Table 1 Overall safety profile, and most common any-grade and grade ≥ 3 TEAEs occurring in ≥10% of patients.
Pevonedistat + azacitidine n = 58 | Azacitidine alone n = 62 | Total N = 120 | |
|---|---|---|---|
AEs, n (%) | |||
Any AE | 57 (98) | 62 (100) | 119 (99) |
Any drug-related AE | 44 (76) | 50 (81) | 94 (78) |
Any grade ≥ 3 AE | 52 (90) | 54 (87) | 106 (88) |
Any drug-related grade ≥3 AE | 26 (45) | 29 (47) | 55 (46) |
Any serious AE | 40 (69) | 39 (63) | 79 (66) |
Any drug-related serious AE | 9 (16) | 10 (16) | 19 (16) |
AE leading to discontinuation, n (%) | 10 (17) | 13 (21) | 23 (19) |
On-study deaths, n (%) | 5 (9) | 10 (16) | 15 (13) |
Most common any-grade AEs (≥10% of patients), n (%) | |||
Constipation | 21 (36) | 29 (47) | 50 (42) |
Nausea | 20 (34) | 28 (45) | 48 (40) |
Pyrexia | 22 (38) | 25 (40) | 47 (39) |
Anemia | 18 (31) | 28 (45) | 46 (38) |
Cough | 22 (38) | 21 (34) | 43 (36) |
Neutropenia | 20 (34) | 18 (29) | 38 (32) |
Fatigue | 12 (21) | 25 (40) | 37 (31) |
Diarrhea | 19 (33) | 17 (27) | 36 (30) |
Febrile neutropenia | 15 (26) | 18 (29) | 33 (28) |
Asthenia | 17 (29) | 12 (19) | 29 (24) |
Dyspnea | 13 (22) | 15 (24) | 28 (23) |
Thrombocytopenia | 14 (24) | 14 (23) | 28 (23) |
Vomiting | 14 (24) | 13 (21) | 27 (23) |
Decreased appetite | 11 (19) | 12 (19) | 23 (19) |
Edema peripheral | 12 (21) | 8 (13) | 20 (17) |
Epistaxis | 13 (22) | 6 (10) | 19 (16) |
Pneumonia | 9 (16) | 10 (16) | 19 (16) |
Back pain | 10 (17) | 8 (13) | 18 (15) |
Neutrophil count decreased | 12 (21) | 6 (10) | 18 (15) |
Arthralgia | 5 (9) | 12 (19) | 17 (14) |
Dizziness | 8 (14) | 8 (13) | 16 (13) |
Hypokalemia | 4 (7) | 11 (18) | 15 (13) |
Abdominal pain | 4 (7) | 10 (16) | 14 (12) |
Fall | 7 (12) | 7 (11) | 14 (12) |
Pain in extremity | 10 (17) | 4 (6) | 14 (12) |
Platelet count decreased | 7 (12) | 7 (11) | 14 (12) |
Insomnia | 6 (10) | 7 (11) | 13 (11) |
Headache | 3 (5) | 9 (15) | 12 (10) |
Most common grade ≥ 3 AEs (≥10% of patients), n (%) | |||
Neutropenia | 19 (33) | 17 (27) | 36 (30) |
Febrile neutropenia | 15 (26) | 18 (29) | 33 (28) |
Anemia | 11 (19) | 17 (27) | 28 (23) |
Thrombocytopenia | 11 (19) | 14 (23) | 25 (21) |
Neutrophil count decreased | 12 (21) | 6 (10) | 18 (15) |
Pneumonia | 7 (12) | 6 (10) | 13 (11) |
