TABLE 4.
Adverse event 26 SOTR (49.1%) |
All SOTR (n = 53) | Description | CTCAE |
---|---|---|---|
Cholestatic liver enzymes elevation | 18 (34) | 13 (72.2) presented ALP/GGT elevation | 18 G1 |
5 (27.7) presented GGT elevation alone | |||
Myopathy | 7 (13.2) | Six associated with concomitant corticosteroid. One discontinued ISA | 5 G1 2 G2 |
Gastrointestinal symptomatology | 3 (5.7) | Nausea and vomiting, one discontinued ISA | 2 G1 1 G2 |
Neurological disorders | 2 (3.8) | One presented dizziness and vertigo One presented eye floaters |
2 G1 |
Hepatotoxicity | 2 (3.8) | AST/ALT and ALP/GGT elevation. Both discontinued ISA | 2 G1 |
General disorders | 3 (5.7) | Fatigue, two of them discontinued ISA | 3 G1 |
1 (1.9) | Wt loss | 1 G1 | |
Total of premature discontinuation of ISA | 6 (11.3%) | 4 G1 2 G2 |
Data are expressed as numbers (%) unless otherwise indicated. ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; CTCAE, Common Terminology Criteria for Adverse Events; GGT, gamma-glutamyltransferase; ISA, isavuconazole; SOTR, solid organ transplant recipient.