1

Table 1 Post-marketing adverse event preferred terms identified in database search

AE Preferred Term PT Count PT Serious Count
Acute myocardial infarction 5 5
Amaurosis fugax 2 2
Aortic embolus 1 1
Blindness transient 3 3
Brain stem infarction 1 1
Brain stem stroke 1 1
Cerebral infarction 1 1
Cerebral thrombosis 2 2
Cerebral venous sinus thrombosis 4 4
Cerebrovascular accident 57 53
Cerebrovascular disorder 1 1
Deep vein thrombosis 15* 15*
Diplegia 8 8
Disseminated intravascular coagulation 1 1
Embolic stroke 1 1
Embolism 1 1
Embolism arterial 1 1
Haemorrhagic infarction 1 1
Table 1 Post-marketing adverse event preferred terms identified in database search
AE Preferred Term PT Count PT Serious Count
Haemorrhagic stroke 3 3
Hemiparesis 15 15
Hemiplegia 6 6
Hepatic vein thrombosis 1 1
Ischaemic stroke 11 11
Mesenteric vein thrombosis 1 1
Monoparesis 10 10
Monoplegia 31 31
Myocardial infarction 34 34
Paraparesis 2 2
Paraplegia 1 1
Paresis 3 2
Pelvic venous thrombosis 1 1
Portal vein thrombosis 1 1
Pulmonary embolism 22 22
Pulmonary infarction 1 1
Quadriplegia 1 1
Splenic infarction 1 1
Splenic vein thrombosis 1 1
Superior sagittal sinus thrombosis 1 1
Thrombophlebitis 1 1
Thrombophlebitis superficial 2
Thrombosis 3 3
Transient ischaemic attack 28 28
Vascular stent occlusion 1 1
Total: 288 281
Table 3 Observed versus expected analysis for Pulmonary embolism and Deep
vein thrombosis
Medical Concept Observed Expected Rate ratio (CI 95%) Conclusion
cases cases
Observed significantly <
Deep vein thrombosis 15 704.87 0.02 ( 0.01 - 0.04 ) expected
Observed significantly <
Pulmonary Embolism 22 861.7 0.02 ( 0.02 - 0.04 ) expected
CI Confidence Interval
Table 4 Cases with Pulmonary embolism by age interval
Age interval, years Gender Time to Onset
Table 5 Cases with Deep vein thrombosis by age group
Age group, years Gender Time to Onset
Male Female Unknown < 1 day 1-7 days 8-13 days Unknown
18 to <65 1 3 0 1 3 0 0
3 8 0 0 4 1 6