Table 5.
The frequency of adverse events in both groups, safety analysis set
| Adverse events, n (%) | Cerebrolysin (n=30) | Placebo (n=30) | |
|---|---|---|---|
| Bronchopneumonia | n, % | 1 (3.33) | 2 (6.66) |
| Deep venous thrombosis | n, % | 1 (3.33) | 0 (0) |
| Urinary infections | n, % | 7 (23.33) | 7 (23.33) |
| Pressure ulcers | n, % | 0 (0) | 1 (3.33) |
| Falls | n, % | 3 (10) | 2 (6.66) |
| Depression | n, % | 2 (6.66) | 3 (10) |
| Psychomotor agitation | n, % | 2 (6.66) | 1 (3.33) |
| Sleep disturbances | n, % | 4 (13.33) | 4 (13.33) |
| Hypertension | n, % | 6 (20) | 5 (16.66) |
| Stable angina | n, % | 1 (3.33) | 1 (3.33) |
| Abdominal pains | n, % | 3 (10) | 4 (13.33) |
| Catheter phlebitis | n, % | 7 (23.33) | 8 (26.66) |
| Articular pains | n, % | 3 (10) | 4 (13.33) |
| Total | 40 | 42 |