A Study to Assess the Safety of a Potential New Drug in C... | NCT00504556

NCT00504556

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	DU-176b 30mg tablet once daily	Drug: Edoxaban (DU-176b)
2	Experimental	DU-176b 60mg once daily	Drug: Edoxaban (DU-176b)
3	Experimental	DU-176b 30mg b.i.d.	Drug: Edoxaban (DU-176b)
4	Experimental	DU-176b 60mg tablets two times a day	Drug: Edoxaban (DU-176b)
5	Active Comparator	warfarin tablets	Drug: warfarin

Name	Type	Description	Arm Group Labels	Other Names
Edoxaban (DU-176b)	Drug	30mg tablet once daily	1
Edoxaban (DU-176b)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adjudicated Incidence of Bleeding Events	Adjudicated Incidence of Bleeding Events during treatment period	3 months
Percent of Subjects With Liver-related Laboratory Marked Abnormalities (MA)	liver enzyme (ALT and/or AST) and/or bilirubin (TBL) abnormalities	3 months

Secondary Outcomes

Measure	Description	Time Frame
Incidence of Major Adverse Cardiac Events MACE)	MACE is defined as the composite of stroke [ischemic or hemorrhagic], Systemic embolic event (SEE), Myocardial Infarction (MI), Cardiovascular (CV) death, and hospitalization for any cardiac condition	3 months
Effects on Biomarker D-dimer

Eligibility Module

Contacts/Locations Module

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	DU-176b 30mg qd	DU-176b 30mg tablet once daily (qd) Edoxaban (DU-176b): 30mg tablet once daily
FG001	DU-176b 30mg Bid	DU-176b 30mg twice daily (bid) Edoxaban (DU-176b): 30mg tablet twice daily

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Arm/Group Information

ID	Title	Description
BG000	DU-176b 30mg qd	DU-176b 30mg tablet once daily (qd) Edoxaban (DU-176b): 30mg tablet once daily
BG001	DU-176b 30mg Bid	DU-176b 30mg twice daily (bid) Edoxaban (DU-176b): 30mg tablet twice daily
BG002	DU-176b 60mg qd	DU-176b 60mg once daily (qd) Edoxaban (DU-176b): 60mg tablet once daily
BG003	DU-176b 60mg Bid	DU-176b 60mg tablet two times a day Edoxaban (DU-176b): 60mg tablet two times a day
BG004	Warfarin Tablets	warfarin tablets warfarin: warfarin tablets
BG005	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020 BG003

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00065.2± 8.34 BG00164.8± 8.83 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00095 BG00194 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Belarus

Title	Measurements
	BG0005 BG0015 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Secondary

Incidence of Major Adverse Cardiac Events MACE)

MACE is defined as the composite of stroke [ischemic or hemorrhagic], Systemic embolic event (SEE), Myocardial Infarction (MI), Cardiovascular (CV) death, and hospitalization for any cardiac condition

safety analysis set

Posted

Number

95% Confidence Interval

percent of subjects experiencing events

3 months

ID	Title	Description
OG000	DU-176b 30mg qd	DU-176b 30mg tablet once daily (qd) Edoxaban (DU-176b): 30mg tablet once daily
OG001	DU-176b 30mg Bid	DU-176b 30mg twice daily (bid) Edoxaban (DU-176b): 30mg tablet twice daily
OG002	DU-176b 60mg qd	DU-176b 60mg once daily (qd) Edoxaban (DU-176b): 60mg tablet once daily
OG003	DU-176b 60mg Bid	DU-176b 60mg tablet two times a day Edoxaban (DU-176b): 60mg tablet two times a day
OG004	Warfarin Tablets	warfarin tablets warfarin: warfarin tablets

Units	Counts
Participants	OG000235 OG001244 OG002234 OG003

Title

Denominators

Categories

MACE

Title	Measurements
	OG0001.7(0.5 to 4.3) OG0012.5(0.9 to 5.3) OG0024.3(2.1 to 7.7) OG003

