Table 4.
Baseline | Week 1 | Week 2 | Week 4 | Week 8 | Week 12 | Week 17 | Week 26 | ||||||||||
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n | Median | n | Median | n | Median | n | Median | n | Median | n | Median | n | Median | n | Median | ||
FSH | Pa100MfxZ, Week 17* | 51 | 5.9 | 51 | 6.5 | 51 | 7.7 | 50 | 6.4 | 50 | 6.8 | 45 | 7.1 | 45 | 7.9 | 37 | 5.9 |
Pa200MfxZ, Week 17† | 48 | 6.7 | 47 | 8.7 | 46 | 8.7 | 47 | 9.2 | 47 | 8.1 | 46 | 7.7 | 44 | 7.2 | 30 | 7.2 | |
Pa200MfxZ, Week 26‡ | 50 | 6.4 | 49 | 7.6 | 47 | 8.5 | 47 | 9.2 | 44 | 6.9 | 45 | 6.8 | 27 | 6.6 | 37 | 6.3 | |
HRZE, Week 17§ | 48 | 5.4 | 48 | 7.1 | 47 | 6.8 | 48 | 6.8 | 45 | 6.4 | 44 | 6.4 | 23 | 5.8 | 43 | 5.6 | |
InhB | Pa100MfxZ, Week 17* | 51 | 117.7 | 51 | 109.9 | 50 | 117.4 | 50 | 134.6 | 48 | 137.9 | 46 | 137.3 | 45 | 130.0 | 34 | 129.2 |
Pa200MfxZ, Week 17† | 48 | 98.7 | 47 | 94.0 | 46 | 95.7 | 48 | 104.2 | 48 | 115.9 | 46 | 118.9 | 45 | 130.4 | 28 | 129.2 | |
Pa200MfxZ, Week 26‡ | 50 | 109.6 | 48 | 106.1 | 47 | 101.6 | 47 | 118.9 | 43 | 149.2 | 47 | 142.6 | 27 | 161.0 | 38 | 151.0 | |
HRZE, Week 17§ | 48 | 123.0 | 47 | 110.8 | 46 | 123.9 | 45 | 129.8 | 46 | 146.1 | 44 | 152.9 | 25 | 155.4 | 43 | 153.2 | |
LH | Pa100MfxZ, Week 17* | 51 | 5.7 | 51 | 5.5 | 51 | 5.0 | 50 | 5.1 | 50 | 5.4 | 46 | 4.6 | 46 | 5.7 | 37 | 5.0 |
Pa200MfxZ, Week 17† | 48 | 5.8 | 47 | 6.0 | 46 | 5.6 | 47 | 6.2 | 47 | 5.5 | 46 | 5.0 | 44 | 5.2 | 30 | 5.4 | |
Pa200MfxZ, Week 26‡ | 50 | 6.7 | 49 | 6.6 | 47 | 5.9 | 47 | 6.5 | 43 | 5.7 | 46 | 5.9 | 27 | 5.0 | 37 | 5.9 | |
HRZE, Week 17§ | 48 | 5.6 | 48 | 5.3 | 47 | 5.8 | 48 | 5.7 | 45 | 4.6 | 43 | 5.6 | 23 | 5.2 | 43 | 6.0 | |
T | Pa100MfxZ, Week 17* | 51 | 9.5 | 51 | 13.5 | 50 | 13.9 | 50 | 13.2 | 50 | 15.9 | 46 | 14.5 | 46 | 15.1 | 36 | 17.8 |
Pa200MfxZ, Week 17† | 48 | 9.5 | 47 | 12.7 | 46 | 12.0 | 47 | 11.6 | 47 | 12.8 | 46 | 13.7 | 44 | 15.3 | 30 | 17.9 | |
Pa200MfxZ, Week 26‡ | 50 | 10.6 | 49 | 15.0 | 47 | 12.0 | 47 | 14.8 | 44 | 15.7 | 45 | 17.0 | 27 | 15.3 | 35 | 18.7 | |
HRZE, Week 17§ | 48 | 11.5 | 48 | 20.0 | 47 | 21.7 | 48 | 22.6 | 45 | 25.5 | 44 | 26.6 | 23 | 23.2 | 42 | 24.8 | |
BMI | Pa100MfxZ, Week 17* | 51 | 18.6 | 51 | 18.8 | 51 | 18.8 | 50 | 19.3 | 50 | 19.2 | 47 | 19.5 | 47 | 19.5 | 37 | 19.5 |
Pa200MfxZ, Week 17† | 48 | 18.0 | 47 | 18.2 | 46 | 18.2 | 48 | 18.7 | 48 | 19.0 | 47 | 19.4 | 45 | 19.5 | 30 | 19.2 | |
Pa200MfxZ, Week 26‡ | 50 | 18.3 | 49 | 18.6 | 47 | 18.6 | 46 | 18.9 | 44 | 18.9 | 48 | 19.4 | 27 | 20.4 | 38 | 19.1 | |
HRZE, Week 17§ | 48 | 18.9 | 48 | 18.7 | 47 | 19.0 | 48 | 19.3 | 46 | 19.6 | 44 | 20.6 | 25 | 20.9 | 43 | 20.4 |
* Pa 100 mg/d for 17 weeks (DS).
† Pa 200 mg/d for 17 weeks (DS).
‡ Pa 200 mg/d for 26 weeks (DR).
§ Standard of care (HRZE/HR).
BMI = body mass index; FSH = follicle stimulating hormone; Pa = pretomanid; Mfx = moxifloxacin; Z = pyrazinamide; H = isoniazid; R = rifampicin; E = ethambutol; inhB = inhibin B; LH = luteinizing hormone; T = (total) testosterone; DS = drug-susceptible; DR = drug-resistant.