Treatment safety in the whole cohort and comparison between patients receiving standard (≤190 days) or prolonged (>190 days) bedaquiline treatment
| Whole cohort | Standard bedaquiline treatment | Prolonged bedaquiline treatment | p-value# | |
| Subjects | 45 | 12 | 33 | |
| Any adverse event | 44 (97.8) | 12 (100) | 32 (97.0) | 1.000 |
| Any severe adverse event | 28 (62.2) | 5 (41.7) | 23 (69.7) | 0.163 |
| Any serious adverse event | 7 (15.6) | 1 (8.3) | 6 (18.2) | 0.655 |
| At least one drug stopped due to adverse events | 37 (82.2) | 8 (66.7) | 29 (87.9) | 0.181 |
| Bedaquiline stopped due to adverse events | 3 (6.7) | 1 (8.3) | 2 (6.1) | 1.000 |
| Liver enzyme elevation | 17 (37.8) | 6 (50.0) | 11 (33.3) | 0.325 |
| Pancreatitis | 1 (2.2) | 1 (8.3) | 0 | 0.267 |
| QTcF >500 ms | 5 (11.1) | 0 | 5 (15.2) | 0.303 |
| QTcF >60 ms increase | 13 (28.9) | 4 (33.3) | 9 (27.3) | 0.721 |
| Maximum QTcF increase during treatment | 36.2 (17.9–68.5) | 31.9 (16.0–73.3) | 41.6 (19.7–63.7) | 0.437 |
Data are presented as n, n (%) or median (interquartile range), unless otherwise stated. QTcF: Fridericia-corrected QT interval. #: comparison between patients with standard and prolonged bedaquiline treatment, calculated with Wilcoxon's test for continuous variables and Fisher's exact test for categorical variables.