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.