Trial Outcomes & Findings for Evaluating the Safety, Tolerability, and Pharmacokinetics of Bedaquiline and Delamanid, Alone and in Combination, For Drug-Resistant Pulmonary Tuberculosis (NCT NCT02583048)
NCT ID: NCT02583048
Last Updated: 2022-01-27
Results Overview
Mean change from baseline in QTcF (ie, QTcF prolongation) in milliseconds (ms), where baseline QTcF was represented by QTcF durations measured at week 0, and post-baseline QTcF was represented by QTcF durations measured at weeks 8 through 24 (pooled). QTcF calculated as average of 1-3 available QTcF values per visit.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
84 participants
Primary outcome timeframe
Baseline and at weeks 8, 10, 12, 14, 16, 18, 20, 22 and 24
Results posted on
2022-01-27
Participant Flow
Participants were enrolled from August 2016 to July 2018 at 3 non-US clinical research sites.
Participants were randomized with equal probability to each of the 3 experimental arms.
Participant milestones
| Measure |
Arm 1: Bedaquiline
Participants received 400 mg of bedaquiline once a day for 2 weeks followed by 200 mg of bedaquiline three times a week for 22 weeks.
For HIV-positive participants only: One 50 mg tablet of Dolutegravir was taken orally once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)
Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 2: Delamanid
Participants received 100 mg of delamanid twice a day for 24 weeks.
For HIV-positive participants only: One 50 mg tablet of Dolutegravir was taken orally once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)
Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 3: Bedaquiline and Delamanid
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: One 50 mg tablet of Dolutegravir was taken orally once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)
Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
|---|---|---|---|
|
Overall Study
STARTED
|
28
|
28
|
28
|
|
Overall Study
COMPLETED
|
28
|
27
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Arm 1: Bedaquiline
Participants received 400 mg of bedaquiline once a day for 2 weeks followed by 200 mg of bedaquiline three times a week for 22 weeks.
For HIV-positive participants only: One 50 mg tablet of Dolutegravir was taken orally once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)
Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 2: Delamanid
Participants received 100 mg of delamanid twice a day for 24 weeks.
For HIV-positive participants only: One 50 mg tablet of Dolutegravir was taken orally once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)
Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 3: Bedaquiline and Delamanid
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: One 50 mg tablet of Dolutegravir was taken orally once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)
Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
|
Overall Study
Failed to meet eligibility criterion
|
0
|
0
|
1
|
Baseline Characteristics
Evaluating the Safety, Tolerability, and Pharmacokinetics of Bedaquiline and Delamanid, Alone and in Combination, For Drug-Resistant Pulmonary Tuberculosis
Baseline characteristics by cohort
| Measure |
Arm 1: Bedaquiline
n=28 Participants
Participants received 400 mg of bedaquiline once a day for 2 weeks followed by 200 mg of bedaquiline three times a week for 22 weeks.
For HIV-positive participants only: One 50 mg tablet of Dolutegravir was taken orally once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)
Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 2: Delamanid
n=28 Participants
Participants received 100 mg of delamanid twice a day for 24 weeks.
For HIV-positive participants only: One 50 mg tablet of Dolutegravir was taken orally once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)
Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 3: Bedaquiline and Delamanid
n=28 Participants
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: One 50 mg tablet of Dolutegravir was taken orally once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)
Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34.5 years
n=5 Participants
|
32 years
n=7 Participants
|
34 years
n=5 Participants
|
34 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black African
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Mestizo
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Coloured
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
South Africa
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
|
Region of Enrollment
Peru
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Baseline QTcF
|
394.3 milliseconds
n=5 Participants
|
406.2 milliseconds
n=7 Participants
|
387.3 milliseconds
n=5 Participants
|
395.5 milliseconds
n=4 Participants
|
|
HIV-1 Positive
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and at weeks 8, 10, 12, 14, 16, 18, 20, 22 and 24Population: Participants with a baseline QTcF measurement, and at least one post-baseline QTcF measurement from a visit conducted at week 8 through 24, prior to permanent discontinuation of study Tuberculosis (TB) drug and without a temporary discontinuation of study TB drug of 7 or more days immediately preceding the measurement.
Mean change from baseline in QTcF (ie, QTcF prolongation) in milliseconds (ms), where baseline QTcF was represented by QTcF durations measured at week 0, and post-baseline QTcF was represented by QTcF durations measured at weeks 8 through 24 (pooled). QTcF calculated as average of 1-3 available QTcF values per visit.
Outcome measures
| Measure |
Arm 3: Bedaquiline and Delamanid
n=25 Participants
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 2: Delamanid
n=26 Participants
Participants received 100 mg of delamanid twice a day for 24 weeks. For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 3: Bedaquiline and Delamanid
n=24 Participants
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)
Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
|---|---|---|---|
|
Mean Change From Baseline in QTcF
|
8.6 milliseconds (ms)
Interval 4.0 to 13.1
|
12.3 milliseconds (ms)
Interval 7.8 to 16.7
|
20.7 milliseconds (ms)
Interval 16.1 to 25.3
|
PRIMARY outcome
Timeframe: Baseline and at weeks 8, 10, 12, 14, 16, 18, 20, 22, and 24.Population: Participants with a baseline QTcF measurement, and at least one post-baseline QTcF measurement from a visit conducted at week 8 through 24, prior to permanent discontinuation of study Tuberculosis (TB) drug and without a temporary discontinuation of study TB drug of 7 or more days immediately preceding the measurement.
