Summary of deaths (safety (intent-to-treat) population)
| While on 120-week study N=233 | During survival follow-up of premature discontinuations N=20 | |
| Deaths n# | 12 | 4 |
| Microbiology response | 7 nonconverters; 4 converters; 1 reverted to positive¶ | 3 nonconverters; 0 converters; 1 reverted to positive¶ |
| Investigator-reported causes of death | TB-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 deaths | 9/12 | 1/4 |
| Median time since last bedaquiline intake days | 376 | 211 |
| Investigator causality (related to bedaquiline) n/n total deaths | 12/12 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.