Red Cell Storage Duration Study | NCT00991341

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Label	Type	Description	Intervention Names
Shorter-storage red blood cell units	Active Comparator	Red blood cell units stored <= 10 days	Biological: Red blood cell units stored <= 10 days
Longer-storage red blood cell units	Active Comparator	Red blood cell units stored >= 21 days	Biological: Red blood cell units stored >= 21 days

Name	Type	Description	Arm Group Labels	Other Names
Red blood cell units stored <= 10 days	Biological	Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.

Measure	Description	Time Frame
The Change in the Composite Multiple Organ Dysfunction Score (MODS) From the Pre-operative Baseline. The Worst Post-operative Values of Each Component of MODS Will be Used to Calculate the Change in MODS.	The follow-up MODS used to calculate 7-day ΔMODS from pre-op baseline was based on the worst value of each component of MODS observed through post-op day 7, hospital discharge, or death, whichever occurred first, even if a subject's worst values for different components occurred on different dates. Subjects who died during this time period were assigned the worst possible follow-up MODS score, 24 points, and each component of MODS was set at 4, which is the worst score. If a subject did not die during this time period but had at least one day where the Glasgow Coma Score couldn't be scored [subject sedated; neurologic function not normal by pre-op history (prior stroke, tumor or trauma sequelae, cognitively challenged, behavioral disorder, etc.) or intra-op history, but currently unable to assess because of sedation], then a post-op MODS score was set to missing and a 7-day ΔMODS was not computed. The total MODS score ranges from 0 (best possible) to 24 points (worst possible).	Through post-operative day 7, hospital discharge, or death, whichever occurs first

Measure	Description	Time Frame
All-cause Mortality	Subjects were randomized for RECESS no earlier than one calendar day before the planned date of surgery, and were followed for all-cause mortality until post-operative Day 28, death, or study withdrawal, whichever occurred first. In some cases the surgery was postponed after randomization had already occurred. If surgery did not occur within 30 days after randomization, the subject ended the study and was not considered evaluable. If surgery did occur within 30 days after randomization, and the subject received at least one RBC transfusion between randomization and 96 hours after the end of surgery, the subject was considered evaluable. Therefore, in a few evaluable subjects, post-operative Day 28 could be nearly two months after the date of randomization. The times in the time-to-event analysis started at randomization.

Name	Affiliation	Role
Susan F Assmann, PhD	Carelon Research	Principal Investigator
Steven Sloan, MD	Boston Children's Hospital	Principal Investigator
Thomas Ortel, MD	Duke University	Principal Investigator
Cassandra Josephson, MD	Emory University	Principal Investigator
Christopher Stowell, MD	Massachusetts General Hospital	Principal Investigator
Meghan Delaney, DO	University of Washington/Fred Hutchinson Cancer Research Center	Principal Investigator
Marie Steiner, MD	University of Minnesota Medical Center Fairview	Principal Investigator
Darrell Triulzi, MD	University of Pittsburgh Presbyterian and Shadyside	Principal Investigator
Lynne Uhl, MD	Beth Israel Deaconess Medical Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Florida		Gainesville	Florida	32610	United States
Emory University

PubMed Identifier	Type	Citation	Retractions
28333704	Derived	Delaney M, Stark PC, Suh M, Triulzi DJ, Hess JR, Steiner ME, Stowell CP, Sloan SR. Massive Transfusion in Cardiac Surgery: The Impact of Blood Component Ratios on Clinical Outcomes and Survival. Anesth Analg. 2017 Jun;124(6):1777-1782. doi: 10.1213/ANE.0000000000001926.
25853746	Derived	Steiner ME, Ness PM, Assmann SF, Triulzi DJ, Sloan SR, Delaney M, Granger S, Bennett-Guerrero E, Blajchman MA, Scavo V, Carson JL, Levy JH, Whitman G, D'Andrea P, Pulkrabek S, Ortel TL, Bornikova L, Raife T, Puca KE, Kaufman RM, Nuttall GA, Young PP, Youssef S, Engelman R, Greilich PE, Miles R, Josephson CD, Bracey A, Cooke R, McCullough J, Hunsaker R, Uhl L, McFarland JG, Park Y, Cushing MM, Klodell CT, Karanam R, Roberts PR, Dyke C, Hod EA, Stowell CP. Effects of red-cell storage duration on patients undergoing cardiac surgery. N Engl J Med. 2015 Apr 9;372(15):1419-29. doi: 10.1056/NEJMoa1414219.

