Table 3.
Anidulafungin | Caspofungin | Micafungin | |
---|---|---|---|
Number of patients, n | 1700 | 4431 | 6547 |
Patient-days in observation period | |||
Total person-days | 26,449 | 85,020 | 102,267 |
Distribution person-days across patients (all patients) | |||
Median [IQR] | 9.0 (2.0, 20.0) | 12.0 (5.0, 23.0) | 10.0 (4.0, 20.0) |
Mean ± SD [Range] | 15.6 ± 23.3 (1–309) | 19.2 ± 31.7 (1–938) | 15.6 ± 20.0 (1–350) |
Severe hepatotoxicity eventsa | |||
Patients with severe hepatotoxicity events, n (% of all patients) | 633 (37.2) | 993 (22.4) | 1522 (23.2) |
Grade of first severe hepatotoxicity event in the observation period, n (% of all patients) | |||
Grade 3 | 504 (29.6) | 870 (19.6) | 1289 (19.7) |
Grade 4 | 129 (7.6) | 123 (2.8) | 233 (3.6) |
Grade 5b | – | – | – |
Status at hospital discharge, n (% of patients with events) | |||
Recovered | 198 (31.3) | 316 (31.8) | 491 (32.3) |
Not recovered | 423 (66.8) | 643 (64.8) | 990 (65.0) |
Unknown | 12 (1.9) | 34 (3.4) | 41 (2.7) |
Abbreviations: IQR inter-quartile range, SD standard deviation
aA severe hepatotoxic event was defined as the first hepatotoxicity of Grade ≥ 3 in the observation period. Hepatotoxicity grade was classified according to the modified Clinical Islet Transplantation study–Terminology Criteria for Adverse Events in trials of adult pancreatic islet transplantation (CIT-TCAE) Version 5.0 [13]
bGrade 5 events cannot be the first event experienced by the patient because Grade 5 events (deaths) must be preceded, by definition, by a liver function test of Grade 4