Baseline and post-baseline absolute QTcF in milliseconds (ms) estimated using an ANOVA model, where baseline QTcF was represented by QTcF durations measured at week 0, and post-baseline QTcF was represented by QTcF durations measured at weeks 8 through 24 (pooled). QTcF calculated as average of 1-3 available QTcF values per visit. Interim analysis conducted when week 24 QT data was available for ≥12 participants stipulated 99.9% confidence interval; original coverage of 95% was widened to 95.1%.
Outcome measures
| Measure |
Arm 3: Bedaquiline and Delamanid
n=25 Participants
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 2: Delamanid
n=26 Participants
Participants received 100 mg of delamanid twice a day for 24 weeks. For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 3: Bedaquiline and Delamanid
n=24 Participants
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)
Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
|---|---|---|---|
|
Post-Baseline QTcF
Baseline
|
404.9 milliseconds (ms)
Interval 396.6 to 413.2
|
397.4 milliseconds (ms)
Interval 389.3 to 405.6
|
391.7 milliseconds (ms)
Interval 383.2 to 400.2
|
|
Post-Baseline QTcF
Post-baseline
|
413.4 milliseconds (ms)
Interval 406.1 to 420.8
|
409.7 milliseconds (ms)
Interval 402.5 to 416.8
|
412.4 milliseconds (ms)
Interval 405.0 to 419.9
|
SECONDARY outcome
Timeframe: At weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24Population: Participants who took at least one dose of study TB treatment.
Participants who experienced QTcF greater than 500 ms at least once at any time from week 2 to 24. QTcF calculated as average of 1-3 available QTcF values per visit.
Outcome measures
| Measure |
Arm 3: Bedaquiline and Delamanid
n=27 Participants
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 2: Delamanid
n=28 Participants
Participants received 100 mg of delamanid twice a day for 24 weeks. For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 3: Bedaquiline and Delamanid
n=27 Participants
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)
Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
|---|---|---|---|
|
Percentage of Participants With an Occurrence of QTcF Greater Than 500 Milliseconds (ms)
|
0 Percentage of participants
Interval 0.0 to 13.0
|
0 Percentage of participants
Interval 0.0 to 12.0
|
0 Percentage of participants
Interval 0.0 to 13.0
|
SECONDARY outcome
Timeframe: Baseline and at weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24Population: Participants who took at least one dose of study TB treatment.
Participants who experienced QTcF increase from baseline greater than 60 ms at least once at any time from week 2 to 24. QTcF calculated as average of 1-3 available QTcF values per visit.
Outcome measures
| Measure |
Arm 3: Bedaquiline and Delamanid
n=27 Participants
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 2: Delamanid
n=28 Participants
Participants received 100 mg of delamanid twice a day for 24 weeks. For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 3: Bedaquiline and Delamanid
n=27 Participants
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)
Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
|---|---|---|---|
|
Percentage of Participants With an Increase in QTcF From Baseline of Greater Than 60 Milliseconds (ms)
|
0 Percentage of participants
Interval 0.0 to 13.0
|
4 Percentage of participants
Interval 0.0 to 18.0
|
7 Percentage of participants
Interval 1.0 to 24.0
|
SECONDARY outcome
Timeframe: Baseline and at weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 and 28.Population: Participants with baseline and at least one post baseline QTcF collected at a scheduled visit while taking study TB drug(s).
Change from baseline in QTcF, calculated as the difference between each post-baseline week and week 0. (QTcF calculated as average of 1-3 available QTcF values per visit.)
Outcome measures
| Measure |
Arm 3: Bedaquiline and Delamanid
n=26 Participants
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 2: Delamanid
n=28 Participants
Participants received 100 mg of delamanid twice a day for 24 weeks. For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 3: Bedaquiline and Delamanid
n=26 Participants
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)
Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
|---|---|---|---|
|
Changes in QTcF From Baseline
Change from baseline to Week 18
|
11.70 milliseconds (ms)
Interval -28.3 to 39.3
|
17.65 milliseconds (ms)
Interval -17.3 to 72.3
|
12.70 milliseconds (ms)
Interval -26.7 to 66.3
|
|
Changes in QTcF From Baseline
Change from baseline to Week 2
|
4.15 milliseconds (ms)
Interval -25.7 to 24.3
|
16.70 milliseconds (ms)
Interval -25.7 to 57.0
|
13.15 milliseconds (ms)
Interval -6.7 to 55.7
|
|
Changes in QTcF From Baseline
Change from baseline to Week 4
|
8.70 milliseconds (ms)
Interval -15.7 to 24.7
|
15.00 milliseconds (ms)
Interval -21.0 to 40.7
|
14.30 milliseconds (ms)
Interval -8.7 to 50.3
|
|
Changes in QTcF From Baseline
Change from baseline to Week 6
|
9.30 milliseconds (ms)
Interval -19.0 to 37.7
|
15.30 milliseconds (ms)
Interval -25.3 to 40.0
|
15.30 milliseconds (ms)
Interval -11.0 to 33.7
|
|
Changes in QTcF From Baseline
Change from baseline to Week 8
|
7.00 milliseconds (ms)
Interval -30.3 to 39.0
|
12.00 milliseconds (ms)
Interval -40.3 to 47.3
|
20.30 milliseconds (ms)
Interval -14.0 to 47.3
|
|
Changes in QTcF From Baseline
Change from baseline to Week 10
|
7.80 milliseconds (ms)
Interval -25.3 to 37.7
|
10.30 milliseconds (ms)
Interval -30.3 to 51.0
