Table 5.
Frequency, Months to First Occurrence, and Incidence Rate of Clinically Relevant Adverse Events of Special Interest in the endTB Observational Study Cohort (N = 2296)a
| Clinically Relevant AESI) | Patients With at Least 1 Occurrence of Clinically Relevant
AESIb N (%) |
Months to First Occurrence of Clinically Relevant AESI,b Median (Interquartile Range) |
Incidence of Clinically Relevant AESIb/1000 Person-Months (95% Confidence Interval) |
|---|---|---|---|
| QT prolongation | 63 (2.7) | 2.5 (0.9–5.1) | 1.8 (1.4–2.3) |
| Peripheral neuropathyc | 606 (26.4) | 3.9 (1.8–7.1) | 21.5 (19.8–23.2) |
| Optic neuritis | 72 (3.1) | 7.6 (4.2–11.5) | 2.1 (1.6–2.6) |
| Myelosuppression | 138 (6.0) | 2.5 (0.9–5.2) | 4.0 (3.4–4.7) |
| Hearing lossd | 304 (13.2) | 4.0 (2.0–6.9) | 9.7 (8.6–10.8) |
| Acute renal failure | 174 (7.6) | 2.6 (0.9–6.2) | 5.1 (4.4–5.9) |
| Hepatotoxicity | 127 (5.5) | 3.1 (1.0–7.0) | 3.6 (3.0–4.3) |
| Electrolyte depletion | 596 (26.0) | 3.0 (1.0–7.2) | 20.7 (19.1–22.4) |
| Hypothyroidism | 155 (6.7) | 4.0 (2.8–7.3) | 4.6 (3.9–5.4) |
Abbreviations: AESI, adverse event of special interest.
N = 2296.
AESIs that occurred at or above the clinically relevant severity threshold, as defined in Table 2, include those reported as serious adverse events.
Peripheral neuropathy maximum severity of first event: grade 1, 347 (57.3%); grade 2, 204 (33.7%); grade 3, 50 (8.2); grade 4, 5 (0.8%).
Hearing loss maximum severity of first event: grade 1, 135, 44.4%; grade 2, 71, 23.4%; grade 3, 87, 28.6%; grade 4, 9, 3.0%; unknown, 2, 0.7 %.