Table 4.
Overview of treatment-emergent adverse events in either treatment group during the study (safety population; n = 85)
| SFOH (N = 66) | CaAc (N = 19) | |||
|---|---|---|---|---|
| Patients, n (%) | Events, n | Patients, n (%) | Events, n | |
| End of stage 1 | ||||
| Any TEAE | 42 (63.6) | 123 | 13 (68.4) | 46 |
| Any treatment-related TEAE | 24 (36.4) | 43 | 7 (36.8) | 13 |
| Any serious TEAE | 13 (19.7) | 19 | 3 (15.8) | 7 |
| Any TEAE leading to death | 0 | 0 | 0 | 0 |
| Any TEAE leading to study drug withdrawal | 11 (16.7) | 17 | 6 (31.6) | 8 |
| End of stage 2 | ||||
| Any TEAE | 50 (75.8) | 204 | 14 (73.7) | 63 |
| Any treatment-related TEAE | 26 (39.4) | 50 | 7 (36.8) | 13 |
| Any serious TEAE | 18 (27.3) | 43 | 3 (15.8) | 9 |
| Any TEAE leading to death | 0 | 0 | 0 | 0 |
| Any TEAE leading to study drug withdrawal | 12 (18.2) | 19 | 6 (31.6) | 8 |
CaAC, calcium acetate; SFOH, sucroferric oxyhydroxide; TEAE, treatment-emergent adverse event