|
18.30 milliseconds (ms)
Interval -15.0 to 58.3
|
|
Changes in QTcF From Baseline
Change from baseline to Week 12
|
10.30 milliseconds (ms)
Interval -21.0 to 38.7
|
9.30 milliseconds (ms)
Interval -11.7 to 46.3
|
20.30 milliseconds (ms)
Interval -20.3 to 50.3
|
|
Changes in QTcF From Baseline
Change from baseline to Week 14
|
5.30 milliseconds (ms)
Interval -18.0 to 49.0
|
12.70 milliseconds (ms)
Interval -16.0 to 53.0
|
21.30 milliseconds (ms)
Interval -19.0 to 51.0
|
|
Changes in QTcF From Baseline
Change from baseline to Week 16
|
7.35 milliseconds (ms)
Interval -46.0 to 38.7
|
15.35 milliseconds (ms)
Interval -34.3 to 55.3
|
21.00 milliseconds (ms)
Interval -22.7 to 62.7
|
|
Changes in QTcF From Baseline
Change from baseline to Week 20
|
13.65 milliseconds (ms)
Interval -21.3 to 29.3
|
9.30 milliseconds (ms)
Interval -24.3 to 46.7
|
21.00 milliseconds (ms)
Interval -18.3 to 70.0
|
|
Changes in QTcF From Baseline
Change from baseline to Week 22
|
9.00 milliseconds (ms)
Interval -15.7 to 34.3
|
12.00 milliseconds (ms)
Interval -16.0 to 56.7
|
20.85 milliseconds (ms)
Interval -19.3 to 75.0
|
|
Changes in QTcF From Baseline
Change from baseline to Week 24
|
13.00 milliseconds (ms)
Interval -19.3 to 40.3
|
11.70 milliseconds (ms)
Interval -26.0 to 46.0
|
24.00 milliseconds (ms)
Interval -19.0 to 46.3
|
|
Changes in QTcF From Baseline
Change from baseline to Week 28
|
6.00 milliseconds (ms)
Interval -25.3 to 38.3
|
13.30 milliseconds (ms)
Interval -20.3 to 43.0
|
17.65 milliseconds (ms)
Interval -16.0 to 55.7
|
SECONDARY outcome
Timeframe: At weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24Population: Participants who took at least one dose of study TB drug(s).
Participants who experienced QTcF \>480 and ≤500 ms at least once at any time from week 2 to 24. QTcF calculated as average of 1-3 available QTcF values per visit.
Outcome measures
| Measure |
Arm 3: Bedaquiline and Delamanid
n=27 Participants
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 2: Delamanid
n=28 Participants
Participants received 100 mg of delamanid twice a day for 24 weeks. For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 3: Bedaquiline and Delamanid
n=27 Participants
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)
Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
|---|---|---|---|
|
Percentage of Participants With an Occurrence of QTcF >480 and ≤500 Milliseconds (ms)
|
0 Percentage of participants
Interval 0.0 to 13.0
|
0 Percentage of participants
Interval 0.0 to 12.0
|
0 Percentage of participants
Interval 0.0 to 13.0
|
SECONDARY outcome
Timeframe: Baseline and at weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24Population: Participants who took at least one dose of study treatment.
Participants who experienced QTcF increase from baseline of \>30 and ≤60 ms at least once at any time from week 2 to 24. QTcF calculated as average of 1-3 available QTcF values per visit.
Outcome measures
| Measure |
Arm 3: Bedaquiline and Delamanid
n=27 Participants
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 2: Delamanid
n=28 Participants
Participants received 100 mg of delamanid twice a day for 24 weeks. For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 3: Bedaquiline and Delamanid
n=27 Participants
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)
Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
|---|---|---|---|
|
Percentage of Participants With an Occurrence of QTcF Increase From Baseline of >30 and ≤60 Milliseconds (ms)
|
41 Percentage of participants
Interval 22.0 to 61.0
|
32 Percentage of participants
Interval 16.0 to 52.0
|
37 Percentage of participants
Interval 19.0 to 58.0
|
SECONDARY outcome
Timeframe: Intensive BDQ PK samples at pre-dose, 5h, 7h, 10h and 22h post-dose at weeks 2, 8 and 24Population: Participants who took at least one dose of study treatment, and were taking study drug at the time of the PK visit.
This evaluates the effect of DLM on the BDQ PK parameter Cmin obtained from participants enrolled in Arms 1 and 3 (without and with co-administration of DLM). Cmin defines minimum concentration observed over the first 22 hours of the BDQ dosing interval.
Outcome measures
| Measure |
Arm 3: Bedaquiline and Delamanid
n=24 Participants
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 2: Delamanid
n=28 Participants
Participants received 100 mg of delamanid twice a day for 24 weeks. For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 3: Bedaquiline and Delamanid
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)
Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
|---|---|---|---|
|
BDQ PK Parameter Minimum Plasma Concentration (Cmin) Determined Based on BDQ Levels From Individual Participants Enrolled in Arms 1 and 3
Week 8
|
601.9 ng/mL
Standard Deviation 212.6
|
505.9 ng/mL
Standard Deviation 218.6
|
—
|
|
BDQ PK Parameter Minimum Plasma Concentration (Cmin) Determined Based on BDQ Levels From Individual Participants Enrolled in Arms 1 and 3
Week 2
|
850.9 ng/mL
Standard Deviation 343.8
|
796.8 ng/mL
Standard Deviation 406.1
|
—
|
|
BDQ PK Parameter Minimum Plasma Concentration (Cmin) Determined Based on BDQ Levels From Individual Participants Enrolled in Arms 1 and 3
Week 24
|
629.4 ng/mL
Standard Deviation 247.0
|
653.4 ng/mL
Standard Deviation 271.3
|
—
|
SECONDARY outcome
Timeframe: Intensive BDQ PK samples at pre-dose, 5h, 7h, 10h and 22h post-dose at weeks 2, 8 and 24Population: Participants who took at least one dose of study treatment, and were taking study drug at the time of the PK visit.
