Efficacy and Safety of Rivaroxaban for the Prevention of... | NCT00494871

Status Module

Name	Class
Janssen R&D, L.L.C.	UNKNOWN

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
Rivaroxaban (Xarelto, BAY59-7939)	Experimental	Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period	Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Warfarin placebo
Warfarin	Active Comparator	Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period	Drug: Warfarin Drug: Rivaroxaban placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rivaroxaban (Xarelto, BAY59-7939)	Drug	Participants orally administered rivaroxaban 15 mg OD (CrCL [creatinine clearance] >= 50 mL/min) or 10 mg OD (CrCL 30-49 mL/min)	Rivaroxaban (Xarelto, BAY59-7939)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Event Rate of the Composite Endpoint of Adjudicated Major Bleeding or Adjudicated Non-major Clinically Relevant Bleeding	Major bleeding: clinically overt bleeding (COB) associated with a fall in hemoglobin ≥2 g/dL, leading to transfusion ≥2 units of packed red blood cells or whole blood, occurring in a critical site or contributing to death. Non-major clinically relevant bleeding: COB that does not meet the definition of major bleeding, but requires medical intervention or unscheduled contact with the physician, (temporary) discontinuation of the study treatment, discomfort to the subject such as pain, or impairment of activities of daily life.	Up to 2 days after the last dose

Secondary Outcomes

Measure	Description	Time Frame
Event Rate of the Composite Endpoint of Adjudicated Stroke and Non-central Nervous System (CNS) Systemic Embolism	This is the principal efficacy endpoint. Stroke included hemorrhagic, ischemic infarction and unknown. Arterial emboli in the following areas were "non-CNS systemic embolism": peripheral arterial in the upper and lower extremities, renal, mesenteric, splenic, hepatic, ocular/retinal and others. Pulmonary embolism or myocardial infarction was excluded.

Eligibility Module

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22664783	Result	Hori M, Matsumoto M, Tanahashi N, Momomura S, Uchiyama S, Goto S, Izumi T, Koretsune Y, Kajikawa M, Kato M, Ueda H, Iwamoto K, Tajiri M; J-ROCKET AF study investigators. Rivaroxaban vs. warfarin in Japanese patients with atrial fibrillation - the J-ROCKET AF study -. Circ J. 2012;76(9):2104-11. doi: 10.1253/circj.cj-12-0454. Epub 2012 Jun 5.
23052711

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Rivaroxaban (Xarelto, BAY59-7939)	Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
FG001	Warfarin

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	Rivaroxaban (Xarelto, BAY59-7939)	Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
BG001	Warfarin	Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
BG002	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, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00071.0± 8.3 BG00171.2± 7.9 BG00271.1± 8.1

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000110 BG001140 BG002

CL(CR) [creatinine clearance]

Number

Participants

Title

Denominators

Categories

<50 mL/min

Title	Measurements
	BG000141 BG001143 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

Primary

Event Rate of the Composite Endpoint of Adjudicated Major Bleeding or Adjudicated Non-major Clinically Relevant Bleeding

Major bleeding: clinically overt bleeding (COB) associated with a fall in hemoglobin ≥2 g/dL, leading to transfusion ≥2 units of packed red blood cells or whole blood, occurring in a critical site or contributing to death. Non-major clinically relevant bleeding: COB that does not meet the definition of major bleeding, but requires medical intervention or unscheduled contact with the physician, (temporary) discontinuation of the study treatment, discomfort to the subject such as pain, or impairment of activities of daily life.

The safety analysis population consisted of randomized participants who took at least one dose of study treatment (639 in each treatment group).

Posted

Number

Events per 100 patient-years

Up to 2 days after the last dose

ID	Title	Description
OG000	Rivaroxaban (Xarelto, BAY59-7939)	Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
OG001	Warfarin	Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period

Units	Counts
Participants	OG000639 OG001639

Title

Denominators

Categories

Title	Measurements
	OG00018.04 OG00116.42

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Cox		0.025		Hazard Ratio (HR)	1.11			2-Sided	95	0.87	1.42				Yes	Non-Inferiority or Equivalence	Non-inferiority margin of 2.0

Secondary

Event Rate of the Composite Endpoint of Adjudicated Stroke and Non-central Nervous System (CNS) Systemic Embolism

This is the principal efficacy endpoint. Stroke included hemorrhagic, ischemic infarction and unknown. Arterial emboli in the following areas were "non-CNS systemic embolism": peripheral arterial in the upper and lower extremities, renal, mesenteric, splenic, hepatic, ocular/retinal and others. Pulmonary embolism or myocardial infarction was excluded.