Primary

Adjudicated Incidence of Bleeding Events

Adjudicated Incidence of Bleeding Events during treatment period

safety analysis set

Posted

Number

95% Confidence Interval

percent of subjects with outcome event

3 months

ID	Title	Description
OG000	DU-176b 30mg qd	DU-176b 30mg tablet once daily (qd) Edoxaban (DU-176b): 30mg tablet once daily
OG001	DU-176b 30mg Bid	DU-176b 30mg twice daily (bid) Edoxaban (DU-176b): 30mg tablet twice daily
OG002	DU-176b 60mg qd	DU-176b 60mg once daily (qd) Edoxaban (DU-176b): 60mg tablet once daily
OG003	DU-176b 60mg Bid	DU-176b 60mg tablet two times a day Edoxaban (DU-176b): 60mg tablet two times a day
OG004	Warfarin Tablets	warfarin tablets warfarin: warfarin tablets

Secondary

Effects on Biomarker D-dimer

Mean (SD) change from baseline in D-dimer

Posted

Mean

Standard Deviation

ng/mL

3 months

ID	Title	Description
OG000	DU-176b 30mg qd	DU-176b 30mg tablet once daily (qd) Edoxaban (DU-176b): 30mg tablet once daily
OG001	DU-176b 30mg Bid	DU-176b 30mg twice daily (bid) Edoxaban (DU-176b): 30mg tablet twice daily
OG002	DU-176b 60mg qd	DU-176b 60mg once daily (qd) Edoxaban (DU-176b): 60mg tablet once daily
OG003	DU-176b 60mg Bid	DU-176b 60mg tablet two times a day Edoxaban (DU-176b): 60mg tablet two times a day
OG004	Warfarin Tablets	warfarin tablets warfarin: warfarin tablets

Secondary

Effects on Biomarker Prothrombin Fragments

Mean (SD) change from baseline in Prothrombin Fragments 1 and 2 (F1 and F2)

Posted

Mean

Standard Deviation

pmol/L

3 months

ID	Title	Description
OG000	DU-176b 30mg qd	DU-176b 30mg tablet once daily (qd) Edoxaban (DU-176b): 30mg tablet once daily
OG001	DU-176b 30mg Bid	DU-176b 30mg twice daily (bid) Edoxaban (DU-176b): 30mg tablet twice daily
OG002	DU-176b 60mg qd	DU-176b 60mg once daily (qd) Edoxaban (DU-176b): 60mg tablet once daily
OG003	DU-176b 60mg Bid	DU-176b 60mg tablet two times a day Edoxaban (DU-176b): 60mg tablet two times a day
OG004	Warfarin Tablets	warfarin tablets warfarin: warfarin tablets

Secondary

Pharmacokinetics (Cmin, Cmax) of DU-176b in Subjects Receiving DU-176b

Median (min, max) values of Cmin,ss; Cmax,ss

Posted

Median

Full Range

ng/mL

3 months

ID	Title	Description
OG000	DU-176b 30mg qd	DU-176b 30mg tablet once daily (qd) Edoxaban (DU-176b): 30mg tablet once daily
OG001	DU-176b 30mg Bid	DU-176b 30mg twice daily (bid) Edoxaban (DU-176b): 30mg tablet twice daily
OG002	DU-176b 60mg qd	DU-176b 60mg once daily (qd) Edoxaban (DU-176b): 60mg tablet once daily
OG003	DU-176b 60mg Bid	DU-176b 60mg tablet two times a day Edoxaban (DU-176b): 60mg tablet two times a day

Units	Counts
Participants

Primary

Percent of Subjects With Liver-related Laboratory Marked Abnormalities (MA)

liver enzyme (ALT and/or AST) and/or bilirubin (TBL) abnormalities

safety analysis set

Posted

Number

95% Confidence Interval

percent subjects with liver related MA

3 months

ID	Title	Description
OG000	DU-176b 30mg qd	DU-176b 30mg tablet once daily (qd) Edoxaban (DU-176b): 30mg tablet once daily
OG001	DU-176b 30mg Bid	DU-176b 30mg twice daily (bid) Edoxaban (DU-176b): 30mg tablet twice daily
OG002	DU-176b 60mg qd	DU-176b 60mg once daily (qd) Edoxaban (DU-176b): 60mg tablet once daily
OG003	DU-176b 60mg Bid	DU-176b 60mg tablet two times a day Edoxaban (DU-176b): 60mg tablet two times a day
OG004	Warfarin Tablets

