Table 2.
Adverse events
| Randomization | ||||
|---|---|---|---|---|
| C7 | C8 | |||
| # of events | # of subjects | # of events | # of subjects | |
| Expected adverse events | ||||
| Diarrhea/loose stools/steatorrhea | 9 | 5 | 12 | 6 |
| Gastrointestinal upset | 24 | 11 | 38 | 12 |
| Emesis/vomiting | 7 | 6 | 0 | 0 |
| Musculoskeletal pain/cramping/elevated CPK | 16 | 11 | 18 | 10 |
| Rhabdomyolysis | 7 | 5 | 7 | 4 |
| Fatigue/lethargy | 3 | 3 | 2 | 2 |
| Unexpected adverse events | ||||
| Headache | 17 | 5 | 7 | 3 |
| Viral illness | 22 | 15 | 17 | 11 |
| Localized pain not associated with rhabdomyolysis | 5 | 4 | 2 | 2 |
| Dermatitis | 1 | 1 | 4 | 4 |
| Hemorrhoids | 1 | 1 | 0 | 0 |
| Depression | 1 | 1 | 0 | 0 |
| Constipation | 1 | 1 | 0 | 0 |
| Avulsion of nail bed on left thumb | 1 | 1 | 0 | 0 |
| Vertigo | 1 | 1 | 0 | 0 |
| Broken front tooth | 1 | 1 | 0 | 0 |
Expected and unexpected adverse events are reported by randomization group (C7 and C8), as the number of each event (# of events) and the number of subjects (# of subjects) who experienced that adverse event