Table 2.
AEs reported in 5% or more subjects and any SAEs
| Enarodustat treatment |
|||
|---|---|---|---|
| correction group (n = 94) |
conversion group (n = 103) |
total (n = 197) |
|
| AEs (≥5% subjects),n (%) | |||
| Any AEs | 71 (75.5) | 78 (75.7) | 149 (75.6) |
| Nasopharyngitis | 26 (27.7) | 25 (24.3) | 51 (25.9) |
| Hypertension | 8 (8.5) | 5 (4.9) | 13 (6.6) |
| Hyperkalemia | 3 (3.2) | 6 (5.8) | 9 (4.6) |
| Constipation | 5 (5.3) | 3 (2.9) | 8 (4.1) |
| Serious AEs,n (%) | |||
| Peripheral arterial occlusive disease | 1 (1.1)a | 0 (0.0) | 1 (0.5) |
| Inguinal hernia | 1 (1.1) | 0 (0.0) | 1 (0.5) |
| Aortic dissection | 1 (1.1)b | 0 (0.0) | 1 (0.5) |
| Large intestine polyp | 1 (1.1) | 0 (0.0) | 1 (0.5) |
| Colon cancer | 1 (1.1) | 0 (0.0) | 1 (0.5) |
| Cardiac failure congestive | 1 (1.1)b | 0 (0.0) | 1 (0.5) |
| Edema peripheral | 0 (0.0) | 1 (1.0) | 1 (0.5) |
| Enterocolitis | 0 (0.0) | 1 (1.0) | 1 (0.5) |
| Loss of consciousness | 0 (0.0) | 1 (1.0) | 1 (0.5) |
| Retinal detachment | 0 (0.0) | 1 (1.0)a | 1 (0.5) |
| Renal cyst infection | 0 (0.0) | 1 (1.0)a | 1 (0.5) |
| Meniscus injury | 0 (0.0) | 1 (1.0) | 1 (0.5) |
| Bone cancer | 0 (0.0) | 1 (1.0)c | 1 (0.5) |
| Bronchitis bacterial | 0 (0.0) | 1 (1.0)a, d | 1 (0.5) |
| Pancreatitis acute | 0 (0.0) | 1 (1.0) | 1 (0.5) |
| Pyelonephritis | 0 (0.0) | 1 (1.0) | 1 (0.5) |
| Sepsis | 0 (0.0) | 1 (1.0) | 1 (0.5) |
| Postrenal failure | 0 (0.0) | 1 (1.0) | 1 (0.5) |
| Atrioventricular block complete | 0 (0.0) | 1 (1.0) | 1 (0.5) |
| Sarcoidosis | 0 (0.0) | 1 (1.0) | 1 (0.5) |
| Deep vein thrombosis | 0 (0.0) | 1 (1.0)b, c | 1 (0.5) |
a
Serious AE reported in Period 1.
b
Serious AE requiring discontinuation of study treatment.
c
Serious AEs judged by the principal investigator to be causally related to the study drug.
d
During the study, the name of one participant's adverse event reported was changed from bronchitis to bronchitis bacterial.
AE, adverse event; SAEs, serious AEs.