A Study Testing the Effectiveness of Nesiritide in Patien... | NCT00475852

NCT00475852

ID	Type	Description
ASCEND-HF	Other Identifier	Johnson & Johnson Pharmaceutical Research & Development, LLC
A093	Other Identifier	Johnson & Johnson Pharmaceutical Research & Development, LLC
NATRECORAHF3002	Other Identifier	Johnson & Johnson Pharmaceutical Research & Development, LLC

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
001	Experimental	Nesiritide 0.01 mcg/kg/min intravenous (IV) infusion (with or without 2 mcg/kg bolus) for 24 to 168 hours (hrs)	Drug: Nesiritide
002	Placebo Comparator	Placebo matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Nesiritide	Drug	0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs	001

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Composite of Rehospitalization Due to Heart Failure and All-Cause Mortality		Randomization to Day 30
Dyspnea Self-Assessment at 6 Hours After Initiation of Study Drug	Dyspnea symptoms were measured by patient self-assessed Likert scale at 6 hours after study drug initiation.The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.)	6 hours after initiation of study drug
Dyspnea Self-Assessment at 24 Hours After Initiation of Study Drug	Dyspnea symptoms were measured by patient self-assessed Likert scale at 24 hours after study drug initiation. The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.)	24 hours after study drug initiation

Secondary Outcomes

Measure	Description	Time Frame
Overall Well-Being Self-Assessment at 6 Hours After Initiation of Study Drug	Overall well-being was measured by patient self-assessed Likert scale at 6 hours after study drug initiation. The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.)	6 hours after study drug initiation

Other Outcomes

Measure	Description	Time Frame
All-Cause Mortality Through Day 30	All deaths were adjudicated by an independent Clinical Events Committee.	Randomization to Day 30
All-Cause Mortality Through Day 180	All deaths were adjudicated by an independent Clinical Events Committee.

Eligibility Module

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37725680	Derived	Gui H, Tang WHW, Francke S, Li J, She R, Bazeley P, Pereira NL, Adams K, Luzum JA, Connolly TM, Hernandez AF, McNaughton CD, Williams LK, Lanfear DE. Common Variants on FGD5 Increase Hazard of Mortality or Rehospitalization in Patients With Heart Failure From the ASCEND-HF Trial. Circ Heart Fail. 2023 Sep;16(9):e010438. doi: 10.1161/CIRCHEARTFAILURE.122.010438. Epub 2023 Jul 26.
36314126

Label	URL
A study testing the effectiveness of Nesiritide in Patients with Acute Decompensated Heart Failure	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Nesiritide	0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
FG001	Placebo	Matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0004 BG0012 BG0026
Between 18 and 65 years

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00065.5± 14.09 BG00165.4± 14.20 BG002

Age, Customized

Number

participants

Title

Denominators

Categories

<=64

Title	Measurements
	BG0001576 BG0011599 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0001197 BG0011247 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

ARG

Title	Measurements
	BG000108 BG001108 BG002

Baseline BMI

Mean

Standard Deviation

kg/cm2

Title

Denominators

Categories

Title	Measurements
	BG00028.9± 7.86 BG00129.1± 7.77 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Composite of Rehospitalization Due to Heart Failure and All-Cause Mortality

The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 141 and 164 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.

Posted

Number

Participants

Randomization to Day 30

ID	Title	Description
OG000	Nesiritide	0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
OG001	Placebo	Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs

Units	Counts
Participants	OG0003423 OG0013413

Title

Denominators

Categories

Title	Measurements
	OG000321 OG001345

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		Cochran-Mantel-Haenszel	Stratified by geographical region.	0.313		Risk Difference (RD)	-0.7			2-Sided	95	-2.1	0.7				No	Superiority or Other

Primary

Dyspnea Self-Assessment at 6 Hours After Initiation of Study Drug

Dyspnea symptoms were measured by patient self-assessed Likert scale at 6 hours after study drug initiation.The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.)

The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 148 and 133 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.

Posted

Number

Participants

6 hours after initiation of study drug

ID	Title	Description
OG000	Nesiritide	0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
OG001	Placebo	Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs

Units	Counts
Participants

Primary

Dyspnea Self-Assessment at 24 Hours After Initiation of Study Drug

Dyspnea symptoms were measured by patient self-assessed Likert scale at 24 hours after study drug initiation. The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.)

The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 193 and 179 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.