This evaluates the effect of DLM on the BDQ PK parameter Cmax obtained from participants enrolled in Arms 1 and 3 (without and with co-administration of DLM). Cmax defines maximum concentration observed over the first 22 hours of the BDQ dosing interval.
Outcome measures
| Measure |
Arm 3: Bedaquiline and Delamanid
n=24 Participants
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 2: Delamanid
n=28 Participants
Participants received 100 mg of delamanid twice a day for 24 weeks. For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 3: Bedaquiline and Delamanid
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)
Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
|---|---|---|---|
|
BDQ PK Parameter Maxmum Plasma Concentration (Cmax) Determined Based on BDQ Levels From Individual Participants Enrolled in Arms 1 and 3
Week 2
|
2405.2 ng/mL
Standard Deviation 1128.2
|
2434.3 ng/mL
Standard Deviation 1148.4
|
—
|
|
BDQ PK Parameter Maxmum Plasma Concentration (Cmax) Determined Based on BDQ Levels From Individual Participants Enrolled in Arms 1 and 3
Week 8
|
1477.2 ng/mL
Standard Deviation 704.7
|
1455.6 ng/mL
Standard Deviation 670.6
|
—
|
|
BDQ PK Parameter Maxmum Plasma Concentration (Cmax) Determined Based on BDQ Levels From Individual Participants Enrolled in Arms 1 and 3
Week 24
|
1368.2 ng/mL
Standard Deviation 518.6
|
1507.3 ng/mL
Standard Deviation 495.8
|
—
|
SECONDARY outcome
Timeframe: Intensive BDQ PK samples at pre-dose, 5h, 7h, 10h and 22h post-dose at Weeks 2, 8 and 24Population: Participants who took at least one dose of study treatment, and were taking study drug at the time of the PK visit.
This evaluates the effect of DLM on the BDQ PK parameter AUC 0-22h obtained from participants enrolled in Arms 1 and 3 (without and with co-administration of DLM). AUC 0-22h defines area under the concentration-time curve over the period of 22 hours post-dose.
Outcome measures
| Measure |
Arm 3: Bedaquiline and Delamanid
n=24 Participants
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 2: Delamanid
n=28 Participants
Participants received 100 mg of delamanid twice a day for 24 weeks. For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 3: Bedaquiline and Delamanid
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)
Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
|---|---|---|---|
|
BDQ PK Parameter Area Under the Concentration Time Curve (AUC 0-22h) Calculated Based on Intensive PK Samples Obtained From Individual Participants Enrolled in Arms 1 and 3
Week 2
|
32399.4 ng*h/mL
Standard Deviation 13625.2
|
31570.9 ng*h/mL
Standard Deviation 14612.8
|
—
|
|
BDQ PK Parameter Area Under the Concentration Time Curve (AUC 0-22h) Calculated Based on Intensive PK Samples Obtained From Individual Participants Enrolled in Arms 1 and 3
Week 8
|
20176.1 ng*h/mL
Standard Deviation 8175.5
|
19234.6 ng*h/mL
Standard Deviation 7785.7
|
—
|
|
BDQ PK Parameter Area Under the Concentration Time Curve (AUC 0-22h) Calculated Based on Intensive PK Samples Obtained From Individual Participants Enrolled in Arms 1 and 3
Week 24
|
19522.6 ng*h/mL
Standard Deviation 7545.7
|
21048.5 ng*h/mL
Standard Deviation 8329.7
|
—
|
SECONDARY outcome
Timeframe: Intensive BDQ Metabolite PK samples at pre-dose, 5h, 7h, 10h and 22h post-dose at weeks 2, 8 and 24Population: Participants who took at least one dose of study treatment, and were taking study drug at the time of the PK visit.
This evaluates the effect of DLM on the N-monodesmethyl Metabolite of BDQ PK parameter Cmin obtained from participants enrolled in Arms 1 and 3 (without and with co-administration of DLM). Cmin defines minimum concentration observed over the first 22 hours of the BDQ dosing interval.
Outcome measures
| Measure |
Arm 3: Bedaquiline and Delamanid
n=26 Participants
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 2: Delamanid
n=28 Participants
Participants received 100 mg of delamanid twice a day for 24 weeks. For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 3: Bedaquiline and Delamanid
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)
Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
|---|---|---|---|
|
N-monodesmethyl Metabolite of BDQ PK Parameter Cmin Determined Based on BDQ Metabolite Levels From Individual Participants Enrolled in Arms 1 and 3
Week 24
|
174.0 ng/mL
Standard Deviation 82.1
|
204.0 ng/mL
Standard Deviation 62.8
|
—
|
|
N-monodesmethyl Metabolite of BDQ PK Parameter Cmin Determined Based on BDQ Metabolite Levels From Individual Participants Enrolled in Arms 1 and 3
Week 2
|
361.6 ng/mL
Standard Deviation 122.8
|
353.3 ng/mL
Standard Deviation 137.8
|
—
|
|
N-monodesmethyl Metabolite of BDQ PK Parameter Cmin Determined Based on BDQ Metabolite Levels From Individual Participants Enrolled in Arms 1 and 3
Week 8
|
204.7 ng/mL
Standard Deviation 76.3
|
200.0 ng/mL
Standard Deviation 81.1
|
—
|
SECONDARY outcome
Timeframe: Intensive BDQ Metabolite PK samples at pre-dose, 5h, 7h, 10h and 22h post-dose at weeks 2, 8 and 24Population: Participants who took at least one dose of study treatment, and were taking study drug at the time of the PK visit.
This evaluates the effect of DLM on the BDQ Metabolite N-monodesmethyl BDQ PK parameter Cmax obtained from participants enrolled in Arms 1 and 3 (without and with co-administration of DLM). Cmax defines maximum concentration observed over the first 22 hours of the BDQ dosing interval.
