 3 (8) | 3 (60) | 1 (20) | 3 (50) | 0 | 49 (34) | 15 (10) |
| Decreased appetite | 8 (26) | 0 | 8 (28) | 1 (3) | 13 (35) | 1 (3) | 14 (38) | 1 (3) | 3 (60) | 0 | 2 (33) | 0 | 48 (33) | 3 (2) |
| Decreased WBC count | 13 (42) | 13 (42) | 7 (24) | 7 (24) | 10 (27) | 10 (27) | 12 (32) | 12 (32) | 2 (40) | 2 (40) | 1 (17) | 1 (17) | 45 (31) | 45 (31) |
| Vomiting | 10 (32) | 0 | 9 (31) | 0 | 10 (27) | 0 | 10 (27) | 0 | 3 (60) | 0 | 2 (33) | 0 | 44 (30) | 0 |
| Anemia | 7 (23) | 7 (23) | 9 (31) | 9 (31) | 11 (30) | 10 (27) | 11 (30) | 9 (24) | 2 (40) | 1 (20) | 0 | 0 | 40 (28) | 36 (25) |
| Cough | 10 (32) | 0 | 6 (21) | 0 | 11 (30) | 0 | 10 (27) | 0 | 2 (40) | 0 | 2 (33) | 0 | 41 (28) | 0 |
| Peripheral edema | 7 (23) | 0 | 10 (34) | 0 | 12 (32) | 0 | 10 (27) | 0 | 1 (20) | 0 | 1 (17) | 0 | 41 (28) | 0 |