The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).

Posted

Number

Events per 100 patient-years

Up to 2 days after the last dose

ID	Title	Description
OG000	Rivaroxaban (Xarelto, BAY59-7939)	Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
OG001	Warfarin	Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period

Units	Counts
Participants

Secondary

Event Rate of the Composite Endpoint of Adjudicated Stroke, Non-CNS Systemic Embolism, and Vascular Death

The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).

Posted

Number

Events per 100 patient-years

Up to 2 days after the last dose

ID	Title	Description
OG000	Rivaroxaban (Xarelto, BAY59-7939)	Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
OG001	Warfarin	Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period

Units	Counts
Participants

Secondary

Event Rate of the Composite Endpoint of Adjudicated Stroke, Non-CNS Systemic Embolism, Myocardial Infarction, and Vascular Death

Stroke included hemorrhagic, ischemic infarction and unknown. Arterial emboli in the following areas were "non-CNS systemic embolism": peripheral arterial in the upper and lower extremities, renal, mesenteric, splenic, hepatic, ocular/retinal and others. Pulmonary embolism or myocardial infarction was excluded. Myocardial infarction: assessed based on either cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for ≥2 leads, or autopsy confirmation. Any death that was not clearly non-vascular.

The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).

Posted

Number

Events per 100 patient-years

Up to 2 days after the last dose

ID	Title	Description
OG000	Rivaroxaban (Xarelto, BAY59-7939)	Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
OG001	Warfarin	Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period

Secondary

Event Rate of Stroke

All events were adjudicated and confirmed by a central independent committee blinded to treatment. Stroke included hemorrhagic (Stroke with local collections of intraparenchymal blood. Subarachnoid hemorrhage, subdural hemorrhage, and epidural hemorrhage were excluded.), ischemic infarction (Stroke without focal collection of intracranial blood) and unknown (No imaging data and anatomic findings were available.).

The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).

Posted

Number

Events per 100 patient-years

Up to 2 days after the last dose

ID	Title	Description
OG000	Rivaroxaban (Xarelto, BAY59-7939)	Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
OG001	Warfarin	Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period

Units	Counts
Participants

Secondary

Event Rate of Non-CNS Systemic Embolism

All events were adjudicated and confirmed by a central independent committee blinded to treatment. Non-CNS systemic embolism was abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms (such as trauma, atherosclerosis, and instrumentation). Arterial emboli in the following areas were "non-CNS systemic embolism": peripheral arterial in the upper and lower extremities, renal, mesenteric, splenic, hepatic, ocular/retinal and others. Pulmonary embolism or myocardial infarction was excluded from this category.

The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).

Posted

Number

Events per 100 patient-years

Up to 2 days after the last dose

ID	Title	Description
OG000	Rivaroxaban (Xarelto, BAY59-7939)	Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
OG001	Warfarin	Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period

Secondary

Event Rate of Myocardial Infarction

All events were adjudicated and confirmed by a central independent committee blinded to treatment. Myocardial infarction was assessed based on either cardiac bio-markers (troponin I, troponin T, or creatine kinase-muscle and brain subunit isozyme), new abnormal Q waves appeared on ECG for 2 or more leads, or autopsy confirmation.

The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).

Posted

Number

Events per 100 patient-years

Up to 2 days after the last dose

ID	Title	Description
OG000	Rivaroxaban (Xarelto, BAY59-7939)	Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
OG001	Warfarin	Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period

Units	Counts
Participants

Secondary

Event Rate of Vascular Death

All events were adjudicated and confirmed by a central independent committee blinded to treatment. Any death that was not clearly non-vascular (e.g., deaths due to spontaneous bleeding, myocardial infarction, stroke, cardiac failure, and arrhythmia)

The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).