Posted

Number

Participants

24 hours after study drug initiation

ID	Title	Description
OG000	Nesiritide	0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
OG001	Placebo	Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs

Units	Counts
Participants

Secondary

Overall Well-Being Self-Assessment at 6 Hours After Initiation of Study Drug

Overall well-being was measured by patient self-assessed Likert scale at 6 hours after study drug initiation. The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.)

The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 158 and 147 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.

Posted

Number

Participants

6 hours after study drug initiation

ID	Title	Description
OG000	Nesiritide	0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
OG001	Placebo	Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs

Units	Counts
Participants

Secondary

Overall Well-Being Self-Assessment at 24 Hours After Initiation of Study Drug

Overall well-being was measured by patient self-assessed Likert scale at 24 hours after study drug initiation. The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.)

The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 200 and 194 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.

Posted

Number

Participants

24 hours after study drug initiation

ID	Title	Description
OG000	Nesiritide	0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
OG001	Placebo	Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs

Units	Counts
Participants

Secondary

Composite of Persistent or Worsening Heart Failure and All-Cause Mortality

Clinical manifestations of worsening or persistent decompensated heart failure were defined by at least one of the following: new, persistent or worsening: dyspnea, orthopnea, paroxysmal nocturnal dyspnea, edema, pulmonary basilar rales/crackles, jugular venous distension, renal hypoperfusion with no other apparent cause, or radiologic evidence of worsening heart failure. And was also defined by a new therapy specifically for the treatment of worsening or persistent decompensated heart failure.

The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 105 and 115 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.

Posted

Number

Participants

Randomization to hospital discharge (up to Day 30)

ID	Title	Description
OG000	Nesiritide	0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
OG001	Placebo	Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs

Secondary

Number of Days Alive and Outside the Hospital

The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 182 and 188 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.

Posted

Mean

Standard Deviation

Days

Randomization to Day 30

ID	Title	Description
OG000	Nesiritide	0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
OG001	Placebo	Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs

Units	Counts
Participants	OG000

Secondary

Composite of Cardiovascular Rehospitalization and Cardiovascular Mortality

The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 141 and 162 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.

Posted

Number

Participants

Randomization to Day 30

ID	Title	Description
OG000	Nesiritide	0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
OG001	Placebo	Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs

Units	Counts
Participants	OG000

Other Pre-specified

All-Cause Mortality Through Day 30

All deaths were adjudicated by an independent Clinical Events Committee.

The safety population consisted of all randomized patients who received any amount of study medication. For all safety analyses, patients were analyzed according to the treatment actually received. 66 and 68 patients in the nesiritide and placebo groups, respectively, were not included in the safety population.

Posted

Number

Participants

Randomization to Day 30

ID	Title	Description
OG000	Nesiritide	0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
OG001	Placebo	Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs

Units	Counts
Participants	OG000

Other Pre-specified

All-Cause Mortality Through Day 180

All deaths were adjudicated by an independent Clinical Events Committee.

Posted

Number

Participants

Randomization to Day 180

ID	Title	Description
OG000	Nesiritide	0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
OG001	Placebo	Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs

Units	Counts
Participants	OG000

Other Pre-specified

Cardiovascular Mortality Through Day 30

All deaths were adjudicated by an independent Clinical Events Committee (CEC) and the cardiovascular deaths were classified by the CEC based on the primary causes.

Posted

Number

Participants

Randomization to Day 30

ID	Title	Description
OG000	Nesiritide	0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
OG001	Placebo	Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs

Units	Counts
Participants	OG000

Other Pre-specified

Number of Patients With Renal Impairment

Renal impairment was defined as a greater than 25% decrease from baseline in the Modification of Diet in Renal Disease calculated glomerular filtration rate.

Posted

Number

Participants

Study drug initiation to Day 30

ID	Title	Description
OG000	Nesiritide	0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
OG001	Placebo	Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Nesiritide	0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs			5	3,498	366	3,498
EG001	Placebo	Matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs			2	3,509	364	3,509

