TABLE 8.
Overview of treatment‐emergent adverse events and death in the ESA‐Converted Study (safety analysis set)
| ESA‐Converted Study (N = 163) | |
|---|---|
| Any TEAEs | 156 (95.7) |
| Serious TEAEs | 46 (28.2) |
| TEAEs leading to withdrawal of treatment | 17 (10.4) |
| Death | 2 (1.2) |
| TEAEs occurring in ≥5% of patients by MedDRA version 19.0 | |
| System organ class and preferred term, n (%) | |
| Gastrointestinal disorders | |
| Diarrhea | 18 (11.0) |
| Vomiting | 17 (10.4) |
| Constipation | 10 (6.1) |
| Dental caries | 9 (5.5) |
| Infections and infestations | |
| Nasopharyngitis | 86 (52.8) |
| Musculoskeletal and connective tissue disorders | |
| Back pain | 12 (7.4) |
| Injury, poisoning, and procedural complications | |
| Contusion | 16 (9.8) |
| Shunt stenosis | 12 (7.4) |
| Shunt occlusion | 10 (6.1) |
| Nervous system disorders | |
| Headache | 9 (5.5%) |
Note: Data are presented as n (%).
Abbreviations: ESA, erythropoiesis‐stimulating agent; TEAEs, treatment‐emergent adverse events.