Table 2.
Frequency of adverse events categorized by organ system
| System | Symptom | Frequency | ||
|---|---|---|---|---|
| OXA | Placebo | OXA and/or placebo | ||
| General | Fatigue, feeling weak | 5 | 3 | 2 |
| Swelling of eye lids or other parts of the body | 2 | 1 | – | |
| Immune system | Symptoms of hypersensitivity involving more than one symptom or organ | 2 | – | – |
| Skin | Rash | 1 | – | – |
| CNS | Vertigo, dizziness | 6 | 4 | 1 |
| Headache | 6 | 4 | 3 | |
| Nausea | 5 | 1 | 2 | |
| Disturbance of concentration | 1 | 2 | – | |
| Listlessness | 1 | – | 1 | |
| Restlessness | 1 | 2 | – | |
| Emotional instability | 2 | 1 | – | |
| Tremor | 2 | – | – | |
| Coordination impaired | 1 | – | – | |
| Nystagmus | – | 1 | – | |
| Visual disturbances | 3 | – | 1 | |
| Cardiac disorders | Rate and rhythm disturbances | – | – | 1 |
| Gastrointestinal disorders | Abdominal pain | 2 | 1 | 1 |
| Obstipation | 1 | 1 | – | |
| Diarrhea | 3 | 1 | – | |
| Hepatobiliary disorders | 1 | 1 | – | |
| Metabolism disorders | Including sodium imbalance | 1 | 1 | 1 |
Frequency gives the number of patients in whom the event occurred under the respective treatment. Multiple occurrences of the same symptom within one patient and treatment phase were counted as 1