Safety summary
Patients, n (%) . | Magrolimab, venetoclax, and azacitidine (n = 189) . | Placebo, venetoclax, and azacitidine (n = 184) . |
---|---|---|
Any TEAE | 188 (99.5) | 184 (100) |
Related to any study drug | 177 (93.7) | 162 (88.0) |
Any grade ≥3 TEAE | 184 (97.4) | 179 (97.3) |
Related to any study drug | 160 (84.7) | 144 (78.3) |
Any serious TEAE | 138 (73.0) | 134 (72.8) |
Related to any study drug | 87 (46.0) | 72 (39.1) |
Any TEAE leading to discontinuation of any study drug | 36 (19.0) | 30 (16.3) |
Leading to discontinuation of magro/PBO | 32 (16.9) | 29 (15.8) |
Leading to discontinuation of AZA | 25 (13.2) | 25 (13.6) |
Leading to discontinuation of VEN | 29 (15.3) | 26 (14.1) |
Any TEAE leading to dose reduction of any study drug | 37 (19.6) | 30 (16.3) |
Leading to dose reduction of magro/PBO | 3 (1.6) | 1 (0.5) |
Leading to dose reduction of AZA | 25 (13.2) | 18 (9.8) |
Leading to dose reduction of VEN | 24 (12.7) | 13 (7.1) |
Any TEAE leading to dose delay or missed dose of any study drug | 110 (58.2) | 114 (62.0) |
Any TEAE leading to drug interruption of any study drug | 140 (74.1) | 132 (71.7) |
Leading to drug interruption of magro/PBO | 71 (37.6) | 59 (32.1) |
Leading to drug interruption of AZA | 77 (40.7) | 91 (49.5) |
Leading to drug interruption of VEN | 128 (67.7) | 124 (67.4) |
Any TEAE leading to death | 36 (19.0) | 21 (11.4) |
All deaths | 84 (44.4) | 69 (37.5) |
Within 30 days of the first study drug | 13 (6.9) | 8 (4.3) |
Within 60 days of the first study drug | 28 (14.8) | 18 (9.8) |
Patients, n (%) . | Magrolimab, venetoclax, and azacitidine (n = 189) . | Placebo, venetoclax, and azacitidine (n = 184) . |
---|---|---|
Any TEAE | 188 (99.5) | 184 (100) |
Related to any study drug | 177 (93.7) | 162 (88.0) |
Any grade ≥3 TEAE | 184 (97.4) | 179 (97.3) |
Related to any study drug | 160 (84.7) | 144 (78.3) |
Any serious TEAE | 138 (73.0) | 134 (72.8) |
Related to any study drug | 87 (46.0) | 72 (39.1) |
Any TEAE leading to discontinuation of any study drug | 36 (19.0) | 30 (16.3) |
Leading to discontinuation of magro/PBO | 32 (16.9) | 29 (15.8) |
Leading to discontinuation of AZA | 25 (13.2) | 25 (13.6) |
Leading to discontinuation of VEN | 29 (15.3) | 26 (14.1) |
Any TEAE leading to dose reduction of any study drug | 37 (19.6) | 30 (16.3) |
Leading to dose reduction of magro/PBO | 3 (1.6) | 1 (0.5) |
Leading to dose reduction of AZA | 25 (13.2) | 18 (9.8) |
Leading to dose reduction of VEN | 24 (12.7) | 13 (7.1) |
Any TEAE leading to dose delay or missed dose of any study drug | 110 (58.2) | 114 (62.0) |
Any TEAE leading to drug interruption of any study drug | 140 (74.1) | 132 (71.7) |
Leading to drug interruption of magro/PBO | 71 (37.6) | 59 (32.1) |
Leading to drug interruption of AZA | 77 (40.7) | 91 (49.5) |
Leading to drug interruption of VEN | 128 (67.7) | 124 (67.4) |
Any TEAE leading to death | 36 (19.0) | 21 (11.4) |
All deaths | 84 (44.4) | 69 (37.5) |
Within 30 days of the first study drug | 13 (6.9) | 8 (4.3) |
Within 60 days of the first study drug | 28 (14.8) | 18 (9.8) |
AZA, azacitidine; Magro, magrolimab; PBO, placebo; VEN, venetoclax.