Number and percentage of AEs causing withdrawal in the two treatment groups
| rhEPO (N=103) | PLACEBO (N=97) | Total (N=200) | |
|---|---|---|---|
| Serious AEs | |||
| N (%) | 17 (16.5) | 8 (8.3) | 25 (12.5) |
| Causes | |||
| Treatment suspended >8 weeks | 4 | 4 | 8 |
| Altered safety examinations | 7 | 2 | 9 |
| Myocardial infarction | 0 | 1 | 1 |
| Pulmonary embolism | 2* | 0 | 2* |
| Deep venous thrombosis | 4 | 1 | 5 |
| Cardiac arrhythmia | 2 | 0 | 2 |
*Secondary to deep venous thrombosis.
AEs, adverse events; rhEPO, recombinant human erythropoietin.