TABLE 2.
Adverse event, n (%) | Active (n = 14) | Placebo (n = 12) | P value |
---|---|---|---|
Headache | 0 | 2 (16.6) | .10 |
Musculoskeletal | 3(21.4) | 1 (8.3) | .36 |
Infection | 5 (35.7) | 5(41.7) | .76 |
Sleep impairment | 1 (7.1) | 1 (8.3) | .91 |
Respiratory disorders (non-infectious) | 0 | 0 | – |
Gastrointestinal disorders | 5 (35.7) | 2 (16.6) | .34 |
Blood disorders | 0 | 0 | – |
Eye and vision disorders | 0 | 1 (8.3) | .27 |
Cardiovascular disorders | 1 (7.1) | 1 (8.3) | .91 |
Renal disorders | 0 | 0 | – |
Reproductive disorders | 0 | 0 | – |
Skin or hair disorders | 0 | 2 (16.6) | .10 |
Immunologic disorders | 0 | 0 | – |
P values are based on Chi-Square test for the categorical variables