Secondary

Pharmacokinetics (AUC) of DU-176b in Subjects Receiving DU-176b

Median (min, max) values of AUCss

Posted

Median

Full Range

ng*h/mL

3 months

ID	Title	Description
OG000	DU-176b 30mg qd	DU-176b 30mg tablet once daily (qd) Edoxaban (DU-176b): 30mg tablet once daily
OG001	DU-176b 30mg Bid	DU-176b 30mg twice daily (bid) Edoxaban (DU-176b): 30mg tablet twice daily
OG002	DU-176b 60mg qd	DU-176b 60mg once daily (qd) Edoxaban (DU-176b): 60mg tablet once daily
OG003	DU-176b 60mg Bid	DU-176b 60mg tablet two times a day Edoxaban (DU-176b): 60mg tablet two times a day

Units	Counts
Participants

Secondary

Effects on Pharmacodynamic Biomarker Anti-Factor Xa Activity in Subjects Receiving DU-176b

Mean (SD) change from baseline in biomarker anti-Factor Xa [FXa] activity on Day 28, 1-3 hours post dose.

Posted

Mean

Standard Deviation

IU/mL

Day 28

ID	Title	Description
OG000	DU-176b 30mg qd	DU-176b 30mg tablet once daily (qd) Edoxaban (DU-176b): 30mg tablet once daily
OG001	DU-176b 30mg Bid	DU-176b 30mg twice daily (bid) Edoxaban (DU-176b): 30mg tablet twice daily
OG002	DU-176b 60mg qd	DU-176b 60mg once daily (qd) Edoxaban (DU-176b): 60mg tablet once daily
OG003	DU-176b 60mg Bid	DU-176b 60mg tablet two times a day Edoxaban (DU-176b): 60mg tablet two times a day

Units	Counts

Secondary

Effects on Pharmacodynamic Biomarker (Endogenous FX Activity) in Subjects Receiving DU-176b

Mean (SD) change from baseline in biomarker endogenous FX activity on Day 28, 1-3 hours post dose.

Posted

Mean

Standard Deviation

percent change of Endogenous FX activity

Day 28

ID	Title	Description
OG000	DU-176b 30mg qd	DU-176b 30mg tablet once daily (qd) Edoxaban (DU-176b): 30mg tablet once daily
OG001	DU-176b 30mg Bid	DU-176b 30mg twice daily (bid) Edoxaban (DU-176b): 30mg tablet twice daily
OG002	DU-176b 60mg qd	DU-176b 60mg once daily (qd) Edoxaban (DU-176b): 60mg tablet once daily
OG003	DU-176b 60mg Bid	DU-176b 60mg tablet two times a day Edoxaban (DU-176b): 60mg tablet two times a day

Units	Counts

Secondary

Effects on Pharmacodynamic Biomarker PICT Activity in Subjects Receiving DU-176b

Mean (SD) change from baseline in biomarker prothrombinase induced clotting time [PICT] on Day 28, 1-3 hours post dose.

PICT was determined by PICT aasay which is a plasma based functional assay to determine the anticoagulant activity on FXa and FIIa inhibition.

Posted

Mean

Standard Deviation

seconds

Day 28

ID	Title	Description
OG000	DU-176b 30mg qd	DU-176b 30mg tablet once daily (qd) Edoxaban (DU-176b): 30mg tablet once daily
OG001	DU-176b 30mg Bid	DU-176b 30mg twice daily (bid) Edoxaban (DU-176b): 30mg tablet twice daily
OG002	DU-176b 60mg qd	DU-176b 60mg once daily (qd) Edoxaban (DU-176b): 60mg tablet once daily
OG003	DU-176b 60mg Bid	DU-176b 60mg tablet two times a day Edoxaban (DU-176b): 60mg tablet two times a day

Secondary

Effects on Pharmacodynamic Biomarker PT in Subjects Receiving DU-176b

Mean (SD) change from baseline in biomarker prothrombin time (PT) on Day 28, 1-3 hours post dose.

Posted

Mean

Standard Deviation

seconds

Day 28

ID	Title	Description
OG000	DU-176b 30mg qd	DU-176b 30mg tablet once daily (qd) Edoxaban (DU-176b): 30mg tablet once daily
OG001	DU-176b 30mg Bid	DU-176b 30mg twice daily (bid) Edoxaban (DU-176b): 30mg tablet twice daily
OG002	DU-176b 60mg qd	DU-176b 60mg once daily (qd) Edoxaban (DU-176b): 60mg tablet once daily
OG003	DU-176b 60mg Bid	DU-176b 60mg tablet two times a day Edoxaban (DU-176b): 60mg tablet two times a day

Units	Counts

Secondary

Effects on Pharmacodynamic Biomarker INR in Subjects Receiving DU-176b

Mean (SD) change from baseline in biomarker International Normalized Ratio (INR) on Day 28, 1-3 hours post dose.

