Table 5.
Summary of analysis of adverse events in all subjects
| Treatment Group | ||
|---|---|---|
| UC-II (n=26) | G + C (n=26) | |
| Severity (n) | ||
| Mild | 15 | 35 |
| Moderate | 19 | 22 |
| Severe | 1 | 1 |
| Relationship to Test Article (n) | ||
| Not related | 17 | 20 |
| Unlikely | 14 | 30 |
| Possible | 4 | 8 |
| Probable | 0 | 0 |
| Most Probable | 0 | 0 |
| Body System (n) | ||
| Pain | 10 | 17 |
| Gastrointestinal | 5 | 15 |
| Musculoskeletal/Soft Tissue | 7 | 5 |
| Neurology | 0 | 2 |
| Pulmonary / Upper Respiratory | 2 | 1 |
| Hemorrhage/Bleeding | 2 | 1 |
| Blood/Bone Marrow | 2 | 1 |
| Dermatology/Skin | 2 | 3 |
| Allergy / Immunology | 0 | 1 |
| Infection | 1 | 3 |
| Lymphatics | 0 | 1 |
| Hepatobilary / Pancreatic | 0 | 0 |
| Renal / Genitoruinary | 0 | 0 |
| Constitutional Symptoms | 2 | 3 |
| Syndromes | 1 | 1 |
| Auditory/Ear | 0 | 1 |
| Ocular / Visual | 0 | 1 |
| Metabolic / Laboratory | 1 | 2 |
| Total Number of Adverse Events Experienced During Study (n) | 35 | 58 |
| Total Number of Subjects Experiencing Adverse Events: n (%) | 16/26 (61.5%) | 20/26 (76.9%) |