Table 3.

Summary of treatment-emergent adverse events

Category of Treatment-Emergent Adverse EventsPlacebo, n=72Esaxerenone 0.625 mg/d, n=71Esaxerenone 1.25 mg/d, n=72Esaxerenone 2.5 mg/d, n=70Esaxerenone 5 mg/d, n=73All, n=358
Participants with at least one treatment-emergent adverse event40 (56)38 (54)50 (69)47 (67)47 (64)222 (62)
Participants with at least one drug-related treatment-emergent adverse event8 (11)6 (9)11 (15)9 (13)21 (29)55 (15)
Participants with at least one serious treatment-emergent adverse event0 (0)0 (0)1 (1)1 (1)1 (1)3 (0.8)
Participants with at least one drug-related serious treatment-emergent adverse event0 (0)0 (0)0 (0)1 (1)0 (0)1 (0.3)
Participants who discontinued treatment because of a treatment-emergent adverse event2 (3)2 (3)3 (4)3 (4)11 (15)21 (6)
Participants who discontinued treatment because of a drug-related treatment-emergent adverse event0 (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
 Nasopharyngitis9 (13)11 (16)15 (21)15 (21)11 (15)61 (17)
 Dizziness postural0 (0)0 (0)0 (0)0 (0)4 (6)4 (1)
 Upper respiratory tract inflammation1 (1)2 (3)0 (0)2 (3)3 (4)8 (2)
 Abdominal discomfort0 (0)1 (1)3 (4)0 (0)0 (0)4 (1)
 Nausea3 (4)0 (0)0 (0)0 (0)0 (0)3 (0.8)
 Periodontal disease0 (0)0 (0)3 (4)0 (0)0 (0)3 (0.8)
 Back pain0 (0)0 (0)3 (4)2 (3)0 (0)5 (1)
 Blood uric acid increased1 (1)1 (1)3 (4)0 (0)2 (3)7 (2)
 C-reactive protein increased3 (4)0 (0)0 (0)3 (4)0 (0)6 (2)
 White blood cell count increased1 (1)0 (0)0 (0)3 (4)0 (0)4 (1)
 Blood K+ increased2 (3)2 (3)5 (7)10 (14)15 (21)34 (9)
 Bruises1 (1)0 (0)5 (7)2 (3)0 (0)8 (2)
 Kidney dysfunction0 (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.