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Hypotension	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Ischaemic Stroke	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected3,498 at risk EG0011 affected3,509 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected3,498 at risk EG0014 affected3,509 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0012 affected3,509 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Aortic Valve Stenosis	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Arrhythmia Supraventricular	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0006 affected3,498 at risk EG0014 affected3,509 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG00046 affected3,498 at risk EG00133 affected3,509 at risk
Atrial Flutter	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0003 affected3,498 at risk EG0012 affected3,509 at risk
Atrial Septal Defect	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Atrial Tachycardia	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Atrioventricular Block Complete	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0011 affected3,509 at risk
Bradycardia	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0007 affected3,498 at risk EG0017 affected3,509 at risk
Cardiac Arrest	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG00016 affected3,498 at risk EG00110 affected3,509 at risk
Cardiac Tamponade	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Congestive Cardiomyopathy	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Electromechanical Dissociation	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Endocarditis	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected3,498 at risk EG0011 affected3,509 at risk
Fluid Overload	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Hepatic Congestion	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Ischaemic Cardiomyopathy	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Mitral Valve Incompetence	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Mitral Valve Prolapse	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Palpitations	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0013 affected3,509 at risk
Sinus Tachycardia	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Subacute Endocarditis	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Tachycardia	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Ventricular Arrhythmia	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Ventricular Extrasystoles	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Ventricular Fibrillation	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG00011 affected3,498 at risk EG0018 affected3,509 at risk
Ventricular Septal Defect	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Ventricular Tachycardia	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG00023 affected3,498 at risk EG00130 affected3,509 at risk
Carcinoid Tumour of the Appendix	Endocrine disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Diabetes Mellitus	Endocrine disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Diabetes Mellitus Inadequate Control	Endocrine disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0011 affected3,509 at risk
Diabetic Neuropathy	Endocrine disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Hyperglycaemia	Endocrine disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected3,498 at risk EG0012 affected3,509 at risk
Hypoglycaemia	Endocrine disorders	MedDRA 13.0	Non-systematic Assessment	EG0005 affected3,498 at risk EG0018 affected3,509 at risk
Hypothyroidism	Endocrine disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Blindness Transient	Eye disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Vision Blurred	Eye disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Abdominal Discomfort	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0005 affected3,498 at risk EG0011 affected3,509 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0012 affected3,509 at risk
Anal Abscess	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Appendicitis	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Constipation	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0011 affected3,509 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0003 affected3,498 at risk EG0012 affected3,509 at risk
Diverticulitis	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected3,498 at risk EG0011 affected3,509 at risk
Faeces Discoloured	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Gastric Ulcer	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0011 affected3,509 at risk
Gastritis	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0011 affected3,509 at risk
Gastroduodenitis	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Gastroenteritis	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0003 affected3,498 at risk EG0012 affected3,509 at risk
Gastroenteritis Viral	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0012 affected3,509 at risk
Gastrointestinal Erosion	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Gastrointestinal Obstruction	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Ileus	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Intestinal Obstruction	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Intestinal Perforation	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Nausea	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0011 affected3,509 at risk
Pancreatitis Chronic	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Rectal Abscess	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Umbilical Hernia, Obstructive	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Vomiting	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected3,498 at risk EG0010 affected3,509 at risk
Asthenia	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0012 affected3,509 at risk
Device Dislocation	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Device Related Infection	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Device Related Sepsis	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected3,498 at risk EG0010 affected3,509 at risk
Hypothermia	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Infusion Site Extravasation	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected3,498 at risk EG0010 affected3,509 at risk
Medical Device Complication	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0011 affected3,509 at risk
Pyrexia	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0011 affected3,509 at risk
Sudden Cardiac Death	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0012 affected3,509 at risk
Sudden Death	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected3,498 at risk EG0010 affected3,509 at risk
Cholecystitis Acute	Hepatobiliary disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected3,498 at risk EG0012 affected3,509 at risk
Cholestasis	Hepatobiliary disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Hepatic Cirrhosis	Hepatobiliary disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Hepatic Encephalopathy	Hepatobiliary disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Hepatic Failure	Hepatobiliary disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Hepatic Function Abnormal	Hepatobiliary disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Hepatocellular Injury	Hepatobiliary disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Guillain-Barre Syndrome	Immune system disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Transfusion Reaction	Immune system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Bacteraemia	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Enterococcal Bacteraemia	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Infection	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Postoperative Wound Infection	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0002 affected3,498 at risk EG0010 affected3,509 at risk
Sepsis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0006 affected3,498 at risk EG0015 affected3,509 at risk
