Table 3.
Adverse Event (AE) by Body System and Treatment
| N=143 | |||
|---|---|---|---|
| Body System | Placebo (n=127) | Treatment (n=129) | P Value |
| Body as a whole | 3 (2.36%) | 5 (3.87%) | 0.72 |
| Cardiovascular | 4 (3.15%) | 8 (6.25%) | 0.25 |
| Edema | 0 (0.00%) | 6 (4.65%) | NA |
| Hemic and lymphatic | 0 (0.00%) | 1 (3.87%) | NA |
| Infection | 5 (3.94%) | 5 (3.87%) | 1.00 |
| Metabolic and nutritional | 3 (2.36%) | 4 (3.10%) | 1.00 |
| Musculoskeletal | 5 (3.94%) | 8 (6.25%) | 0.57 |
| Nervous system | 2 (1.57%) | 4 (3.1%) | 0.68 |
| Respiratory | 1 (0.79%) | 6 (4.65%) | 0.12 |
| Skin and appendages | 4 (3.15%) | 3 (2.33%) | 0.72 |
| Total number of AEs | 27 (21.26%) | 50 (38.75%) | 0.003 |
| Total number of subjects with at least one AE | 23 (18.11%) | 39 (30.23%) | 0.028 |
Values in bold are statistically significant.