Table 3. Adverse Events by Study Group.
| Adverse Event | No. (%) | |
|---|---|---|
| Combination Therapy Group (n = 23) | Placebo Group (n = 24) | |
| ≥1 Event | 17 (73.9) | 13 (54.1) |
| Mild or moderate | ||
| Gastrointestinal symptoms | 4 (17.4) | 2 (8.3) |
| Exanthema | 2 (8.7) | 3 (12.5) |
| Fall with contusion of the leg | 2 (8.7) | 1 (4.2) |
| Common cold | 1 (4.3) | 2 (8.3) |
| Vomiting | 0 (0) | 2 (8.3) |
| Swollen pharyngeal tonsils | 2 (8.7) | 0 |
| Nausea | 1 (4.3) | 1 (4.2) |
| Mycosis | 1 (4.3) | 1 (4.2) |
| Flatulence | 0 | 2 (8.3) |
| Distortion of the upper ankle joint | 1 (4.3) | 0 |
| Fever | 0 | 1 (4.2) |
| Cough | 0 | 1 (4.2) |
| Inflammation of the middle ear | 0 | 1 (4.2) |
| Vertigo | 1 (4.3) | 0 |
| Loss of appetite | 1 (4.3) | 0 |
| Epistaxis | 0 | 1 (4.2) |
| Bug bite | 1 (4.3) | 0 |
| Back pain | 1 (4.3) | 0 |
| Severe | ||
| Bone fracture (tibia/femur) | 2 (8.7) | 0 |
| Deep cut in the leg | 1 (4.3) | 0 |
| Fatal | 0 | 0 |
| Discontinuation of treatment | ||
| Abnormal laboratory value | 0 | 0 |
| Other | 0 | 0 |