A 30 Day Study to Evaluate Efficacy and Safety of Pre-hos... | NCT01347580

NCT01347580

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
Ticagrelor	Experimental	Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.	Drug: Ticagrelor
Placebo	Experimental	Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Ticagrelor	Drug	Oral Ticagrelor loading dose (180 mg) followed by matching placebo	Ticagrelor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3 of MI Culprit Vessel at Initial Angiography (Co-primary Endpoint)	(TIMI) flow grade classification is used to assess coronary blood flow in acute coronary syndromes. grade 0:no reperfusion, grade 1: penetration without perfusion, grade 2: Partial reperfusion, grade 3: complete perfusion.	At initial angiography, pre PCI
ST-segment Elevation Resolution Pre PCI ≥70% (Co-primary Endpoint)	ST segment elevation resolution is the mean ST elevation pre-hospital minus the mean STelevation pre-PCI divided by the mean ST elevation pre-hospital. It is expressed as a percentage and split in 2 categories , complete (≥70%) versus incomplete (<70%) resolution.	Between baseline and PCI

Secondary Outcomes

Measure	Description	Time Frame
1st Composite Clinical Endpoint	death/MI/stroke/urgent revascularization/stent thrombosis. Adjudicated events except death	during the 30 days of treatment
2nd Composite Clinical Endpoint	Death/MI/urgent revascularization. Adjudicated events except death

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Dr Judith Hsia, MD	AstraZeneca	Study Director
Pr Gilles Montalescot	Pitie Salpetriere Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Algiers			Algeria
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25175921	Result	Montalescot G, van 't Hof AW, Lapostolle F, Silvain J, Lassen JF, Bolognese L, Cantor WJ, Cequier A, Chettibi M, Goodman SG, Hammett CJ, Huber K, Janzon M, Merkely B, Storey RF, Zeymer U, Stibbe O, Ecollan P, Heutz WM, Swahn E, Collet JP, Willems FF, Baradat C, Licour M, Tsatsaris A, Vicaut E, Hamm CW; ATLANTIC Investigators. Prehospital ticagrelor in ST-segment elevation myocardial infarction. N Engl J Med. 2014 Sep 11;371(11):1016-27. doi: 10.1056/NEJMoa1407024. Epub 2014 Sep 1.
30353444

Label	URL
D5130L00006\_Protocol	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Pre-hospital Ticagrelor	Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
FG001	In-hospital Ticagrelor

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Pre-hospital Ticagrelor	Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
BG001	In-hospital Ticagrelor	Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
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

Years

Title	Measurements
	BG00060.6± 12.38 BG00161.0± 12.49 BG00260.8± 12.43

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000173 BG001196 BG002

Diabetes mellitus

Number

patients

Title

Denominators

Categories

yes

Title	Measurements
	BG000115 BG001138 BG002

TIMI risk score

Thrombolysis in Myocardial Infarction (TIMI) is a scoring system based on independant predictors of mortality such as age, diabetes mellitus, history of hypertension, history of angina, ST segment elevation. The death rate at 30 days for the following scores are: 0-2: 0.8%-2.2%, 3-6: 4.4% -16.1%, score>6: 23.4% to 35.9%.

Number

patients

Title

Denominators

Categories

0-2

Title	Measurements
	BG000552 BG001

Killip class

Killip class assesses the presence and severity of heart failure by physical examination. Class I :No rales, no 3rd heart sound. Class 2: Rales in <1⁄2 lung field or presence of a 3rd heart sound. Class 3: Rales in >1⁄2 lung field-pulmonary edema.Class 4 : Cardiogenic shock-determined clinically.

Number

patients

Title

Denominators

Categories

Title	Measurements
	BG000819 BG001

First medical contact

Number

patients

Title

Denominators

Categories

in ambulance

Title	Measurements
	BG000689 BG001723 BG002

PCI

Percutaneous coronary intervention (PCI) is a non-surgery intervention performed to open blocked coronary arteries and to restore arterial blood flow to the heart tissue.

Number

Patients

Title

Denominators

Categories

yes

Title	Measurements
	BG000800 BG001830

type of PCI

on patients with PCI

Number

patients

Title

Denominators

Categories

with stent

Title	Measurements
	BG000760 BG001776 BG002

Time between the 2 loading doses

Median

Inter-Quartile Range

minutes

Title

Denominators

Categories

Title	Measurements
	BG00032(22 to 45) BG00130(22 to 43) 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

Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3 of MI Culprit Vessel at Initial Angiography (Co-primary Endpoint)

(TIMI) flow grade classification is used to assess coronary blood flow in acute coronary syndromes. grade 0:no reperfusion, grade 1: penetration without perfusion, grade 2: Partial reperfusion, grade 3: complete perfusion.

mITT, on patients with non missing values

Posted

Number

patients

At initial angiography, pre PCI

ID	Title	Description
OG000	Pre-hospital Ticagrelor	Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
OG001	In-hospital Ticagrelor	Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.