Outcome measures
| Measure |
Arm 3: Bedaquiline and Delamanid
n=26 Participants
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 2: Delamanid
n=28 Participants
Participants received 100 mg of delamanid twice a day for 24 weeks. For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 3: Bedaquiline and Delamanid
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)
Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
|---|---|---|---|
|
N-monodesmethyl Metabolite of BDQ PK Parameter Cmax Determined Based on BDQ Metabolite Levels From Individual Participants Enrolled in Arms 1 and 3
Week 2
|
429.8 ng/mL
Standard Deviation 139.8
|
404.8 ng/mL
Standard Deviation 143.7
|
—
|
|
N-monodesmethyl Metabolite of BDQ PK Parameter Cmax Determined Based on BDQ Metabolite Levels From Individual Participants Enrolled in Arms 1 and 3
Week 8
|
241.5 ng/mL
Standard Deviation 87.2
|
248.5 ng/mL
Standard Deviation 95.4
|
—
|
|
N-monodesmethyl Metabolite of BDQ PK Parameter Cmax Determined Based on BDQ Metabolite Levels From Individual Participants Enrolled in Arms 1 and 3
Week 24
|
196.8 ng/mL
Standard Deviation 92.5
|
232.9 ng/mL
Standard Deviation 68.6
|
—
|
SECONDARY outcome
Timeframe: Intensive BDQ PK samples at pre-dose, 5h, 7h, 10h and 22h post-dose at Weeks 2, 8 and 24Population: Participants who took at least one dose of study treatment, and were taking study drug at the time of the PK visit.
This evaluates the effect of DLM on the N-monodesmethyl Metabolite of BDQ PK parameter AUC 0-22h obtained from participants enrolled in Arms 1 and 3 (without and with co-administration of DLM). AUC 0-22h defines area under the concentration-time curve over the period of 22 hours post-dose.
Outcome measures
| Measure |
Arm 3: Bedaquiline and Delamanid
n=26 Participants
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 2: Delamanid
n=28 Participants
Participants received 100 mg of delamanid twice a day for 24 weeks. For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 3: Bedaquiline and Delamanid
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)
Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
|---|---|---|---|
|
N-monodesmethyl Metabolite of BDQ PK Parameter AUC 0-22h Calculated Based on Intensive PK Samples Obtained From Individual Participants Enrolled in Arms 1 and 3
Week 2
|
8713.4 ng*h/mL
Standard Deviation 2858.9
|
8435.5 ng*h/mL
Standard Deviation 3220.1
|
—
|
|
N-monodesmethyl Metabolite of BDQ PK Parameter AUC 0-22h Calculated Based on Intensive PK Samples Obtained From Individual Participants Enrolled in Arms 1 and 3
Week 8
|
4963.4 ng*h/mL
Standard Deviation 1847.6
|
5067.5 ng*h/mL
Standard Deviation 2017.6
|
—
|
|
N-monodesmethyl Metabolite of BDQ PK Parameter AUC 0-22h Calculated Based on Intensive PK Samples Obtained From Individual Participants Enrolled in Arms 1 and 3
Week 24
|
4033.5 ng*h/mL
Standard Deviation 1978.7
|
4771.4 ng*h/mL
Standard Deviation 1577.9
|
—
|
SECONDARY outcome
Timeframe: Intensive DLM PK samples at pre-dose, 4h, 8h, and 11h post-dose at weeks 2, 8 and 24Population: Participants who took at least one dose of study treatment, and were taking study drug at the time of the PK visit.
This evaluates the effect of BDQ on the DLM PK parameter Cmin obtained from participants enrolled in Arms 2 and 3 (without and with co-administration of BDQ). Cmin defines minimum concentration observed over the first 11 hours of the DLM dosing interval.
Outcome measures
| Measure |
Arm 3: Bedaquiline and Delamanid
n=26 Participants
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 2: Delamanid
n=25 Participants
Participants received 100 mg of delamanid twice a day for 24 weeks. For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 3: Bedaquiline and Delamanid
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)
Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
|---|---|---|---|
|
DLM PK Parameter Cmin Determined Based on DLM Levels From Individual Participants Enrolled in Arms 2 and 3
Week 2
|
206.8 ng/mL
Standard Deviation 64.8
|
224.8 ng/mL
Standard Deviation 59.0
|
—
|
|
DLM PK Parameter Cmin Determined Based on DLM Levels From Individual Participants Enrolled in Arms 2 and 3
Week 8
|
217.2 ng/mL
Standard Deviation 64.6
|
198.2 ng/mL
Standard Deviation 64.3
|
—
|
|
DLM PK Parameter Cmin Determined Based on DLM Levels From Individual Participants Enrolled in Arms 2 and 3
Week 24
|
182.2 ng/mL
Standard Deviation 78.5
|
220.9 ng/mL
Standard Deviation 78.9
|
—
|
SECONDARY outcome
Timeframe: Intensive DLM PK samples at pre-dose, 4h, 8h, and 11h post-dose at weeks 2, 8 and 24Population: Participants who took at least one dose of study treatment, and were taking study drug at the time of the PK visit.
This evaluates the effect of BDQ on the DLM PK parameter Cmax obtained from participants enrolled in Arms 2 and 3 (without and with co-administration of BDQ). Cmax defines maximum concentration observed over the first 11 hours of the DLM dosing interval.
