Table 2.
Frequency of ADRs to NFX stratified by systems and symptoms
| Systems or organs | Frequency | Symptom | Frequency | ||
|---|---|---|---|---|---|
| n | % (n/217) | n | % (n/76) | ||
| Gastrointestinal | 67 | 30.9 | Epigastric pain | 18 | 23.7 |
| Nausea | 14 | 18.4 | |||
| Abdominal bloating | 13 | 17.1 | |||
| Abdominal pain | 6 | 7.9 | |||
| Vomiting | 6 | 7.9 | |||
| Diarrhea | 4 | 5.3 | |||
| Constipation | 3 | 3.9 | |||
| Dysphagia | 3 | 3.9 | |||
| Central and peripheral nervous system | 46 | 21.2 | Sleep disturbance | 14 | 18.4 |
| Temporary loss of memory | 12 | 15.8 | |||
| Lack of concentration | 9 | 11.8 | |||
| Depression | 6 | 7.9 | |||
| Vertigo | 3 | 3.9 | |||
| Paresthesia | 2 | 2.6 | |||
| Body as a whole, general disorders | 24 | 11.1 | Headache | 12 | 15.8 |
| Adynamia | 6 | 7.9 | |||
| Asthenia | 5 | 6.6 | |||
| Fever | 1 | 1.3 | |||
| Autonomic nervous system | 18 | 8.3 | Loss of appetite | 13 | 17.1 |
| Increase in appetite | 5 | 6.6 | |||
| Musculoskeletal | 17 | 7.8 | Myalgia | 11 | 14.5 |
| Arthralgia | 6 | 7.9 | |||
| Skin and appendages | 17 | 7.8 | Exanthema | 6 | 7.9 |
| Itching | 5 | 6.6 | |||
| Urticaria | 3 | 3.9 | |||
| Bullous eruption | 2 | 2.6 | |||
| Skin peeling | 1 | 1.3 | |||
| Hematological | 17 | 7.8 | Eosinophilia | 9 | 11.8 |
| Leukopenia | 3 | 3.9 | |||
| Neutrophilia | 3 | 3.9 | |||
| Lymphocytosis | 2 | 2.6 | |||
| Liver | 11 | 5.1 | Increased AST levels | 6 | 7.9 |
| Increased ALT levels | 5 | 6.6 | |||
| Total | 217 | ||||
ADRs = adverse drug reactions; ALT = alanine aminotransferase; AST = aspartate aminotransferase; NFX = nifurtimox.