Skip to main content

Table 2 Number of patients with an unfavourable outcome by treatment arm and groupings of time to culture negative status on LJ and MGIT. Groupings are quartiles or approximate quartiles for time to culture negative status

From: Limited role of culture conversion for decision-making in individual patient care and for advancing novel regimens to confirmatory clinical trials

  Time Control Isoniazid Ethambutol Total
Grouping n (%) / N n (%) / N n (%) / N n (%) / N n (%) / N
Time to culture negative status on LJa <4 weeks 8 (8 %) / 103 10 (9 %) / 106 14 (11 %) / 122 32 (10 %) / 331
4 to <6 weeks 7 (6 %) / 117 13 (9 %) / 139 19 (16 %) / 117 39 (10 %) / 373
6 to <8 weeks 6 (4 %) / 134 16 (12 %) / 132 33 (20 %) / 161 55 (13 %) / 427
8+ weeks 19 (12 %) / 153 37 (27 %) / 135 36 (30 %) / 121 92 (22 %) / 409
Total 40 (8 %) / 507 76 (15 %) / 512 102 (20 %) / 521 218 (14 %) / 1,540
Test for trend p = 0.275 p <0.001 p <0.001 p <0.001
Time to culture negative status in MGITb <6 weeks 4 (5 %) / 85 9 (8 %) / 109 12 (11 %) / 110 25 (8 %) / 304
6 to <8 weeks 4 (4 %) / 99 12 (10 %) / 116 15 (13 %) / 120 31 (9 %) / 335
8 to <12 weeks 3 (4 %) / 74 11 (14 %) / 76 14 (19 %) / 74 28 (13 %) / 224
12+ weeks 29 (12 %) / 249 43 (20 %) / 210 58 (27 %) / 214 130 (19 %) / 673
Total 40 (8 %) / 507 75 (15 %) / 511 99 (19 %) / 518 214 (14 %) / 1,536
Test for trend p = 0.013 p = 0.002 p <0.001 p <0.001
BA(0–56), daily rate of change in log10(TTP) to day 56c <0.01153 17 (10 %) / 165 22 (19 %) / 116 30 (31 %) / 98 69 (18 %) / 379
0.01153 to <0.0137 11 (9 %) / 119 27 (21 %) / 130 30 (23 %) / 131 68 (18 %) / 380
0.0137 to <0.01581 7 (6 %) / 111 15 (11 %) / 133 24 (18 %) / 135 46 (12 %) / 379
>0.01581 4 (4 %) / 104 11 (9 %) / 127 20 (13 %) / 149 35 (9 %) / 380
Total 39 (8 %) / 499 75 (15 %) / 506 104 (20 %) / 513 218 (14 %) / 1,518
Test for trend p = 0.040 p = 0.004 p = 0.001 p <0.001
Time to smear negative statusd <4 weeks 11 (8 %) / 134 11 (7 %) / 154 21 (17 %) / 127 43 (10 %) / 415
4 to <6 weeks 10 (8 %) / 122 13 (13 %) / 101 17 (15 %) / 115 40 (12 %) / 338
6 to <8 weeks 4 (4 %) / 93 14 (17 %) / 82 15 (16 %) / 95 33 (12 %) / 270
8+ weeks 15 (9 %) / 158 37 (21 %) / 173 50 (27 %) / 185 102 (20 %) / 516
Total 40 (8 %) / 507 75 (15 %) / 510 103 (20 %) / 522 218 (14 %) / 1,539
Test for trend p = 0.926 p <0.001 p = 0.026 p <0.001
  1. aExcluding 8 patients censored before time to culture negative status before 8 weeks; bexcluding 12 patients censored before time to culture negative status before 12 weeks; cexcluding 30 patients with insufficient data to be included in model; dexcluding 9 patients censored before time to culture negative status before 8 weeks. n, number of patients with an unfavourable outcome; N, number of assessable patients; %, number of patients with an unfavourable outcome relative to the number of assessable patients