Table 6.
OC study | Warfarin study | Rosuvastatin study | Simvastatin study | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Preferred term | OC alone n = 33 |
OC + fostamatinib n = 30 |
Warfarin alone n = 15 |
Fostamatinib alone n = 14 |
Warfarin + fostamatinib n = 14 |
Rosuvastatin alone n = 21 |
Fostamatinib alone n = 21 |
Rosuvastatin + fostamatinib n = 21 |
Simvastatin alone n = 21 |
Fostamatinib alone n = 20 |
Simvastatin + fostamatinib n = 19 |
Any AE | 16 (48.5) | 8 (26.7) | 3 (20.0) | 1 (7.0) | 2 (14.0) | 3 (14.3) | 2 (9.5) | 3 (14.3) | 3 (14.3) | 6 (30.0) | 2 (10.5) |
Abdominal pain | 1 (3.0) | 1 (3.3) | 0 | 0 | 0 | 0 | 1 (5.0) | 0 | |||
Constipation | 1 (3.0) | 0 | 1 (4.8) | 0 | 0 | 0 | 1 (5.0) | 0 | |||
Diarrhea | 0 | 0 | 1 (4.8) | 0 | 1 (5.0) | 0 | |||||
Nausea | 1 (3.0) | 1 (3.3) | 1 (7.0) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Headache | 8 (24.2) | 0 | 1 (4.8) | 0 | 0 | 0 | 0 | 0 | |||
Pre-syncope | 2 (6.1) | 1 (3.3) | 0 | 0 | 0 | 0 | 0 | 0 | |||
Hypoesthesia | 0 | 1 (7.0) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
Lethargy | 1 (7.0) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
Fatigue | 3 (9.1) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
Vaginal hemorrhage | 2 (6.1) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
Pollakiuria | 1 (7.0) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
Vessel puncture site reaction | 0 | 0 | 2 (9.5) | 0 | 0 | 0 | |||||
Upper respiratory tract infection | 0 | 1 (3.3) | 0 | 0 | 1 (4.8) | 0 | 1 (5.0) | 0 | |||
Vulvovaginal candidiasis | 2 (6.1) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
Cough | 0 | 0 | 0 | 1 (4.8) | 1 (5.0) | 0 | |||||
Nasal congestion | 0 | 0 | 0 | 1 (4.8) | 0 | 1 (5.3) | |||||
Oropharyngeal pain | 2 (6.1) | 0 | 0 | 0 | 0 | 0 | 1 (5.0) | 0 | |||
Rash | 0 | 1 (3.3) | 0 | 0 | 2 (14.0) | 0 | 0 | 0 | 0 | 0 | 0 |
Contact dermatitis | 0 | 0 | 0 | 0 | 1 (5.0) | 1 (5.3) |
In the warfarin study, the fostamatinib alone phase relates to days 8–12 where fostamatinib was dosed alone before warfarin was co-administered on day 13
AE adverse event, OC oral contraceptive