Table 1.
Adverse Events in Children (N = 70) Treated for Multidrug-resistant Tuberculosis With Levofloxacin
| Adverse Event | All Adverse Events | Adverse Effects Possibly, Probably, or Definitely Attributed to Levofloxacin |
||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No. of Patients With Event | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Total No. of Events | Event Rate (per 100 PY) | No. of Patients With Event | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Total No. of Events | Event Rate (per 100 PY) | |
| Arthralgia | 3 | 3 | 0 | 0 | 0 | 3 | 4.4 | 2 | 2 | 0 | 0 | 0 | 2 | 2.9 |
| Arthritis | 0 | 0 | 0 | 0 | 0 | 0 | … | 0 | 0 | 0 | 0 | 0 | 0 | … |
| Pain other than trauma | 11 | 11 | 0 | 0 | 0 | 11 | 16.1 | 4 | 4 | 0 | 0 | 0 | 4 | 5.8 |
| Headache | 4 | 4 | 0 | 1 | 0 | 5 | 7.3 | 2 | 1 | 0 | 1 | 0 | 2 | 2.9 |
| Neurosensory alteration | 1 | 1 | 0 | 0 | 0 | 1 | 1.5 | 0 | 0 | 0 | 0 | 0 | 0 | … |
| Insomnia | 1 | 0 | 1 | 0 | 0 | 1 | 1.5 | 1 | 0 | 1 | 0 | 0 | 1 | 1.5 |
| Fatigue/malaise | 1 | 1 | 0 | 0 | 0 | 1 | 1.5 | 0 | 0 | 0 | 0 | 0 | 0 | … |
| Nausea | 12 | 13 | 0 | 0 | 0 | 13 | 19.0 | 8 | 9 | 0 | 0 | 0 | 9 | 13.1 |
| Vomiting | 19 | 23 | 1 | 0 | 0 | 24 | 35.1 | 14 | 16 | 0 | 0 | 0 | 16 | 23.4 |
| Anorexia | 11 | 8 | 5 | 0 | 0 | 13 | 19.0 | 7 | 4 | 3 | 0 | 0 | 7 | 10.2 |
| Cutaneous reaction | 12 | 8 | 6 | 0 | 0 | 14 | 20.4 | 7 | 3 | 4 | 0 | 0 | 7 | 10.2 |
| Pruritus | 13 | 16 | 1 | 0 | 0 | 17 | 24.8 | 7 | 7 | 1 | 0 | 0 | 8 | 11.7 |
| ALT elevation | 22 | 17 | 3 | 2 | 5 | 27 | 39.4 | 16 | 16 | 2 | 0 | 0 | 18 | 26.3 |
| Bilirubin elevation | 0 | 0 | 0 | 0 | 0 | 0 | … | 0 | 0 | 0 | 0 | 0 | 0 | … |
Total person-time of observation = 68.5 years.
Abbreviations: ALT, alanine aminotransferase; PY, person-years.