Summary of deaths (safety (intent-to-treat) population)

While on 120-week study
During survival follow-up of premature discontinuations
Deaths n#124
Microbiology response7 nonconverters; 4 converters; 1 reverted to positive3 nonconverters; 0 converters; 1 reverted to positive
Investigator-reported causes of deathTB-related illness (n=5); haemoptysis (n=1); renal impairment (n=1); lung infection (n=1); pneumonia (n=1); respiratory failure (n=1); congestive cardiac failure (n=1); hypertension (n=1)TB-related illness (n=4)
Completed 24 weeks of bedaquiline  treatment n with full exposure/n  total deaths9/121/4
Median time since last bedaquiline  intake days376211
Investigator causality (related to  bedaquiline) n/n total deaths12/12 not related+, including 1 doubtfully related (renal impairment)4/4 not related+ including 1 doubtfully related (TB-related illness)
  • TB: tuberculosis; QTcF: Fridericia-corrected QT. #: none of the patients who died had QTcF prolongation >500 ms or had grade 3 or 4 liver adverse events (AEs) identified by the Standardised MedDRA Queries (SMQs) for hepatic AEs or AEs identified by the SMQ for acute pancreatitis; : patient whose sputum became culture-positive after initial sputum conversion; +: not related or doubtfully related deaths were summarised as not related to bedaquiline.