Table 2. Overall TEAEs and TEAEs occurring in ⩾5% of patients in either treatment group, stage 1 (SS; N=1055).
| PA21 (N=707) (%) | Sevelamer (N=348) (%) | |
|---|---|---|
| Any TEAE | 83.2 | 76.1 |
| Any severe TEAE | 11.5 | 10.9 |
| Any serious TEAE | 18.2 | 19.8 |
| Withdrawals due to TEAEs | 15.7 | 6.6 |
| Death | 1.8 | 2.0 |
| Any GI TEAE | 45.1 | 33.6 |
| Any GI TEAE, excluding isolated discolored feces | 39.0 | 33.3 |
| Diarrhea | 20.1 | 7.5 |
| Feces discolored | 15.4 | 0.3 |
| Hyperphosphatemia | 11.2 | 7.8 |
| Nausea | 7.2 | 11.2 |
| Hypertension | 6.4 | 7.5 |
| Vomiting | 4.4 | 5.5 |
| Constipation | 3.8 | 7.2 |
Abbreviations: GI, gastrointestinal; PA21, sucroferric oxyhydroxide; SS, safety set; TEAE, treatment-emergent adverse event.