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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
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BMC Medicine

ISSN: 1741-7015

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