Table 1. Baseline Characteristics of mITT Population.
Treatment arm | ||||||
---|---|---|---|---|---|---|
FDC Arm | LF ARM | Total | ||||
No. | % | No. | % | No. | % | |
Study country | ||||||
Ethiopia | 239 | 52 | 242 | 52 | 481 | 52 |
Nigeria | 220 | 48 | 223 | 48 | 443 | 48 |
Age (yr) | ||||||
<25 | 173 | 38 | 172 | 37 | 345 | 37 |
25-39 | 185 | 40 | 203 | 44 | 388 | 42 |
> = 40 | 101 | 22 | 90 | 19 | 191 | 21 |
Sex | ||||||
Female | 188 | 41 | 206 | 44 | 394 | 43 |
Male | 271 | 59 | 259 | 56 | 530 | 57 |
Weight (Kg) | ||||||
40–45 | 130 | 28 | 129 | 28 | 259 | 28 |
46–55 | 281 | 61 | 280 | 60 | 561 | 61 |
56–66 | 39 | 8 | 51 | 11 | 90 | 10 |
67+ | 9 | 2 | 5 | 1 | 14 | 2 |
BMI (kg/m2) | ||||||
Underweight <18.5 | 299 | 65 | 292 | 63 | 591 | 64 |
Overweight (26.0–29.9) | 2 | 0 | 0 | 0 | 2 | 0 |
Obese (> = 30.0) | 0 | 1 | 0 | 1 | 0 | 0 |
Healthy(18.5–25.9) | 158 | 34 | 172 | 37 | 330 | 36 |
Duration of TB symptoms | ||||||
<3 weeks | 10 | 2 | 13 | 3 | 23 | 2 |
-6 wks | 64 | 14 | 63 | 14 | 127 | 14 |
7–12 wks | 183 | 40 | 183 | 39 | 366 | 40 |
12–24 wks | 136 | 30 | 114 | 25 | 250 | 27 |
>24 wks | 66 | 14 | 92 | 20 | 158 | 17 |
Haemoglobin (g/dL) | ||||||
<8.0 | 2 | 0 | 8 | 2 | 10 | 1 |
> = 8.0 | 457 | 100 | 457 | 98 | 914 | 99 |
HIV test | ||||||
Positive | 20 | 4 | 30 | 6 | 50 | 5 |
Negative | 438 | 95 | 435 | 94 | 873 | 94 |
Not available | 1 | 0 | 0 | 0 | 1 | 0 |
CD4 Count | ||||||
<350 | 4 | 20 | 6 | 20 | 10 | 20 |
> = 350 | 16 | 80 | 24 | 80 | 40 | 80 |
Concurrent disease at baseline | ||||||
Yes | 7 | 2 | 6 | 1 | 13 | 1 |
No | 452 | 98 | 459 | 99 | 911 | 99 |