TABLE 2.
Per-protocol patient baseline clinical evaluation and endoscopic evaluation grades
| Condition and grade | No. of patients (%)a |
||||
|---|---|---|---|---|---|
| Isavuconazoleb |
Fluconazolec |
||||
| Arm A (200/50 mg QD, n = 38) | Arm B (400 mg weekly, n = 40) | Arm C (400/100 mg QD, n = 38) | Arm D (200/100 mg QD, n = 37) | Total (N = 153) | |
| Dysphagia | |||||
| Grade 0 | 0 | 0 | 1 (2.6) | 0 | 1 (0.7) |
| Grade 1 | 28 (73.7) | 26 (65.0) | 28 (73.7) | 27 (73.0) | 109 (71.2) |
| Grade 2 | 10 (26.3) | 14 (35.0) | 9 (23.7) | 10 (27.0) | 43 (28.1) |
| Grade 3 | 0 | 0 | 0 | 0 | 0 |
| Odynophagia | |||||
| Grade 0 | 0 | 0 | 0 | 0 | 0 |
| Grade 1 | 23 (60.5) | 25 (62.5) | 29 (76.3) | 24 (64.9) | 101 (66.0) |
| Grade 2 | 15 (39.5) | 15 (37.5) | 9 (23.7) | 12 (32.4) | 51 (33.3) |
| Grade 3 | 0 | 0 | 0 | 1 (2.7) | 1 (0.7) |
| Retrosternal pain | |||||
| Grade 0 | 10 (26.3) | 5 (12.5) | 9 (23.7) | 6 (16.2) | 30 (19.6) |
| Grade 1 | 20 (52.6) | 22 (55.0) | 23 (60.5) | 22 (59.5) | 87 (56.9) |
| Grade 2 | 8 (21.1) | 13 (32.5) | 6 (15.8) | 8 (21.6) | 35 (22.9) |
| Grade 3 | 0 | 0 | 0 | 1 (2.7) | 1 (0.7) |
| Endoscopic mucosal evaluation | |||||
| Grade 1 | 22 (57.9) | 17 (42.5) | 22 (57.9) | 17 (45.9) | 78 (51.0) |
| Grade 2 | 11 (28.9) | 19 (47.5) | 13 (34.2) | 13 (35.1) | 56 (36.6) |
| Grade 3 | 3 (7.9) | 3 (7.5) | 3 (7.9) | 7 (18.9) | 16 (10.5) |
| Grade 4 | 2 (5.3) | 1 (2.5) | 0 | 0 | 3 (2.0) |
a
QD, once daily.
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.