Table 1.
Baseline characteristics of the intention-to-treat population
| Control (n=40) | CC-11050 (n=40) | Everolimus (n=39) | Auranofin (n=40) | Ergocalciferol (n=40) | Total (n=199) | ||
|---|---|---|---|---|---|---|---|
| Age, years | 32 (26–43) | 34 (27–41) | 35 (26–43) | 38 (30–43) | 37 (29–49) | 35 (27–43) | |
| Weight, kg | 54·7 (51·8–61·3) | 54·5 (49·8–61·2) | 55·2 (51·6–59·7) | 53·3 (50·1–60·8) | 53·8 (49·9–58·9) | 54·4 (50·4–59·7) | |
| Body-mass index, kg/m2 | 18·5 (16·8–19·9) | 18·6 (17·0–19·6) | 19·3 (17·1–21·5) | 18·4 (17·2–20·0) | 18·3 (16·5–20·0) | 18·6 (17·0–20·3) | |
| Sex | |||||||
| Female | 2 (5%) | 7 (18%)* | 5 (13%) | 3 (8%)* | 7 (18%)* | 24 (12%) | |
| Male | 38 (95%) | 33 (83%)* | 34 (87%) | 37 (93%)* | 33 (83%)* | 175 (88%) | |
| Smoking history (former or current smoker)† | 25 (63%) | 24 (62%) | 19 (50%) | 20 (54%) | 18 (46%) | 106 (55%) | |
| Total cavity diameter | |||||||
| 0 cm | 11 (28%)* | 6 (15%)* | 9 (23%) | 2 (5%) | 4 (10%) | 32 (16%) | |
| >0 cm and <4 cm | 24 (60%)* | 23 (58%)* | 20 (51%) | 26 (65%) | 28 (70%) | 121 (61%) | |
| ≥4 cm | 5 (13%)* | 11 (28%)* | 10 (26%) | 12 (30%) | 8 (20%) | 46 (23%) | |
| Radiographic extent of disease | |||||||
| Moderately advanced | 24 (60%) | 23 (58%)* | 27 (69%) | 21 (53%)* | 21 (53%)* | 116 (58%) | |
| Far advanced | 16 (40%) | 17 (43%)* | 12 (31%) | 19 (48%)* | 19 (48%)* | 83 (42%) | |
| Mean FEV1%‡ | 61·7 (56·3–67·1) | 62·4 (55·2–69·5) | 68·8 (62·9–74·8) | 61·0 (54·6–67·4) | 66·1 (58·0–74·2) | 64·0 (61·1–66·9) | |
| Mean FVC, L | 3·12 (2·88–3·37) | 3·00 (2·67–3·32) | 3·08 (2·81–3·35) | 3·07 (2·77–3·37) | 3·04 (2·69–3·40) | 3·06 (2·93–3·19) | |
| Mean Xpert cycle threshold§ | 16·4 (15·4–17·4) | 16·6 (15·6–17·7) | 17·6 (16·2–19·1) | 17·3 (16·2–18·4) | 16·2 (15·0–17·4) | 16·8 (16·3–17·4) | |
| Time to positivity in mycobacterial growth indicator tube cultures, h | 103 (84–140) | 111 (100–135) | 102 (88–144) | 101 (91–127) | 114 (87–132) | 103 (89–134) | |
Data are median (IQR), n (%), or mean (95% CI). All participants were Black Africans. For more information on the definitions of radiographic disease extent, please see the appendix (pp 29–30). FEV1%=forced expiratory volume in 1 s as a proportion of predicted. FVC=forced vital capacity.
*
Percentages do not add up to 100% because of rounding.
†
Six patients had missing smoking history (n=1 for CC-11050, n=1 for everolimus, n=3 for auranofin, and n=1 for ergocalciferol). These patients are not included in the denominator for the calculation of percentages.
‡
One patient in the CC-11050 group had missing FEV1% data.
§
Two patients in the control group had missing Xpert cycle threshold data.