TABLE 5.
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) |
TEAE, treatment-emergent adverse event.
Isavuconazole administered as a 200-mg once-daily maintenance regimen.
Isavuconazole administered as a 400-mg once-daily maintenance regimen.
EOT, end of treatment.
TEAEs were reported by ≥2 patients in either cohort.