Table 1.
Baseline characteristics of study participants in the modified intent-to-treat analysis
| Analysis dataset (OFLOTUB, REMoxTB, RIFAQUIN) | Validation dataset (DMID 01-009) | |||
|---|---|---|---|---|
| Experimental group (n = 2,001) | Control group (n = 1,404) | Experimental group (n = 193) | Control group (n = 193) | |
| Country (no. of participants (%)) | ||||
| Benin | 122 (6) | 108 (8) | – | – |
| Botswana | 11 (<1) | 12 (<1) | – | – |
| China | 12 (<1) | 8 (<1) | – | – |
| Guinea | 191 (10) | 184 (13) | – | – |
| India | 228 (11) | 114 (8) | – | – |
| Kenya | 165 (8) | 122 (9) | – | – |
| Malaysia | 43 (2) | 20 (1) | – | – |
| Senegal | 129 (6) | 138 (10) | – | – |
| South Africa | 811 (41) | 516 (37) | – | – |
| Tanzania | 122 (6) | 67 (5) | – | – |
| Thailand | 65 (3) | 34 (2) | – | – |
| Zambia | 35 (2) | 21 (1) | – | – |
| Zimbabwe | 67 (3) | 60 (4) | – | – |
| Brazil | – | – | 67 (35) | 68 (35) |
| Philippines | – | – | 46 (24) | 46 (24) |
| Uganda | – | – | 80 (41) | 79 (41) |
| Sex (no. of participants (%)) | ||||
| Female | 592 (30) | 415 (30) | 76 (39) | 76 (39) |
| Race (no. of participants (%)) a | ||||
| Black or African American | 1,326 (66) | 1,066 (76) | – | – |
| Asian | 349 (17) | 178 (13) | – | – |
| Other | 326 (16) | 160 (11) | – | – |
| Age (years) b | ||||
| Median | 30 | 29 | 29 | 27 |
| Interquartile range | 24–39 | 24–38 | 23–38 | 22–36 |
| Weight (kg) | ||||
| Median | 52 | 52 | 54 | 55 |
| Interquartile range | 46–58 | 47–58 | 49–62 | 49–61 |
| BMI (kg m−2)c | ||||
| Median | 18.4 | 18.3 | 20.3 | 19.5 |
| Interquartile range | 16.9–20.2 | 16.9–20.1 | 18.7–22.2 | 18.5–22.0 |
| HIV status (no. of participants (%)) d | ||||
| HIV positive | 248 (12) | 220 (16) | 0 (0) | 0 (0) |
| CD4 + cell count e | ||||
| Median | 363 | 317 | – | – |
| Interquartile range | 265–493 | 241–444 | – | – |
| ≤300 (no. of participants) | 74 | 81 | – | – |
| >300 (no. of participants) | 135 | 99 | – | – |
| Cavitation (no. of participants (%)) f | ||||
| Cavitation present | 1,247 (62) | 847 (60) | 0 (0) | 0 (0) |
| Smear (no. of participants (%)) g | ||||
| Negative | 151 (8) | 85 (6) | 85 (44) | 85 (44) |
| 1+ | 332 (17) | 232 (17) | 26 (14) | 30 (15) |
| 2+ | 503 (25) | 404 (29) | 32 (17) | 36 (18) |
| 3+ | 988 (49) | 667 (48) | 50 (26) | 42 (22) |
aRace was missing for all OFLOTUB study participants; black race was assigned to all study participants given all OFLOTUB sites were in Africa.
bAge was missing for 5 study participants.
cBMI was defined as the weight in kilograms divided by the squared height in meters. Height was missing for 291 study participants; median height for females and males were used to calculate BMI for those participants.
dHIV status was missing for 9 study participants.
eCD4+ cell count cutoff was variable across trials (described in Supplementary Table 2). CD4+ cell count summary statistics were based only on study participants co-infected with HIV but were missing for 79 HIV co-infected study participants.
fCavitation status was missing for 200 study participants.
gSmear grade was based on clinical trial-defined grading but readjusted so all data were on the same scale. Smear grade was missing for 43 study participants.