TABLE 3.
Summary of patients who experienced adverse eventsa
| Parameter | Isavuconazoleb |
Fluconazolec | ||
|---|---|---|---|---|
| Arm A | Arm B | Arm C | Arm D | |
| Treatment regimen | 200/50 mg QD | 400 mg weekly | 400/100 mg QD | 200/100 mg QD |
| Total no. of patients | 40 | 40 | 41 | 38 |
| No. of patients (%) with ≥1 TEAE | 22 (55.0) | 18 (45.0) | 29 (70.7) | 22 (57.9) |
| Mild | 12 (30.0) | 11 (27.5) | 14 (34.1) | 11 (28.9) |
| Moderate | 11 (27.5) | 9 (22.5) | 18 (43.9) | 13 (34.2) |
| Severe | 1 (2.5) | 1 (2.5) | 3 (7.3) | 5 (13.2) |
| Life-threatening | 1 (2.5) | 1 (2.5) | 1 (2.4) | 2 (5.3) |
| Drug related | 7 (17.5) | 4 (10.0) | 11 (26.8) | 7 (18.4) |
| Seriousd | 1 (2.5) | 2 (5.0) | 3 (7.3) | 4 (10.5) |
| TEAE leading to discontinuation | 1 (2.5) | 1 (2.5) | 2 (4.9) | 1 (2.6) |
a
That is, in an intent-to-treat (ITT) population. QD, once daily; TEAE, treatment-emergent adverse event.
b
200/50 mg QD, 200 mg on day 1 and then 50 mg once daily; 400 mg weekly, 400 mg on day 1 and then 400 mg once weekly; 400/100 mg QD, 400 mg on day 1 and then 100 mg once daily.
c
200/100 mg QD, 200 mg on day 1 and then 100 mg once daily.
d
Four serious TEAEs of pulmonary tuberculosis, pleural effusion, hepatic enzyme increased, and AIDS were experienced by one patient in arm D.