TABLE 2

Safety and tolerability profile of bedaquiline-containing regimens in a cohort of 428 culture-confirmed multidrug-resistant tuberculosis patients

Interruption of bedaquiline51/428 (11.9)
Interruption of bedaquiline due to adverse events25/428 (5.8)
Adverse events presumably due to bedaquiline80/213 (19.4)
Bedaquiline restarted if interrupted25/69 (36.2)
Total bedaquiline exposure days168 (86–180)
Creatinine >1.4×ULN91/411 (22.1)
Lipase >1.6×ULN1/239 (0.4)
ALT >3×ULN92/413 (22.3)
Bilirubin >2×ULN47/413 (11.4)
Albumin g·dL−136 (30–40)
Potassium <3.4 or >5.6 mmol·L−198/412 (23.8)
Magnesium <0.59 mmol·L−121/199 (10.6)
Calcium <1.75 mmol·L−123/302 (7.6)
Adverse effects
 Nausea130/413 (31.5)
 Peripheral neuropathy96/412 (23.3)
 Otovestibular toxicity96/412 (23.3)
 Vomiting87/411 (21.2)
 Anaemia86/412 (20.9)
 Arthralgia84/412 (20.4)
 Skin rash63/412 (15.3)
 Diarrhoea56/412 (13.6)
 Renal failure47/413 (11.4)
 Thrombocytopenia41/413 (9.9)
 Neutropenia40/413 (9.7)
 Lymphocytopenia40/413 (9.7)
 QT prolongation24/248 (9.7)
 Hypothyroidism38/410 (9.3)
 Psychiatric disorder29/413 (7.0)
 Tendinopathy18/413 (4.4)
 Optic neuropathy10/413 (2.4)
 Deep vein thrombosis7/412 (1.7)
 Pancreatitis4/318 (1.3)
 Hallucinations2/411 (0.5)
 Stroke1/318 (0.3)
  • Data are presented as n/N (%) or median (interquartile range). ULN: upper limit of normal; ALT: alanine-transaminase.