Table 3.
Treatment-emergent adverse events occurring in ≥2% of patients and adverse drug reactions occurring in ≥2 patients in any group (safety analysis set)
| Esaxerenone | ||||
|---|---|---|---|---|
| Monotherapy (n = 245) | + CCB (n = 59) | + RAS inhibitor (n = 64) | Total (N = 368) | |
| Any TEAE | 160 (65.3) | 46 (78.0) | 47 (73.4) | 253 (68.8) |
| Viral upper respiratory tract infection | 54 (22.0) | 21 (35.6) | 26 (40.6) | 101 (27.4) |
| Upper respiratory tract infection | 8 (3.3) | 0 (0.0) | 0 (0.0) | 8 (2.2) |
| Upper respiratory tract inflammation | 8 (3.3) | 3 (5.1) | 4 (6.3) | 15 (4.1) |
| Influenza | 6 (2.4) | 1 (1.7) | 4 (6.3) | 11 (3.0) |
| Bronchitis | 8 (3.3) | 0 (0.0) | 0 (0.0) | 8 (2.2) |
| Gastroenteritis | 7 (2.9) | 1 (1.7) | 2 (3.1) | 10 (2.7) |
| Dental caries | 5 (2.0) | 0 (0.0) | 3 (4.7) | 8 (2.2) |
| Diarrhea | 7 (2.9) | 1 (1.7) | 2 (3.1) | 10 (2.7) |
| Headache | 9 (3.7) | 0 (0.0) | 0 (0.0) | 9 (2.4) |
| Dermatitis contact | 10 (4.1) | 0 (0.0) | 1 (1.6) | 11 (3.0) |
| Arthralgia | 3 (1.2) | 5 (8.5) | 1 (1.6) | 9 (2.4) |
| Back pain | 6 (2.4) | 2 (3.4) | 4 (6.3) | 12 (3.3) |
| Renal impairmenta | 6 (2.4) | 0 (0.0) | 2 (3.1) | 8 (2.2) |
| Hyperuricemia | 3 (1.2) | 6 (10.2) | 0 (0.0) | 9 (2.4) |
| Laboratory test | 42 (17.1) | 7 (11.9) | 11 (17.2) | 60 (16.3) |
| Serum K+ increaseda | 19 (7.8) | 1 (1.7) | 6 (9.4) | 26 (7.1) |
| Any adverse drug reaction | 45 (18.4) | 14 (23.7) | 12 (18.8) | 71 (19.3) |
| Anemia | 3 (1.2) | 3 (5.1) | 0 (0.0) | 6 (1.6) |
| Hyperuricemia | 1 (0.4) | 6 (10.2) | 0 (0.0) | 7 (1.9) |
| Dizziness | 0 (0.0) | 1 (1.7) | 1 (1.6) | 2 (0.5) |
| Dizziness postural | 1 (0.4) | 0 (0.0) | 1 (1.6) | 2 (0.5) |
| Headache | 2 (0.8) | 0 (0.0) | 0 (0.0) | 2 (0.5) |
| Hepatic function abnormal | 3 (1.2) | 3 (5.1) | 0 (0.0) | 6 (1.6) |
| Renal impairment | 4 (1.6) | 0 (0.0) | 1 (1.6) | 5 (1.4) |
| Laboratory test | 26 (10.6) | 3 (5.1) | 8 (12.5) | 37 (10.1) |
| Serum K+ increased | 18 (7.3) | 1 (1.7) | 6 (9.4) | 25 (6.8) |
| Serum uric acid increased | 2 (0.8) | 0 (0.0) | 0 (0.0) | 2 (0.5) |
| Gamma-glutamyltransferase increased | 2 (0.8) | 0 (0.0) | 0 (0.0) | 2 (0.5) |
| Platelet count decreased | 1 (0.4) | 0 (0.0) | 1 (1.6) | 2 (0.5) |
| White blood cell count decreased | 1 (0.4) | 0 (0.0) | 1 (1.6) | 2 (0.5) |
| Lymphocyte percentage decreased | 1 (0.4) | 1 (1.7) | 0 (0.0) | 2 (0.5) |
| Serum K+ ≥5.5 mEq/L at any visit | 14 (5.7) | 2 (3.4) | 4 (6.3) | 20 (5.4) |
| Serum K+ ≥6.0 mEq/L or ≥5.5 mEq/L on two consecutive measurements | 4 (1.6) | 0 (0.0) | 0 (0.0) | 4 (1.1) |
| Serum K+ ≥6.0 mEq/L | 2 (0.8) | 0 (0.0) | 0 (0.0) | 2 (0.5) |
| Serum K+ ≥5.5 mEq/L on two consecutive measurements | 3 (1.2) | 0 (0.0) | 0 (0.0) | 3 (0.8) |
Values are number of patients (%)
CCB calcium channel blocker, RAS renin–angiotensin system, TEAE treatment-emergent adverse events
aRenal impairment and serum K+ increased were defined as adverse events based on the judgement of the primary investigator as no clearly defined threshold values were available for these events