Table 3.
Summary of AEs (Safety Analysis Set)
| AE | Patients, n (%) | |
|---|---|---|
| SZC 10 g (n = 29) | Placebo (n = 33) | |
| AE occurring 0–24 hours after start of dosing | ||
| Any AE | 7 (24.1) | 9 (27.3) |
| Most common AEs (frequency of >5%) | ||
| Hypoglycemia* | 4 (13.8) | 3 (9.1) |
| Nausea | 1 (3.4) | 2 (6.1) |
| Any serious AE† | 1 (3.4) | 2 (6.1) |
| AE leading to discontinuation | 0 (0.0) | 1 (3.0) |
| Death | 0 (0.0) | 1 (3.0) |
| AE occurring ≥24 hours after start of dosing | ||
| Any AE | 7 (24.1) | 3 (9.1) |
| Most common AEs (frequency of >5%) | ||
| Hyperkalemia | 0 (0.0) | 2 (6.1) |
| Nausea | 2 (6.9) | 0 (0.0) |
| Procedural pain# | 2 (6.9) | 0 (0.0) |
| Any serious AE† | 2 (6.9) | 3 (9.1) |
| AE leading to discontinuation | 0 (0.0) | 0 (0.0) |
| Death | 0 (0.0) | 0 (0.0) |
| Hypokalemia (sK+ < 3.5 mmol/L) | ||
| Any event | 0 (0.0) | 0 (0.0) |
| Hypoglycemia (blood glucose < 70 mg/dL)‡ | ||
| Baseline§ | 2 (6.9) | 1 (3.1) |
| Postbaseline | 16 (55.2) | 13 (40.6) |
| ≤4 hours postbaseline | 15 (51.7) | 12 (37.5) |
| >4 hours postbaseline | 1 (4.0) | 1 (4.3) |
Patients with multiple events in the same category are counted only once in that category. Patients with events in more than one category are counted once in each of those categories. Percentages are based on the total number of patients in the treatment group (n).
AE = adverse event; sK+ = serum potassium; SZC = sodium zirconium cyclosilicate.
Indicates AEs as determined by study investigators.
Including events with death as the outcome.
AEs of procedural pain were left arm surgical pain and right foot surgical pain and were considered unlikely to be related to the investigational product by the study investigator.
Hypoglycemia defined by central laboratory value and not necessarily considered an AE by study investigators.
Baseline is defined as the measurement at 0 hours.