Bedaquiline <190 days | Bedaquiline >190 days | Overall | p-value# between standard and prolonged | |
Number of patients | 83 | 30 | 113 | – |
Total treatment duration months | 1807.8 | 722.7 | 2530.5 | – |
Total treatment with bedaquiline months | 440.3 | 257.2 | 697.5 | – |
All adverse events | ||||
Patients experiencing any adverse event | 81 (97.6) | 28 (93.3) | 109 (96.4) | – |
Events during treatment total | 1448 | 585 | 2033 | – |
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 treatment | 783 | 280 | 1063 | – |
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 cessation | N/A | 62 | 62 | – |
Incidence per 100 person-months (95% CI) | N/A | 87.8 (67.3–112.6) | 87.8 (67.3–112.6) | – |
Events after stopping bedaquiline up to 5 months after bedaquiline cessation | 288 | 120 | 408 | – |
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 treatment | 377 | 123 | 500 | – |
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 bedaquiline | 783 | 342 | 1125 | – |
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 bedaquiline | 1071 | 462 | 1533 | – |
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 event | 12 | 3 | 15 | – |
Number of bedaquiline-related adverse events up to 5 months after bedaquiline cessation | 25 | 4 | 29 | – |
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 prolongation | 18 (72) | 4 (100) | 22 (75.7) | – |
Liver enzyme elevation | 3 (12) | 0 (0) | 3 (10.3) | – |
Hyperuricaemia | 1 (4) | 0 (0) | 1 (3.4) | – |
Pancreatitis | 1 (4) | 0 (0) | 1 (3.4) | – |
Anxiety | 1 (4) | 0 (0) | 1 (3.4) | – |
Cardiac failure | 1 (4) | 0 (0) | 1 (3.4) | |
Patients stopping treatment due to bedaquiline-related adverse event | 6 | 0 | 6 | – |
Median (IQR) months to bedaquiline cessation | 5.5 (5.1–5.5) | N/A | 5.5 (5.1–5.5) | – |
Data reported as n (%) unless otherwise specified. #: exact Fisher two-sided test was used to calculate p-value.