Age at screening years |
28.0 (18–61) |
Sex |
|
Female |
33 (57.9%) |
Male |
24 (42.1%) |
Previous use of second-line drugs# |
|
No |
4 (7.0%) |
Yes |
53(93.0%) |
阻力的程度M. tuberculosis筛选时应变 |
|
Pre-XDR |
27 (47.4%) |
FQ-resistant |
14 (24.6%) |
SLI-resistant |
13(22.8%) |
XDR |
30 (52.6%) |
Resistance to other TB therapies at baseline |
N进行观察/N测试 |
环丝氨酸 |
3/27 |
Ethambutol |
44/55 |
Ethionamide |
31/41 |
Linezolid |
0/5 |
PAS |
4/30 |
Prothionamide |
1/2 |
Pyrazinamide |
20/22 |
中断 |
ITT population (N=57) |
Total discontinuations |
14 (24.6%) |
Discontinuations due to AEs |
5 (8.8%) |
Deaths |
3(5.3%) |
Discontinued bedaquiline |
2¶(3.5%) |
Lost to follow-up |
2 (3.5%) |
Noncompliance |
1 (1.8%) |
Withdrawal of consent |
2 (3.5%) |
Patient moved city/country |
4 (7.0%) |
死亡人数 |
Case 1 |
Case 2 |
Case 3 |
Infection subtype |
Pre-XDR-TB (FQ resistant) |
Pre-XDR-TB (SLI resistant) |
XDR-TB |
Considered related to bedaquiline or BR |
不 |
不 |
不 |
Time since last bedaquiline intake days |
441 |
442 |
411 |
QTcF at week 24 ms |
414 |
436 |
310 |
Sputum culture conversion |
不 |
不 |
是的 |
Treatment phase |
Post-investigational+ |
Post-investigational+ |
Follow-up |
Considered TB-related |
是的§ |
是的§ |
不ƒ |
安全分析 |
|
Treatment duration weeks |
97.7 (2.1–131.1) |
任何AE无论原因或严重性如何 |
50(87.7%) |
Most common (>15%) AEs regardless of cause or severity |
|
AST increased |
28 (49.1%) |
ALT increased |
15 (26.3%) |
Eosinophilia |
13##(22.8%) |
Any AE leading to discontinuation of bedaquiline |
2##(3.5%) |
Any AE at least possibly related to bedaquiline |
6(10.5%) |
Most common AEs (>2%) at least possibly related to bedaquiline¶¶ |
|
AST increased |
4 (7.0%) |
ALT increased |
2 (3.5%) |
ECG QT interval prolonged |
2 (3.5%) |
Any serious AE++ |
8##(14.0%) |
Any grade 3 or 4 AE§§ |
15##(26.3%) |
Most common (>5%) grade 3 or 4 AEs |
|
ALT increased, grade 3 |
5##(8.8%) |
AST increased, grade 3 |
4##(7.0%) |
痰培养随着时间的推移转化 |
N进行观察/N测试 |
第24周 |
31/36(86.1%) |
Week 72 |
17/20 (85.0%) |
Week 120 |
6/6(100%) |
Last visit |
39/43(90.7%) |