TABLE 1.
Summary of patients’ characteristics presented as the median (range) or number of subjects (%)
| Variable | C208–PLC, n = 105 | C208–BDQ, n = 98 | C209–BDQ, n = 226 | Total patients, n = 429 |
|---|---|---|---|---|
| Sex | ||||
| Male | 66 (63) | 67 (68) | 146 (65) | 279 (65) |
| Female | 39 (37) | 31 (32) | 80 (35) | 150 (35) |
| Age, years | 34 (18–61) | 31 (18–63) | 32 (18–68) | 33 (18–68) |
| Weight, kg | 53 (35–83) | 53 (37–81) | 57 (30–113) | 55 (30–113) |
| Race/ethnicity | ||||
| Caucasian or White | 13 (12) | 8 (8) | 56 (25) | 77 (18) |
| Black | 40 (38) | 40 (41) | 73 (32) | 153 (36) |
| Hispanic | 15 (14) | 13 (13) | 0 (0) | 28 (7) |
| Asian | 6 (6) | 9 (9) | 89 (39) | 104 (24) |
| Other | 31 (30) | 28 (29) | 8 (4) | 67 (16) |
| TB type | ||||
| Drug‐sensitive TB | 4 (4) | 3 (3) | 3 (1) | 10 (2) |
| MDR‐TB | 63 (60) | 70 (71) | 89 (39) | 222 (52) |
| pre‐XDR‐TB | 16 (15) | 17 (17) | 43 (19) | 76 (18) |
| XDR‐TB | 5 (5) | 3 (3) | 37 (16) | 45 (10) |
| Missing | 17 (16) | 5 (5) | 54 (24) | 76 (18) |
| HIV | ||||
| Negative | 86 (82) | 85 (87) | 210 (93) | 381 (89) |
| Positive | 19 (18) | 11 (11) | 11 (5) | 41 (9.5) |
| Missing | 0 (0) | 2 (2) | 5 (2) | 7 (1.5) |
| Baseline albumin, g/L | 31 (17–46) | 34 (15–49) | 38 (24–49) | 35 (15–49) |
| Baseline (albumin‐corrected) calcium, IU/L | 2.53 (2.28–2.84) | 2.53 (2.30–2.81) | 2.43 (2.15–2.86) | 2.48 (2.15–2.86) |
| Baseline potassium, IU/L | 4.30 (3.40–5.80) | 4.40 (3.60–5.80) | 4.10 (2.70–5.40) | 4.30 (2.70–5.80) |
| Concomitant medication with QT liability | ||||
| None | 101 (96) | 95 (97) | 200 (88) | 396 (92) |
| Clofazimine | 0 (0) | 0 (0) | 24 (11) | 24 (6) |
| Moxifloxacin | 4 (4) | 3 (3) | 2 (1) | 9 (2) |
Abbreviations: BDQ, bedaquiline; MDR, multidrug resistant; PLC, placebo; TB, tuberculosis; XDR, extensively drug resistant.