TABLE 3

All adverse events registered during the treatment course among patients on standard and prolonged treatment with bedaquiline

Bedaquiline <190 daysBedaquiline >190 daysOverallp-value#
between standard and prolonged
Number of patients8330113
Total treatment duration months1807.8722.72530.5
Total treatment with bedaquiline months440.3257.2697.5
All adverse events
 Patients experiencing any adverse event81 (97.6)28 (93.3)109 (96.4)
 Events during treatment total14485852033
 Incidence per 100 person-months (95% CI)80.1 (76.0–84.3)80.9 (74.5–87.8)80.3 (76.9–83.9)0.83
Adverse events during periods of treatment
 Events with bedaquiline up to day 190 of treatment7832801063
  Incidence per 100 person-months (95% CI)177.8 (165.6–190.7)150.1 (133.1–168.8)169.6 (159.5–180.1)0.01
 Events with bedaquiline from day 190 to cessationN/A6262
  Incidence per 100 person-months (95% CI)N/A87.8 (67.3–112.6)87.8 (67.3–112.6)
 Events after stopping bedaquiline up to 5 months after bedaquiline cessation288120408
  Incidence per 100 person-months (95% CI)81.5 (67.5–97.4)72.7 (64.5–81.6)75.1 (68.0–81.6)0.31
 Events >5 months after stopping bedaquiline, to end of treatment377123500
  Incidence per 100 person-months (95% CI)38.8 (35.0–42.9)38.7 (32.1–46.1)38.8 (35.4–42.3)0.97
 All events during bedaquiline7833421125
  Incidence per 100 person-months (95% CI)177.8 (165.6–190.7)133.0 (119.2–147.8)161.3 (152.0–171.0)<0.001
 All events up to 5 months after stopping bedaquiline10714621533
  Incidence per 100 person-months (95% CI)128.0 (1120.5–135.9)114.2 (104.0–125.1)123.5 (117.4–129.9)0.04
Bedaquiline-related adverse events
 Patients with at least one bedaquiline-related adverse event12315
 Number of bedaquiline-related adverse events up to 5 months after bedaquiline cessation25429
  Incidence per 100 person-months (95% CI)3.0 (1.9–4.4)1.0 (0.3–2.5)2.3 (1.6–3.4)0.01
 Category of adverse events
  QTcF prolongation18 (72)4 (100)22 (75.7)
  Liver enzyme elevation3 (12)0 (0)3 (10.3)
  Hyperuricaemia1 (4)0 (0)1 (3.4)
  Pancreatitis1 (4)0 (0)1 (3.4)
  Anxiety1 (4)0 (0)1 (3.4)
  Cardiac failure1 (4)0 (0)1 (3.4)
 Patients stopping treatment due to bedaquiline-related adverse event606
  Median (IQR) months to bedaquiline cessation5.5 (5.1–5.5)N/A5.5 (5.1–5.5)

Data reported as n (%) unless otherwise specified. #: exact Fisher two-sided test was used to calculate p-value.