Adverse Events of Special Interest (AESI) Clinically Relevant or Reported as Serious Adverse Events (SAE), Occurring During Concomitant Treatment With Bedaquiline and Delamanid Among 472 MDR/RR-TB Patients in 14 Countries
| . | Frequency . | Time to First Event . | Incidence/1000 person-month (95% CI) . |
|---|---|---|---|
| . | n (%) . | Median [IQR] . | |
| Peripheral neuropathy | 134 (28.4) | 3.0 [1.0–5.3] | 39.0 (33.0–46.9) |
| Electrolyte depletion | 94 (19.9) | 4.0 [1.4–7.6] | 23.8 (19.4–29.1) |
| Acute renal failure | 40 (8.5) | 3.7 [1.7–8.4] | 9.4 (6.9–12.9) |
| Myelosuppression | 24 (5.1) | 2.8 [1.3–7.8] | 5.6 (3.7–8.4) |
| Hearing loss | 16 (3.4) | 2.3 [1.0–6.4] | 3.6 (2.2–5.9) |
| Hepatotoxicity | 13 (2.7) | 2.1 [1.8–10.0] | 2.9 (1.6–4.9) |
| Optic neuritis | 12 (2.5) | 6.9 [5.2–9.3] | 2.7 (1.5–4.8) |
| Hypothyroidism | 7 (1.5) | 2.2 [0.4–2.8] | 1.6 (0.7–3.3) |
| QT prolongation | 7 (1.5) | 3.2 [2.0–5.5] | 1.5 (0.7–3.2) |
| . | Frequency . | Time to First Event . | Incidence/1000 person-month (95% CI) . |
|---|---|---|---|
| . | n (%) . | Median [IQR] . | |
| Peripheral neuropathy | 134 (28.4) | 3.0 [1.0–5.3] | 39.0 (33.0–46.9) |
| Electrolyte depletion | 94 (19.9) | 4.0 [1.4–7.6] | 23.8 (19.4–29.1) |
| Acute renal failure | 40 (8.5) | 3.7 [1.7–8.4] | 9.4 (6.9–12.9) |
| Myelosuppression | 24 (5.1) | 2.8 [1.3–7.8] | 5.6 (3.7–8.4) |
| Hearing loss | 16 (3.4) | 2.3 [1.0–6.4] | 3.6 (2.2–5.9) |
| Hepatotoxicity | 13 (2.7) | 2.1 [1.8–10.0] | 2.9 (1.6–4.9) |
| Optic neuritis | 12 (2.5) | 6.9 [5.2–9.3] | 2.7 (1.5–4.8) |
| Hypothyroidism | 7 (1.5) | 2.2 [0.4–2.8] | 1.6 (0.7–3.3) |
| QT prolongation | 7 (1.5) | 3.2 [2.0–5.5] | 1.5 (0.7–3.2) |
Frequencies include SAEs also reported in Table 3.
Abbreviations: CI, confidence interval; IQR, interquartile range; MDR/RR-TB, multi-drug/rifampicin resistant tuberculosis.
Adverse Events of Special Interest (AESI) Clinically Relevant or Reported as Serious Adverse Events (SAE), Occurring During Concomitant Treatment With Bedaquiline and Delamanid Among 472 MDR/RR-TB Patients in 14 Countries
| . | Frequency . | Time to First Event . | Incidence/1000 person-month (95% CI) . |
|---|---|---|---|
| . | n (%) . | Median [IQR] . | |
| Peripheral neuropathy | 134 (28.4) | 3.0 [1.0–5.3] | 39.0 (33.0–46.9) |
| Electrolyte depletion | 94 (19.9) | 4.0 [1.4–7.6] | 23.8 (19.4–29.1) |
| Acute renal failure | 40 (8.5) | 3.7 [1.7–8.4] | 9.4 (6.9–12.9) |
| Myelosuppression | 24 (5.1) | 2.8 [1.3–7.8] | 5.6 (3.7–8.4) |
| Hearing loss | 16 (3.4) | 2.3 [1.0–6.4] | 3.6 (2.2–5.9) |
| Hepatotoxicity | 13 (2.7) | 2.1 [1.8–10.0] | 2.9 (1.6–4.9) |
| Optic neuritis | 12 (2.5) | 6.9 [5.2–9.3] | 2.7 (1.5–4.8) |
| Hypothyroidism | 7 (1.5) | 2.2 [0.4–2.8] | 1.6 (0.7–3.3) |
| QT prolongation | 7 (1.5) | 3.2 [2.0–5.5] | 1.5 (0.7–3.2) |
| . | Frequency . | Time to First Event . | Incidence/1000 person-month (95% CI) . |
|---|---|---|---|
| . | n (%) . | Median [IQR] . | |
| Peripheral neuropathy | 134 (28.4) | 3.0 [1.0–5.3] | 39.0 (33.0–46.9) |
| Electrolyte depletion | 94 (19.9) | 4.0 [1.4–7.6] | 23.8 (19.4–29.1) |
| Acute renal failure | 40 (8.5) | 3.7 [1.7–8.4] | 9.4 (6.9–12.9) |
| Myelosuppression | 24 (5.1) | 2.8 [1.3–7.8] | 5.6 (3.7–8.4) |
| Hearing loss | 16 (3.4) | 2.3 [1.0–6.4] | 3.6 (2.2–5.9) |
| Hepatotoxicity | 13 (2.7) | 2.1 [1.8–10.0] | 2.9 (1.6–4.9) |
| Optic neuritis | 12 (2.5) | 6.9 [5.2–9.3] | 2.7 (1.5–4.8) |
| Hypothyroidism | 7 (1.5) | 2.2 [0.4–2.8] | 1.6 (0.7–3.3) |
| QT prolongation | 7 (1.5) | 3.2 [2.0–5.5] | 1.5 (0.7–3.2) |
Frequencies include SAEs also reported in Table 3.
Abbreviations: CI, confidence interval; IQR, interquartile range; MDR/RR-TB, multi-drug/rifampicin resistant tuberculosis.
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