Posted

Number

Events per 100 patient-years

Up to 2 days after the last dose

ID	Title	Description
OG000	Rivaroxaban (Xarelto, BAY59-7939)	Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
OG001	Warfarin	Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period

Units	Counts
Participants	OG000

Secondary

Event Rate of Stroke With Serious Residual Disability

All events were adjudicated and confirmed by a central independent committee blinded to treatment. A stroke was considered disabling if the participant's modified Rankin score was between 3 and 5, inclusive.

The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).

Posted

Number

Events per 100 patient-years

Up to 2 days after the last dose

ID	Title	Description
OG000	Rivaroxaban (Xarelto, BAY59-7939)	Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
OG001	Warfarin	Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period

Units	Counts
Participants	OG000

Secondary

Event Rate of All-cause Death

All events were adjudicated and confirmed by a central independent committee blinded to treatment. All-cause death included vascular death and non-vascular death.

The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).

Posted

Number

Events per 100 patient-years

Up to 2 days after the last dose

ID	Title	Description
OG000	Rivaroxaban (Xarelto, BAY59-7939)	Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
OG001	Warfarin	Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period

Units	Counts
Participants	OG000

Secondary

Event Rate of Adjudicated Major Bleeding

All events were adjudicated and confirmed by a central independent committee blinded to treatment. Major bleeding was clinically overt bleeding associated with a fall in hemoglobin of 2 g/dL or higher, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death.

The safety analysis population consisted of randomized participants who took at least one dose of study treatment (639 in each treatment group).

Posted

Number

Events per 100 patient-years

Up to 2 days after the last dose

ID	Title	Description
OG000	Rivaroxaban (Xarelto, BAY59-7939)	Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
OG001	Warfarin	Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period

Units	Counts
Participants

Secondary

Event Rate Adjudicated Non-major Clinically Relevant Bleeding

All events were adjudicated and confirmed by a central independent committee blinded to treatment. Non-major clinically relevant bleeding was clinically overt bleeding that does not meet the definition of major bleeding, but requires medical intervention or unscheduled contact with the physician, (temporary) discontinuation of the study treatment, discomfort to the subject such as pain, or impairment of activities of daily life.

The safety analysis population consisted of randomized participants who took at least one dose of study treatment (639 in each treatment group).

Posted

Number

Events per 100 patient-years

Up to 2 days after the last dose

ID	Title	Description
OG000	Rivaroxaban (Xarelto, BAY59-7939)	Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
OG001	Warfarin	Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	RG1: Rivaroxaban Double-blind (DB) Period	Participants orally administered a rivaroxaban 15 mg tablet (a 10 mg tablet for participants with creatinine clearance of 30 to 49 mL/min, inclusive, at screening) and a warfarin placebo tablet once daily (OD) during the double-blind treatment period. Safety data collected start with the first dose of study drug up to 2 days after the last dose	151	639	474	639
EG001	RG2: Warfarin DB Period	Participants orally administered a warfarin potassium tablet and a rivaroxaban placebo tablet OD during the double-blind treatment period. Safety data collected start with the first dose of study drug up to 2 days after the last dose	155	639	470	639
EG002	RG3: Rivaroxaban Follow-up (FU) Period	Participants orally administered a rivaroxaban 15 mg tablet (a 10 mg tablet for participants with creatinine clearance of 30 to 49 mL/min, inclusive, at screening) and a warfarin placebo tablet once daily (OD) during the double-blind treatment period. Safety data collected from last dose plus 2 days to end of trial	50	628	73	628
EG003	RG4: Warfarin FU Period	Participants orally administered a warfarin potassium tablet and a rivaroxaban placebo tablet OD during the double-blind treatment period. Safety data collected from last dose plus 2 days to end of trial	37	630	61	630

