A Study of Abciximab and Reteplase When Administered Prio... | NCT00046228

Name	Class
Eli Lilly and Company	INDUSTRY

Label	Type	Description	Intervention Names
001	Experimental	Abciximab; reteplase; abciximab placebo; abciximab 0.25 mg/kg bolus; 1-2, 5 unit boluses; placebo bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h	Drug: abciximab placebo; reteplase placebo, abciximab, abciximab Drug: Abciximab; reteplase; abciximab placebo; abciximab
002	Experimental	abciximab; reteplase placebo; abciximab placebo; abciximab 0.25 mg/kg bolus; 1-2 placebo boluses; placebo bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h	Drug: Abciximab; reteplase; abciximab placebo; abciximab Drug: abciximab; reteplase placebo; abciximab placebo; abciximab
003	Experimental	abciximab placebo; reteplase placebo, abciximab, abciximab placebo bolus; 1-2 placebo bolus; 0.25 mg/kg bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h	Drug: abciximab; reteplase placebo; abciximab placebo; abciximab Drug: abciximab placebo; reteplase placebo, abciximab, abciximab

Name	Type	Description	Arm Group Labels	Other Names
abciximab placebo; reteplase placebo, abciximab, abciximab	Drug	placebo bolus; 1-2 placebo bolus; 0.25 mg/kg bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h	001

Measure	Description	Time Frame
The Composite of All-Cause Mortality or Complications of MI at 90 Days.	Occurs within 90 days and is composite of all-cause mortality or complications of myocardial infarction (MI) (rehospitalization or emergency department visit for congestive heart failure (CHF), cardiogenic shock, or resuscitated ventricular fibrillation occurring > 48 hours after randomization).	90 days

Measure	Description	Time Frame
Complications of MI as Defined in the Primary Outcome Measure Through 90 Days	The complications of myocardial infarction (MI) is defined as any event of rehospitalization or emergency department visit for CHF, cardiogenic shock, or resuscitated ventricular fibrillation occurring > 48 hours after randomization.	90 Days

Measure	Description	Time Frame
Subjects With Intracranial Hemorrhage (Including Hemorrhagic Transformation) Through Discharge/Day 7	All cases of cerebrovascular event were confirmed by a CEC (Clinical Endpoints Committee).	Discharge/Day 7
Subjects With Non Intracranial Thrombolysis In Myocardial Infarction (TIMI) Bleeding Events Through Discharge/Day 7

Name	Affiliation	Role
Centocor, Inc. Clinical Trial	Centocor, Inc.	Study Director

PubMed Identifier	Type	Citation	Retractions
15077099	Result	Ellis SG, Armstrong P, Betriu A, Brodie B, Herrmann H, Montalescot G, Neumann FJ, Smith JJ, Topol E; Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events Investigators. Facilitated percutaneous coronary intervention versus primary percutaneous coronary intervention: design and rationale of the Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events (FINESSE) trial. Am Heart J. 2004 Apr;147(4):E16. doi: 10.1016/j.ahj.2003.07.025.
18499565

Label	URL
A Study of Abciximab and Reteplase When Administered Prior to Catheterization After a Myocardial Infarction - Finesse	View source

ID	Title	Description
FG000	Primary PCI Group	Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
FG001	Abciximab Facilitated PCI Group	Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI

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

The Composite of All-Cause Mortality or Complications of MI at 90 Days.

Occurs within 90 days and is composite of all-cause mortality or complications of myocardial infarction (MI) (rehospitalization or emergency department visit for congestive heart failure (CHF), cardiogenic shock, or resuscitated ventricular fibrillation occurring > 48 hours after randomization).

Population is the intent-to-treat subjects. The intent-to-treat population is defined as all subjects randomly assigned to a treatment group and classified according to the randomization assignment.

