Table 1.
Demographic and other baseline characteristics of the safety analysis population
|
Patients with drug-susceptible tuberculosis |
Patients with rifampicin-resistant tuberculosis (BPaMZ group [n=60]) | |||||
|---|---|---|---|---|---|---|
| BloadPaZ group (n=59) | B200PaZ group (n=60) | HRZE group (n=61) | ||||
| Age*, years | 35·1 (13·0) | 33·9 (10·5) | 33·3 (8·6) | 34·0 (12·7) | ||
| Sex | ||||||
| Female | 14 (24%) | 12 (20%) | 15 (25%) | 17 (28%) | ||
| Male | 45 (76%) | 48 (80%) | 46 (75%) | 43 (72%) | ||
| Race | ||||||
| Black or African American | 46 (78%) | 49 (82%) | 49 (80%) | 53 (88%) | ||
| Native Hawaiian or other Pacific Islander | 0 | 0 | 0 | 1 (2%) | ||
| White | 0 | 0 | 0 | 1 (2%) | ||
| Mixed race | 13 (22%) | 11 (18%) | 12 (18%) | 5 (8%) | ||
| Site | ||||||
| TASK, Cape Town | 11 (19%) | 12 (20%) | 13 (21%) | 10 (17%) | ||
| UCTLI, Cape Town | 13 (22%) | 13 (22%) | 13 (21%) | 0 | ||
| CHIVRU, Helen Joseph | 5 (9%) | 5 (8%) | 5 (8%) | 0 | ||
| Aurum Institute, Tembisa | 5 (9%) | 5 (8%) | 4 (7%) | 0 | ||
| Tshepong, Klerksdorp | 0 | 0 | 0 | 25 (42%) | ||
| Ifakara, Bagamoyo | 10 (17%) | 10 (17%) | 11 (18%) | 0 | ||
| Mbeya Research Centre, Mbeya | 11 (19%) | 11 (18%) | 10 (16%) | 0 | ||
| UWCHIVRU, Johannesburg | 0 | 0 | 0 | 2 (3%) | ||
| THINK, Durban | 4 (7%) | 4 (7%) | 5 (8%) | 0 | ||
| Case Western, Kampala | 0 | 0 | 0 | 23 (38%) | ||
| Weight, kg | 56·1 (10·8) | 54·4 (9·1) | 52·7 (8·8) | 50·8 (8·4) | ||
| HIV status | ||||||
| Positive | 8 (14%) | 10 (17%) | 10 (16%) | 25 (42%) | ||
| CD4 cell count | 456·5 (135·1) | 264·7 (89·6) | 620·6 (307·4) | 400·3 (220·5) | ||
| Negative | 51 (86%) | 50 (83%) | 51 (84%) | 35 (58%) | ||
| Antiretroviral therapy at randomisation | ||||||
| Yes | 0 | 1 (10%) | 0 | 16 (64%) | ||
| No | 8 (100%) | 9 (90%) | 10 (100%) | 9 (36%) | ||
| Pyrazinamide susceptibility | ||||||
| Susceptible | 57 (97%) | 57 (95%) | 59 (97%) | 38 (63%) | ||
| Resistant | 2 (3%) | 3 (5%) | 2 (3%) | 22 (37%) | ||
| Ethambutol susceptibility | ||||||
| Susceptible | 54 (96%) | 51 (93%) | 57 (97%) | 39 (78%) | ||
| Resistant | 2 (4%) | 4 (7%) | 2 (3%) | 11 (22%) | ||
| Not done | 0 | 0 | 0 | 1 (2%) | ||
| Compliance to study drug | ||||||
| <80% | 0 | 0 | 0 | 0 | ||
| ≥80% | 59 (100%) | 60 (100%) | 61 (100%) | 60 (100%) | ||
Data are n (%) or mean (SD). BloadPaZ=bedaquiline (loading dose), pretomanid, and pyrazinamide. B200PaZ=bedaquiline (daily dose), pretomanid, and pyrazinamide. BPaMZ=bedaquiline (daily dose), pretomanid, and pyrazinamide plus moxifloxacin. CHIVRU=Clinical HIV Research Unit. HRZE=isoniazid, rifampicin, pyrazinamide, and ethambutol. UCTLI=University of Cape Town Lung Institute. UWCHIVRU=University of Witwatersrand Clinical HIV Research Unit.
*
Calculated relative to informed consent.