TTP data were available for 47 subjects (23 in the bedaquiline arm) from stage 1 and for 159 subjects (79 in the bedaquiline arm) from stage 2. Individual pharmacokinetic data were available for all patients on bedaquiline except four. Demographic characteristics and mean TTP at baseline are summarized in Table 1. Samples collected during the period up to week 8 for the bedaquiline arm of stage 1 or up to week 24 otherwise, and as long as the patient had not dropped out of the study, were considered in the analysis. In total, the dataset included 7385 MGIT evaluations, of which 3900 samples resulted in a positive signal before 42 days. The data are shown in Figure S1. A detailed description of which patients and observations that were excluded from the model development process can be found in the Supplementary data. Baseline TTP values from before initiation of treatment were used as a covariate and not as observations. The dataset used for model building included 5833 TTP observations (56.6% positive) from 189 individuals (98 in the placebo arm and 91 in the bedaquiline arm).
Variable (unit) . | Value [median (range) or n (%)] . |
---|---|
Age (years) | 33 (18–63) |
Weight (kg) | 54 (35–83) |
Female sex | 71 (34.5) |
HIV-positive | 30 (14.6) |
Presence of lung cavitation | 188 (91.7) |
Race | |
Caucasian | 21 (10.2) |
Black | 82 (39.8) |
Hispanic | 28 (13.6) |
Asian | 15 (7.3) |
other | 59 (28.6) |
missing | 1 (0.5) |
TB type | |
drug susceptible | 8 (3.86) |
MDR | 96 (46.4) |
pre-XDR | 52 (25.1) |
XDR | 11 (5.31) |
missing | 39 (18.9) |
Mean TTP MGITa (n = 191) (days) | 6.8 (2.3–42) |
Variable (unit) . | Value [median (range) or n (%)] . |
---|---|
Age (years) | 33 (18–63) |
Weight (kg) | 54 (35–83) |
Female sex | 71 (34.5) |
HIV-positive | 30 (14.6) |
Presence of lung cavitation | 188 (91.7) |
Race | |
Caucasian | 21 (10.2) |
Black | 82 (39.8) |
Hispanic | 28 (13.6) |
Asian | 15 (7.3) |
other | 59 (28.6) |
missing | 1 (0.5) |
TB type | |
drug susceptible | 8 (3.86) |
MDR | 96 (46.4) |
pre-XDR | 52 (25.1) |
XDR | 11 (5.31) |
missing | 39 (18.9) |
Mean TTP MGITa (n = 191) (days) | 6.8 (2.3–42) |
The average of the three TTP observations from MGIT.
Variable (unit) . | Value [median (range) or n (%)] . |
---|---|
Age (years) | 33 (18–63) |
Weight (kg) | 54 (35–83) |
Female sex | 71 (34.5) |
HIV-positive | 30 (14.6) |
Presence of lung cavitation | 188 (91.7) |
Race | |
Caucasian | 21 (10.2) |
Black | 82 (39.8) |
Hispanic | 28 (13.6) |
Asian | 15 (7.3) |
other | 59 (28.6) |
missing | 1 (0.5) |
TB type | |
drug susceptible | 8 (3.86) |
MDR | 96 (46.4) |
pre-XDR | 52 (25.1) |
XDR | 11 (5.31) |
missing | 39 (18.9) |
Mean TTP MGITa (n = 191) (days) | 6.8 (2.3–42) |
Variable (unit) . | Value [median (range) or n (%)] . |
---|---|
Age (years) | 33 (18–63) |
Weight (kg) | 54 (35–83) |
Female sex | 71 (34.5) |
HIV-positive | 30 (14.6) |
Presence of lung cavitation | 188 (91.7) |
Race | |
Caucasian | 21 (10.2) |
Black | 82 (39.8) |
Hispanic | 28 (13.6) |
Asian | 15 (7.3) |
other | 59 (28.6) |
missing | 1 (0.5) |
TB type | |
drug susceptible | 8 (3.86) |
MDR | 96 (46.4) |
pre-XDR | 52 (25.1) |
XDR | 11 (5.31) |
missing | 39 (18.9) |
Mean TTP MGITa (n = 191) (days) | 6.8 (2.3–42) |
The average of the three TTP observations from MGIT.
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