Posted

Number

participants

90 days

ID	Title	Description
OG000	Primary PCI Group	Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
OG001	Abciximab Facilitated PCI Group	Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
OG002	Reteplase/Abciximab Facilitated PCI Group	Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI

Units	Counts
Participants	OG000806 OG001818 OG002828

Title

Denominators

Categories

Title	Measurements
	OG00086 OG00186 OG00281

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 OG002	The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the primary PCI in terms of the primary efficacy outcome. Assuming the relative risk reduction for the reteplase/abciximab facilitated PCI group versus the Primary PCI group is 15% in lower risk, 25% in medium risk, and 35% in high risk, the power of this comparison (1,000 subjects per group) is 83.4 %.	Log Rank	Independent Clinical Endpoints Committee confirmed components of primary endpoint except for death & resuscitated v fib assessed by the investigator)	0.551	The null hypothesis was tested at the significance level of 0.049. If it is significant, the significance level of null hypotheses tested in the analyses 2 and 3 will be adjusted according to the modified Hochberg approach.	Hazard Ratio (HR)	0.91				95	0.67	1.23

Secondary

Complications of MI as Defined in the Primary Outcome Measure Through 90 Days

The complications of myocardial infarction (MI) is defined as any event of rehospitalization or emergency department visit for CHF, cardiogenic shock, or resuscitated ventricular fibrillation occurring > 48 hours after randomization.

Population is the intent-to-treat subjects. The intent-to-treat population is defined as all subjects that have been randomly assigned to a treatment group and classified according to the randomization assignment.

Posted

Number

participants

90 Days

ID	Title	Description
OG000	Primary PCI Group	Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
OG001	Abciximab Facilitated PCI Group	Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
OG002	Reteplase/Abciximab Facilitated PCI Group	Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI

Secondary

All-Cause Mortality Through 90 Days

All cause mortality occurred through 90 days from randomization.

Population is the intent-to-treat subjects. The intent-to-treat population is defined as all randomized subjects classified according to the randomization assignment.

Posted

Number

participants

90 days

ID	Title	Description
OG000	Primary PCI Group	Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
OG001	Abciximab Facilitated PCI Group	Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
OG002	Reteplase/Abciximab Facilitated PCI Group	Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI

Units	Counts

Secondary

Subjects With ST-Segment Resolution > 70% From Baseline at 60 to 90 Minutes Following Randomization

Population is the intent-to-treat subjects who were selected for evaluation by electrocardiogram (ECG) core laboratory.Subjects, who were not evaluable for a 60-90 minute ECG, were considered not having a ST segment resolution.

Posted

Number

participants

60 to 90 minutes

ID	Title	Description
OG000	Primary PCI Group	Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
OG001	Abciximab Facilitated PCI Group	Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
OG002	Reteplase/Abciximab Facilitated PCI Group	Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI

Units	Counts

Secondary

All-Cause Mortality Through 1 Year

All-cause mortality through 1 year from randomization.

Population is the intent-to-treat subjects. The intent-to-treat population is defined as all randomized subjects classified according to the randomization assignment.

Posted

Number

participants

1 year

ID	Title	Description
OG000	Primary PCI Group	Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
OG001	Abciximab Facilitated PCI Group	Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
OG002	Reteplase/Abciximab Facilitated PCI Group	Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI

Units	Counts
Participants

Other Pre-specified

Subjects With Intracranial Hemorrhage (Including Hemorrhagic Transformation) Through Discharge/Day 7

All cases of cerebrovascular event were confirmed by a CEC (Clinical Endpoints Committee).

The population was defined as all subjects who were randomized and treated with any study agent, including those who discontinued for any reasons. Subjects randomized and treated was classified according to the study drug(s) received.

Posted

Number

participants

Discharge/Day 7

ID	Title	Description
OG000	Primary PCI Group	Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
OG001	Abciximab Facilitated PCI Group	Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
OG002	Reteplase/Abciximab Facilitated PCI Group	Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI

Other Pre-specified

Subjects With Non Intracranial Thrombolysis In Myocardial Infarction (TIMI) Bleeding Events Through Discharge/Day 7

Subjects with nonintracranial TIMI bleeding (either major or minor) through discharge/day 7, originating from vascular instrumentation sites, non-instrument related bleeding, as well as overall, were examined.

Posted

Number

participant

Discharge/Day 7

ID	Title	Description
OG000	Primary PCI Group	Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
OG001	Abciximab Facilitated PCI Group	Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
OG002	Reteplase/Abciximab Facilitated PCI Group	Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI

Other Pre-specified

Subjects With Severe Thrombocytopenia Through Discharge/Day 7

Severe thrombocytopenia is defined as platelet count < 50,000 cells/μL.

