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. 2015 Mar 11;59(4):2078–2085. doi: 10.1128/AAC.04569-14

TABLE 5.

Drug-related TEAEs by dosing phasea

TEAE data Low-dose cohortb
High-dose cohortc
800 mg, day 1 400 mg, day 2 200 mg, day 2 to EOTd 1,600 mg, day 1 800 mg, day 2 400 mg, day 3 to EOT
n 11 10 8 12 11 11
Patients with drug-related TEAEs (no. [%]) 3 (27.3) 2 (20.0) 2 (25.0) 3 (25.0) 1 (9.1) 6 (54.5)
Total no. of TEAEs 4 3 5 5 1 15
Most commonly reported AEs (no. [%])e
    Cough 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 2 (18.2)
    Headache 1 (9.1) 1 (10.0) 0 (0) 0 (0) 0 (0) 2 (18.2)
    Hypotension 0 (0) 1 (10.0) 1 (12.5) 0 (0) 0 (0) 0 (0)
    Rash 0 (0) 0 (0) 1 (12.5) 1 (8.3) 0 (0) 1 (9.1)
    Vertigo 1 (9.1) 1 (10.0) 0 (0) 0 (0) 0 (0) 0 (0)
a

TEAE, treatment-emergent adverse event.

b

Isavuconazole administered as a 200-mg once-daily maintenance regimen.

c

Isavuconazole administered as a 400-mg once-daily maintenance regimen.

d

EOT, end of treatment.

e

TEAEs were reported by ≥2 patients in either cohort.