ID	Title	Description
FG000	Shorter-storage Red Blood Cell Units	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
FG001

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 Change in the Composite Multiple Organ Dysfunction Score (MODS) From the Pre-operative Baseline. The Worst Post-operative Values of Each Component of MODS Will be Used to Calculate the Change in MODS.

The follow-up MODS used to calculate 7-day ΔMODS from pre-op baseline was based on the worst value of each component of MODS observed through post-op day 7, hospital discharge, or death, whichever occurred first, even if a subject's worst values for different components occurred on different dates. Subjects who died during this time period were assigned the worst possible follow-up MODS score, 24 points, and each component of MODS was set at 4, which is the worst score. If a subject did not die during this time period but had at least one day where the Glasgow Coma Score couldn't be scored [subject sedated; neurologic function not normal by pre-op history (prior stroke, tumor or trauma sequelae, cognitively challenged, behavioral disorder, etc.) or intra-op history, but currently unable to assess because of sedation], then a post-op MODS score was set to missing and a 7-day ΔMODS was not computed. The total MODS score ranges from 0 (best possible) to 24 points (worst possible).

Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).

Posted

Mean

Standard Deviation

MOD score points

Through post-operative day 7, hospital discharge, or death, whichever occurs first

ID	Title	Description
OG000	Shorter-storage Red Blood Cell Units	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
OG001	Longer-storage Red Blood Cell Units	Red blood cell units stored >= 21 days Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.

Units	Counts
Participants	OG000534 OG001553

Title

Denominators

Categories

Title	Measurements
	OG0008.49± 3.62 OG0018.66± 3.55

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		ANCOVA	The treatment groups were compared with respect to the change in MODS, adjusting for baseline MODS.	0.44		Mean Difference (Net)	-0.17			2-Sided	95	-0.60	0.26			The longer storage red blood cell units arm is the reference category. After adjusting for baseline MODS, the difference in the means was -0.17, positive values are in favor of longer storage duration.	No	Superiority or Other

Secondary

All-cause Mortality

Subjects were randomized for RECESS no earlier than one calendar day before the planned date of surgery, and were followed for all-cause mortality until post-operative Day 28, death, or study withdrawal, whichever occurred first. In some cases the surgery was postponed after randomization had already occurred. If surgery did not occur within 30 days after randomization, the subject ended the study and was not considered evaluable. If surgery did occur within 30 days after randomization, and the subject received at least one RBC transfusion between randomization and 96 hours after the end of surgery, the subject was considered evaluable. Therefore, in a few evaluable subjects, post-operative Day 28 could be nearly two months after the date of randomization. The times in the time-to-event analysis started at randomization.

Posted

Number

participants with event

28 days post-surgery

ID	Title	Description
OG000	Shorter-storage Red Blood Cell Units	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
OG001	Longer-storage Red Blood Cell Units

Secondary

Change in Multiple Organ Dysfunction Score From Pre-operative Baseline.

The follow-up MODS used to calculate 28-day ΔMODS from pre-op baseline was based on the worst value of each component of MODS observed through post-op day 28, hospital discharge, or death, whichever occurred first, even if a subject's worst values for different components occurred on different dates. Subjects who died during this time period were assigned the worst possible follow-up MODS score, 24 points, and each component of MODS was set at 4, which is the worst score. If a subject did not die during this time period but had at least one day where the Glasgow Coma Score couldn't be scored[subject sedated; neurologic function not normal by pre-op history (prior stroke, tumor or trauma sequelae, cognitively challenged, behavioral disorder, etc.) or intra-op history, but currently unable to assess because of sedation], then a post-op MODS score was set to missing and a 28-day ΔMODS was not computed. The total MODS score ranges from 0 (best possible) to 24 points (worst possible).

Posted

Mean

Standard Deviation

MOD score points

Through 28 days post-surgery, hospital discharge, or death, whichever occurs first

ID	Title	Description
OG000	Shorter-storage Red Blood Cell Units	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.

Secondary

Composite of Major In-hospital Post-operative Complications (Death, Stroke, Myocardial Infarction, Renal Failure, Culture-proven Sepsis/Septic Shock)

Posted

Number

participants with event

Through post-operative day 7, hospital discharge, or death, whichever occurs first

ID	Title	Description
OG000	Shorter-storage Red Blood Cell Units	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
OG001	Longer-storage Red Blood Cell Units	Red blood cell units stored >= 21 days Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.