Staphylococcal Bacteraemia	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0012 affected3,509 at risk
Staphylococcal Infection	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0003 affected3,498 at risk EG0010 affected3,509 at risk
Staphylococcal Sepsis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Streptococcal Sepsis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Wound Infection	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0002 affected3,498 at risk EG0012 affected3,509 at risk
Road Traffic Accident	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0011 affected3,509 at risk
Therapeutic Agent Toxicity	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Wound Dehiscence	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Antimicrobial Susceptibility Test Resistant	Investigations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Blood Creatinine Increased	Investigations	MedDRA 13.0	Non-systematic Assessment	EG0002 affected3,498 at risk EG0010 affected3,509 at risk
Blood Glucose Increased	Investigations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Catheter Culture Positive	Investigations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Fibrin D Dimer Increased	Investigations	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Gastric Ph Decreased	Investigations	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Hepatic Enzyme Increased	Investigations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
International Normalised Ratio Increased	Investigations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0012 affected3,509 at risk
Prostatic Specific Antigen Increased	Investigations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0005 affected3,498 at risk EG0016 affected3,509 at risk
Gout	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected3,498 at risk EG0012 affected3,509 at risk
Hyperbilirubinaemia	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0005 affected3,498 at risk EG0014 affected3,509 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0012 affected3,509 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Arthritis Bacterial	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Hip Fracture	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Joint Sprain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Lower Limb Fracture	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Monarthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Osteomyelitis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected3,498 at risk EG0011 affected3,509 at risk
Patella Fracture	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Pelvic Fracture	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Soft Tissue Infection	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Colonic Polyp	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Small Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Confusional State	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0004 affected3,498 at risk EG0012 affected3,509 at risk
Convulsion	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Dyskinesia	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Epilepsy	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Headache	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0012 affected3,509 at risk
Loss of Consciousness	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Unresponsive to Stimuli	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Acute Psychosis	Psychiatric disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Alcohol Withdrawal Syndrome	Psychiatric disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Delirium	Psychiatric disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Failure to Thrive	Psychiatric disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0012 affected3,509 at risk
Mental Status Changes	Psychiatric disorders	MedDRA 13.0	Non-systematic Assessment	EG0004 affected3,498 at risk EG0011 affected3,509 at risk
Azotaemia	Renal and urinary disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Bladder Neoplasm	Renal and urinary disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Cystitis	Renal and urinary disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Haematuria	Renal and urinary disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Renal Artery Stenosis	Renal and urinary disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Renal Colic	Renal and urinary disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Ureteric Haemorrhage	Renal and urinary disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Urinary Retention	Renal and urinary disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected3,498 at risk EG0011 affected3,509 at risk
Urinary Tract Infection	Renal and urinary disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0017 affected3,509 at risk
Urinary Tract Obstruction	Renal and urinary disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Urosepsis	Renal and urinary disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0011 affected3,509 at risk
Benign Prostatic Hyperplasia	Reproductive system and breast disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Breast Cancer	Reproductive system and breast disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Endometrial Cancer	Reproductive system and breast disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Orchitis	Reproductive system and breast disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Acute Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected3,498 at risk EG0010 affected3,509 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Bronchitis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0007 affected3,498 at risk EG0011 affected3,509 at risk
Bronchitis Bacterial	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Chest Pain	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0006 affected3,498 at risk EG0018 affected3,509 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0006 affected3,498 at risk EG0013 affected3,509 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected3,498 at risk EG0012 affected3,509 at risk
Eosinophilic Pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected3,498 at risk EG0010 affected3,509 at risk
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected3,498 at risk EG0011 affected3,509 at risk
Hypoxic Encephalopathy	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Idiopathic Pulmonary Fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Infective Exacerbation of Chronic Obstructive Airways Disease	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Influenza	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Lobar Pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected3,498 at risk EG0011 affected3,509 at risk
Lower Respiratory Tract Infection	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Lung Cancer Metastatic	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Lung Disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Lung Infection	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Lung Neoplasm	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Lung Neoplasm Malignant	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0011 affected3,509 at risk
Mediastinitis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Mediastinum Neoplasm	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Musculoskeletal Chest Pain	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Non-Cardiac Chest Pain	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0013 affected3,509 at risk
Pharyngitis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected3,498 at risk EG0010 affected3,509 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0008 affected3,498 at risk EG0014 affected3,509 at risk
Pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG00022 affected3,498 at risk EG00118 affected3,509 at risk
Pneumonia Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Pneumonia Bacterial	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Pneumonia Mycoplasmal	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Pneumonia Staphylococcal	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0014 affected3,509 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0006 affected3,498 at risk EG0014 affected3,509 at risk
