A prospective patient registry to monitor safety, effectiveness, and utilisation of bedaquiline in patients with multidrug-resistant tuberculosis in South Korea

Table 3 Summary of treatment-emergent adverse events (TEAEs): safety population

Parameter, n (%)	Bedaquiline N = 88	No bedaquiline N = 84
≥ 1 TEAE	84 (95.5)	76 (90.5)
≥ 1 bedaquiline-related TEAE	35 (39.8)	NA
≥ 1 TEAE leading to bedaquiline withdrawal	2 (2.3)	NA
≥ 1 serious TEAE	42 (47.7)	27 (32.1)
≥ 1 TEAE leading to death^a	12 (13.6)	3 (3.6)
TEAEs by preferred term reported in > 10% of patients overall
Nausea	20 (22.7)	27 (32.1)
Arthralgia	16 (18.2)	24 (28.6)
Diarrhoea^b	24 (27.3)	9 (10.7)
Cough	16 (18.2)	12 (14.3)
Pruritus	15 (17.0)	12 (14.3)
Decreased appetite	12 (13.6)	15 (17.9)
Dyspepsia	9 (10.2)	15 (17.9)
Dizziness	13 (14.8)	11 (13.1)
Paresthaesia^b	15 (17.0)	7 (8.3)
Headache	7 (8.0)	13 (15.5)
Rash	8 (9.1)	12 (14.3)
Dyspnoea^b	14 (15.9)	5 (6.0)
Electrocardiogram QT prolonged^b	17 (19.3)	2 (2.4)
Anaemia	10 (11.4)	8 (9.5)

NA not available
^aBased on adverse event (AE) reporting, 12 and 3 patients were reported with one or more fatal AEs. One additional fatal case was reported in the bedaquiline-treated group based on efforts to confirm the vital status of patients who were previously reported as lost to follow-up
^bReported more frequently in bedaquiline-treated patients (> 5% difference)

ISSN: 1471-2334