Table 3.
Summary of treatment-emergent adverse events, adverse events with a frequency of ≥3%, and occurrences of increased serum potassium
| Category of Adverse Events | Placebo, n=229a | Esaxerenone 1.25–2.5 mg/d, n=226a |
|---|---|---|
| Total number of treatment-emergent adverse events | 528 | 530 |
| Patients with at least one treatment-emergent adverse event | 177 (77) | 177 (78) |
| Patients with at least one drug-related treatment-emergent adverse event | 16 (7) | 44 (19) |
| Patients with at least one serious treatment-emergent adverse event | 24 (10) | 18 (8) |
| Patients with at least one drug-related serious treatment-emergent adverse event | 0 (0) | 0 (0) |
| Patients with at least one severe treatment-emergent adverse event | 6 (3) | 8 (4) |
| Patients with at least one drug-related severe treatment-emergent adverse event | 0 (0) | 0 (0) |
| Patients who discontinued from study treatment due to a treatment-emergent adverse event | 8 (3) | 21 (9) |
| Patients who discontinued study treatment due to a drug-related treatment-emergent adverse event | 2 (1) | 13 (6) |
| Patients who died | 0 (0) | 1 (0.4) |
| Patients who died due to a drug-related treatment-emergent adverse event | 0 (0) | 0 (0) |
| Frequent adverse events (>3%) | ||
| Influenza | 10 (4) | 15 (7) |
| Viral upper respiratory tract infection | 61 (27) | 66 (29) |
| Hyperuricemia | 6 (3) | 7 (3) |
| Cataract | 11 (5) | 3 (1) |
| Upper respiratory tract inflammation | 9 (4) | 14 (6) |
| Abdominal discomfort | 9 (4) | 6 (3) |
| Constipation | 7 (3) | 6 (3) |
| Back pain | 13 (6) | 12 (5) |
| Blood creatinine increased | 3 (1) | 7 (3) |
| Blood potassium increased | 5 (2) | 27 (12) |
| Contusion | 8 (3) | 7 (3) |
| Increased serum potassium | ||
| Serum potassium ≥6.0 or ≥5.5 mEq/L on two consecutive measurements | 5 (2) | 20 (9) |
| Population with serum potassium ≥4.5 mEq/L at baseline | 4/87 (5) | 13/94 (14) |
| Population with serum potassium <4.5 mEq/L at baseline | 1/142 (1) | 7/132 (5) |
| Population with eGFR <60 ml/min per 1.73 m2 at baseline | 5/75 (7) | 14/73 (19) |
| Population with eGFR ≥60 ml/min per 1.73 m2 at baseline | 0/154 (0) | 6/153 (4) |
| Discontinuation due to increased serum potassium | 1 (0.4) | 10 (4) |
Data are n (%).
a
These values are the denominator for percentage calculations unless stated otherwise.