Units	Counts

Secondary

Composite of Major Cardiac Events (Death, Myocardial Infarction, Low Cardiac Output, Ventricular Tachycardia, Ventricular Fibrillation)

Posted

Number

participants with event

Through post-operative day 7, hospital discharge, or death, whichever occurs first

ID	Title	Description
OG000	Shorter-storage Red Blood Cell Units	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
OG001	Longer-storage Red Blood Cell Units	Red blood cell units stored >= 21 days Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.

Units	Counts

Secondary

Composite of Major Pulmonary Events (Any Mechanical Ventilation From 48 Hours Post-operation to Day 7, Hospital Discharge or Death, Whichever Comes First, or Pulmonary Embolism)

Posted

Number

participants with event

Through post-operative day 7, hospital discharge, or death, whichever occurs first

ID	Title	Description
OG000	Shorter-storage Red Blood Cell Units	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
OG001	Longer-storage Red Blood Cell Units	Red blood cell units stored >= 21 days Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.

Units	Counts

Secondary

Ventilation Duration

Because some subjects may experience multiple periods of ventilator use, the total duration that they were on a ventilator was compared between the two groups.

Posted

Mean

Standard Deviation

days

Through post-operative day 28, hospital discharge, or death, whichever occurs first

ID	Title	Description
OG000	Shorter-storage Red Blood Cell Units	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
OG001	Longer-storage Red Blood Cell Units	Red blood cell units stored >= 21 days Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.

Secondary

Change in Serum Creatinine From Pre-operative Value to Worst Post-operative Value

Posted

Mean

Standard Deviation

mg/dL

Through post-operative day 7, hospital discharge, or death, whichever occurs first

ID	Title	Description
OG000	Shorter-storage Red Blood Cell Units	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
OG001	Longer-storage Red Blood Cell Units	Red blood cell units stored >= 21 days Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.

Units	Counts
Participants

Secondary

Change in Troponin-I From Pre-operative Value to Worst Post-operative Value

Posted

Mean

Standard Deviation

ng/mL

Through post-operative day 7, hospital discharge, or death, whichever occurs first

ID	Title	Description
OG000	Shorter-storage Red Blood Cell Units	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
OG001	Longer-storage Red Blood Cell Units	Red blood cell units stored >= 21 days Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.

Units	Counts
Participants

Secondary

Change in Lactate From Pre-operative Value to Worst Post-operative Value

The arterial lactate levels were adjusted to make them comparable to venous lactate levels.

Posted

Mean

Standard Deviation

mmol/L

Through post-operative day 7, hospital discharge, or death, whichever occurs first

ID	Title	Description
OG000	Shorter-storage Red Blood Cell Units	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
OG001	Longer-storage Red Blood Cell Units	Red blood cell units stored >= 21 days Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.

Units

Secondary

Change in Bilirubin From Pre-operative Value to Worst Post-operative Value

Posted

Mean

Standard Deviation

mg/dL

Through post-operative day 7, hospital discharge, or death, whichever occurs first

ID	Title	Description
OG000	Shorter-storage Red Blood Cell Units	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
OG001	Longer-storage Red Blood Cell Units	Red blood cell units stored >= 21 days Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.

Units	Counts
Participants

Secondary

Change in ALT From Pre-operative Value to Worst Post-operative Value (for Pediatric Subjects Only)

Only 4 pediatric subjects were enrolled. One treatment arm had only one subject with available data for analyzing the change in ALT. Therefore, to protect patient confidentiality, results were not entered.

Posted

Through post-operative day 7, hospital discharge, or death, whichever occurs first

ID	Title	Description
OG000	Shorter-storage Red Blood Cell Units	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
OG001	Longer-storage Red Blood Cell Units	Red blood cell units stored >= 21 days Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.

Units	Counts
Participants

Secondary

Days to First Bowel Movement

Subjects were randomized for RECESS no earlier than one calendar day before the planned date of surgery, and were followed until post-operative Day 28, death, or study withdrawal, whichever occurred first. In some cases the surgery was postponed after randomization had already occurred. If surgery did not occur within 30 days after randomization, the subject ended the study and was not considered evaluable. If surgery did occur within 30 days after randomization, and the subject received at least one RBC transfusion between randomization and 96 hours after the end of surgery, the subject was considered evaluable. Therefore, in a few evaluable subjects, post-operative Day 28 could be nearly two months after the date of randomization. The times in the time-to-event analyses are from randomization to first post-operative bowel movement.

