Table 2.
Treatment Outcomes
| Variable | Patients, No./Total No. (%) | P Value | |
|---|---|---|---|
| Bedaquiline Group (n = 162) | Control Group (n = 168) | ||
| At 12 mo | |||
| Composite unfavorable outcome (primary)a | 35/146 (23.9) | 51/141 (36.2) | .02 |
| Composite unfavorable outcome (secondary)b | 44/158 (27.9) | 58/152 (38.2) | .053 |
| Death | 11/145 (7.6) | 11/147 (7.5) | .97 |
| Loss to follow-up | 17/162 (10.5) | 21/168 (12.5) | .57 |
| Treatment failurec | 7/119 (5.9) | 19/109 (17.4) | .006 |
| Modified treatment failured | 16/138 (11.6) | 29/131 (22.1) | .02 |
| At 18 mo | |||
| Death | 13/79 (16.5) | 15/100 (15.0) | .79 |
| Failure to achieve sustained culture conversion | 3/93 (3.2) | 16/81 (19.8) | <.001 |
aDefined as death, loss to follow-up, or treatment failure. Outcomes were recorded as missing in cases where there was no failure event and ≥1 of the components of the composite end point was absent.
bDefined as death, loss to follow-up, or modified definition of treatment failure. Outcomes were recorded as missing in cases where there were no data for all of the components of the composite end point. Note that the components of the secondary composite outcome do not sum in the bedaquiline group owing to overlap in outcomes in 2 patients (modified treatment failure plus death in 1 and modified treatment failure plus loss to follow-up in the other).
cDefined as failure to achieve sustained culture conversion (≥2 consecutive negative cultures with the last culture performed 12 months (±2 months) after the start of antituberculosis treatment). Outcomes were recorded as missing in cases where sustained culture conversion, per the prespecified definition, could not be assessed owing to missing sputum culture results. Proportions with missing sputum results were similar between the groups (P = .09).
dDefined as any positive sputum culture result between 6 and 12 months after initiation of multidrug-resistant tuberculosis treatment. Outcomes were recorded as missing in cases where there were no sputum culture results available after 6 months of therapy. Proportions with missing sputum results were similar between the groups (P = .09).