Outcome measures
| Measure |
Arm 3: Bedaquiline and Delamanid
n=26 Participants
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 2: Delamanid
n=25 Participants
Participants received 100 mg of delamanid twice a day for 24 weeks. For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 3: Bedaquiline and Delamanid
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)
Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
|---|---|---|---|
|
DLM PK Parameter Cmax Determined Based on DLM Levels From Individual Participants Enrolled in Arms 2 and 3
Week 24
|
259.0 ng/mL
Standard Deviation 102.8
|
290.3 ng/mL
Standard Deviation 81.6
|
—
|
|
DLM PK Parameter Cmax Determined Based on DLM Levels From Individual Participants Enrolled in Arms 2 and 3
Week 2
|
298.3 ng/mL
Standard Deviation 84.2
|
317.8 ng/mL
Standard Deviation 88.7
|
—
|
|
DLM PK Parameter Cmax Determined Based on DLM Levels From Individual Participants Enrolled in Arms 2 and 3
Week 8
|
320.9 ng/mL
Standard Deviation 98.4
|
294.1 ng/mL
Standard Deviation 100.0
|
—
|
SECONDARY outcome
Timeframe: Intensive DLM PK samples at pre-dose, 4h, 8h, and 11h post-dose at weeks 2, 8 and 24Population: Participants who took at least one dose of study treatment, and were taking study drug at the time of the PK visit.
This evaluates the effect of BDQ on the DLM PK parameter AUC 0-11h obtained from participants enrolled in Arms 2 and 3 (without and with co-administration of BDQ). AUC 0-11h defines area under the concentration-time curve over the first 11 hours of the DLM dosing interval.
Outcome measures
| Measure |
Arm 3: Bedaquiline and Delamanid
n=26 Participants
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 2: Delamanid
n=25 Participants
Participants received 100 mg of delamanid twice a day for 24 weeks. For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 3: Bedaquiline and Delamanid
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)
Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
|---|---|---|---|
|
DLM PK Area Under the Concentration Time Curve (AUC 0-11h) Determined Based on Intensive PK Samples Obtained From Individual Participants Enrolled in Arms 2 and 3
Week 2
|
2654.9 ng*h/mL
Standard Deviation 724.3
|
2789.6 ng*h/mL
Standard Deviation 761.9
|
—
|
|
DLM PK Area Under the Concentration Time Curve (AUC 0-11h) Determined Based on Intensive PK Samples Obtained From Individual Participants Enrolled in Arms 2 and 3
Week 8
|
2823.2 ng*h/mL
Standard Deviation 792.7
|
2547.6 ng*h/mL
Standard Deviation 838.4
|
—
|
|
DLM PK Area Under the Concentration Time Curve (AUC 0-11h) Determined Based on Intensive PK Samples Obtained From Individual Participants Enrolled in Arms 2 and 3
Week 24
|
2324.9 ng*h/mL
Standard Deviation 987.3
|
2473.0 ng*h/mL
Standard Deviation 778.2
|
—
|
SECONDARY outcome
Timeframe: Intensive DLM PK samples at pre-dose, 4h, 8h, and 11h post-dose at weeks 2, 8 and 24Population: Participants who took at least one dose of study treatment, and were taking study drug at the time of the PK visit.
This evaluates the effect of BDQ on the DLM Metabolite DM6705 PK parameter Cmin obtained from participants enrolled in Arms 2 and 3 (without and with co-administration of BDQ). Cmin defines minimum concentration observed over the first 11 hours of the DLM dosing interval.
Outcome measures
| Measure |
Arm 3: Bedaquiline and Delamanid
n=26 Participants
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 2: Delamanid
n=25 Participants
Participants received 100 mg of delamanid twice a day for 24 weeks. For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 3: Bedaquiline and Delamanid
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)
Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
|---|---|---|---|
|
DLM Metabolite DM6705 PK Parameter Cmin Determined Based on DLM Metabolite Levels From Individual Participants Enrolled in Arms 2 and 3
Week 2
|
58.5 ng/mL
Standard Deviation 17.0
|
61.9 ng/mL
Standard Deviation 19.3
|
—
|
|
DLM Metabolite DM6705 PK Parameter Cmin Determined Based on DLM Metabolite Levels From Individual Participants Enrolled in Arms 2 and 3
Week 8
|
94.4 ng/mL
Standard Deviation 37.8
|
90.6 ng/mL
Standard Deviation 38.2
|
—
|
|
DLM Metabolite DM6705 PK Parameter Cmin Determined Based on DLM Metabolite Levels From Individual Participants Enrolled in Arms 2 and 3
Week 24
|
71.0 ng/mL
Standard Deviation 46.6
|
75.7 ng/mL
Standard Deviation 41.6
|
—
|
SECONDARY outcome
Timeframe: Intensive DLM PK samples at pre-dose, 4h, 8h, and 11h post-dose at weeks 2, 8 and 24Population: Participants who took at least one dose of study treatment, and were taking study drug at the time of the PK visit.
This evaluates the effect of BDQ on the DLM Metabolite DM6705 PK parameter Cmax obtained from participants enrolled in Arms 2 and 3 (without and with co-administration of BDQ). Cmax defines maximum concentration observed over the first 11 hours of the DLM dosing interval.