Posted

Mean

Standard Error

days

Through post-operative day 28, hospital discharge, or death, whichever occurs first

ID	Title	Description
OG000	Shorter-storage Red Blood Cell Units	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.

Secondary

Days to First Solid Food

Posted

Mean

Standard Error

days

Through post-operative day 28, hospital discharge, or death, whichever occurs first

ID	Title	Description
OG000	Shorter-storage Red Blood Cell Units	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.

Secondary

Days Alive and Ventilator Free Through Post-op Day 28

Posted

Mean

Standard Deviation

days

Through post-op day 28

ID	Title	Description
OG000	Shorter-storage Red Blood Cell Units	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
OG001	Longer-storage Red Blood Cell Units	Red blood cell units stored >= 21 days Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.

Units	Counts
Participants

Secondary

Any Mechanical Ventilation More Than 48 Hours Post-operation

Posted

Number

participants with event

48 hours post-operation through day 28, hospital discharge, or death, whichever occurs first

ID	Title	Description
OG000	Shorter-storage Red Blood Cell Units	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
OG001	Longer-storage Red Blood Cell Units	Red blood cell units stored >= 21 days Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0012 events2 affected560 at risk
Autoimmune thrombocytopenia	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0011 events1 affected560 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0012 events2 affected560 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Heparin-induced thrombocytopenia	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0005 events5 affected538 at risk EG0013 events3 affected560 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0007 events7 affected538 at risk EG0015 events4 affected560 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0014 events4 affected560 at risk
Accelerated idioventricular rhythm	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events3 affected538 at risk EG0010 events0 affected560 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0009 events9 affected538 at risk EG0019 events9 affected560 at risk
Acute right ventricular failure	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0011 events1 affected560 at risk
Angina pectoris	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0010 events0 affected560 at risk
Angina unstable	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Arrhythmia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0012 events2 affected560 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG00033 events31 affected538 at risk EG00128 events25 affected560 at risk
Atrial flutter	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected538 at risk EG0011 events1 affected560 at risk
Atrial tachycardia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected538 at risk EG0013 events3 affected560 at risk
Atrioventricular block	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0011 events1 affected560 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected538 at risk EG0013 events3 affected560 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Bradycardia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0009 events7 affected538 at risk EG00110 events10 affected560 at risk
Cardiac arrest	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events3 affected538 at risk EG0014 events4 affected560 at risk
Cardiac disorder	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0013 events3 affected560 at risk
Cardiac tamponade	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0006 events6 affected538 at risk EG0016 events5 affected560 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Cardiogenic shock	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0009 events9 affected538 at risk EG00113 events13 affected560 at risk
Cardiomyopathy acute	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Conduction disorder	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Myocardial infarction	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0011 events1 affected560 at risk
Negative cardiac inotropic effect	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Nodal arrhythmia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Pericardial effusion	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected538 at risk EG0010 events0 affected560 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0012 events2 affected560 at risk
Sinus bradycardia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG00020 events20 affected538 at risk EG00124 events24 affected560 at risk
Sinus tachycardia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG00017 events16 affected538 at risk EG00128 events26 affected560 at risk
Supraventricular tachyarrhythmia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected538 at risk EG0012 events2 affected560 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0013 events3 affected560 at risk
Tachycardia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0016 events5 affected560 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0011 events1 affected560 at risk
Ventricular asystole	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0012 events2 affected560 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0012 events2 affected560 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events4 affected538 at risk EG0016 events6 affected560 at risk
Ventricular tachyarrhythmia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events3 affected538 at risk EG0014 events4 affected560 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0009 events6 affected538 at risk EG0018 events7 affected560 at risk
Familial hypocalciuric hypercalcaemia	Congenital, familial and genetic disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Heart block congenital	Congenital, familial and genetic disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0012 events2 affected560 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Antidiuretic hormone abnormality	Endocrine disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Visual acuity reduced transiently	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Visual impairment	Eye disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Abdominal compartment syndrome	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0011 events1 affected560 at risk
Ascites	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Colitis	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Colonic obstruction	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected538 at risk EG0011 events1 affected560 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0012 events2 affected560 at risk
Gastric perforation	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0012 events2 affected560 at risk
Ileus	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Internal hernia	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Megacolon	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Mesenteric occlusion	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Oesophageal perforation	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Peritoneal haemorrhage	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Pneumoperitoneum	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Adverse drug reaction	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Application site bleeding	General disorders	MedDRA (12.0)	Systematic Assessment	EG00013 events13 affected538 at risk EG00111 events11 affected560 at risk
Cardiac death	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Chest discomfort	General disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0010 events0 affected560 at risk
Chest pain	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Infusion related reaction	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Infusion site dermatitis	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Multi-organ disorder	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Multi-organ failure	General disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected538 at risk EG0013 events3 affected560 at risk
