Table 2.
AEs, n (%) | 320 mg q.d. N = 20 | 480 mg q.d. N = 7 | 480 mg q.d., Fasted N = 17 | All N = 44 | ||||
---|---|---|---|---|---|---|---|---|
All Grades | Grade ≥3 | All Grades | Grade ≥3 | All Grades | Grade ≥3 | All Grades | Grade ≥3 | |
Any AEs | 16 (80.0) | 6 (30.0) | 7 (100.0) | 5 (71.4) | 15 (88.2) | 10 (58.8) | 38 (86.4) | 21 (47.7) |
Rash | 6 (30.0) | 0 | 2 (28.6) | 0 | 6 (35.3) | 1 (5.9) | 14 (31.8) | 1 (2.3) |
Neutropenia | 4 (20.0) | 2 (100) | 2 (71.4) | 0 | 4 (20.0) | 2 (11.8) | 10 (22.7) | 4 (9.1) |
Leukopenia | 2 (10.0) | 1 (5.0) | 3 (42.9) | 0 | 3 (17.6) | 2 (11.8) | 8 (18.2) | 3 (6.8) |
Lymphopenia | 2 (10.0) | 0 | 3 (42.9) | 2 (28.6) | 2 (11.8) | 1 (5.9) | 7 (15.9) | 3 (6.8) |
Thrombocytopenia | 1 (5.0) | 0 | 3 (42.9) | 0 | 1 (5.9) | 0 | 5 (11.4) | 0 |
Erythema multiforme | 2 (10.0) | 1 (5.0) | 3 (42.9) | 2 (28.6) | 0 | 0 | 5 (11.4) | 3 (6.8) |
Constipation | 1 (5.0) | 0 | 0 | 0 | 4 (23.5) | 0 | 5 (11.4) | 0 |
Drug eruption | 2 (10.0) | 1 (5.0) | 1 (14.3) | 1 (14.3) | 1 (5.9) | 0 | 4 (9.1) | 2 (4.5) |
Blood bilirubin increased | 4 (20.0) | 1 (5.0) | 0 | 0 | 0 | 0 | 4 (9.1) | 1 (2.3) |
Nausea | 1 (5.0) | 0 | 1 (14.3) | 0 | 2 (11.8) | 1 (5.9) | 4 (9.1) | 1 (2.3) |
Stomatitis | 2 (10.0) | 0 | 1 (14.3) | 0 | 1 (5.9) | 0 | 4 (9.1) | 0 |
Anemia | 1 (5.0) | 0 | 1 (14.3) | 0 | 2 (11.8) | 0 | 4 (9.1) | 0 |
Vomiting | 1 (5.0) | 0 | 0 | 0 | 3 (17.6) | 0 | 4 (9.1) | 0 |
Aspartate aminotransferase increased | 2 (10.0) | 1 (5.0) | 0 | 0 | 1 (5.9) | 1 (5.9) | 3 (6.8) | 2 (4.5) |
Hypertriglyceridemia | 0 | 0 | 0 | 0 | 3 (17.6) | 2 (11.8) | 3 (6.8) | 2 (4.5) |
Dyslipidemia | 1 (5.0) | 0 | 1 (14.3) | 0 | 1 (5.9) | 1 (5.9) | 3 (6.8) | 1 (2.3) |
Seizure | 1 (5.0) | 0 | 0 | 0 | 2 (11.8) | 1 (5.9) | 3 (6.8) | 1 (2.3) |
Rash maculopapular | 1 (5.0) | 0 | 0 | 0 | 2 (11.8) | 1 (5.9) | 3 (6.8) | 1 (2.3) |
Urinary tract infection | 0 | 0 | 2 (28.6) | 0 | 1 (5.9) | 1 (5.9) | 3 (6.8) | 1 (2.3) |
Headache | 2 (10.0) | 0 | 1 (14.3) | 0 | 0 | 0 | 3 (6.8) | 0 |