Table 2.
Tolerability and Reasons for Discontinuation Among Children in the Modified Intention-to-Treat Population
| Patients, No. (%) |
||||
|---|---|---|---|---|
| Characteristic | Isoniazid (n = 434) | Rifapentine Plus Isoniazid (n = 471) | P Valuea | Difference (95% CI)b |
| Treatment completion | 351 (80.9) | 415 (88.1) | .003 | −7.2 (−2.0 to −2.5) |
| Reason for not completing treatment | ||||
| All reasons | 83 (19.2) | 56 (11.9) | .003 | 7.2 (2.5 to 12.0) |
| Discontinuation because of AEc | 2 (0.5) | 8 (1.7) | .11 | −1.2 (−2.6 to 0.1) |
| Withdrawal of informed consent | 5 (1.2) | 4 (0.9) | .74 | 0.3 (−1.0 to 1.6) |
| Lost for ≥3 mo during treatment | 26 (6.0) | 5 (1.1) | <.001 | 4.9 (2.5 to 7.4) |
| Physician decision to cancel other than AE | 7 (1.6) | 3 (0.6) | .21 | 1.0 (−0.4 to 2.4) |
| Participant refusal | 15 (3.5) | 16 (3.4) | >.99 | 0.1 (−2.3 to 2.4) |
| Total dose count and/or administration period outside of protocol guidelinesd | 28 (6.5) | 20 (4.3) | .18 | 2.2 (−0.7 to 5.2) |
Abbreviation: AE, adverse event.
a
P value based on Fisher exact test.
b
95% CI for the difference in proportions using the Wilson Score Interval method.
c
Combination-therapy group included 3 influenza-like AEs (grade 2), 3 cutaneous (all with pruritic rash [2 were grade 2], 1 with oral blisters and fever [grade 3]), and 2 gastrointestinal reactions (1 was grade 1 and 1 was grade 2). Isoniazid-only group included 1 cutaneous AE (grade 2) and 1 gastrointestinal reaction (grade 3).
d
Measure of adherence.