TABLE 4.
Adverse events in children treated for multidrug-resistant tuberculosis with ofloxacina
| Adverse event | Adverse event by grade |
Adverse effects possibly, probably, or definitely attributed to ofloxacin by grade |
||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No. of patients with event | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Total no. of events | Event rate (per person-yr) | No. of patients with event | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Total no. of events | Event rate (per person-yr) | |
| Arthralgia | 1 | 1 | 0 | 0 | 0 | 1 | 0.042 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Arthritis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| Pain other than traumatic injury | 10 | 10 | 2 | 0 | 0 | 12 | 0.504 | 1 | 1 | 0 | 0 | 0 | 1 | 0.042 |
| Headache | 7 | 5 | 3 | 0 | 0 | 8 | 0.336 | 1 | 1 | 0 | 0 | 0 | 1 | 0.042 |
| Neurosensory alteration | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| Insomnia | 2 | 0 | 2 | 0 | 0 | 2 | 0.084 | 2 | 0 | 2 | 0 | 0 | 2 | 0.084 |
| Fatigue/malaise | 3 | 3 | 0 | 0 | 0 | 3 | 0.126 | 1 | 1 | 0 | 0 | 0 | 1 | 0.042 |
| Nausea | 8 | 9 | 0 | 0 | 0 | 9 | 0.378 | 2 | 2 | 0 | 0 | 0 | 2 | 0.084 |
| Vomiting | 12 | 16 | 1 | 0 | 0 | 17 | 0.714 | 3 | 4 | 0 | 0 | 0 | 4 | 0.168 |
| Anorexia | 4 | 3 | 1 | 0 | 0 | 4 | 0.168 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Cutaneous reaction | 4 | 5 | 0 | 0 | 0 | 5 | 0.210 | 1 | 1 | 0 | 0 | 0 | 1 | 0.042 |
| Pruritus | 12 | 13 | 0 | 0 | 0 | 13 | 0.546 | 4 | 4 | 0 | 0 | 0 | 4 | 0.168 |
| Acute systemic allergic reaction | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| ALT | 8 | 5 | 1 | 1 | 1 | 8 | 0.336 | 5 | 4 | 1 | 0 | 0 | 5 | 0.210 |
| Bilirubin | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
a
Fourty-six patients were followed for a median time of 149.5 days (IQR, 36 to 308 days); total number of person-years was equal to 23.80.