Posted

Number

participants

Discharge/Day 7

ID	Title	Description
OG000	Primary PCI Group	Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
OG001	Abciximab Facilitated PCI Group	Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
OG002	Reteplase/Abciximab Facilitated PCI Group	Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI

Other Pre-specified

Subjects With Any Investigator Reported Bleeding Events Through Discharge/Day 7

Posted

Number

participants

Discharge/Day 7

ID	Title	Description
OG000	Primary PCI Group	Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
OG001	Abciximab Facilitated PCI Group	Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
OG002	Reteplase/Abciximab Facilitated PCI Group	Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI

Units	Counts

Other Pre-specified

Subjects With Pre-Specified Complications of Index Myocardial Infarction Through Discharge/Day 7

Number of subjects with one or more of the following: 2nd or 3rd Degree AVB, Asystole, Sustained V Tach, A Fib/Flutter, EMD/Pulseless Electrical Activity, Heart Failure, Tamponade, Myocardial Rupture, Papillary Muscle Rupture, Ventricular Septal Defect, Pulmonary Embolism, Systemic Arterial Embolism and/or Pericarditis/Pericardial Effusion.

Population is the intent-to-treat subjects. The intent-to-treat population is defined as all randomized subjects classified according to the randomization assignment.

Posted

Number

participants

Discharge/Day 7

ID	Title	Description
OG000	Primary PCI Group	Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
OG001	Abciximab Facilitated PCI Group	Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
OG002	Reteplase/Abciximab Facilitated PCI Group	Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Coronary stenosis	Cardiac disorders	WHOART	Systematic Assessment	EG00023 affected795 at risk EG00138 affected805 at risk EG00227 affected814 at risk
Shock cardiogenic	Cardiac disorders	WHOART	Systematic Assessment	EG0004 affected795 at risk EG0019 affected805 at risk EG00213 affected814 at risk
Unstable angina	Cardiac disorders	WHOART	Systematic Assessment	EG0004 affected795 at risk EG0012 affected805 at risk EG0026 affected814 at risk
Myocardial infarction	Cardiac disorders	WHOART	Systematic Assessment	EG0006 affected795 at risk EG00110 affected805 at risk EG0025 affected814 at risk
Angina pectoris	Cardiac disorders	WHOART	Systematic Assessment	EG0002 affected795 at risk EG0013 affected805 at risk EG0024 affected814 at risk
Congestive heart failure	Cardiac disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0013 affected805 at risk EG0024 affected814 at risk
Myocardial ischemia	Cardiac disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0011 affected805 at risk EG0024 affected814 at risk
Cardiac failure	Cardiac disorders	WHOART	Systematic Assessment	EG0003 affected795 at risk EG0015 affected805 at risk EG0023 affected814 at risk
Acute myocardial infarction	Cardiac disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0013 affected805 at risk EG0022 affected814 at risk
Left ventricular dysfunction	Cardiac disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0022 affected814 at risk
Chronic congestive heart failure	Cardiac disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Heart disorder	Cardiac disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Myocardial rupture	Cardiac disorders	WHOART	Systematic Assessment	EG0002 affected795 at risk EG0012 affected805 at risk EG0021 affected814 at risk
Pericarditis	Cardiac disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0021 affected814 at risk
Spiral coronary artery dissection	Cardiac disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Stable angina pectoris	Cardiac disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Tricuspid insufficiency	Cardiac disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Anginal pain	Cardiac disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Aortic stenosis	Cardiac disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Coronary artery occlusion	Cardiac disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0012 affected805 at risk EG0020 affected814 at risk
Coronary artery perforation	Cardiac disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0012 affected805 at risk EG0020 affected814 at risk
Coronary in-stent restenosis	Cardiac disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Coronary restenosis	Cardiac disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Endocarditis	Cardiac disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Left ventricular ejection fraction decreased	Cardiac disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Mitral insufficiency	Cardiac disorders	WHOART	Systematic Assessment	EG0002 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Mitral regurgitation	Cardiac disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Pericardial effusion	Cardiac disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0012 affected805 at risk EG0020 affected814 at risk
Ventricular septal defect	Cardiac disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Fibrillation ventricular	Cardiac disorders	WHOART	Systematic Assessment	EG00026 affected795 at risk EG00121 affected805 at risk EG00216 affected814 at risk
Cardiac arrest	Cardiac disorders	WHOART	Systematic Assessment	EG0005 affected795 at risk EG0012 affected805 at risk EG0023 affected814 at risk
Tachycardia ventricular	Cardiac disorders	WHOART	Systematic Assessment	EG0002 affected795 at risk EG0015 affected805 at risk EG0022 affected814 at risk
AV block complete	Cardiac disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
AV block third degree	Cardiac disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0011 affected805 at risk EG0021 affected814 at risk
Junctional bradycardia	Cardiac disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Nonsustained ventricular tachycardia	Cardiac disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Sinus bradycardia	Cardiac disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0021 affected814 at risk
Arrhythmia supraventricular	Cardiac disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Arrhythmia ventricular	Cardiac disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Asystolia	Cardiac disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Atrial fibrillation	Cardiac disorders	WHOART	Systematic Assessment	EG0004 affected795 at risk EG0012 affected805 at risk EG0020 affected814 at risk
