Table 6 Summary of analysis of adverse events (AEs) in all subjects
Study groups | Adverse event | Number of AEs |
|---|---|---|
(Body system) | ||
UC-II | Upper respiratory infection (Pulmonary) | 3 |
Food poisoning (Gastrointestinal) | 1 | |
Total number of AEs | 4 | |
Total number of subjects reporting AEs: n | 4/27 | |
Placebo | Bilateral ankle edema (Musculoskeletal) | 1 |
Right ankle fracture (Musculoskeletal) | 1 | |
Sinusitis (Ears/Nose/Throat) | 1 | |
Skin infection right ankle (Dermatological) | 1 | |
Total number of AEs | 4 | |
Total number of subjects reporting AEs: n | 2/28 | |