Table 1. Baseline characteristics of the per protocol population.
| Control (N = 40) | CC-11050 (N = 38) | Everolimus (N = 35) | Auranofin (N = 38) | Ergocalciferol (N = 38) | Total (N = 189) | |
|---|---|---|---|---|---|---|
| Clinical | ||||||
| Age years, median (IQR) | 32 (26;42.5) | 33.5 (27;39) | 32 (26;42) | 37.5 (30;44) | 38 (28;49) | 35 (27;42) |
| Weight kg, median (IQR) | 54.7 (51.8;61.3) | 54.5 (49.2;61.6) | 55.2 (51.9;59.7) | 53.4 (50.2;59.3) | 53.9 (49.8;59.5) | 54.4 (50.5;59.7) |
| BMI kg/m2, median (IQR) | 18.5 (16.9;19.9) | 18.7 (16.8;19.7) | 19.4 (17.4;21.5) | 18.4 (17.3;20.0) | 18.3 (16.6;19.7) | 18.6 (17.1;20.1) |
| Female, N (%) | 2 (5.0) | 7 (18.4) | 4 (11.4) | 3 (7.89) | 7 (18.4) | 23 (12.2) |
| Smoking history, N (%) | 25 (62.5) | 22 (57.9) | 16 (45.7) | 19 (50.0) | 17 (44.7) | 99 (52.4) |
| Radiography | ||||||
| Total cavity diameter, N (%) | ||||||
| 0 cm | 11 (27.5) | 4 (10.5) | 7 (20.0) | 2 (5.26) | 3 (7.89) | 27 (14.3) |
| >0 and <4 cm | 24 (60.0) | 23 (60.5) | 18 (51.4) | 25 (65.8) | 27 (71.1) | 117 (61.9) |
| ≥4 cm | 5 (12.5) | 11 (29.0) | 10 (28.6) | 11 (29.0) | 8 (21.1) | 45 (23.8) |
| Radiographic extent of disease, N (%) | ||||||
| Moderately advanced | 24 (60.0) | 22 (57.9) | 23 (65.7) | 21 (55.3) | 20 (52.6) | 110 (58.2) |
| Far advanced | 16 (40.0) | 16 (42.1) | 12 (34.3) | 17 (44.7) | 18 (47.4) | 79 (41.8) |
| Spirometry | ||||||
| FEV1%, mean (95%CI) | 61.7 (56.3;67.1) | 62.3 (54.9;69.7) | 70.1 (63.7;76.5) | 60.1 (53.4;66.7) | 65.2 (56.8;73.6) | 63.8 (60.7;66.8) |
| FVC, L mean (95%CI) | 3.12 (2.88;3.37) | 2.96 (2.63;3.29) | 3.12 (2.83;3.41) | 2.97 (2.70;3.24) | 2.97 (2.61;3.33) | 3.03 (2.90;3.16) |
| Microbiology | ||||||
| Xpert Ct, mean (95%CI) | 16.4 (15.4;17.4) | 16.5 (15.4;17.6) | 17.7 (16.1;19.2) | 17.4 (16.3;18.6) | 16.3 (15.1;17.6) | 16.9 (16.3;17.4) |
| MGIT TTP hrs, median (IQR) | 122 (94.9;149) | 117 (103;132) | 116 (96.2;136) | 110 (96.1;123) | 115 (102;127) | 116 (108;124) |
| PET/CT | ||||||
| Log peak SUVbw, mean (95%CI) | 1.00 (0.95;1.06) | 1.00 (0.94;1.06) | 0.96 (0.88;1.03) | 1.04 (1.00;1.09) | 1.05 (0.98;1.12) | 1.01 (0.99;1.04) |
| Log maximum SUVbw, mean (95%CI) | 1.11 (1.06;1.16) | 1.11 (1.06;1.16) | 1.08 (1.02;1.14) | 1.14 (1.10;1.18) | 1.16 (1.10;1.21) | 1.12 (1.10;1.14) |
| Log total SUVbw*ml, mean (95%CI) | 3.62 (3.55;3.69) | 3.57 (3.51;3.63) | 3.52 (3.45;3.59) | 3.63 (3.57;3.70) | 3.63 (3.57;3.70) | 3.60 (3.57;3.63) |
| Log total mHU*ml, mean (95%CI) | 3.06 (3.03;3.10) | 3.03 (3.00;3.06) | 3.03 (2.99;3.06) | 3.63 (3.57;3.70) | 3.08 (3.05;3.11) | 3.05 (3.04;3.07) |
| CRP mg/L (95%CI) | 74.7 (60.7;88.7) | 76.6 (57.6;95.5) | 66.9 (44.1;89.7) | 93.2 (73.1;113.4) | 90.2 (69.4;111.0) | 80.6 (72.1;89.1) |
IQR = interquartile range; BMI = body mass index; CI = confidence interval; FEV1 = 1-second forced expiratory volume; FVC = forced vital capacity; Xpert Ct = cycle threshold; MGIT TTP = time to positivity in mycobacterial growth indicator tube cultures; PET = positron emission tomography; CT = computer tomography; SUVbw = standardized uptake value adjusted for body weight; mHU = modified Hounsfield units; CRP = C reactive protein.