Atrial fibrillation paroxysmal	Cardiac disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Atrial flutter	Cardiac disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
AV block second degree	Cardiac disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Bradycardia	Cardiac disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Cardiac arrhythmia nos	Cardiac disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Cardiac rhythm disturbance	Cardiac disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Cardiopulmonary arrest	Cardiac disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Electromechanical dissociation	Cardiac disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Intraventricular conduction defect	Cardiac disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Tachycardia atrial paroxysmal	Cardiac disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Ventricular bigeminy	Cardiac disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Ventricular febrillation paroxysm	Cardiac disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Pneumonia	Respiratory, thoracic and mediastinal disorders	WHOART	Systematic Assessment	EG0007 affected795 at risk EG0018 affected805 at risk EG0027 affected814 at risk
Bronchopneumonia	Respiratory, thoracic and mediastinal disorders	WHOART	Systematic Assessment	EG0002 affected795 at risk EG0012 affected805 at risk EG0023 affected814 at risk
Pulmonary edema	Respiratory, thoracic and mediastinal disorders	WHOART	Systematic Assessment	EG0003 affected795 at risk EG0014 affected805 at risk EG0023 affected814 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0012 affected805 at risk EG0022 affected814 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0013 affected805 at risk EG0022 affected814 at risk
Aspiration pneumonia	Respiratory, thoracic and mediastinal disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Breathing difficult	Respiratory, thoracic and mediastinal disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Bronchitis	Respiratory, thoracic and mediastinal disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0021 affected814 at risk
Coughing	Respiratory, thoracic and mediastinal disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0021 affected814 at risk
Pleuritis	Respiratory, thoracic and mediastinal disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Repiratory tract infection	Respiratory, thoracic and mediastinal disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Respiratory tract lesion	Respiratory, thoracic and mediastinal disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Adult respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Breathlessness	Respiratory, thoracic and mediastinal disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	WHOART	Systematic Assessment	EG0002 affected795 at risk EG0012 affected805 at risk EG0020 affected814 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Lower respiratory tract infection	Respiratory, thoracic and mediastinal disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0012 affected805 at risk EG0020 affected814 at risk
Pleural exudate	Respiratory, thoracic and mediastinal disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Pneumonia interstitial	Respiratory, thoracic and mediastinal disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Atherosclerosis	Cardiac disorders	WHOART	Systematic Assessment	EG00014 affected795 at risk EG0014 affected805 at risk EG00214 affected814 at risk
Hypotension	Cardiac disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0022 affected814 at risk
Syncope	Cardiac disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0012 affected805 at risk EG0022 affected814 at risk
Blood pressure high	Cardiac disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Hypertension	Cardiac disorders	WHOART	Systematic Assessment	EG0002 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Transient hypotension	Cardiac disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Collapse	Cardiac disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Hypertension arterial	Cardiac disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Hypovolemic shock	Cardiac disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Septic shock	Cardiac disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Shock	Cardiac disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Chest pain	General disorders	WHOART	Systematic Assessment	EG00010 affected795 at risk EG00119 affected805 at risk EG00212 affected814 at risk
Death	General disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0012 affected805 at risk EG0021 affected814 at risk
Non-anginal pain	General disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Non-ischemic chest pain	General disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0021 affected814 at risk
Allergic reaction	General disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Allergic reaction to diagnostic agent	General disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Incarcerated abdonimal hernia	General disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Inguinal hernia	General disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Interstitial fluid increased	General disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Intolerance induced	General disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Malaise	General disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Musculoskeletal pain	General disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Nontoxic drug overdose	General disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Pain	General disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Abdominal pain	Gastrointestinal disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Diarrhea	Gastrointestinal disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0011 affected805 at risk EG0021 affected814 at risk
Diverticulitis	Gastrointestinal disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0021 affected814 at risk
