Table 5 TEAEs in bedaquiline- and non-bedaquiline-treated MDR-TB patients in South Africa
Parameter, n (%) | Bedaquiline N = 3747 | No bedaquiline N = 2234 | Total N = 5981 |
|---|---|---|---|
 ≥ 1 TEAE | 3139 (83.8) | 1282 (57.4) | 4421 (73.9) |
 ≥ 1 bedaquiline-related TEAE | 67 (1.8) | NA | 67 (1.1) |
 ≥ 1 TEAE leading to bedaquiline withdrawal | 54 (1.4) | NA | NA |
 ≥ 1 serious TEAE | 1491 (39.8) | 581 (26.0) | 2072 (34.6) |
TEAEs by preferred term reported in > 10% of patients in either arm | |||
 Vomiting | 884 (23.6) | 304 (13.6) | 1188 (19.9) |
 Arthralgia | 843 (22.5) | 198 (8.9) | 1041 (17.4) |
 Rash | 783 (20.9) | 199 (8.9) | 982 (16.4) |
 Hypothyroidism | 669 (17.9) | 155 (6.9) | 824 (13.8) |
 Peripheral neuropathy | 619 (16.5) | 159 (7.1) | 778 (13.0) |
 Ototoxicity | 542 (14.5) | 421 (18.8) | 963 (16.1) |
 Pain in extremity | 500 (13.3) | 131 (5.9) | 631 (10.6) |
Serious TEAEs by preferred term reported in > 2% of patients in either arm | |||
 Ototoxicity | 472 (12.6) | 317 (14.2) | 789 (13.2) |
 Anemia | 190 (5.1) | 4 (0.2) | 194 (3.2) |
 Optic neuritis | 175 (4.7) | 35 (1.6) | 210 (3.5) |
 ECG QT prolonged | 109 (2.9) | 3 (0.1) | 112 (1.9) |
 Peripheral neuropathy | 90 (2.4) | 15 (0.7) | 105 (1.8) |
 Decreased hemoglobin | 89 (2.4) | 2 (0.1) | 91 (1.5) |
 Vomiting | 88 (2.3) | 27 (1.2) | 115 (1.9) |
 Psychotic disorder | 74 (2.0) | 32 (1.4) | 106 (1.8) |