Retrospective cohort study comparing the risk of severe hepatotoxicity in hospitalized patients treated with echinocandins for invasive candidiasis in the presence of confounding by indication

Table 3 Outcome distribution among the three echinocandin groups

	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 events^a
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 5^b	–	–	–
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

ISSN: 1471-2334