Table 3.
Summary of treatment-emergent adverse events
| Adverse Event | Placebo (n=80) | Bardoxolone Methyl (n=77) |
|---|---|---|
| Patients with SAE, n (%) | 15 (19) | 8 (10) |
| Patients with AE, n (%) | 77 (96) | 75 (97) |
| Discontinuations due to AE, n (%) | 4 (5) | 10 (13) |
| AEs reported in >10% of patients in either treatment group, n (%) | ||
| Muscle spasms | 27 (34) | 38 (49) |
| Alanine aminotransferase increased | 2 (3) | 36 (47) |
| Aspartate aminotransferase increased | 1 (1) | 19 (25) |
| Nasopharyngitis | 24 (30) | 18 (23) |
| Headache | 16 (20) | 16 (21) |
| Fatigue | 12 (15) | 14 (18) |
| Nausea | 11 (14) | 13 (17) |
| Peripheral edema | 11 (14) | 12 (16) |
| Diarrhea | 6 (8) | 12 (16) |
| Upper respiratory tract infection | 8 (10) | 12 (16) |
| Hyperkalemia | 5 (6) | 11 (14) |
| B-type natriuretic peptide increased | 3 (4) | 11 (14) |
| Weight decreased | 1 (1) | 10 (13) |
| Back pain | 13 (16) | 9 (12) |
| Abdominal pain | 13 (16) | 8 (10) |
| Proteinuria | 7 (9) | 8 (10) |
| Urine albumin-creatinine ratio increased | 7 (9) | 8 (10) |
| Cough | 3 (4) | 8 (10) |
| Blood creatine phosphokinase increased | 9 (11) | 5 (7) |
| Dizziness | 12 (15) | 3 (4) |
SAE, serious adverse event; AE, adverse event.