Table 1.
Summary of treatment related adverse events
| Doses in mg (number of subjects) | ||||||||
|---|---|---|---|---|---|---|---|---|
| Body systems(Preferred term) | 100 (4) | 300 (9) | 750 (8) | 750* (4) | 1125 (4) | 1125* (12) | 1500* (12) | Placebo (8) |
| Body as a whole – general disorders | 1 | 1 | 4 | |||||
| Fatigue | 1 | 3 | ||||||
| Temperature changed sensation | 1 | 1 | ||||||
| Central and peripheral nervous system disorders | 2 | 1 | 1 | 1 | ||||
| Dizziness | 1 | 1 | ||||||
| Headache | 2 | 1 | ||||||
| Gastro-intestinal disorders | 1 | 1 | 2 | 3 | 6 | 7 | 1 | |
| Abdominal pain | 1 | |||||||
| Diarrhoea | 1 | |||||||
| Dyspepsia | 1 | 1 | 1 | 2 | 2 | 2 | ||
| Eructation | 1 | |||||||
| Gastro-esophageal reflux | 2 | 1 | ||||||
| Nausea | 1 | 2 | 2 | 1 | ||||
| Psychiatric disorders | 1 | 1 | 3 | |||||
| Insomnia | 1 | |||||||
| Somnolence | 1 | 3 | ||||||
| Skin and appendages disorders | 1 | 1 | 1 | |||||
| Pruritis | 1 | |||||||
| Skin reaction localized | 1 | 1 | ||||||
| Vision disorders | 1 | |||||||
| Vision abnormal | 1 | |||||||
*
Dose administered with standardized meal.