Pyrexia	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Hepatic ischaemia	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG00028 events26 affected538 at risk EG00158 events51 affected560 at risk
Liver injury	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Pneumobilia	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Anaphylactoid shock	Immune system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Abdominal infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0002 events1 affected538 at risk EG0012 events2 affected560 at risk
Abdominal sepsis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0012 events2 affected560 at risk
Acute endocarditis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Adenoviral upper respiratory infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0010 events0 affected560 at risk
Bacterial diarrhoea	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Bacterial infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Bacterial sepsis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected538 at risk EG0016 events6 affected560 at risk
Bronchitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Bronchitis pneumococcal	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Bronchopneumonia	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG00012 events11 affected538 at risk EG0019 events9 affected560 at risk
Candida pneumonia	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Cellulitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected538 at risk EG0010 events0 affected560 at risk
Clostridium colitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected538 at risk EG0013 events3 affected560 at risk
Cystitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Cystitis klebsiella	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Endocarditis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Enterobacter infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Enterobacter pneumonia	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0012 events2 affected560 at risk
Enterococcal infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0011 events1 affected560 at risk
Febrile infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0013 events3 affected560 at risk
Genitourinary tract infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0009 events8 affected538 at risk EG0016 events6 affected560 at risk
Incision site infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0011 events1 affected560 at risk
Infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Lung infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Osteomyelitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Post procedural infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Postoperative wound infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0012 events2 affected560 at risk
Pseudomonal bacteraemia	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Pseudomonas infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Sepsis syndrome	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Septic shock	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0011 events1 affected560 at risk
Serratia infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Urinary tract infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0011 events1 affected560 at risk
Airway complication of anaesthesia	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Allergic transfusion reaction	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Anaphylactic transfusion reaction	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Cardiac function disturbance postoperative	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Cardiac valve replacement complication	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Confusion postoperative	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Deep vein thrombosis postoperative	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0014 events4 affected560 at risk
Endotracheal intubation complication	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Iatrogenic injury	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Mental status changes postoperative	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0012 events2 affected560 at risk
Operative haemorrhage	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Pneumothorax traumatic	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0011 events1 affected560 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0016 events6 affected560 at risk
Post procedural myocardial infarction	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0011 events1 affected560 at risk
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0011 events1 affected560 at risk
Postoperative renal failure	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected538 at risk EG0013 events3 affected560 at risk
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected538 at risk EG0019 events9 affected560 at risk
Renal injury	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0012 events2 affected560 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Urinary retention postoperative	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG00010 events10 affected538 at risk EG00110 events10 affected560 at risk
Weaning failure	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0011 events1 affected560 at risk
Wound necrosis	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Activated partial thromboplastin time	Investigations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Anticoagulation drug level below therapeutic	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Aspiration pleural cavity	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0011 events1 affected560 at risk
Bacteria blood identified	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Bacteria sputum identified	Investigations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Blood gases abnormal	Investigations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Blood pressure abnormal	Investigations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Blood pressure decreased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0006 events6 affected538 at risk EG0015 events5 affected560 at risk
Blood pressure systolic decreased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Blood urea nitrogen/creatinine ratio increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Blood urine present	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0011 events1 affected560 at risk
Body temperature decreased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0010 events0 affected560 at risk
Body temperature increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0013 events3 affected560 at risk
Bronchoalveolar lavage abnormal	Investigations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Cardiac enzymes increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0012 events2 affected560 at risk
Cardiac output decreased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Clostridium difficile toxin test positive	Investigations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
ECG signs of myocardial ischaemia	Investigations	MedDRA (12.0)	Systematic Assessment	EG0004 events4 affected538 at risk EG0012 events2 affected560 at risk
Ejection fraction decreased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Fungus culture positive	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Heart rate decreased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0012 events2 affected560 at risk
Heart rate increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
International normalised ratio abnormal	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Kidney injury molecule-1	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0011 events1 affected560 at risk
