Table 2.
Summary of adverse events
| Adverse events, n (%) | Low-salt diet | Normal-salt diet | |||||
|---|---|---|---|---|---|---|---|
| Pooled placebo (n = 6) |
2.5 mg baxdrostat (n = 9) |
5.0 mg baxdrostat (n = 9) |
Pooled placebo (n = 8) |
0.5 mg baxdrostat (n = 9) |
1.5 mg baxdrostat (n = 9) |
2.5 mg baxdrostat (n = 6) |
|
| Any AE | 2 (33.3) | 3 (33.3) | 3 (33.3) | 1 (12.5) | 1 (11.1) | 1 (11.1) | 3 (50.0) |
| Any TEAE | 2 (33.3) | 3 (33.3) | 3 (33.3) | 1 (12.5) | 1 (11.1) | 1 (11.1) | 3 (50.0) |
| Palpitations | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (12.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Ventricular tachycardia | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Eye irritation | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) |
| Abdominal pain | 0 (0.0) | 0 (0.0) | 1 (11.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Constipation | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (11.1) | 0 (0.0) |
| Nausea | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Rhinitis | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) |
| Viral infection | 0 (0.0) | 1 (11.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Back pain | 0 (0.0) | 0 (0.0) | 1 (11.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Headache | 0 (0.0) | 1 (11.1) | 1 (11.1) | 0 (0.0) | 1 (11.1) | 0 (0.0) | 1 (16.7) |
| Dizziness postural | 0 (0.0) | 1 (11.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (33.3) |
| Dizziness | 0 (0.0) | 0 (0.0) | 1 (11.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) |
| Presyncope | 0 (0.0) | 1 (11.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Anxiety | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) |
| Dry throat | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) |
| Dysphonia | 0 (0.0) | 0 (0.0) | 1 (11.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Any treatment-emergent SAE | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Any drug-related treatment-emergent SAE | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Any TEAE leading to death | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Any TEAE leading to discontinuation | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
TEAEs are defined as any AE, regardless of relationship to the study drug, which began after the first dose was administered
AE adverse event, SAE serious adverse event, TEAE treatment-emergent adverse event