Posted

Mean

Standard Deviation

ratio

Day 28

ID	Title	Description
OG000	DU-176b 30mg qd	DU-176b 30mg tablet once daily (qd) Edoxaban (DU-176b): 30mg tablet once daily
OG001	DU-176b 30mg Bid	DU-176b 30mg twice daily (bid) Edoxaban (DU-176b): 30mg tablet twice daily
OG002	DU-176b 60mg qd	DU-176b 60mg once daily (qd) Edoxaban (DU-176b): 60mg tablet once daily
OG003	DU-176b 60mg Bid	DU-176b 60mg tablet two times a day Edoxaban (DU-176b): 60mg tablet two times a day

Units	Counts

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	DU-176b 30mg qd	DU-176b 30mg tablet once daily (qd) Edoxaban (DU-176b): 30mg tablet once daily	10	235	3	235
EG001	DU-176b 30mg Bid	DU-176b 30mg twice daily (bid) Edoxaban (DU-176b): 30mg tablet twice daily	16	244	8	244
EG002	DU-176b 60mg qd	DU-176b 60mg once daily (qd) Edoxaban (DU-176b): 60mg tablet once daily	15	234	4	234
EG003	DU-176b 60mg Bid	DU-176b 60mg tablet two times a day Edoxaban (DU-176b): 60mg tablet two times a day	14	180	10	180
EG004	Warfarin Tablets	warfarin tablets warfarin: warfarin tablets	11	250	22	250

