Table 5.
Common SAEs
| FC (n = 289) | AC (n = 149) | P | |
|---|---|---|---|
| Any SAE | 39.1 | 49.0 | 0.05 |
| Infections and infestations | 12.5 | 18.1 | 0.1 |
| Surgical and medical procedures | 7.6 | 6.7 | 0.9 |
| Kidney transplantation | 4.2 | 4.0 | 0.9 |
| Vascular | 7.3 | 10.1 | 0.4 |
| General disorders and administration site | 7.3 | 7.4 | 0.9 |
| Cardiac | 7.3 | 12.1 | 0.1 |
| Gastrointestinal | 6.9 | 12.8 | 0.05 |
| Respiratory, thoracic, and mediastinal | 6.6 | 8.7 | 0.4 |
| Injury, poisoning, and procedural | 5.2 | 6.7 | 0.5 |
| Metabolism and nutrition | 5.5 | 6.7 | 0.7 |
Note: Values are given as percentages. Common SAE indicates occurring in >5% of participants. Percentage of patients with treatment-emergent SAEs in the indicated categories, including adverse events occurring after study drug initiation and prior to 30 days after discontinuation of study drug. P values were computed using Fisher exact test. The number of participants analyzed includes all who received at least 1 dose of study drug.
Abbreviations: AC, active control; FC, ferric citrate; SAE, serious adverse event.