Table 1. Baseline Characteristics of the Patients Included in the Modified Intention-to-Treat Analysis.
| Characteristic | Control Regimen (N = 188) | 4-Month Regimen (N = 193) | 6-Month Regimen (N = 212) | Total (N = 593) |
|---|---|---|---|---|
| Male sex — no. (%) | 121 (64) | 121 (63) | 137 (65) | 379 (64) |
| HIV-positive — no. (%) | 54 (29) | 55 (28) | 49 (23) | 158 (27) |
| Age — no. (%) | ||||
| 18–34 yr | 115 (61) | 132 (68) | 127 (60) | 374 (63) |
| 35–54 yr | 66 (35) | 55 (28) | 78 (37) | 199 (34) |
| ≥55 | 7 (4) | 6 (3) | 7 (3) | 20 (3) |
| Weight — no. (%) | ||||
| <40 kg | 9 (5) | 8 (4) | 8 (4) | 25 (4) |
| 40–54 kg | 103 (55) | 100 (52) | 120 (57) | 323 (54) |
| 55–69 kg | 71 (38) | 77 (40) | 82 (39) | 230 (39) |
| ≥70 kg | 5 (3) | 8 (4) | 2 (1) | 15 (3) |
| Smoking status — no. (%) | ||||
| Former smoker | 47 (25) | 46 (24) | 47 (22) | 140 (24) |
| Current smoker | 46 (24) | 51 (26) | 64 (30) | 161 (27) |
| Never smoked | 95 (51) | 96 (50) | 101 (48) | 292 (49) |
| Cavitation — no. (%)* | ||||
| None | 57 (33) | 64 (35) | 73 (37) | 194 (35) |
| 1–5 cm | 86 (50) | 85 (47) | 91 (46) | 262 (48) |
| >5 cm | 30 (17) | 32 (18) | 33 (17) | 95 (17) |
| CD4 cell count† | ||||
| Median | 355 | 317 | 298 | 314 |
| Interquartile range | 247–455 | 256–427 | 247–383 | 253–441 |
| Days of previous tuberculosis treatment at randomization — no. | ||||
| Median | 5 | 4 | 4 | 4 |
| Interquartile range | 1–8 | 1–8 | 1–7 | 1–8 |
*
Radiographs obtained at baseline were not available for 42 patients. Between-group baseline characteristics were compared by means of a chi-square test for independence for categorical variables and a nonparametric K-sample test of the equality of the medians for continuous variables. There were no statistically significant between-group differences in any of these baseline characteristics among the three treatment groups (P>0.1).
†
CD4 cell counts are based on counts from 158 patients coinfected with the human immunodeficiency virus (HIV).