Table 4.
Adverse events reported in epoetin zeta clinical trials
| Baldamus et al79 | Krivoshiev et al41 | Krivoshiev et al28 | Wizemann et al24 | |
|---|---|---|---|---|
| Study design | Open, noncontrolled, follow-up, multicenter, multinational | Randomized, observer-blind, verum controlled, multicenter, Phase III | Randomized, double-blind, multicenter, multinational, Phase III | Randomized, double-blind, crossover, Phase III |
| Study population (n) | 745 | 232 | 305 | 313 |
| Overall treatment period (weeks) | 56 | 28 | 24 | 12 |
| Route of administration | Intravenous | Subcutaneous | Intravenous | Intravenous |
| Case of neutralizing anti-EPO antibodies | 0 | 0 | 0 | 0 |
| Case of PRCA | 0 | 0 | 0 | 0 |
| Most common adverse events (reported by >5% of patients), n (%) | ||||
| Infections and infestations | 254 (34.1) | 35 (15.1) | 38 (12.5) | 83 (26.5) |
| Metabolism and nutritional disorders | 51 (6.8) | 14 (6.0) | ||
| Nervous system disorders | 108 (14.5) | 19 (8.2) | 17 (5.6) | 20 (6.4) |
| Psychiatric disorders | 40 (5.4) | |||
| Cardiac disorders | 93 (12.5) | 17 (7.3) | 19 (6.1) | |
| Vascular disorders | 149 (20.0) | 17 (7.3) | 26 (8.5) | 17 (5.4) |
| Hypertension | 20 (6.6) | |||
| Respiratory, thoracic, and mediastinal disorders | 81 (10.9) | 27 (8.6) | ||
| Gastrointestinal disorders | 163 (21.9) | 27 (11.6) | 16 (5.2) | 43 (13.7) |
| Skin and subcutaneous disorders | 13 (4.2) | |||
| Musculoskeletal and connective tissue disorders | 105 (14.1) | 16 (6.9) | 27 (8.6) | |
| General disorders and administration site conditions | 78 (10.5) | 9 (3.9) | 22 (7.0) | |
| Injury, poisoning, and procedural complications | 192 (25.8) | 23 (9.9) | 22 (7.2) | 35 (11.2) |
| Surgical and medical procedures | 93 (12.5) | 15 (6.5) | 16 (5.1) | |
| Serious adverse events | ||||
| Patients, n (%) | 278 (37.3) | 38 (16.4) | 54 (17.7) | 43 (13.7) |
| Number of events, n | 715 | 91 | 71 | |
Abbreviations: EPO, erythropoietin; PRCA, pure red cell aplasia.