Units	Counts
Participants	OG000824 OG001856

Title

Denominators

Categories

Title	Measurements
	OG000143 OG001145

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, Logistic		0.8214	pvalue at 0.025 , adjusted for multiple comparisons	Odds Ratio (OR)	1.030			2-Sided	95	0.799	1.327				No	Superiority or Other

Primary

ST-segment Elevation Resolution Pre PCI ≥70% (Co-primary Endpoint)

ST segment elevation resolution is the mean ST elevation pre-hospital minus the mean STelevation pre-PCI divided by the mean ST elevation pre-hospital. It is expressed as a percentage and split in 2 categories , complete (≥70%) versus incomplete (<70%) resolution.

mITT, on patients with non missing values

Posted

Number

patients

Between baseline and PCI

ID	Title	Description
OG000	Pre-hospital Ticagrelor	Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
OG001	In-hospital Ticagrelor	Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.

Units	Counts
Participants	OG000

Secondary

1st Composite Clinical Endpoint

death/MI/stroke/urgent revascularization/stent thrombosis. Adjudicated events except death

mITT

Posted

Number

patients

during the 30 days of treatment

ID	Title	Description
OG000	Pre-hospital Ticagrelor	Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
OG001	In-hospital Ticagrelor	Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.

Units	Counts
Participants	OG000

Secondary

2nd Composite Clinical Endpoint

Death/MI/urgent revascularization. Adjudicated events except death

mITT

Posted

Number

patients

within 30 days of study

ID	Title	Description
OG000	Pre-hospital Ticagrelor	Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
OG001	In-hospital Ticagrelor	Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.

Units	Counts
Participants	OG000

Secondary

Definite Stent Thrombosis

Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. It is an adjudicated endpoint

mITT

Posted

Number

patients

during 30 days of treatment

ID	Title	Description
OG000	Pre-hospital Ticagrelor	Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
OG001	In-hospital Ticagrelor	Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.

Units	Counts
Participants	OG000

Secondary

TIMI Flow Grade 3 Post -PCI

TIMI) flow grade 3 is complete perfusion post-PCI.

mITT, on patients with non missing TIMI flow grade values

Posted

Number

patients

at coroangiography post-PCI

ID	Title	Description
OG000	Pre-hospital Ticagrelor	Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
OG001	In-hospital Ticagrelor	Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.

Units	Counts
Participants	OG000

Secondary

ST Segment Elevation Resolution Post-PCI >= 70%

ST segment elevation resolution post PCI >=70% is defined as complete resolution

mITT on patients with non missing ECG values

Posted

Number

patients

Between baseline and ECG 60 mn post-PCI

ID	Title	Description
OG000	Pre-hospital Ticagrelor	Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
OG001	In-hospital Ticagrelor	Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.

Units	Counts
Participants	OG000

Secondary

Thrombotic Bail-out With GPIIb/IIIa Inhibitors at Initial PCI

Glycoprotein (GP) IIb/IIIa inhibitors are often used as a rescue or bailout therapy to manage complications arising during percutaneous coronary intervention.

mITT

Posted

Number

patients

during PCI

ID	Title	Description
OG000	Pre-hospital Ticagrelor	Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
OG001	In-hospital Ticagrelor	Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.

Units	Counts
Participants	OG000

Secondary

Major Bleeds Within 48 Hours

non CABG related bleeds, (PLATO definition) include Life threatening and other major bleeds

Safety

Posted

Number

patients

within 48 hours of first dose

ID	Title	Description
OG000	Pre-hospital Ticagrelor	Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
OG001	In-hospital Ticagrelor	Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.

Units	Counts
Participants	OG000

Secondary

Minor and Major Bleedings Within 48 Hours

non CABG related bleeds (PLATO definition)

Safety

Posted

Number

patients

within 48 hours of first dose

ID	Title	Description
OG000	Pre-hospital Ticagrelor	Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
OG001	In-hospital Ticagrelor	Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.

Units	Counts
Participants	OG000

Secondary

Major Bleeds After 48 Hours

non CABG related bleeds (PLATO definition) include life threatening and other major bleedings

safety

Posted

Number

patients

after 48hours post-first dose

ID	Title	Description
OG000	Pre-hospital Ticagrelor	Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
OG001	In-hospital Ticagrelor	Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.

