Table 1. Baseline characteristics of participants in the mITT population.
| Characteristic | 9BLMZ (N = 118) |
9BCLLfxZ (N = 115) |
9BDLLfxZ (N = 122) |
9DCLLfxZ (N = 118) |
9DCMZ (N = 107) |
Control (N = 119) |
Total (N = 699) |
|---|---|---|---|---|---|---|---|
| Female sex – no. (%) | 41 (34.7%) | 37 (32.2%) | 55 (45.1%) | 38 (32.2%) | 45 (42.1%) | 48 (40.3%) | 264 (37.8%) |
| Median age, years (IQR) [range] |
31.0 (25.0;41.0) [15.0;69.0] |
38.0 (26.0;50.0) [15.0;70.0] |
32.0 (22.0;45.0) [15.0;70.0] |
30.5 (22.0;41.0) [15.0;69.0] |
32.0 (24.0;46.0) [15.0;71.0] |
31.0 (22.0;42.0) [15.0;70.0] |
32.0 (23.0;44.0) [15.0;71.0] |
| Study country – no. (%) | |||||||
| Georgia | 2 (1.7%) | 2 (1.7%) | 1 (0.8%) | 3 (2.5%) | 1 (0.9%) | 3 (2.5%) | 12 (1.7%) |
| India | 8 (6.8%) | 4 (3.5%) | 3 (2.5%) | 3 (2.5%) | 1 (0.9%) | 4 (3.4%) | 23 (3.3%) |
| Kazakhstan | 30 (25.4%) | 35 (30.4%) | 33 (27.0%) | 22 (18.6%) | 24 (22.4%) | 23 (19.3%) | 167 (24.0%) |
| Lesotho | 14 (11.9%) | 11 (9.6%) | 15 (12.3%) | 11 (9.3%) | 14 (13.1%) | 12 (10.1%) | 77 (11.0%) |
| Pakistan | 18 (15.3%) | 16 (13.9%) | 13 (10.7%) | 11 (9.3%) | 16 (15.0%) | 18 (15.1%) | 92 (13.2%) |
| Peru | 38 (32.2%) | 39 (33.9%) | 49 (40.2%) | 54 (45.8%) | 45 (42.1%) | 51 (42.9%) | 276 (39.5%) |
| South Africa | 8 (6.8%) | 8 (7.0%) | 8 (6.6%) | 14 (11.9%) | 6 (5.6%) | 8 (6.7%) | 52 (7.4%) |
| Median body mass index (kg/m2) (IQR) |
19.9 (17.5;22.1) |
20.0 (18.4;23.6) |
20.9 (18.8;22.8) |
20.6 (18.1;23.6) |
19.9 (17.9;22.2) |
20.8 (17.6;23.0) |
20.4 (18.0;22.8) |
| ECOG – no. (n/%) | |||||||
| 0 | 42 (35.6%) | 35 (30.4%) | 51 (41.8%) | 47 (39.8%) | 35 (32.7%) | 43 (36.1%) | 253 (36.2%) |
| 1 | 55 (46.6%) | 62 (53.9%) | 53 (43.4%) | 54 (45.8%) | 53 (49.5%) | 63 (52.9%) | 340 (48.6%) |
| 2 | 17 (14.4%) | 15 (13.0%) | 12 (9.8%) | 16 (13.6%) | 17 (15.9%) | 11 (9.2%) | 88 (12.6%) |
| 3 | 4 (3.4%) | 3 (2.6%) | 6 (4.9%) | 1 (0.9%) | 2 (1.9%) | 2 (1.7%) | 18 (2.6%) |
| HIV, positive – no. (%) | 15 (12.7%) | 14 (12.2%) | 17 (13.9%) | 18 (15.3%) | 15 (14.0%) | 19 (16.0%) | 98 (14.0%) |
| Median CD4 count among HIV-positive participants† (IQR) |
170.5 (41.0;505.0) |
190 (85.0;377.0) |
314.5 (157.0;478.5) |
328.5 (170.5;579.5) |
404.0 (143.0;643.0) |
269.0 (83.0;443.0) |
296.0 (118.0;497.0) (N=91) |
| Antiretroviral treatment among HIV-positive participants | 12 (80.0%) | 9 (64.3%) | 10 (58.8%) | 14 (77.8%) | 11 (73.3%) | 12 (63.2%) | 68 (69.4%) |
| Hepatitis B, HbsAg positive – no. (%) |
3 (2.5%) | 3 (2.6%) | 0 (0.0%) | 2 (1.7%) | 4 (3.7%) | 4 (3.4%) | 16 (2.3%) |
| Hepatitis C, positive – no. (%) |
5 (4.2%) | 5 (4.3%) | 3 (2.5%) | 4 (3.4%) | 3 (2.8%) | 6 (5.0%) | 26 (3.7%) |
| Diabetes* – no. (%) | 19 (16.1%) | 19 (16.5%) | 20 (16.4%) | 16 (13.6%) | 16 (15.0%) | 15 (12.6%) | 105 (15.0%) |
| Smear result – no. (%) | |||||||
| Negative/Scanty | 20 (16.9%) | 19 (16.5%) | 31 (25.4%) | 24 (20.3%) | 18 (16.8%) | 19 (16.0%) | 131 (18.7%) |
