Table 3.
Safety End Points Among Children Who Received at Least 1 Dose of Study Medication
| Patients, No. (%) |
||||
|---|---|---|---|---|
| Characteristic | Isoniazid (n = 493) | Rifapentine Plus Isoniazid (n = 539) | P Valuea | Difference (95% CI)b |
| AEs attributed to treatment | ||||
| Grades 1 and 2 | 5 (1.0) | 11 (2.0) | .21 | −1.0 (−2.5 to 0.5) |
| Grade 3 | 1 (0.2) | 3 (0.6) | .63 | −0.4 (−1.1 to 0.4) |
| Grade 4 | 0 | 0 | NA | NA |
| Grade 5, death | 0 | 0 | NA | NA |
| Serious AEs | 0 | 0 | NA | NA |
| AEs not attributed to treatment | ||||
| Grades 1 and 2 | 35 (7.1) | 25 (4.6) | .11 | 2.0 (−0.4 to 5.3) |
| Grade 3 | 5 (0.2) | 3 (0.6) | .49 | 0.4 (−0.6 to 1.5) |
| Grade 4 | 2 (0.4) | 1 (0.2) | .61 | 0.2 (−0.5 to 0.9) |
| Grade 5, deathc | 2 (0.4) | 0 | .23 | 0.4 (−0.2 to 1.0) |
| Serious AEsd | 7 (1.4) | 0 | .01 | 1.0 (0.4 to 2.5) |
Abbreviations: AE, adverse event; NA, not available.
a
P value based on Fisher exact test.
b
95% CI for the differences in proportions using the Wilson Score Interval method.
c
Death 1 was due to malignant arrhythmia in a 16-year-old girl on day 201 of study treatment; death 2, gunshot injury in a 16-year-old boy at study day 901 (approximately 657 days after the end of the study treatment phase).
d
Serious AEs include deaths while receiving therapy or within 60 days of the last dose, life-threatening events, hospitalization, disability or permanent damage, and congenital anomaly. For children aged 2 through 16 years, 6 had 1 serious AE and 1 had more than 1 serious AE.