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected235 at risk EG0010 events0 affected244 at risk EG0020 events0 affected234 at risk EG0031 events1 affected180 at risk EG0040 events0 affected250 at risk
acute myocardial infarction	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected235 at risk EG0010 events0 affected244 at risk EG0021 events1 affected234 at risk EG003
angina unstable	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected235 at risk EG0011 events1 affected244 at risk EG0023 events3 affected234 at risk EG003
atrial fibrillation	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0010 events0 affected244 at risk EG0020 events0 affected234 at risk EG003
cardiac failure	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0010 events0 affected244 at risk EG0021 events1 affected234 at risk EG003
cardiac failure acute	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected235 at risk EG0010 events0 affected244 at risk EG0020 events0 affected234 at risk EG003
cardiac failure congestive	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0011 events1 affected244 at risk EG0020 events0 affected234 at risk EG003
cardiogenic shock	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected235 at risk EG0010 events0 affected244 at risk EG0020 events0 affected234 at risk EG003
cardiomyopathy	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0011 events1 affected244 at risk EG0020 events0 affected234 at risk EG003
cardiovascular disorder	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0010 events0 affected244 at risk EG0020 events0 affected234 at risk EG003
coronary artery insufficiency	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0011 events1 affected244 at risk EG0020 events0 affected234 at risk EG003
left ventricular failure	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0011 events1 affected244 at risk EG0020 events0 affected234 at risk EG003
myocardial fibrosis	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected235 at risk EG0010 events0 affected244 at risk EG0020 events0 affected234 at risk EG003
myocardial infarction	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0010 events0 affected244 at risk EG0023 events3 affected234 at risk EG003
ventricular fibrillation	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected235 at risk EG0010 events0 affected244 at risk EG0020 events0 affected234 at risk EG003
deafness neurosensory	Ear and labyrinth disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0010 events0 affected244 at risk EG0020 events0 affected234 at risk EG003
gastric ulcer	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0010 events0 affected244 at risk EG0020 events0 affected234 at risk EG003
gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0010 events0 affected244 at risk EG0020 events0 affected234 at risk EG003
gastroduodenal ulcer	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0010 events0 affected244 at risk EG0020 events0 affected234 at risk EG003
gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0014 events3 affected244 at risk EG0020 events0 affected234 at risk EG003
intestinal angina	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected235 at risk EG0010 events0 affected244 at risk EG0020 events0 affected234 at risk EG003
intestinal obstruction	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0010 events0 affected244 at risk EG0021 events1 affected234 at risk EG003
cholecystitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected235 at risk EG0011 events1 affected244 at risk EG0020 events0 affected234 at risk EG003
haematoma infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0011 events1 affected244 at risk EG0020 events0 affected234 at risk EG003
pneumonia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected235 at risk EG0010 events0 affected244 at risk EG0020 events0 affected234 at risk EG003
urinary tract infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected235 at risk EG0010 events0 affected244 at risk EG0020 events0 affected234 at risk EG003
clavicle fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0011 events1 affected244 at risk EG0020 events0 affected234 at risk EG003
overdose	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected235 at risk EG0010 events0 affected244 at risk EG0020 events0 affected234 at risk EG003
upper limb fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0010 events0 affected244 at risk EG0020 events0 affected234 at risk EG003
haemoglobin decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0010 events0 affected244 at risk EG0021 events1 affected234 at risk EG003
diabetes mellitus	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0010 events0 affected244 at risk EG0020 events0 affected234 at risk EG003
diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0010 events0 affected244 at risk EG0020 events0 affected234 at risk EG003
gout	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0010 events0 affected244 at risk EG0020 events0 affected234 at risk EG003
gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0010 events0 affected244 at risk EG0020 events0 affected234 at risk EG003
gastric neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0011 events1 affected244 at risk EG0020 events0 affected234 at risk EG003
cerebral artery thrombosis	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected235 at risk EG0010 events0 affected244 at risk EG0020 events0 affected234 at risk EG003
cerebral haemorrhage	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0010 events0 affected244 at risk EG0021 events1 affected234 at risk EG003
diabetic neuropathy	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0011 events1 affected244 at risk EG0020 events0 affected234 at risk EG003
dizziness	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0010 events0 affected244 at risk EG0021 events1 affected234 at risk EG003
heamorrhage intracranial	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0011 events1 affected244 at risk EG0020 events0 affected234 at risk EG003
haemorrhagic stroke	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected235 at risk EG0011 events1 affected244 at risk EG0020 events0 affected234 at risk EG003
ischaemic stroke	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0003 events3 affected235 at risk EG0010 events0 affected244 at risk EG0020 events0 affected234 at risk EG003
subarachnoid haemorrhage	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0010 events0 affected244 at risk EG0020 events0 affected234 at risk EG003
transient ischaemic attack	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0011 events1 affected244 at risk EG0020 events0 affected234 at risk EG003
haematuria	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0010 events0 affected244 at risk EG0022 events1 affected234 at risk EG003
metrorrhagia	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0010 events0 affected244 at risk EG0020 events0 affected234 at risk EG003
acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0010 events0 affected244 at risk EG0021 events1 affected234 at risk EG003
dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0011 events1 affected244 at risk EG0020 events0 affected234 at risk EG003
chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected235 at risk EG0010 events0 affected244 at risk EG0020 events0 affected234 at risk EG003
epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0010 events0 affected244 at risk EG0020 events0 affected234 at risk EG003
haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0010 events0 affected244 at risk EG0020 events0 affected234 at risk EG003
pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected235 at risk EG0011 events1 affected244 at risk EG0020 events0 affected234 at risk EG003
pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected235 at risk EG0010 events0 affected244 at risk EG0020 events0 affected234 at risk EG003
aortic aneurysm	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0010 events0 affected244 at risk EG0021 events1 affected234 at risk EG003
diabetic vascular disorder	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0011 events1 affected244 at risk EG0020 events0 affected234 at risk EG003
haematoma	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected235 at risk EG0011 events1 affected244 at risk EG0020 events0 affected234 at risk EG003
hypertension	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected235 at risk EG0010 events0 affected244 at risk EG0021 events1 affected234 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
INR increased	Investigations	MedDRA (10.0)	Systematic Assessment		EG0000 affected235 at risk EG0011 affected244 at risk EG0022 affected234 at risk EG0030 affected180 at risk EG00418 affected250 at risk
hematuria	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment		EG0003 affected235 at risk EG0017 affected244 at risk EG0022 affected234 at risk EG003

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D016769	Embolism and Thrombosis
D014652	Vascular Diseases

Ancestor Terms

ID	Term
D015110	4-Hydroxycoumarins
D003374	Coumarins
D001578	Benzopyrans
D011714	Pyrans
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Facility	Status	City	State	ZIP	Country	Contacts
		Huntsville	Alabama		United States

ID	Term
D001281	Atrial Fibrillation
D013923	Thromboembolism
D054556	Venous Thromboembolism