Pulmonary Fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Pulmonary Hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Pulmonary Infarction	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0012 affected3,509 at risk
Respiratory Arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected3,498 at risk EG0012 affected3,509 at risk
Respiratory Distress	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected3,498 at risk EG0010 affected3,509 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected3,498 at risk EG0019 affected3,509 at risk
Respiratory Tract Infection	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0012 affected3,509 at risk
Stridor	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Upper Respiratory Tract Infection	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Acarodermatitis	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0012 affected3,509 at risk
Cellulitis	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0004 affected3,498 at risk EG0012 affected3,509 at risk
Dermatitis Allergic	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Dermatitis Exfoliative	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Diabetic Foot	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Diabetic Foot Infection	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Gangrene	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Subcutaneous Haematoma	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Abdominal Wall Haematoma	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0012 affected3,509 at risk
Acute Coronary Syndrome	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Angina Pectoris	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected3,498 at risk EG0018 affected3,509 at risk
Angina Unstable	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0013 affected3,509 at risk
Aortic Aneurysm	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Aortic Dissection	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected3,498 at risk EG0010 affected3,509 at risk
Aortic Stenosis	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Arterial Haemorrhage	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0012 affected3,509 at risk
Bleeding Varicose Vein	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Cardiogenic Shock	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG00014 affected3,498 at risk EG00116 affected3,509 at risk
Catheter Site Haemorrhage	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Cerebellar Haemorrhage	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Cerebrovascular Accident	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Colitis Ischaemic	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Coronary Artery Disease	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0015 affected3,509 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0004 affected3,498 at risk EG0013 affected3,509 at risk
Dizziness	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0014 affected3,509 at risk
Duodenal Ulcer Haemorrhage	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Embolic Stroke	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected3,498 at risk EG0011 affected3,509 at risk
Embolism	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Femoral Artery Occlusion	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Gastrointestinal Haemorrhage	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0004 affected3,498 at risk EG0018 affected3,509 at risk
Haematemesis	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected3,498 at risk EG0010 affected3,509 at risk
Haematoma	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0011 affected3,509 at risk
Haemorrhagic Anaemia	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Haemorrhagic Stroke	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0003 affected3,498 at risk EG0014 affected3,509 at risk
Haemorrhoidal Haemorrhage	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Hypertension	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected3,498 at risk EG0011 affected3,509 at risk
Hypertensive Crisis	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0012 affected3,509 at risk
Hypoperfusion	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Hypotension	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0006 affected3,498 at risk EG00110 affected3,509 at risk
Iliac Artery Embolism	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Iliac Artery Thrombosis	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Infusion Site Phlebitis	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Intracardiac Thrombus	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0011 affected3,509 at risk
Ischaemic Cerebral Infarction	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Ischaemic Hepatitis	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Ischaemic Stroke	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG00011 affected3,498 at risk EG00120 affected3,509 at risk
Lower Gastrointestinal Haemorrhage	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Melaena	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Myocardial Infarction	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG00019 affected3,498 at risk EG00115 affected3,509 at risk
Myocardial Ischaemia	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected3,498 at risk EG0010 affected3,509 at risk
Orthostatic Hypotension	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0003 affected3,498 at risk EG0011 affected3,509 at risk
Peptic Ulcer Haemorrhage	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Peripheral Embolism	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Peripheral Ischaemia	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Phlebitis	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0011 affected3,509 at risk
Post Procedural Haematoma	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0012 affected3,509 at risk
Post Procedural Haemorrhage	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Presyncope	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0015 affected3,509 at risk
Raynaud's Phenomenon	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Rectal Haemorrhage	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0004 affected3,498 at risk EG0013 affected3,509 at risk
Retroperitoneal Haemorrhage	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0011 affected3,509 at risk
Septic Shock	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0003 affected3,498 at risk EG0013 affected3,509 at risk
Shock	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Small Intestinal Haemorrhage	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Subarachnoid Haemorrhage	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected3,498 at risk EG0010 affected3,509 at risk
Syncope	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0006 affected3,498 at risk EG0015 affected3,509 at risk
Systemic Inflammatory Response Syndrome	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Thrombophlebitis Superficial	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Thrombosis	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected3,498 at risk EG0011 affected3,509 at risk
Transient Ischaemic Attack	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected3,498 at risk EG0014 affected3,509 at risk
Upper Gastrointestinal Haemorrhage	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0004 affected3,498 at risk EG0012 affected3,509 at risk

Certain Agreements

Facility	Status	City	State	ZIP	Country	Contacts
		Huntsville	Alabama		United States

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D045265	Natriuretic Peptides
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D009419	Nerve Tissue Proteins
D011506	Proteins

ID	Title	Description
BG000	Nesiritide	0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
BG001	Placebo	Matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
BG002	Total	Total of all reporting groups