Methicillin-resistant staphylococcal aureus test positive	Investigations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
NIH stroke scale	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
NIH stroke scale score increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Occult blood positive	Investigations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0012 events1 affected560 at risk
Oxygen saturation	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Oxygen saturation decreased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0011 events1 affected560 at risk
Pathology test	Investigations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Radial pulse abnormal	Investigations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Red blood cells urine positive	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Sputum culture positive	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0011 events1 affected560 at risk
Transaminases increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0011 events1 affected560 at risk
Troponin I increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0010 events0 affected560 at risk
Urine output decreased	Investigations	MedDRA (12.0)	Systematic Assessment	EG00015 events15 affected538 at risk EG00118 events18 affected560 at risk
White blood cell count increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0011 events1 affected560 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Feeding disorder	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0012 events2 affected560 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0018 events7 affected560 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG00015 events15 affected538 at risk EG00116 events15 affected560 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0005 events5 affected538 at risk EG0016 events6 affected560 at risk
Hyperphosphatasaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0011 events1 affected560 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG00056 events55 affected538 at risk EG00152 events46 affected560 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0011 events1 affected560 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Metabolic alkalosis	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Compartment syndrome	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Hypercreatinaemia	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Altered state of consciousness	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Anoxic encephalopathy	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0012 events2 affected560 at risk
Aphasia	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Atonic seizures	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Brain stem stroke	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Cerebellar infarction	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Cerebral artery embolism	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0010 events0 affected560 at risk
Cerebral infarction	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Cerebral venous thrombosis	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0011 events1 affected560 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Embolic stroke	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0005 events5 affected538 at risk EG0013 events3 affected560 at risk
Encephalopathy	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0011 events1 affected560 at risk
Essential tremor	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Grand mal convulsion	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Hemiparesis	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0012 events2 affected560 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0005 events5 affected538 at risk EG0012 events2 affected560 at risk
Partial seizures	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Seizure anoxic	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Serotonin syndrome	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Simple partial seizures	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Stroke in evolution	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Adjustment disorder with depressed mood	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Confusional state	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Paranoia	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Acute prerenal failure	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG00016 events15 affected538 at risk EG00114 events14 affected560 at risk
Anuria	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Azotaemia	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Haematuria	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Haemoglobinuria	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0012 events2 affected560 at risk
Oliguria	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0005 events5 affected538 at risk EG0013 events3 affected560 at risk
Renal disorder	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Renal failure	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0015 events5 affected560 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0008 events8 affected538 at risk EG0012 events2 affected560 at risk
Renal impairment	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0013 events3 affected560 at risk
Renal mass	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Urinary bladder haemorrhage	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Urinary retention	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected538 at risk EG0015 events5 affected560 at risk
Bleeding anovulatory	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Scrotal swelling	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Acute interstitial pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected538 at risk EG0011 events1 affected560 at risk
Acute lung injury	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0011 events1 affected560 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events4 affected538 at risk EG0015 events5 affected560 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG00010 events9 affected538 at risk EG00111 events11 affected560 at risk
Anaemic hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected538 at risk EG0016 events6 affected560 at risk
Apnoeic attack	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0010 events0 affected560 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Clotted haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected538 at risk EG0015 events5 affected560 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG00028 events27 affected538 at risk EG00125 events24 affected560 at risk
Dyspnoea at rest	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0009 events8 affected538 at risk EG00112 events12 affected560 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0006 events6 affected538 at risk EG0016 events6 affected560 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG00036 events33 affected538 at risk EG00139 events39 affected560 at risk
Idiopathic pneumonia syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Lung consolidation	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Mediastinal disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Mediastinal haematoma	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Mediastinal haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0006 events6 affected538 at risk EG0016 events6 affected560 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG00013 events11 affected538 at risk EG0019 events9 affected560 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected538 at risk EG0010 events0 affected560 at risk
Pneumothorax spontaneous tension	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0011 events1 affected560 at risk
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events2 affected538 at risk EG0011 events1 affected560 at risk
