Table 3.
Treatment-related adverse events reported by ≥20% of patients or in grade 3 or more severity in each dose level
Fostamatinib Dosea: | 50 mg (n = 10) | 100 mg (n = 15) | 150 mg (n = 5) | 200 mg (n = 7) | ||||
---|---|---|---|---|---|---|---|---|
| ||||||||
Adverse event, n (%): | All grades | Grade ≥3 | All grades | Grade ≥3 | All grades | Grade ≥3 | All grades | Grade ≥3 |
Anemia | 4 (40) | 0 | 2 (13) | 0 | 4 (80) | 1 (20) | 2 (29) | 0 |
Leukopenia | 3 (30) | 0 | 2 (13) | 0 | 4 (80) | 0 | 4 (57) | 0 |
Neutropenia | 0 | 0 | 0 | 0 | 1 (20) | 0 | 1 (14) | 0 |
Thrombocytopenia | 1 (10) | 0 | 2 (13) | 0 | 0 | 0 | 2 (29) | 0 |
Lymphopenia | 6 (60) | 0 | 5 (33) | 0 | 3 (60) | 1 (20) | 5 (71) | 1 (14) |
Diarrhea | 1 (10) | 0 | 0 | 0 | 2 (40) | 0 | 1 (14) | 0 |
Nausea | 2 (20) | 0 | 4 (27) | 0 | 1 (20) | 0 | 0 | 0 |
Fatigue | 4 (40) | 0 | 2 (13) | 0 | 1 (20) | 0 | 1 (14) | 0 |
Hair loss | 0 | 0 | 0 | 0 | 1 (20) | 0 | 0 | 0 |
Diaphoresis | 0 | 0 | 0 | 0 | 1 (20) | 0 | 0 | 0 |
Hypertension | 2 (20) | 0 | 3 (20) | 0 | 2 (40) | 1 (20) | 3 (43) | 2 (29) |
Thrombosis/embolismb | 0 | 0 | 2 (13) | 2 (13) | 0 | 0 | 0 | 0 |
Proteinuriab | 0 | 0 | 1 (7) | 0 | 0 | 0 | 0 | 0 |
Elevated AST | 3 (30) | 1 (10) | 4 (27) | 0 | 4 (80) | 0 | 5 (71) | 1 (14) |
Elevated ALT | 4 (40) | 1 (10) | 4 (27) | 0 | 2 (40) | 0 | 5 (71) | 0 |
Elevated ALP | 1 (10) | 1 (10) | 2 (13) | 0 | 1 (20) | 0 | 3 (43) | 2 (29) |
Hyperbilirubinemia | 3 (30) | 0 | 1 (7) | 1 (7) | 2 (40) | 1 (20) | 3 (43) | 1 (14) |
Hypophosphatemia | 2 (20) | 0 | 0 | 0 | 1 (20) | 0 | 0 | 0 |
Hypocalcemia | 0 | 0 | 0 | 0 | 2 (40) | 0 | 0 | 0 |
Hypokalemia | 0 | 0 | 0 | 0 | 2 (40) | 0 | 0 | 0 |
Hyperkalemia | 0 | 0 | 0 | 0 | 1 (20) | 0 | 0 | 0 |
Hypomagnesemia | 0 | 0 | 0 | 0 | 1 (20) | 0 | 0 | 0 |
Hypercholesterolemia | 0 | 0 | 0 | 0 | 1 (20) | 0 | 0 | 0 |
Elevated CK | 0 | 0 | 1 (7) | 0 | 1 (20) | 0 | 0 | 0 |
AST, aspartate aminotransferase; ALT, alanine aminotransferase; ALP, alkaline phosphatase; CK, creatine kinase.
One dosage of Fostamatinib; i.e., “50” means Fostamatinib twice a day continuously.
Included due to clinical relevance.