Table 3.
Summary of treatment-emergent adverse events
| Category of Treatment-Emergent Adverse Events | Placebo, n=72 | Esaxerenone 0.625 mg/d, n=71 | Esaxerenone 1.25 mg/d, n=72 | Esaxerenone 2.5 mg/d, n=70 | Esaxerenone 5 mg/d, n=73 | All, n=358 |
|---|---|---|---|---|---|---|
| Participants with at least one treatment-emergent adverse event | 40 (56) | 38 (54) | 50 (69) | 47 (67) | 47 (64) | 222 (62) |
| Participants with at least one drug-related treatment-emergent adverse event | 8 (11) | 6 (9) | 11 (15) | 9 (13) | 21 (29) | 55 (15) |
| Participants with at least one serious treatment-emergent adverse event | 0 (0) | 0 (0) | 1 (1) | 1 (1) | 1 (1) | 3 (0.8) |
| Participants with at least one drug-related serious treatment-emergent adverse event | 0 (0) | 0 (0) | 0 (0) | 1 (1) | 0 (0) | 1 (0.3) |
| Participants who discontinued treatment because of a treatment-emergent adverse event | 2 (3) | 2 (3) | 3 (4) | 3 (4) | 11 (15) | 21 (6) |
| Participants who discontinued treatment because of a drug-related treatment-emergent adverse event | 0 (0) | 1 (1) | 1 (1) | 3 (4) | 9 (12) | 14 (4) |
| Participants who discontinued treatment because of increased serum K+ (≥6.0 mEq/L or two consecutive measurements of ≥5.5 mEq/L) | 1 (1) | 2 (3) | 2 (3) | 2 (3) | 7 (10) | 14 (4) |
| Treatment-emergent adverse events reported in ≥3% of participants | ||||||
| Nasopharyngitis | 9 (13) | 11 (16) | 15 (21) | 15 (21) | 11 (15) | 61 (17) |
| Dizziness postural | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 4 (6) | 4 (1) |
| Upper respiratory tract inflammation | 1 (1) | 2 (3) | 0 (0) | 2 (3) | 3 (4) | 8 (2) |
| Abdominal discomfort | 0 (0) | 1 (1) | 3 (4) | 0 (0) | 0 (0) | 4 (1) |
| Nausea | 3 (4) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 3 (0.8) |
| Periodontal disease | 0 (0) | 0 (0) | 3 (4) | 0 (0) | 0 (0) | 3 (0.8) |
| Back pain | 0 (0) | 0 (0) | 3 (4) | 2 (3) | 0 (0) | 5 (1) |
| Blood uric acid increased | 1 (1) | 1 (1) | 3 (4) | 0 (0) | 2 (3) | 7 (2) |
| C-reactive protein increased | 3 (4) | 0 (0) | 0 (0) | 3 (4) | 0 (0) | 6 (2) |
| White blood cell count increased | 1 (1) | 0 (0) | 0 (0) | 3 (4) | 0 (0) | 4 (1) |
| Blood K+ increased | 2 (3) | 2 (3) | 5 (7) | 10 (14) | 15 (21) | 34 (9) |
| Bruises | 1 (1) | 0 (0) | 5 (7) | 2 (3) | 0 (0) | 8 (2) |
| Kidney dysfunction | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 4 (6) | 4 (1) |
Data are n (%). System Organ Classes and Preferred Terms are coded using MedDRA/J version 18.0. The percentage was calculated using the number of participants in the column heading as the denominator. K+, potassium.