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0013 events3 affected639 at risk EG0022 events2 affected628 at risk EG0030 events0 affected630 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected639 at risk EG0022 events2 affected628 at risk EG003
Hypoprothrombinaemia	Blood and lymphatic system disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected639 at risk EG0022 events2 affected628 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA (12.1)	Non-systematic Assessment	EG0002 events2 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0013 events2 affected639 at risk EG0020 events0 affected628 at risk EG003
Angina unstable	Cardiac disorders	MedDRA (12.1)	Non-systematic Assessment	EG0002 events2 affected639 at risk EG0010 events0 affected639 at risk EG0022 events2 affected628 at risk EG003
Aortic valve incompetence	Cardiac disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (12.1)	Non-systematic Assessment	EG0005 events4 affected639 at risk EG0012 events2 affected639 at risk EG0020 events0 affected628 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Atrioventricular block complete	Cardiac disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Bradycardia	Cardiac disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0021 events1 affected628 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA (12.1)	Non-systematic Assessment	EG00012 events12 affected639 at risk EG00118 events11 affected639 at risk EG0023 events3 affected628 at risk EG003
Cardiac failure acute	Cardiac disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0013 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Cardiac failure chronic	Cardiac disorders	MedDRA (12.1)	Non-systematic Assessment	EG0003 events3 affected639 at risk EG0013 events3 affected639 at risk EG0020 events0 affected628 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA (12.1)	Non-systematic Assessment	EG0002 events2 affected639 at risk EG0013 events3 affected639 at risk EG0021 events1 affected628 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0012 events2 affected639 at risk EG0021 events1 affected628 at risk EG003
Cor pulmonale	Cardiac disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected639 at risk EG0021 events1 affected628 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected639 at risk EG0021 events1 affected628 at risk EG003
Sick sinus syndrome	Cardiac disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0012 events2 affected639 at risk EG0020 events0 affected628 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA (12.1)	Non-systematic Assessment	EG0002 events2 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Auditory meatus external erosion	Ear and labyrinth disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Sudden hearing loss	Ear and labyrinth disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0012 events2 affected639 at risk EG0020 events0 affected628 at risk EG003
Cataract	Eye disorders	MedDRA (12.1)	Non-systematic Assessment	EG00010 events9 affected639 at risk EG0018 events7 affected639 at risk EG0020 events0 affected628 at risk EG003
Glaucoma	Eye disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Macular degeneration	Eye disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Retinal detachment	Eye disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Retinal haemorrhage	Eye disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Macular hole	Eye disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Anal polyp	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Colonic polyp	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0005 events5 affected639 at risk EG00112 events9 affected639 at risk EG0020 events0 affected628 at risk EG003
Dental caries	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0013 events3 affected639 at risk EG0020 events0 affected628 at risk EG003
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0012 events2 affected639 at risk EG0020 events0 affected628 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0002 events2 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0003 events3 affected639 at risk EG0012 events2 affected639 at risk EG0020 events0 affected628 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0014 events4 affected639 at risk EG0020 events0 affected628 at risk EG003
Gingival bleeding	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0014 events4 affected639 at risk EG0020 events0 affected628 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0012 events2 affected639 at risk EG0020 events0 affected628 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Large intestine perforation	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Mallory-Weiss syndrome	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0012 events1 affected639 at risk EG0021 events1 affected628 at risk EG003
Mouth haemorrhage	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Periodontal disease	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Periodontitis	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0014 events3 affected639 at risk EG0020 events0 affected628 at risk EG003
Peritonitis	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Rectal polyp	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Tooth loss	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Subileus	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Mechanical ileus	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Malaise	General disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0012 events2 affected639 at risk EG0020 events0 affected628 at risk EG003
Oedema	General disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Oedema peripheral	General disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Pyrexia	General disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Sudden death	General disorders	MedDRA (12.1)	Non-systematic Assessment	EG0004 events4 affected639 at risk EG0012 events2 affected639 at risk EG0023 events3 affected628 at risk EG003
Sudden cardiac death	General disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0021 events1 affected628 at risk EG003
Catheter site haemorrhage	General disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0012 events2 affected639 at risk EG0020 events0 affected628 at risk EG003
