Table 3.
Summary of adverse events (safety analysis set)
| AE | No. (%) of Patients | |
|---|---|---|
| SZC, n=97 | PBO, n=99 | |
| Any AE | 40 (41.7) | 46 (46.5) |
| Any serious AEa | 7 (7.3) | 8 (8.1) |
| AE leading to discontinuation of treatment | 4 (4.2) | 2 (2.0) |
| Death | 1 (1.0) | 0 (0.0) |
| AEs in >2% patients | ||
| Constipation | 4 (4.2) | 3 (3.0) |
| Diarrhea | 4 (4.2) | 6 (6.1) |
| Headache | 3 (3.1) | 2 (2.0) |
| Nasopharyngitis | 3 (3.1) | 5 (5.1) |
| Hyperkalemia | 2 (2.1) | 6 (6.1) |
| Hordeolum (stye) | 2 (2.1) | 0 (0.0) |
| Muscle spasms | 2 (2.1) | 2 (2.0) |
| Dizziness | 1 (1.0) | 4 (4.0) |
| Dyspnea | 1 (1.0) | 3 (3.0) |
| Pruritus | 1 (1.0) | 3 (3.0) |
| Shunt stenosis | 1 (1.0) | 3 (3.0) |
AE, adverse event; SZC, sodium zirconium cyclosilicate; PBO, placebo.
a
Including events with death as the outcome.