Outcome measures
| Measure |
Arm 3: Bedaquiline and Delamanid
n=26 Participants
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 2: Delamanid
n=25 Participants
Participants received 100 mg of delamanid twice a day for 24 weeks. For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 3: Bedaquiline and Delamanid
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)
Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
|---|---|---|---|
|
DLM Metabolite DM6705 PK Parameter Cmax Determined Based on DLM Metabolite Levels From Individual Participants Enrolled in Arms 2 and 3
Week 24
|
75.6 ng/mL
Standard Deviation 47.9
|
82.1 ng/mL
Standard Deviation 46.1
|
—
|
|
DLM Metabolite DM6705 PK Parameter Cmax Determined Based on DLM Metabolite Levels From Individual Participants Enrolled in Arms 2 and 3
Week 8
|
105.4 ng/mL
Standard Deviation 46.2
|
99.7 ng/mL
Standard Deviation 41.0
|
—
|
|
DLM Metabolite DM6705 PK Parameter Cmax Determined Based on DLM Metabolite Levels From Individual Participants Enrolled in Arms 2 and 3
Week 2
|
64.3 ng/mL
Standard Deviation 19.8
|
66.6 ng/mL
Standard Deviation 18.1
|
—
|
SECONDARY outcome
Timeframe: Intensive DLM PK samples at pre-dose, 4h, 8h, and 11h post-dose at weeks 2, 8 and 24Population: Participants who took at least one dose of study treatment, and were taking study drug at the time of the PK visit.
This evaluates the effect of BDQ on the DLM Metabolite DM6705 PK parameter AUC 0-11h obtained from participants enrolled in Arms 2 and 3 (without and with co-administration of BDQ). AUC 0-11h defines area under the concentration-time curve over the first 11 hours of the DLM dosing interval.
Outcome measures
| Measure |
Arm 3: Bedaquiline and Delamanid
n=26 Participants
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 2: Delamanid
n=25 Participants
Participants received 100 mg of delamanid twice a day for 24 weeks. For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 3: Bedaquiline and Delamanid
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)
Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
|---|---|---|---|
|
DLM Metabolite DM6705 PK AUC 0-11h Determined Based on Intensive PK Samples Obtained From Individual Participants Enrolled in Arms 2 and 3
Week 2
|
621.2 ng*h/mL
Standard Deviation 178.3
|
628.0 ng*h/mL
Standard Deviation 188.1
|
—
|
|
DLM Metabolite DM6705 PK AUC 0-11h Determined Based on Intensive PK Samples Obtained From Individual Participants Enrolled in Arms 2 and 3
Week 8
|
990.9 ng*h/mL
Standard Deviation 378.1
|
953.9 ng*h/mL
Standard Deviation 395.2
|
—
|
|
DLM Metabolite DM6705 PK AUC 0-11h Determined Based on Intensive PK Samples Obtained From Individual Participants Enrolled in Arms 2 and 3
Week 24
|
742.5 ng*h/mL
Standard Deviation 479.5
|
749.9 ng*h/mL
Standard Deviation 420.4
|
—
|
SECONDARY outcome
Timeframe: From initiation of study TB treatment (week 0) to week 24Population: Participants who took at least one dose of study TB treatment.
Participants with an occurrence of an adverse event (laboratory value, sign/symptom, diagnosis) of grade 3 or 4. Severity grading based on DAIDS AE Grading Table Version 2.0. Participants were counted once at the highest grade (grade 3 or grade 4).
Outcome measures
| Measure |
Arm 3: Bedaquiline and Delamanid
n=27 Participants
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 2: Delamanid
n=28 Participants
Participants received 100 mg of delamanid twice a day for 24 weeks. For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 3: Bedaquiline and Delamanid
n=27 Participants
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)
Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
|---|---|---|---|
|
Percentage of Participants With an Occurrence of Grade 3 or Higher Adverse Event
Grade 3 adverse event
|
11 Percentage of participants
Interval 2.0 to 29.0
|
36 Percentage of participants
Interval 19.0 to 56.0
|
19 Percentage of participants
Interval 6.0 to 38.0
|
|
Percentage of Participants With an Occurrence of Grade 3 or Higher Adverse Event
Grade 4 adverse event
|
11 Percentage of participants
Interval 2.0 to 29.0
|
4 Percentage of participants
Interval 0.0 to 18.0
|
19 Percentage of participants
Interval 6.0 to 38.0
|
SECONDARY outcome
Timeframe: From initiation of study TB treatment (week 0) to week 24Population: Participants who took at least one dose of study TB treatment.
Percentage of participants who discontinued study TB drug(s) for any reason
Outcome measures
| Measure |
Arm 3: Bedaquiline and Delamanid
n=27 Participants
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 2: Delamanid
n=28 Participants
Participants received 100 mg of delamanid twice a day for 24 weeks. For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 3: Bedaquiline and Delamanid
n=27 Participants
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)
Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
|---|---|---|---|
|
Percentage of Participants Who Discontinued Study TB Drug(s) For Any Reason
|
19 Percentage of participants
Interval 6.0 to 38.0
|
11 Percentage of participants
Interval 2.0 to 28.0
|
22 Percentage of participants
Interval 9.0 to 42.0
|
SECONDARY outcome
Timeframe: From initiation of study TB treatment (week 0) to week 24Population: Participants who took at least one dose of study TB treatment.
Among participants who took at least one dose of study TB treatment, percentage of participants who died on or before week 24. Note that the all-cause mortality includes deaths that occurred at any time during treatment or follow-up through week 128.
Outcome measures
| Measure |
Arm 3: Bedaquiline and Delamanid
n=27 Participants
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 2: Delamanid
n=28 Participants
Participants received 100 mg of delamanid twice a day for 24 weeks. For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 3: Bedaquiline and Delamanid
n=27 Participants
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.)
Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
|---|---|---|---|
|
Percentage of Participants Who Died
|
0 Percentage of participants
Interval 0.0 to 13.0
|
0 Percentage of participants
Interval 0.0 to 12.0
|
0 Percentage of participants
Interval 0.0 to 13.0
|
Adverse Events
Arm 1: Bedaquiline
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Arm 2: Delamanid
Serious events: 3 serious events
Other events: 16 other events
Deaths: 1 deaths
Arm 3: Bedaquiline and Delamanid
Serious events: 8 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: Bedaquiline
n=28 participants at risk
Participants received 400 mg of bedaquiline once a day for 2 weeks followed by 200 mg of bedaquiline three times a week for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 2: Delamanid
n=27 participants at risk
Participants received 100 mg of delamanid twice a day for 24 weeks. For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 3: Bedaquiline and Delamanid
n=27 participants at risk
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
|---|---|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
3.7%
1/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
3.7%
1/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
3.7%
1/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
3.7%
1/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
3.7%
1/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
14.8%
4/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Investigations
Electrocardiogram QT prolonged
|
3.6%
1/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.6%
1/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Nervous system disorders
Focal dyscognitive seizures
|
0.00%
0/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
3.7%
1/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
3.7%
1/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Nervous system disorders
Seizure
|
0.00%
0/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
3.7%
1/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
3.7%
1/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.00%
0/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
3.7%
1/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
3.7%
1/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
Other adverse events
| Measure |
Arm 1: Bedaquiline
n=28 participants at risk
Participants received 400 mg of bedaquiline once a day for 2 weeks followed by 200 mg of bedaquiline three times a week for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 2: Delamanid
n=27 participants at risk
Participants received 100 mg of delamanid twice a day for 24 weeks. For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
Arm 3: Bedaquiline and Delamanid
n=27 participants at risk
Participants received 400 mg of bedaquiline once a day and 100 mg of delamanid twice a day for 2 weeks. They then received 200 mg of bedaquiline three times a week and 100 mg of delamanid twice a day for 22 weeks.
For HIV-positive participants only: dolutegravir was administered at a dose of one 50 mg tablet once daily, to be used in combination with two NRTIs until study completion. (NRTIs not provided by the study.) Participants also took Multidrug Background Treatment (MBT) for TB (not provided by the study).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.7%
3/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
3.7%
1/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Ear and labyrinth disorders
Deafness
|
10.7%
3/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
7.4%
2/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
22.2%
6/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
28.6%
8/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
14.8%
4/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
14.8%
4/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Ear and labyrinth disorders
Tinnitus
|
7.1%
2/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
7.4%
2/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
7.4%
2/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
3.7%
1/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Eye disorders
Optic neuropathy
|
0.00%
0/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
7.4%
2/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
3.7%
1/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
2/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
7.4%
2/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
7.4%
2/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
3.7%
1/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
7.4%
2/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.6%
1/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
11.1%
3/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
3.7%
1/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
7.4%
2/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
11.1%
3/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
1/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
7.4%
2/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
General disorders
Injection site reaction
|
0.00%
0/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
7.4%
2/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Infections and infestations
Acute sinusitis
|
3.6%
1/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
11.1%
3/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
3.7%
1/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
22.2%
6/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
3.7%
1/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Infections and infestations
Oral herpes
|
3.6%
1/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
7.4%
2/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Infections and infestations
Pharyngitis
|
10.7%
3/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
18.5%
5/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
7.4%
2/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
7.4%
2/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
2/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
3.7%
1/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Investigations
Blood albumin decreased
|
3.6%
1/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
7.4%
2/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Investigations
Blood glucose decreased
|
0.00%
0/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
3.7%
1/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
7.4%
2/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Investigations
Blood uric acid increased
|
10.7%
3/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
3.7%
1/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Investigations
Haemoglobin decreased
|
10.7%
3/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
3.7%
1/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Investigations
Weight decreased
|
10.7%
3/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
3.7%
1/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.1%
2/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
3.7%
1/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
2/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
3.6%
1/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
7.4%
2/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
4/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
3.7%
1/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Nervous system disorders
Dizziness
|
10.7%
3/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
7.4%
2/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Nervous system disorders
Headache
|
10.7%
3/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
7.4%
2/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Nervous system disorders
Hypoaesthesia
|
7.1%
2/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
3.7%
1/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Nervous system disorders
Neuropathy peripheral
|
21.4%
6/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
7.4%
2/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
11.1%
3/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Nervous system disorders
Paraesthesia
|
14.3%
4/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
3.7%
1/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
7.4%
2/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Nervous system disorders
Seizure
|
0.00%
0/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
11.1%
3/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
7.4%
2/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
2/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
7.4%
2/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.1%
2/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
7.4%
2/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.1%
2/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
11.1%
3/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
7.4%
2/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
3.6%
1/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
7.4%
2/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
14.3%
4/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
7.4%
2/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
3.7%
1/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Skin and subcutaneous tissue disorders
Acne
|
28.6%
8/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
22.2%
6/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
29.6%
8/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
3.6%
1/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
3.7%
1/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
7.4%
2/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.7%
3/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
7.4%
2/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
14.8%
4/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.6%
1/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
7.4%
2/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
3.7%
1/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Vascular disorders
Hypertension
|
7.1%
2/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
3.7%
1/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
3.7%
1/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
|
Vascular disorders
Orthostatic hypotension
|
7.1%
2/28 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
0.00%
0/27 • From start of study treatment to study completion at Week 128 or premature study discontinuation.
For participants who took at least one dose of study TB treatment. All diagnoses (per ACTG criteria for clinical events and other diseases); signs/symptoms (S/S) of grade 3 or higher or any S/S that led to a change in BDQ, DLM and/or DTG regardless of grade; hematologies, LFTs and chemistries of grade 3 and higher, or any laboratory finding that led to a change in BDQ, DLM and/or DTG regardless of grade.The DAIDS AE Grading Table Version 2.0, and the DAIDS EAE Manual Version 2.0 were used.
|
Additional Information
ACTG Clinicaltrials.gov Coordinator
ACTG Network Coordinating Center, Social and Scientific Systems, a DLH Holdings Company.
Phone: (301) 628-3348
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER