Table 6.
Summary of treatment‐emergent adverse events (safety analysis set)†
| ESA‐Naïve group (n = 13) | ESA‐Converted group (n = 43) | Total (n = 56) | |
|---|---|---|---|
| Overall TEAEs | 10 (76.9) | 39 (90.7) | 49 (87.5) |
| Serious TEAEs | 3 (23.1) | 5 (11.6) | 8 (14.3) |
| Drug‐related serious TEAEs ‡ | 0 | 1 (2.3) | 1 (1.8) |
| TEAEs leading to withdrawal of treatment | 0 | 4 (9.3) | 4 (7.1) |
| TEAEs occurring in ≥5% of patients by MedDRA v19.0 system organ class and preferred term | |||
| Gastrointestinal disorders | 1 (7.7) | 18 (41.9) | 19 (33.9) |
| Diarrhea | 0 | 4 (9.3) | 4 (7.1) |
| Vomiting | 0 | 4 (9.3) | 4 (7.1) |
| Abdominal pain | 0 | 3 (7.0) | 3 (5.4) |
| Constipation | 0 | 3 (7.0) | 3 (5.4) |
| Nausea | 0 | 3 (7.0) | 3 (5.4) |
| Infections and infestations | 7 (53.8) | 21 (48.8) | 28 (50.0) |
| Nasopharyngitis | 0 | 14 (32.6) | 14 (25.0) |
| Catheter site infection | 0 | 4 (9.3) | 4 (7.1) |
| Conjunctivitis | 2 (15.4) | 1 (2.3) | 3 (5.4) |
| Musculoskeletal and connective tissue disorders | 3 (23.1) | 8 (18.6) | 11 (19.6) |
| Back pain | 3 (23.1) | 2 (4.7) | 5 (8.9) |
| Skin and subcutaneous tissue disorders | 3 (23.1) | 5 (11.6) | 8 (14.3) |
| Pruritus | 0 | 3 (7.0) | 3 (5.4) |
†
Data are presented as n (%).
‡
Possible or probable as assessed by the investigator or records where relationship was missing.
ESA, erythropoiesis stimulating agent; MedDRA, Medical Dictionary for Regulatory Activities; TEAEs, treatment‐emergent adverse events.