Serious adverse events registered during the treatment course among patients on standard and prolonged treatment with bedaquiline
| 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 | – |
| Total treatment up to 5 months after bedaquiline cessation, months | 836.5 | 404.4 | 1240.9 | – |
| Serious adverse events | ||||
| Patients experiencing any serious adverse event | 32 (38.6) | 16 (53.3) | 48 (42.5) | – |
| Events during treatment total | 50 | 26 | 76 | – |
| Incidence per 100 person-months (95% CI) | 2.8 (2.1–3.6) | 3.6 (2.4–5.3) | 3.0 (2.4–3.8) | 0.30 |
| Serious adverse events during periods of treatment | ||||
| Events with bedaquiline up to day 190 of treatment | 37 | 10 | 47 | – |
| Incidence per 100 person-months (95% CI) | 7.5 (5.5–10.0) | 5.4 (2.6–9.9) | 8.4 (5.9–11.6) | 0.07 |
| Events with bedaquiline from day 190 to cessation | N/A | 0 | 0 | – |
| Incidence per 100 person-months (95% CI) | N/A | 0 (0–5.2) | 0 (0–5.2) | – |
| Events after stopping bedaquiline up to 5 months after bedaquiline cessation | 8 | 8 | 16 | – |
| Incidence per 100 person-months (95% CI) | 2.0 (0.9–4.0) | 5.4 (2.3–10.7) | 2.9 (1.7–4.8) | 0.10 |
| Events > 5 months after stopping bedaquiline, to end of treatment | 5 | 8 | 13 | – |
| Incidence per 100 person-months (95% CI) | 0.5 (0.2–1.2) | 2.5 (1.1–5.0) | 1.0 (0.5–1.7) | 0.03 |
| All events up to 5 months after stopping bedaquiline | 45 | 18 | 63 | – |
| Incidence per 100 person-months (95% CI) | 5.4 (3.9–7.2) | 4.4 (2.6–7.0) | 5.1 (3.9–6.5) | 0.48 |
| Bedaquiline-related serious adverse events | ||||
| Patients with at least one bedaquiline-related serious adverse event | 5 | 1 | 6 | – |
| Number of bedaquiline-related serious adverse events up to 5 months after bedaquiline cessation | 6¶ | 1 | 7 | – |
| Incidence per 100 person-months (95% CI) | 0.7 (0.3–1.6) | 0.2 (0.1–1.4) | 0.6 (0.2–1.2) | 0.22 |
| Category of serious adverse events | – | |||
| QTcF prolongation | 2 (33.3) | 1 (100) | 3 (42.8) | – |
| Liver enzyme elevation | 1 (16.7) | 0 (0) | 1 (14.3) | – |
| Pancreatitis | 1 (16.7) | 0 (0) | 1 (14.3) | – |
| Hyperuricaemia | 1 (16.7) | 0 (0) | 1 (14.3) | – |
| Cardiac failure | 1 (16.7) | 0 (0) | 1 (14.3) | – |
| Patients stopping treatment due to bedaquiline-related serious adverse event | 1 | 0 | 1 | – |
| Months to bedaquiline cessation | 1.4 | N/A | N/A | – |
Data reported as n (%) unless otherwise specified. #: exact Fisher two-sided test was used to calculate p-value; ¶: patient experienced two serious adverse events: the first was hyperuricaemia 21 days into treatment and the second was aspartate aminotransferase elevation 147 days into treatment.