Table 5.
Adverse Events in 88 Patients With Endemic Mycoses Enrolled in Study Comparing Conventional and Super-Bioavailability Itraconazole, 2018–2021
| System | AEs in SUBA-itra Group, No. | AEs in c-itra Group, No. | ||||
|---|---|---|---|---|---|---|
| Total AEs | TEAEs | SAEs | Total AEs | TEAEs | SAEs | |
| Respiratory | 8 | 0 | 1 | 18 | 1 | 1 |
| Reproductive | 1 | 0 | 0 | 2 | 0 | 1 |
| Renal | 2 | 0 | 0 | 8 | 0 | 0 |
| Psychiatric | 0 | 0 | 0 | 2 | 0 | 0 |
| Ophthalmologic | 3 | 0 | 0 | 3 | 0 | 0 |
| Neurologic | 15 | 1 | 0 | 15 | 0 | 1 |
| Musculoskeletal | 12 | 0 | 0 | 12 | 1 | 1 |
| Metabolic | 1 | 0 | 1 | 4 | 0 | 0 |
| Integumentary | 12 | 1 | 1 | 15 | 1 | 0 |
| Infectious | 5 | 0 | 0 | 10 | 0 | 3 |
| Hepatobiliary | 3 | 0 | 0 | 9 | 1 | 2 |
| Hematologic | 5 | 1 | 0 | 5 | 1 | 0 |
| General | 27 | 1 | 0 | 16 | 0 | 2 |
| Gastrointestinal | 23 | 3 | 0 | 26 | 9 | 8 |
| Cardiovascular | 25 | 14 | 2 | 34 | 19 | 4 |
| Total | 142 | 21 | 5 | 179 | 33 | 23 |
Abbreviations: AEs, adverse events; c-itra, conventional itraconazole; SAEs, serious AEs; SUBA-itra, SUBA itraconazole; TEAEs, treatment-emergent AEs.