Overall safety profile, and most common any-grade and grade ≥3 TEAEs occurring in ≥10% (any grade) or ≥10% (grade ≥3) of patients in the safety population
| . | Pevonedistat+ azacitidine n = 223 . | Azacitidine alone n = 220 . |
|---|---|---|
| Incidence of TEAEs, n (%) | ||
| Any TEAE | 221 (99) | 219 (100) |
| Any drug-related TEAE | 179 (80) | 173 (79) |
| Any grade ≥3 TEAE | 200 (90) | 191 (87) |
| Any drug-related grade ≥3 TEAE | 130 (58) | 121 (55) |
| Any serious TEAE | 153 (69) | 142 (65) |
| Any drug-related serious TEAE | 58 (26) | 50 (23) |
| TEAE leading to discontinuation, n (%) | 67 (30) | 57 (26) |
| On-study deaths, n (%) | 38 (17) | 36 (16) |
| Most common any-grade TEAEs (≥10% of patients) | ||
| Constipation | 82 (37) | 90 (41) |
| Anemia | 83 (37) | 84 (38) |
| Neutropenia | 73 (33) | 77 (35) |
| Thrombocytopenia | 74 (33) | 76 (35) |
| Nausea | 78 (35) | 64 (29) |
| Pyrexia | 58 (26) | 64 (29) |
| Diarrhea | 63 (28) | 52 (24) |
| Vomiting | 51 (23) | 46 (21) |
| Febrile neutropenia | 51 (23) | 44 (20) |
| Asthenia | 36 (16) | 42 (19) |
| Pneumonia | 39 (17) | 38 (17) |
| Fatigue | 41 (18) | 33 (15) |
| Cough | 39 (17) | 25 (11) |
| Decreased appetite | 39 (17) | 25 (11) |
| Edema peripheral | 29 (13) | 30 (14) |
| Platelet count decreased | 33 (15) | 21 (10) |
| Dyspnea | 26 (12) | 26 (12) |
| Arthralgia | 27 (12) | 24 (11) |
| Neutrophil count decreased | 33 (15) | 18 (8) |
| Hypokalemia | 29 (13) | 19 (9) |
| Headache | 26 (12) | 20 (9) |
| Most common grade ≥3 AEs (≥5% of patients) | ||
| Anemia | 73 (33) | 75 (34) |
| Neutropenia | 70 (31) | 72 (33) |
| Thrombocytopenia | 67 (30) | 66 (30) |
| Febrile neutropenia | 51 (23) | 44 (20) |
| Pneumonia | 33 (15) | 32 (15) |
| Neutrophil count decreased | 33 (15) | 17 (8) |
| Platelet count decreased | 25 (11) | 16 (7) |
| White blood cell count decreased | 11 (5) | 11 (5) |
| Leukopenia | 10 (4) | 13 (6) |
| . | Pevonedistat+ azacitidine n = 223 . | Azacitidine alone n = 220 . |
|---|---|---|
| Incidence of TEAEs, n (%) | ||
| Any TEAE | 221 (99) | 219 (100) |
| Any drug-related TEAE | 179 (80) | 173 (79) |
| Any grade ≥3 TEAE | 200 (90) | 191 (87) |
| Any drug-related grade ≥3 TEAE | 130 (58) | 121 (55) |
| Any serious TEAE | 153 (69) | 142 (65) |
| Any drug-related serious TEAE | 58 (26) | 50 (23) |
| TEAE leading to discontinuation, n (%) | 67 (30) | 57 (26) |
| On-study deaths, n (%) | 38 (17) | 36 (16) |
| Most common any-grade TEAEs (≥10% of patients) | ||
| Constipation | 82 (37) | 90 (41) |
| Anemia | 83 (37) | 84 (38) |
| Neutropenia | 73 (33) | 77 (35) |
| Thrombocytopenia | 74 (33) | 76 (35) |
| Nausea | 78 (35) | 64 (29) |
| Pyrexia | 58 (26) | 64 (29) |
| Diarrhea | 63 (28) | 52 (24) |
| Vomiting | 51 (23) | 46 (21) |
| Febrile neutropenia | 51 (23) | 44 (20) |
| Asthenia | 36 (16) | 42 (19) |
| Pneumonia | 39 (17) | 38 (17) |
| Fatigue | 41 (18) | 33 (15) |
| Cough | 39 (17) | 25 (11) |
| Decreased appetite | 39 (17) | 25 (11) |
| Edema peripheral | 29 (13) | 30 (14) |
| Platelet count decreased | 33 (15) | 21 (10) |
| Dyspnea | 26 (12) | 26 (12) |
| Arthralgia | 27 (12) | 24 (11) |
| Neutrophil count decreased | 33 (15) | 18 (8) |
| Hypokalemia | 29 (13) | 19 (9) |
| Headache | 26 (12) | 20 (9) |
| Most common grade ≥3 AEs (≥5% of patients) | ||
| Anemia | 73 (33) | 75 (34) |
| Neutropenia | 70 (31) | 72 (33) |
| Thrombocytopenia | 67 (30) | 66 (30) |
| Febrile neutropenia | 51 (23) | 44 (20) |
| Pneumonia | 33 (15) | 32 (15) |
| Neutrophil count decreased | 33 (15) | 17 (8) |
| Platelet count decreased | 25 (11) | 16 (7) |
| White blood cell count decreased | 11 (5) | 11 (5) |
| Leukopenia | 10 (4) | 13 (6) |