TABLE 4.

Treatment-emergent AEs and drug-related TEAEs by severity grade^a

TEAE characteristics by type	No. (%) by severity in:
	Low-dose cohort (n = 11)b			High-dose cohort (n = 12)c
	Mild	Moderate	Severe	Mild	Moderate	Severe
All TEAEs
Total no.	45	28	4	45	49	25
Most commonly reportedd
Fever	3 (27.3)	1 (9.1)	2 (18.2)	2 (16.7)	6 (50.0)	4 (33.3)
Diarrhea	3 (27.3)	1 (9.1)	0 (0)	4 (33.3)	2 (16.7)	0 (0)
Rash	1 (9.1)	3 (27.3)	0 (0)	2 (16.7)	1 (8.3)	1 (8.3)
Cough	1 (9.1)	2 (18.2)	0 (0)	3 (25.0)	1 (8.3)	1 (8.3)
Nausea	0 (0)	1 (9.1)	0 (0)	4 (33.3)	2 (16.7)	2 (16.7)
Thrombocytopenia	0 (0)	0 (0)	0 (0)	0 (0)	1 (8.3)	3 (25.0)
Drug-related
Total no.	6	3	2	9	8	4
Most commonly reportede
Hypotension	2 (18.2)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
Vertigo	2 (18.2)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
Headache	0 (0)	1 (9.1)	0 (0)	1 (8.3)	1 (8.3)	0 (0)
Rash	1 (9.1)	0 (0)	0 (0)	1 (8.3)	1 (8.3)	0 (0)
Cough	0 (0)	0 (0)	0 (0)	2 (16.7)	0 (0)	0 (0)

^aSafety population (received ≥1 dose of study medication); AE severity defined by the Common Terminology Criteria for Adverse Events guidelines (30). TEAE, treatment-emergent adverse event.

^bIsavuconazole administered as a 200-mg once-daily maintenance regimen; no life-threatening TEAEs were reported in this cohort.

^cIsavuconazole administered as a 400-mg once-daily maintenance regimen; a single life-threatening TEAE of respiratory distress that was not drug related was reported in this cohort.

^dTEAEs were reported by >30% of patients in either cohort; each AE was counted only once at its most extreme severity in each patient.

^eTEAEs were reported by ≥2 patients in either cohort.