Table 1. Baseline characteristics of participants in the intention-to-treat analysis population.
Abbreviations: AST, aspartate aminotransferase; IQR, inter-quartile range.
| Characteristic | Overall n = 121 | Investigational Arm PMHZ (n = 62)n = 62 | Control ArmArm REHZ (n = 59) |
|---|---|---|---|
| Median age, years (IQR) | 32 (24,47) | 33 (25, 48) | 30 (24, 45) |
| Male, n (%) | 83 (69) | 47 (76) | 36 (61) |
| Current or former cigarette smoking, n (%) | 60 (50) | 30 (48) | 30 (51) |
| HIV-positive, n (%) | 0 | 0 | 0 |
| Median body mass index, kg/m2 (IQR) | 20 (19,23) | 20 (19,22) | 20 (19,23) |
| Baseline smear grade 2 or higher, n (%) | 78 (64) | 40 (65) | 38 (64) |
| Cavitation on chest X-ray at enrollment, n (%) | 92 (76) | 47 (76) | 45 (76) |
| AST > upper limit of normal, n (%) | 18 (15) | 10 (16) | 8 (14) |
| Bilirubin > upper limit of normal, n (%) | 1 (0.8) | 0 | 1 (1.7) |
| Median Karnofsky score (IQR) | 90 (80, 90) | 90 (80, 90) | 90 (80, 90) |
| Tuberculosis treatment initiated prior to study drugs, n (%) | 31 (26) | 17 (27) | 14 (24) |
| Median number of days of pre-study tuberculosis treatment (IQR) | 0 | 0 | 0 |