TABLE 4

Treatment safety in the whole cohort and comparison between patients receiving standard (≤190 days) or prolonged (>190 days) bedaquiline treatment

Whole cohortStandard bedaquiline treatmentProlonged bedaquiline treatmentp-value#
Subjects451233
Any adverse event44 (97.8)12 (100)32 (97.0)1.000
Any severe adverse event28 (62.2)5 (41.7)23 (69.7)0.163
Any serious adverse event7 (15.6)1 (8.3)6 (18.2)0.655
At least one drug stopped due to adverse events37 (82.2)8 (66.7)29 (87.9)0.181
Bedaquiline stopped due to adverse events3 (6.7)1 (8.3)2 (6.1)1.000
Liver enzyme elevation17 (37.8)6 (50.0)11 (33.3)0.325
Pancreatitis1 (2.2)1 (8.3)00.267
QTcF >500 ms5 (11.1)05 (15.2)0.303
QTcF >60 ms increase13 (28.9)4 (33.3)9 (27.3)0.721
Maximum QTcF increase during treatment36.2 (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.