Dysphagia	Gastrointestinal disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Esophageal reflux	Gastrointestinal disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Gastritis	Gastrointestinal disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Ileus	Gastrointestinal disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Intestinal Polyp	Gastrointestinal disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Nontropical sprue	Gastrointestinal disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Pancreatitis acute	Gastrointestinal disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Preploric ulcer	Gastrointestinal disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Digestion impaired	Gastrointestinal disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Duodenal ulcer	Gastrointestinal disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Epigastric pain	Gastrointestinal disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Esophagitis	Gastrointestinal disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Gastric ulcer	Gastrointestinal disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Gastroesophageal reflux disease	Gastrointestinal disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Intestinal obstruction	Gastrointestinal disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Irritable bowel syndrome	Gastrointestinal disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Stomach pain	Gastrointestinal disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Stomach upset	Gastrointestinal disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Acute renal failure	Renal and urinary disorders	WHOART	Systematic Assessment	EG0002 affected795 at risk EG0011 affected805 at risk EG0024 affected814 at risk
Urinary tract infection	Renal and urinary disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0012 affected805 at risk EG0022 affected814 at risk
Chronic renal failure	Renal and urinary disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Creatinine increased	Renal and urinary disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Renal function decreased	Renal and urinary disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Urethral disorder nos	Renal and urinary disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Urinary retention	Renal and urinary disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Acute renal insufficiency	Renal and urinary disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Bladder stricture	Renal and urinary disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Nephritis	Renal and urinary disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Pyelonephritis	Renal and urinary disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Renal failure	Renal and urinary disorders	WHOART	Systematic Assessment	EG0003 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Renal insufficiency	Renal and urinary disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0012 affected805 at risk EG0020 affected814 at risk
Hemorrhagic stroke	Vascular disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0022 affected814 at risk
Gastric hemorrhage	Vascular disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
GI hemorrhage	Vascular disorders	WHOART	Systematic Assessment	EG0002 affected795 at risk EG0011 affected805 at risk EG0021 affected814 at risk
GI hemorrhage - upper	Vascular disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Hematoma	Vascular disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0011 affected805 at risk EG0021 affected814 at risk
Hemoptysis	Vascular disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Hemorrhage nos	Vascular disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0021 affected814 at risk
Hematemesis	Vascular disorders	WHOART	Systematic Assessment	EG0002 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Hemorrhage rectum	Vascular disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Pulmonary hemorrhage	Vascular disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Puncture site hematoma	Vascular disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Retroperitoneal hemorrhage (type unknown)	Vascular disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Vomiting blood	Vascular disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Stroke	Vascular disorders	WHOART	Systematic Assessment	EG0003 affected795 at risk EG0012 affected805 at risk EG0023 affected814 at risk
Claudication intermittent	Vascular disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0022 affected814 at risk
Arterial stenosis	Vascular disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Pseudoaneurysm	Vascular disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0021 affected814 at risk
Vasculitis	Vascular disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Cerebral infarction	Vascular disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Cerebrovascular accident	Vascular disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0013 affected805 at risk EG0020 affected814 at risk
Claudication	Vascular disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Extracardiact arterial aneurysm	Vascular disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Peripheral ischemia	Vascular disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Phlebitis	Vascular disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Transient ischemic attack	Vascular disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Pulmonary cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Pulmonary carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Rectal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Adenocarcinoma nos	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Ovarian cyst malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Thrombosis coronary artery	Vascular disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0022 affected814 at risk
Thrombosis cardiac chamber	Vascular disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Atheroembolism limb	Vascular disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Embolism pulmonary	Vascular disorders	WHOART	Systematic Assessment	EG0002 affected795 at risk EG0013 affected805 at risk EG0020 affected814 at risk