Stridor	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0012 events2 affected560 at risk
Thoracic haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Vocal cord disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0007 events6 affected538 at risk EG00112 events12 affected560 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Itching scar	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Pruritus allergic	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Abdominal exploration	Surgical and medical procedures	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Allergy prophylaxis	Surgical and medical procedures	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Aneurysm repair	Surgical and medical procedures	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Cardiac pacemaker insertion	Surgical and medical procedures	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0011 events1 affected560 at risk
Dialysis	Surgical and medical procedures	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Extracorporeal membrane oxygenation	Surgical and medical procedures	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Hypotensive anaesthesia procedure	Surgical and medical procedures	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected538 at risk EG0012 events2 affected560 at risk
Incisional drainage	Surgical and medical procedures	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0012 events2 affected560 at risk
Intracerebral haematoma evacuation	Surgical and medical procedures	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Pericardial drainage	Surgical and medical procedures	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Removal of foreign body	Surgical and medical procedures	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Tracheostomy	Surgical and medical procedures	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0012 events1 affected560 at risk
Accelerated hypertension	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0011 events1 affected560 at risk
Aortic intramural haematoma	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Arterial thrombosis	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Arteriovenous fistula	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Diastolic hypertension	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0012 events2 affected560 at risk
Diastolic hypotension	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG00014 events14 affected538 at risk EG00114 events14 affected560 at risk
Essential hypertension	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0005 events5 affected538 at risk EG0013 events3 affected560 at risk
Haematoma	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Haemodynamic instability	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Haemorrhage	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Hypertension	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG00014 events13 affected538 at risk EG00113 events13 affected560 at risk
Hypotension	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG000106 events97 affected538 at risk EG00196 events87 affected560 at risk
Hypovolaemic shock	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0012 events2 affected560 at risk
Ischaemic limb pain	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Labile hypertension	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0011 events1 affected560 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0010 events0 affected560 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Poor peripheral circulation	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Venous thrombosis limb	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Haemolysis	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0010 events0 affected560 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0007 events7 affected538 at risk EG0014 events4 affected560 at risk
Accessory cardiac pathway	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected538 at risk EG0012 events2 affected560 at risk
Arrhythmia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0011 events1 affected560 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Atrial tachycardia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0011 events1 affected560 at risk
Bradycardia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events4 affected538 at risk EG00110 events10 affected560 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Myocardial infarction	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0011 events1 affected560 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0012 events2 affected560 at risk
Sinus bradycardia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG00012 events12 affected538 at risk EG00112 events11 affected560 at risk
Sinus tachycardia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG00027 events25 affected538 at risk EG00128 events28 affected560 at risk
Supraventricular tachyarrhythmia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Tachycardia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0011 events1 affected560 at risk
Ventricular tachyarrhythmia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected538 at risk EG0010 events0 affected560 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0007 events7 affected538 at risk EG0013 events3 affected560 at risk
Familial hypocalciuric hypercalcaemia	Congenital, familial and genetic disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events4 affected538 at risk EG0012 events2 affected560 at risk
Adverse reaction	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Catheter site phlebitis	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Chest pain	General disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Chills	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Hyperthermia	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Oedema peripheral	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Pyrexia	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG00089 events78 affected538 at risk EG001107 events98 affected560 at risk
Hyperbilirubinaemia neonatal	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Alloimmunisation	Immune system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Hypersensitivity	Immune system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Acinetobacter infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Actinomycotic pulmonary infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Acute sinusitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Adenoviral upper respiratory infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0011 events1 affected560 at risk
Application site cellulitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0010 events0 affected560 at risk
Arteriovenous graft site infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Aspergillosis oral	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Asymptomatic bacteriuria	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Bacteriuria	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Bronchopneumonia	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0012 events2 affected560 at risk
Catheter site cellulitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Cytomegalovirus urinary tract infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Enterobacter tracheobronchitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0013 events3 affected560 at risk
Genitourinary tract infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG00010 events10 affected538 at risk EG00110 events9 affected560 at risk
Incision site infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Influenza	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Klebsiella bacteraemia	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Parotitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Upper respiratory fungal infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Urinary tract infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0010 events0 affected560 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0012 events2 affected560 at risk
