Table 3.
Incidence of adverse events.
| Adverse events, N = 305 | Events | n (%) |
|---|---|---|
| At least one adverse event | 16 | 14 (4.6) |
| Chronic obstructive pulmonary disease | 3 | 3 (1.0) |
| Diarrhoea | 2 | 2 (0.7) |
| Pneumonia | 2 | 2 (0.7) |
| Bronchitis | 1 | 1 (0.3) |
| Condition aggravated | 1 | 1 (0.3) |
| Death | 1 | 1 (0.3) |
| Fatigue | 1 | 1 (0.3) |
| Gastrointestinal disorder | 1 | 1 (0.3) |
| Headache | 1 | 1 (0.3) |
| Nausea | 1 | 1 (0.3) |
| Vomiting | 1 | 1 (0.3) |
| Plasma cell myeloma | 1 | 1 (0.3) |
|
| ||
| At least one serious adverse event | 7 | 6 (2.0) |
| Chronic obstructive pulmonary diseasea | 2 | 2 (0.7) |
| Pneumoniaa | 2 | 2 (0.7) |
| Plasma cell myelomaa | 1 | 1 (0.3) |
| Diarrhoea | 1 | 1 (0.3) |
| Death | 1 | 1 (0.3) |
|
| ||
| At least one adverse event assessed to be related to prulifloxacin | 4 | 4 (1.3) |
| At least one serious adverse event assessed to be related to prulifloxacin | 2 | 2 (0.7) |
| Diarrhoea | 1 | 1 (0.3) |
| Death | 1 | 1 (0.3) |
|
| ||
| At least one nonserious adverse event assessed to be related to prulifloxacin | 2 | 2 (0.7) |
| Diarrhoea | 1 | 1 (0.3) |
| Headache | 1 | 1 (0.3) |
aThe four patients who experienced these events were hospitalized. One patient experienced two serious adverse events, namely, pneumonia and plasma cell myeloma.