Adverse event (AE) randomization to study end: full analysis set.
| N (%) of Patients, Event Rate per 100 Patient-yrs | |||
|---|---|---|---|
| Fostamatinib 100 mg bid, n = 105 | Fostamatinib 100 mg bid (4 weeks) then 150 mg qd, n = 108 | Placebo, n = 109 | |
| Patients with an AE | 87 (82.9), 212.6 | 81 (75.0), 196.3 | 78 (71.6), 211.2 |
| Any SAE (including events with outcome of death) | 7 (6.7), 17.1 | 7 (6.5), 17.0 | 6 (5.5), 16.2 |
| Infections and infestations | 3 (2.9), 7.3 | 2 (1.9), 4.8 | 2 (1.8), 5.4 |
| Neoplasms benign, malignant, and unspecified | 0 (0.0), 0.0 | 1 (0.9), 2.4 | 0 (0.0), 0.0 |
| Blood and lymphatic system disorders | 0 (0.0), 0.0 | 0 (0.0), 0.0 | 1 (0.9), 2.7 |
| Metabolism and nutrition disorders | 2 (1.9), 4.9 | 0 (0.0), 0.0 | 1 (0.9), 2.7 |
| Nervous system disorders | 1 (1.0), 2.4 | 1 (0.9), 2.4 | 0 (0.0), 0.0 |
| Cardiac disorders | 1 (1.0), 2.4 | 3 (2.8), 7.3 | 1 (0.9), 2.7 |
| Gastrointestinal disorders | 1 (1.0), 2.4 | 0 (0.0), 0.0 | 2 (1.8), 5.4 |
| Hepatobiliary disorders | 1 (1.0), 2.4 | 0 (0.0), 0.0 | 0 (0.0), 0.0 |
| General disorders and administration site conditions | 1 (1.0), 2.4 | 1 (0.9), 2.4 | 0 (0.0), 0.0 |
| Any AE with outcome of death | 0 | 1 (0.9), 2.4 | 1 (0.9), 2.7 |
| Any AE leading to discontinuation of treatment | 10 (9.5), 24.4 | 11 (10.2), 26.7 | 9 (8.3), 24.4 |
| AE (≥ 5% in any group) | |||
| Diarrhea | 21 (20.0), 51.3 | 29 (26.9), 70.3 | 7 (6.4), 19.0 |
| Hypertension | 14 (13.3), 34.2 | 15 (13.9), 36.3 | 9 (8.3), 24.4 |
| Headache | 8 (7.6), 19.6 | 9 (8.3), 21.8 | 11 (10.1), 29.8 |
| Dizziness | 7 (6.7), 17.1 | 6 (5.6), 14.5 | 2 (1.8), 5.4 |
| Arthralgia | 6 (5.7), 14.7 | 0 | 5 (4.6), 13.5 |
| Flatulence | 6 (5.7), 14.7 | 2 (1.9), 4.8 | 4 (3.7), 10.8 |
| Gastritis | 6 (5.7), 14.7 | 2 (1.9), 4.8 | 3 (2.8), 8.1 |
| Nasopharyngitis | 6 (5.7), 14.7 | 4 (3.7), 9.7 | 4 (3.7), 10.8 |
| Upper respiratory tract infection | 6 (5.7), 14.7 | 2 (1.9), 4.8 | 1 (0.9), 2.7 |
| Nausea | 4 (3.8), 9.8 | 7 (6.5), 17.0 | 9 (8.3), 24.4 |
| Rheumatoid arthritis | 4 (3.8), 9.8 | 6 (5.6), 14.5 | 11 (10.1), 29.8 |
| Vomiting | 1 (1.0), 2.4 | 6 (5.6), 14.5 | 5 (4.6), 13.5 |
| Fatigue | 0 (0.0), 0.0 | 0 (0.0), 0.0 | 6 (5.5), 16.2 |
SAE: serious adverse event; bid: twice daily; qd: once daily.