Table 8.
New or worsening retinal hemorrhage by subgroup (total number of retinal hemorrhages at baseline) (safety analysis set at the end of Week 24)
| Subgroup | Analysis visit | Darbepoetin alfa |
Roxadustat |
|---|---|---|---|
| (comparative) (n = 131) | (comparative) (n = 131) | ||
| Total | Treatment period | 51/128 (39.8%) | 38/121 (31.4%) |
| Week 12 compared with baseline | 32/124 (25.8%) | 27/113 (23.9%) | |
| Week 24 compared with baseline | 41/121 (33.9%) | 21/104 (20.2%) | |
| End of Week 24 | 44/128 (34.4%) | 26/121 (21.5%) | |
| No retinal hemorrhages at baseline | Treatment period | 18/72 (25.0%) | 8/62 (12.9%) |
| Week 12 compared with baseline | 8/69 (11.6%) | 6/59 (10.2%) | |
| Week 24 compared with baseline | 13/67 (19.4%) | 3/56 (5.4%) | |
| End of Week 24 | 15/72 (20.8%) | 4/62 (6.5%) | |
| One or more retinal hemorrhage at baseline | Treatment period | 33/56 (58.9%) | 30/59 (50.8%) |
| Week 12 compared with baseline | 24/55 (43.6%) | 21/54 (38.9%) | |
| Week 24 compared with baseline | 28/54 (51.9%) | 18/48 (37.5%) | |
| End of Week 24 | 29/56 (51.8%) | 22/59 (37.3%) |
Treatment period = Detected throughout the entire 24-week treatment period.