Units	Counts
Participants	OG000

Secondary

Minor and Major Bleeds After 48 Hours

non CABG related bleeds (PLATO definition)

safety

Posted

Number

patients

after 48 hours post first dose

ID	Title	Description
OG000	Pre-hospital Ticagrelor	Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
OG001	In-hospital Ticagrelor	Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Ticagrelor In-Hosp	Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.			143	950	529	950
EG001	Ticagrelor Pre-Hosp	Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.			140	908	469	908

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected950 at risk EG0011 events1 affected908 at risk
LEUKOCYTOSIS	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0011 events1 affected908 at risk
ANGINA PECTORIS	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected950 at risk EG0013 events3 affected908 at risk
ANGINA UNSTABLE	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0011 events1 affected908 at risk
AORTIC VALVE INCOMPETENCE	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
ARRHYTHMIA	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0011 events1 affected908 at risk
ARTERIOSPASM CORONARY	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected950 at risk EG0010 events0 affected908 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected950 at risk EG0014 events4 affected908 at risk
ATRIOVENTRICULAR BLOCK COMPLETE	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected950 at risk EG0011 events1 affected908 at risk
BRADYCARDIA	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected950 at risk EG0011 events1 affected908 at risk
CARDIAC ARREST	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0007 events7 affected950 at risk EG00111 events11 affected908 at risk
CARDIAC ASTHMA	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
CARDIAC FAILURE	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0007 events7 affected950 at risk EG0017 events7 affected908 at risk
CARDIAC FAILURE ACUTE	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0012 events2 affected908 at risk
CARDIAC TAMPONADE	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
CARDIOGENIC SHOCK	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG00016 events16 affected950 at risk EG00117 events17 affected908 at risk
CARDIOPULMONARY FAILURE	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
CONGESTIVE CARDIOMYOPATHY	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
CORONARY ARTERY OCCLUSION	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
DRESSLER'S SYNDROME	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0012 events2 affected908 at risk
INTERVENTRICULAR SEPTUM RUPTURE	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
INTRACARDIAC THROMBUS	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0004 events4 affected950 at risk EG0012 events2 affected908 at risk
LEFT VENTRICULAR DYSFUNCTION	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
LEFT VENTRICULAR FAILURE	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0012 events2 affected908 at risk
MYOCARDIAL RUPTURE	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0011 events1 affected908 at risk
PALPITATIONS	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected950 at risk EG0010 events0 affected908 at risk
PERICARDIAL EFFUSION	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0004 events4 affected950 at risk EG0010 events0 affected908 at risk
PERICARDITIS	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
TORSADE DE POINTES	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
VENTRICLE RUPTURE	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0011 events1 affected908 at risk
VENTRICULAR EXTRASYSTOLES	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
VENTRICULAR FIBRILLATION	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG00030 events30 affected950 at risk EG00123 events23 affected908 at risk
VENTRICULAR SEPTAL DEFECT ACQUIRED	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
VENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0007 events7 affected950 at risk EG0016 events6 affected908 at risk
VENTRICULAR SEPTAL DEFECT	Congenital, familial and genetic disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
VERTIGO	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
COLITIS	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
COLITIS ISCHAEMIC	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0011 events1 affected908 at risk
GASTRIC ULCER	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
GASTRIC ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
GASTRITIS	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0012 events2 affected908 at risk
GASTROINTESTINAL TELANGIECTASIA	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
HAEMATEMESIS	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
HAEMATOCHEZIA	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
INTESTINAL ISCHAEMIA	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
MELAENA	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0011 events1 affected908 at risk
RECTAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
RETROPERITONEAL HAEMATOMA	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0012 events2 affected908 at risk
ASTHENIA	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
CARDIAC DEATH	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
CHEST PAIN	General disorders	MedDRA 16.1	Systematic Assessment	EG0004 events4 affected950 at risk EG0011 events1 affected908 at risk
DEVICE MALFUNCTION	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
MULTI-ORGAN FAILURE	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0012 events2 affected908 at risk
NON-CARDIAC CHEST PAIN	General disorders	MedDRA 16.1	Systematic Assessment	EG0005 events5 affected950 at risk EG0014 events4 affected908 at risk
SUDDEN CARDIAC DEATH	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
SUDDEN DEATH	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0012 events2 affected908 at risk
THROMBOSIS IN DEVICE	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
VESSEL PUNCTURE SITE HAEMATOMA	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
BILIARY COLIC	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
CHOLECYSTITIS ACUTE	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0012 events2 affected908 at risk
BILIARY SEPSIS	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
BRONCHITIS	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
GASTROENTERITIS VIRAL	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
GROIN INFECTION	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
LUNG INFECTION	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
PNEUMONIA	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0012 events2 affected908 at risk
RELAPSING FEVER	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