Cholangitis acute	Hepatobiliary disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0021 events1 affected628 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA (12.1)	Non-systematic Assessment	EG0002 events2 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Liver disorder	Hepatobiliary disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected639 at risk EG0021 events1 affected628 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Appendicitis	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Bronchitis	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Bronchopneumonia	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Cellulitis	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0002 events2 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Diverticulitis	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0003 events3 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Herpes zoster	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Liver abscess	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected639 at risk EG0021 events1 affected628 at risk EG003
Meningitis bacterial	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Otitis media	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Pneumonia	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG00015 events14 affected639 at risk EG00111 events10 affected639 at risk EG0023 events3 affected628 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Sepsis	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0012 events2 affected639 at risk EG0022 events2 affected628 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0002 events2 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Anal abscess	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Lung infection	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Enterocolitis viral	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Infective spondylitis	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0021 events1 affected628 at risk EG003
Accident	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Accidental exposure	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG0002 events2 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Fibula fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0012 events2 affected639 at risk EG0020 events0 affected628 at risk EG003
Patella fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG0006 events4 affected639 at risk EG0012 events2 affected639 at risk EG0020 events0 affected628 at risk EG003
Spinal cord injury	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Spinal cord injury cervical	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0021 events1 affected628 at risk EG003
Tendon rupture	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Therapeutic agent toxicity	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0012 events2 affected639 at risk EG0020 events0 affected628 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0012 events2 affected639 at risk EG0020 events0 affected628 at risk EG003
Ulna fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG0002 events2 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Brain contusion	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Ligament injury	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Skull fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Blood pressure decreased	Investigations	MedDRA (12.1)	Non-systematic Assessment	EG0002 events2 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Haemoglobin decreased	Investigations	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
International normalised ratio increased	Investigations	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected639 at risk EG0023 events3 affected628 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (12.1)	Non-systematic Assessment	EG0006 events4 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Chondrocalcinosis pyrophosphate	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected639 at risk EG0021 events1 affected628 at risk EG003
Compartment syndrome	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0002 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0012 events2 affected639 at risk EG0020 events0 affected628 at risk EG003
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0021 events1 affected628 at risk EG003
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Non-systematic Assessment	EG0002 events2 affected639 at risk EG0014 events4 affected639 at risk EG0022 events2 affected628 at risk EG003
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Malignant ascites	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0012 events2 affected639 at risk EG0020 events0 affected628 at risk EG003
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected639 at risk EG0021 events1 affected628 at risk EG003
Metastases to neck	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Nasal sinus cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected639 at risk EG0022 events2 affected628 at risk EG003
Small cell lung cancer stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Non-systematic Assessment	EG0002 events2 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0021 events1 affected628 at risk EG003
Large intestine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Non-systematic Assessment	EG0002 events2 affected639 at risk EG0011 events1 affected639 at risk EG0021 events1 affected628 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Non-systematic Assessment	EG0003 events3 affected639 at risk EG0010 events0 affected639 at risk EG0021 events1 affected628 at risk EG003
Brain stem haemorrhage	Nervous system disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0012 events2 affected639 at risk EG0020 events0 affected628 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0021 events1 affected628 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected639 at risk EG0021 events1 affected628 at risk EG003
Cholinergic syndrome	Nervous system disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Convulsion	Nervous system disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0014 events3 affected639 at risk EG0021 events1 affected628 at risk EG003
Dizziness	Nervous system disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Epilepsy	Nervous system disorders	MedDRA (12.1)	Non-systematic Assessment	EG0005 events4 affected639 at risk EG0011 events1 affected639 at risk EG0021 events1 affected628 at risk EG003
Facial palsy	Nervous system disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected639 at risk EG0021 events1 affected628 at risk EG003
Haemorrhagic cerebral infarction	Nervous system disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected639 at risk EG0022 events2 affected628 at risk EG003
