Table 3 Commonly reported SAEs and TEAEs
DE cohort | LDAC cohort | Overall | |||||||
|---|---|---|---|---|---|---|---|---|---|
(N = 36) | (N = 36) | (N = 72) | |||||||
n | (%) | E | n | (%) | E | n | (%) | E | |
SAEs reported in ≥ 10% of patients in either cohort | |||||||||
Febrile neutropenia | 6 | (17%) | 7 | 10 | (28%) | 14 | 16 | (22%) | 21 |
Pneumonia | 9 | (25%) | 9 | 5 | (14%) | 6 | 14 | (19%) | 15 |
Lung infection | 4 | (11%) | 4 | 1 | (3%) | 1 | 5 | (7%) | 5 |
Pyrexia | 2 | (6%) | 3 | 4 | (11%) | 4 | 6 | (8%) | 7 |
TEAEs of any grade reported in ≥ 20% of patients in either cohort | |||||||||
Diarrhea | 17 | (47%) | 29 | 17 | (47%) | 34 | 34 | (47%) | 63 |
Nausea | 12 | (33%) | 15 | 15 | (42%) | 29 | 27 | (38%) | 44 |
Electrocardiogram QT prolonged | 9 | (25%) | 20 | 17 | (47%) | 33 | 26 | (36%) | 53 |
Fatigue | 12 | (33%) | 18 | 10 | (28%) | 15 | 22 | (31%) | 33 |
Anemia | 5 | (14%) | 7 | 16 | (44%) | 29 | 21 | (29%) | 36 |
Febrile neutropenia | 10 | (28%) | 11 | 11 | (31%) | 20 | 21 | (29%) | 31 |
Pyrexia | 12 | (33%) | 15 | 8 | (22%) | 9 | 20 | (28%) | 24 |
Hypokalaemia | 10 | (28%) | 12 | 8 | (22%) | 9 | 18 | (25%) | 21 |
Oedema peripheral | 7 | (19%) | 10 | 11 | (31%) | 12 | 18 | (25%) | 22 |
Pneumonia | 10 | (28%) | 10 | 6 | (17%) | 7 | 16 | (22%) | 17 |
Vomiting | 8 | (22%) | 10 | 8 | (22%) | 10 | 16 | (22%) | 20 |
Thrombocytopenia | 5 | (14%) | 8 | 10 | (28%) | 11 | 15 | (21%) | 19 |
Platelet count decreased | 3 | (8%) | 3 | 11 | (31%) | 22 | 14 | (19%) | 25 |
Dyspnoea | 5 | (14%) | 6 | 9 | (25%) | 9 | 14 | (19%) | 15 |
Cough | 9 | (25%) | 10 | 5 | (14%) | 7 | 14 | (19%) | 17 |
Headache | 9 | (25%) | 10 | 4 | (11%) | 5 | 13 | (18%) | 15 |
Constipation | 3 | (8%) | 3 | 9 | (25%) | 10 | 12 | (17%) | 13 |
Mouth hemorrhage | 1 | (3%) | 1 | 8 | (22%) | 9 | 9 | (13%) | 10 |
