Table 6.
Incidence Rate of Clinically Relevant Adverse Events of Special Interest Among Patients During Exposure to a Drug of Interest
| Clinically Relevanta Adverse Event of Interest | Drug of Interest | Person-Months of Exposure to Drug of Interest | Patients With at Least 1 Occurrence of a Clinically Relevant AESI,a (n/N, %) | Incidence of Clinically Relevant AESI/1000 Person-Monthsa (95% Confidence Interval) |
|---|---|---|---|---|
| QT prolongation | Bedaquiline or delamanid | 19 543 | 50/2296 (2.2) | 2.6 (1.9–3.4) |
| Hearing loss | Kanamycin, amikacin, capreomycin |
4936 | 182/925 (19.7) | 36.9 (31.9–42.6) |
| Hearing loss or acute renal failure or electrolyte depletion | Kanamycin, amikacin, capreomycin |
5864 | 340/925 (36.8) | 72.8 (66.0–80.0) |
| Peripheral neuropathy or optic neuritis or myelosuppression | Linezolid | 23 660 | 507/1826 (27.8) | 22.8 (20.9–24.8) |
Abbreviation: AESI, adverse event of special interest.
Events that occurred at or above the clinically relevant severity threshold, as defined in Table 2, include those reported as serious adverse events.