Hemiplegia	Nervous system disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Hypertensive encephalopathy	Nervous system disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0021 events1 affected628 at risk EG003
Subarachnoid haemorrhage	Nervous system disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Syncope	Nervous system disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA (12.1)	Non-systematic Assessment	EG0002 events2 affected639 at risk EG0012 events2 affected639 at risk EG0021 events1 affected628 at risk EG003
Vertebral artery stenosis	Nervous system disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Carotid artery occlusion	Nervous system disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Thalamus haemorrhage	Nervous system disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Putamen haemorrhage	Nervous system disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA (12.1)	Non-systematic Assessment	EG0009 events9 affected639 at risk EG00118 events18 affected639 at risk EG00212 events10 affected628 at risk EG003
Postresuscitation encephalopathy	Nervous system disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Psychosomatic disease	Psychiatric disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Acute prerenal failure	Renal and urinary disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA (12.1)	Non-systematic Assessment	EG0002 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Renal artery stenosis	Renal and urinary disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Renal embolism	Renal and urinary disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Prostatitis	Reproductive system and breast disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0003 events3 affected639 at risk EG0015 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0002 events2 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected639 at risk EG0021 events1 affected628 at risk EG003
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0002 events2 affected639 at risk EG0013 events3 affected639 at risk EG0020 events0 affected628 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Status asthmaticus	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Bronchial haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected639 at risk EG0021 events1 affected628 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected639 at risk EG0021 events1 affected628 at risk EG003
Haemorrhage subcutaneous	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Aortic dissection	Vascular disorders	MedDRA (12.1)	Non-systematic Assessment	EG0002 events2 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Haematoma	Vascular disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected639 at risk EG0020 events0 affected628 at risk EG003
Shock haemorrhagic	Vascular disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected639 at risk EG0021 events1 affected628 at risk EG003
Peripheral embolism	Vascular disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected639 at risk EG0020 events0 affected628 at risk EG003
Arteriosclerosis obliterans	Vascular disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected639 at risk EG0012 events2 affected639 at risk EG0020 events0 affected628 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac failure	Cardiac disorders	MedDRA (12.1)	Non-systematic Assessment	EG00039 events36 affected639 at risk EG00135 events29 affected639 at risk EG0026 events5 affected628 at risk EG0032 events2 affected630 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA (12.1)	Non-systematic Assessment	EG00032 events26 affected639 at risk EG00157 events42 affected639 at risk EG0029 events9 affected628 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG00046 events38 affected639 at risk EG00140 events32 affected639 at risk EG00212 events12 affected628 at risk EG003
Dental caries	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG00032 events28 affected639 at risk EG00135 events34 affected639 at risk EG0021 events1 affected628 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG00071 events57 affected639 at risk EG00147 events40 affected639 at risk EG0023 events3 affected628 at risk EG003
Gingival bleeding	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG00072 events54 affected639 at risk EG00138 events31 affected639 at risk EG0021 events1 affected628 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG000378 events206 affected639 at risk EG001412 events232 affected639 at risk EG00216 events16 affected628 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG00082 events58 affected639 at risk EG00180 events56 affected639 at risk EG0024 events4 affected628 at risk EG003
Wound haemorrhage	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG00038 events33 affected639 at risk EG00131 events27 affected639 at risk EG0021 events1 affected628 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (12.1)	Non-systematic Assessment	EG00048 events43 affected639 at risk EG00134 events31 affected639 at risk EG0020 events0 affected628 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG00057 events50 affected639 at risk EG00160 events56 affected639 at risk EG0025 events5 affected628 at risk EG003
Headache	Nervous system disorders	MedDRA (12.1)	Non-systematic Assessment	EG00029 events24 affected639 at risk EG00143 events39 affected639 at risk EG0026 events6 affected628 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG000203 events102 affected639 at risk EG00186 events59 affected639 at risk EG0028 events6 affected628 at risk EG003
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG00076 events55 affected639 at risk EG001102 events74 affected639 at risk EG0023 events3 affected628 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG00050 events37 affected639 at risk EG00149 events43 affected639 at risk EG0022 events2 affected628 at risk EG003
Haemorrhage subcutaneous	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG000147 events67 affected639 at risk EG001175 events79 affected639 at risk EG0029 events9 affected628 at risk EG003
Hypertension	Vascular disorders	MedDRA (12.1)	Non-systematic Assessment	EG00025 events24 affected639 at risk EG00136 events32 affected639 at risk EG0023 events3 affected628 at risk EG003

Ancestor Terms

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D009025	Morpholines
D010078	Oxazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D015110	4-Hydroxycoumarins
D003374	Coumarins
D001578	Benzopyrans
D011714	Pyrans
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Facility	Status	City	State	ZIP	Country	Contacts
		Kasugai	Aichi-ken	487-0013	Japan

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