Wound infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Allergic transfusion reaction	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0012 events2 affected560 at risk
Iatrogenic injury	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0012 events2 affected560 at risk
Post procedural haematuria	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0012 events2 affected560 at risk
Postoperative renal failure	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected538 at risk EG0012 events2 affected560 at risk
Urethral stricture traumatic	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Urinary retention postoperative	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0007 events7 affected538 at risk EG00110 events10 affected560 at risk
Bacteria blood identified	Investigations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Bacteria sputum identified	Investigations	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0011 events1 affected560 at risk
Bacteria urine	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Bilirubin conjugated abnormal	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Bilirubin conjugated increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0012 events2 affected560 at risk
Blood pressure abnormal	Investigations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Blood pressure decreased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0005 events5 affected538 at risk EG0013 events3 affected560 at risk
Blood pressure orthostatic decreased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Blood urine	Investigations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Body temperature increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0008 events8 affected538 at risk EG0013 events3 affected560 at risk
Cardiac enzymes increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0007 events7 affected538 at risk EG0019 events9 affected560 at risk
Differential white blood cell count normal	Investigations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
ECG signs of myocardial ischaemia	Investigations	MedDRA (12.0)	Systematic Assessment	EG0007 events7 affected538 at risk EG0018 events8 affected560 at risk
Heart rate decreased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Methicillin-resistant staphylococcal aureus test positive	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Oxygen saturation decreased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Sputum culture	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Sputum culture positive	Investigations	MedDRA (12.0)	Systematic Assessment	EG0003 events2 affected538 at risk EG0010 events0 affected560 at risk
Troponin	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Urine output decreased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected538 at risk EG0011 events1 affected560 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0012 events2 affected560 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG00018 events18 affected538 at risk EG00118 events18 affected560 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG00030 events25 affected538 at risk EG00113 events11 affected560 at risk
Hyperphosphatasaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0013 events3 affected560 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG000230 events187 affected538 at risk EG001228 events191 affected560 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0012 events2 affected560 at risk
Aphasia	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Embolic stroke	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Acute prerenal failure	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0008 events8 affected538 at risk EG0017 events5 affected560 at risk
Haematuria	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0011 events1 affected560 at risk
Haemoglobinuria	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0011 events1 affected560 at risk
Hypocalciuria	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events3 affected538 at risk EG0010 events0 affected560 at risk
Oliguria	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0014 events4 affected560 at risk
Renal failure	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0012 events2 affected560 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0011 events1 affected560 at risk
Renal impairment	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0013 events2 affected560 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0012 events2 affected560 at risk
Urinary retention	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0005 events5 affected538 at risk EG0013 events3 affected560 at risk
Urine flow decreased	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Scrotal oedema	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Anaemic hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0012 events2 affected560 at risk
Bradypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected538 at risk EG0012 events2 affected560 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG00011 events10 affected538 at risk EG00111 events11 affected560 at risk
Dyspnoea at rest	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected538 at risk EG0014 events4 affected560 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG00016 events15 affected538 at risk EG00120 events20 affected560 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0008 events8 affected538 at risk EG00114 events14 affected560 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events3 affected538 at risk EG0013 events3 affected560 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG00017 events16 affected538 at risk EG00112 events12 affected560 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected538 at risk EG0011 events1 affected560 at risk
Haemophilus influenzae type b immunisation	Surgical and medical procedures	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Hypotensive anaesthesia procedure	Surgical and medical procedures	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0011 events1 affected560 at risk
Accelerated hypertension	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events4 affected538 at risk EG0015 events5 affected560 at risk
Diastolic hypertension	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0003 events2 affected538 at risk EG0011 events1 affected560 at risk
Diastolic hypotension	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0006 events6 affected538 at risk EG0014 events4 affected560 at risk
Essential hypertension	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0012 events2 affected560 at risk
Hypertension	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG00020 events20 affected538 at risk EG00123 events21 affected560 at risk
Hypertensive crisis	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk
Hypotension	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG00076 events71 affected538 at risk EG00176 events73 affected560 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected538 at risk EG0011 events1 affected560 at risk
Thrombophlebitis	Vascular disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected538 at risk EG0010 events0 affected560 at risk

ID	Type	Link
U01HL072268	U.S. NIH Grant/Contract	View source
HL072268
HL072033
HL072291
HL072196
HL072289
HL072248
HL072191
HL072299
HL072305
HL072274
HL072028
HL072359
HL072072
HL072355
HL072283
HL072346
HL072331
HL072290

ID	Title	Description
BG000	Shorter-storage Red Blood Cell Units	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
BG001	Longer-storage Red Blood Cell Units	Red blood cell units stored >= 21 days Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Shorter-storage Red Blood Cell Units	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.			283	538	324	538
EG001	Longer-storage Red Blood Cell Units	Red blood cell units stored >= 21 days Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.			288	560	334	560