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. 2016 Jan 9;16(1):93–107. doi: 10.1007/s40268-015-0120-x

Table 6.

Number (%) of subjects with most frequently reported AEs

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