Table 3 Frequency of adverse events reported
Events | Patients (n = 1162), n (%) |
|---|---|
Any AE | 547 (47.1) |
Bedaquiline-related AE | 278 (23.9) |
SAE | 91 (7.8) |
Bedaquiline-related SAE | 45 (3.9) |
AE leading to death | 14 (1.2) |
Bedaquiline-related AE leading to death | 0 |
AE leading to bedaquiline withdrawal | 52 (4.5) |
QT prolongation leading to bedaquiline discontinuation | 49 (4.2) |
AE reported ≥ 2% of patients | |
  QT prolongation | 287 (24.7) |
  Hepatotoxicity | 190 (16.4) |
  Blood disorder | 64 (5.5) |
  Nephrotoxicity | 53 (4.6) |
  Electrolyte imbalance | 49 (4.2) |
  Gastrointestinal disorder | 48 (4.1) |
  Peripheral neuropathy | 48 (4.1) |
  Ototoxicity | 31 (2.7) |
  Vestibular disorder | 31 (2.7) |
  Optic neuritis | 28 (2.4) |