SEPSIS	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
SEPTIC SHOCK	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
SKIN INFECTION	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
UROSEPSIS	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
FEMORAL NECK FRACTURE	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
POST PROCEDURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0011 events1 affected908 at risk
POST PROCEDURAL HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected950 at risk EG0011 events1 affected908 at risk
PROCEDURAL HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0013 events3 affected908 at risk
SUBDURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
TRAUMATIC HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
UPPER LIMB FRACTURE	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
VASCULAR PSEUDOANEURYSM	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
HAEMOGLOBIN DECREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
HEPATIC ENZYME INCREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
NUTRITIONAL CONDITION ABNORMAL	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
PLATELET COUNT DECREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
TROPONIN INCREASED	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0012 events2 affected908 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
MUSCULOSKELETAL CHEST PAIN	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
PAIN IN JAW	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
PATHOLOGICAL FRACTURE	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
ADRENAL ADENOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
BLADDER NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
CARDIAC MYXOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
EXTRANODAL MARGINAL ZONE B-CELL LYMPHOMA (MALT TYPE)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
RECTAL NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
RENAL CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
CEREBRAL HAEMORRHAGE	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected950 at risk EG0010 events0 affected908 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
DIZZINESS	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
DYSARTHRIA	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
HAEMORRHAGE INTRACRANIAL	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
HEMIPARESIS	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
LACUNAR INFARCTION	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
PRESYNCOPE	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
SYNCOPE	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected950 at risk EG0011 events1 affected908 at risk
ANXIETY	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
CONFUSIONAL STATE	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
SUICIDE ATTEMPT	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
HAEMATURIA	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
RENAL COLIC	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
RENAL FAILURE	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected950 at risk EG0012 events2 affected908 at risk
RENAL FAILURE ACUTE	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0012 events2 affected908 at risk
ACUTE PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0003 events3 affected950 at risk EG0013 events3 affected908 at risk
ACUTE RESPIRATORY DISTRESS SYNDROME	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
ATELECTASIS	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
DIAPHRAGMATIC PARALYSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0012 events2 affected908 at risk
HAEMOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected950 at risk EG0010 events0 affected908 at risk
LUNG DISORDER	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0011 events1 affected908 at risk
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0014 events4 affected908 at risk
RESPIRATORY DISTRESS	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
RASH PRURITIC	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
AORTIC DISSECTION	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0012 events2 affected908 at risk
ARTERY DISSECTION	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0002 events2 affected950 at risk EG0010 events0 affected908 at risk
HAEMATOMA	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
HAEMODYNAMIC INSTABILITY	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
HYPERTENSION	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk
HYPOTENSION	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0011 events1 affected908 at risk
ORTHOSTATIC HYPOTENSION	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0001 events1 affected950 at risk EG0010 events0 affected908 at risk
THROMBOPHLEBITIS	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0000 events0 affected950 at risk EG0011 events1 affected908 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Ventricular tachycardia	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG00081 affected950 at risk EG00179 affected908 at risk
Dyspnoea	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00086 affected950 at risk EG00162 affected908 at risk
Nausea	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00049 affected950 at risk EG00141 affected908 at risk
Non cardiac chest pain	General disorders	MedDRA 16.1	Systematic Assessment	EG00052 affected950 at risk EG00142 affected908 at risk
Hypotension	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG00030 affected950 at risk EG00144 affected908 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG00026 affected950 at risk EG00128 affected908 at risk
Headache	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG00031 affected950 at risk EG00119 affected908 at risk
Vomiting	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00040 affected950 at risk EG00134 affected908 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG00038 affected950 at risk EG00130 affected908 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG00037 affected950 at risk EG00132 affected908 at risk
Cardiac failure	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG00033 affected950 at risk EG00130 affected908 at risk
Bradycardia	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG00026 affected950 at risk EG00128 affected908 at risk

ID	Term
D009203	Myocardial Infarction
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D020521	Stroke

ID	Term
D017202	Myocardial Ischemia
D014652	Vascular Diseases
D007238	Infarction
D007511	Ischemia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009336	Necrosis
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D000241	Adenosine
D011684	Purine Nucleosides
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D012263	Ribonucleosides