[Table/Fig-4]:
Distribution of adverse events according to system in the study population (n=304).
| System | ADRs | |
|---|---|---|
| n | Percentage | |
| Central nervous System | ||
| Headache | 17 | 5.6 |
| Giddiness | 17 | 5.6 |
| Peripheral neuropathy | 16 | 5.3 |
| Disorders of sleep | 12 | 3.9 |
| Sleep disturbance Excessive sleep |
6 6 |
|
| Slurred speech | 1 | 0.3 |
| Memory impairment | 1 | 0.3 |
| Dizziness | 1 | 0.3 |
| Gastro-Intestinal System | ||
| Flatulence | 9 | 3 |
| Epigastric pain | 4 | 1.3 |
| Gastritis | 4 | 1.3 |
| Constipation | 2 | 0.6 |
| Dryness of mouth | 1 | 0.3 |
| Difficulty swallowing | 1 | 0.3 |
| Abdominal pain | 1 | 0.3 |
| Nausea | 1 | 0.3 |
| Vomiting | 1 | 0.3 |
| Diarrhea | 1 | 0.3 |
| Musculoskeletal System | ||
| Myalgia | 75 | 24.6 |
| Muscle pain | 53 17 5 |
17.4 5.6 1.6 |
| Soreness/Tiredness | ||
| Non -specific /Joint pain | ||
| Nutrition and Metabolism | ||
| Increased appetite | 1 | 0.3 |
| Weight gain | 2 | 0.6 |
| Respiratory System | ||
| Cough | 1 | 0.3 |
| Rhinitis | 1 | 0.3 |
| Skin and Integumentary System | ||
| Itching | 4 | 1.3 |
| Others | ||
| New Onset Diabetes Mellitus (NOD) | 4 | 1.3 |
| Creatine kinase elevation | 5 | 1.6 |