Thrombophlebitis	Vascular disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Thrombosis venous deep	Vascular disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Thrombosis	Vascular disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Venous thrombosis leg	Vascular disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Aseptic necrosis bone	Musculoskeletal and connective tissue disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Bone fracture	Musculoskeletal and connective tissue disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0021 affected814 at risk
Myalgia	Musculoskeletal and connective tissue disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Skeletal pain	Musculoskeletal and connective tissue disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Arthritis	Musculoskeletal and connective tissue disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Synovitis	Musculoskeletal and connective tissue disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Hypercholesterolemia	Metabolism and nutrition disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0022 affected814 at risk
Adult onset diabetes mellitus	Metabolism and nutrition disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Dehydration	Metabolism and nutrition disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Diabetes mellitus	Metabolism and nutrition disorders	WHOART	Systematic Assessment	EG0002 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Hyponatremia	Metabolism and nutrition disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0012 affected805 at risk EG0020 affected814 at risk
Cellulitis	Infections and infestations	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Fever	Infections and infestations	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Infection bacterial	Infections and infestations	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Influenza	Infections and infestations	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Urosepsis	Infections and infestations	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0012 affected805 at risk EG0020 affected814 at risk
Wound healing impaired	Infections and infestations	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Wound infection	Infections and infestations	WHOART	Systematic Assessment	EG0002 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Epilepsy grand mal	Nervous system disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Pre-syncope	Nervous system disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0021 affected814 at risk
Carpal tunnel syndrome	Nervous system disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Coma	Nervous system disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0012 affected805 at risk EG0020 affected814 at risk
Dizziness	Nervous system disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Cholecystitis	Hepatobiliary disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0021 affected814 at risk
Gall bladder distention	Hepatobiliary disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Hepatobiliary dysfunction	Hepatobiliary disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Jaundice	Hepatobiliary disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Vasovagal reaction	Nervous system disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Thrombocytopenia	Blood and lymphatic system disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0013 affected805 at risk EG0021 affected814 at risk
Hemoglobin decreased	Blood and lymphatic system disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Anemia	Blood and lymphatic system disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0013 affected805 at risk EG0020 affected814 at risk
Anemia microcytic	Blood and lymphatic system disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Eruption	Skin and subcutaneous tissue disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Hyperthyroidism	Endocrine disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Anxiety	Psychiatric disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Delirium tremens	Psychiatric disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Leukopenia	Blood and lymphatic system disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Coronary artery dissection	Cardiac disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0021 affected814 at risk
Ventricular aneurysm	Cardiac disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0010 affected805 at risk EG0021 affected814 at risk
Cardiac tamponade	Cardiac disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0012 affected805 at risk EG0020 affected814 at risk
Breath shortness	Respiratory, thoracic and mediastinal disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0022 affected814 at risk
Left ventricular thrombus	Vascular disorders	WHOART	Systematic Assessment	EG0002 affected795 at risk EG0012 affected805 at risk EG0022 affected814 at risk
Phlebothrombosis	Vascular disorders	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk
Sepsis	Infections and infestations	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0012 affected805 at risk EG0021 affected814 at risk
Anemia iron deficiency	Blood and lymphatic system disorders	WHOART	Systematic Assessment	EG0000 affected795 at risk EG0011 affected805 at risk EG0020 affected814 at risk
Renal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	WHOART	Systematic Assessment	EG0001 affected795 at risk EG0010 affected805 at risk EG0020 affected814 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Phoenix	Arizona		United States

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases
D007238	Infarction
D007511	Ischemia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009336	Necrosis

ID	Term
D007140	Immunoglobulin Fab Fragments
D007128	Immunoglobulin Fragments
D010446	Peptide Fragments
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Title	Description
BG000	Primary PCI Group	Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
BG001	Abciximab Facilitated PCI Group	Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
BG002	Reteplase/Abciximab Facilitated PCI Group	Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (At Risk)
EG000	Primary PCI Group	Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)	159	795	795
EG001	Abciximab Facilitated PCI Group	Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI	182	805	805
EG002	Reteplase/Abciximab Facilitated PCI Group	Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI	175	814	814

ID	Type	Description	Link
FINESSE
CR005410