| 1-2+ | 57 (48.3%) | 59 (51.3%) | 58 (47.5%) | 49 (41.5%) | 43 (40.2%) | 52 (43.7%) | 318 (45.5%) |
| 3+ | 41 (34.7%) | 37 (32.2%) | 33 (27.0%) | 45 (38.1%) | 46 (43.0%) | 48 (40.3%) | 250 (35.8%) |
| Cavitation‡ – no. (%) | 68 (57.6%) | 69 (60.0%) | 73 (59.8%) | 53 (44.9%) | 61 (57.0%) | 75 (63.0%) | 399 (57.1%) |
| Extent of TB disease£§ – no. (%) | |||||||
| Limited | 21 (17.8%) | 14 (12.2%) | 18 (14.8%) | 23 (19.5%) | 20 (18.7%) | 18 (15.1%) | 114 (16.3%) |
| Moderate | 70 (59.3%) | 77 (67.0%) | 77 (63.1%) | 67 (56.8%) | 64 (59.8%) | 71 (59.7%) | 426 (60.9%) |
| Extensive | 27 (22.9%) | 24 (20.9%) | 26 (21.3%) | 25 (21.2%) | 23 (21.5%) | 29 (24.4%) | 154 (22.0%) |
| Prior exposure to TB treatment# - no. (%) |
|||||||
| None | 76 (64.4%) | 67 (58.3%) | 78 (63.9%) | 80 (67.8%) | 72 (67.3%) | 74 (62.2%) | 447 (63.9%) |
| First-line drugs only | 20 (16.9%) | 23 (20.0%) | 27 (22.1%) | 25 (21.2%) | 23 (21.5%) | 31 (26.1%) | 149 (21.3%) |
| Other drugs | 15 (12.7%) | 19 (16.5%) | 15 (12.3%) | 7 (5.9%) | 11 (10.3%) | 11 (9.2%) | 78 (11.2%) |
| Pyrazinamide resistance§& – no. (%) | 57 (48.3%) | 63 (54.8%) | 66 (54.1%) | 66 (55.9%) | 66 (61.7%) | 59 (49.6%) | 377 (53.9%) |
| Second-line injectable resistance°§& – no. (%) |
14 (11.9%) | 18 (15.7%) | 15 (12.3%) | 13 (11.0%) | 14 (13.1%) | 16 (13.4%) | 90 (12.9%) |
The modified-intention-to treat population included randomized participants with culture-positive, FQ-susceptible and MDR/RR-TB whose isolated M. tuberculosis strains were not determined to be resistant to bedaquiline, clofazimine, delamanid, fluoroquinolone, or linezolid. Participants who did not have a pre-treatment sputum culture positive for M. tuberculosis were also excluded from the modified-intention-to treat population. ECOG denotes eastern cooperative oncology group performance status, HIV human immunodeficiency virus, TB tuberculosis, HBsAg hepatitis surface antigen, and IQR interquartile range;
Data on diabetes were missing for one participant;
data on CD4 count were unknown for 7 participants;
data on cavitation were unknown for 5 participants;
extent of TB disease was classified by Study Investigators, as follows: limited = presence of lesions with slight to moderate density, but no cavitations, not exceeding the size of the apex of the lung; moderate = lesions present in one or both lungs, not exceeding a) scattered lesions of slight to moderate density that involve the total volume of one lung or partially involve both lungs, b) dense, confluent lesions that extend up to one third of the volume of one lung, and c) cavitation with a diameter of < 4 cm in any single cavity; extensive = lesions that are more extended than those defined as moderate;
data on extent of TB disease, pyrazinamide, and second-line injectable resistance were unknown for 5 participants;
data on previous exposure to TB treatment were unknown for 25 participants;
phenotypic drug susceptibility testing; ° second-line injectables are amikacin, capreomycin, and kanamycin.