Effect of Serelaxin Versus Standard of Care in Acute Hear... | NCT02064868

NCT02064868

ID	Type	Description	Link
2013-002513-35	EudraCT Number

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
Serelaxin + Standard of Care	Experimental	Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.	Drug: Serelaxin Drug: Standard of Care
Standard of Care (SOC)	Other	All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.	Drug: Standard of Care

Name	Type	Description	Arm Group Labels	Other Names
Serelaxin	Drug	30 µg/kg/day IV infusion	Serelaxin + Standard of Care

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Worsening Heart Failure (WHF) / All Cause of Deaths Through Day 5	In-hospital WHF through Day 5 post-randomization included worsening signs and/or symptoms of heart failure that required an intensification of intravenous therapy for heart failure or mechanical ventilation, renal or circulatory support. A central event adjudication committee was appointed to oversee the WHF primary endpoint adjudication.	5 days

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With In-hospital Worsening Heart Failure/All-Cause Death/Readmission for Heart Failure Through Day 14	WHF/death/readmission for heart failure through Day 14. WHF/deaths through Day 5 were adjudicated and confirmed by the Clinical Endpoint Committee, WHF/deaths after Day 5 through Day 14 and readmission through Day 14 were as reported by the investigators.	14 days

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Feldkirch		A-6807	Austria
Novartis Investigative Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35184572	Derived	Grand J, Miger K, Sajadieh A, Kober L, Torp-Pedersen C, Ertl G, Lopez-Sendon J, Pietro Maggioni A, Teerlink JR, Sato N, Gimpelewicz C, Metra M, Holbro T, Nielsen OW. Blood Pressure Drops During Hospitalization for Acute Heart Failure Treated With Serelaxin: A Patient-Level Analysis of 4 Randomized Controlled Trials. Circ Heart Fail. 2022 Apr;15(4):e009199. doi: 10.1161/CIRCHEARTFAILURE.121.009199. Epub 2022 Feb 21.
34514815

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Serelaxin + Standard of Care	Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.
FG001	Standard of Care (SOC)	All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 19, 2016	Apr 24, 2018

Arm/Group Information

ID	Title	Description
BG000	Serelaxin + Standard of Care	Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.
BG001	Standard of Care (SOC)	All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00075.24± 10.349 BG00175.95± 9.905 BG00275.48± 10.205

Sex: Female, Male

Full Analysis Set

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000760 BG001383 BG002

Race/Ethnicity, Customized

Full Analysis Set

Count of Participants

Participants

Title

Denominators

Categories

Caucasian

Title	Measurements
	BG0001706 BG001869 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

Percentage of Participants With Worsening Heart Failure (WHF) / All Cause of Deaths Through Day 5

In-hospital WHF through Day 5 post-randomization included worsening signs and/or symptoms of heart failure that required an intensification of intravenous therapy for heart failure or mechanical ventilation, renal or circulatory support. A central event adjudication committee was appointed to oversee the WHF primary endpoint adjudication.

Full Analysis Set

Posted

Number

Percentage of Participants

5 days

ID	Title	Description
OG000	Serelaxin + Standard of Care	Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.
OG001	Standard of Care (SOC)	All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.

Units	Counts
Participants	OG0001756 OG001894

Title

Denominators

Categories

Title	Measurements
	OG0004.95 OG0016.94

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		Gehan's generalized Wilcoxon test		0.0172	One-sided p-value	Hazard Ratio (HR)	0.71			2-Sided	95	0.51	0.98					Superiority

Secondary

Percentage of Participants With In-hospital Worsening Heart Failure/All-Cause Death/Readmission for Heart Failure Through Day 14

WHF/death/readmission for heart failure through Day 14. WHF/deaths through Day 5 were adjudicated and confirmed by the Clinical Endpoint Committee, WHF/deaths after Day 5 through Day 14 and readmission through Day 14 were as reported by the investigators.

Full Analysis Set

Posted

Number

Percentage of Patients

14 days

ID	Title	Description
OG000	Serelaxin + Standard of Care	Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.
OG001	Standard of Care (SOC)	All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.

Units	Counts
Participants

Secondary

Percentage of Participants With Persistent Sign or Symptoms of Heart Failure / Non-Improvement at Any Post Baseline Visit Through Day 5

Persistent or non-improvement in any signs or symptoms of HF at any post baseline visit up to Day 5.

Full Analysis Set (only evaluable patients with non-missing information included)

Posted

Number

95% Confidence Interval

Percentage of Participants

5 days

ID	Title	Description
OG000	Serelaxin + Standard of Care	Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.
OG001	Standard of Care (SOC)	All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.

Units	Counts
Participants

Secondary

Percentage of Participants With Renal Deterioration at Any Post Baseline Visit Through Day 14

Renal deterioration is defined as > or = 0.3 mg/dL increase from screening in serum creatinine.

Full Analysis Set (only evaluable patients with non-missing information included)

Posted

Number

95% Confidence Interval

Percentage of Participants

14 days

ID	Title	Description
OG000	Serelaxin + Standard of Care	Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.
OG001	Standard of Care (SOC)	All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.

Units	Counts
Participants

Secondary

Length of Index Hospital Stay

Length of stay (in hours) is defined as the index hospitalization discharge date and time minus the index hospitalization start date and time.

Full Analysis Set

Posted

Mean

Standard Deviation

hours

30 Days

ID	Title	Description
OG000	Serelaxin + Standard of Care	Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.
OG001	Standard of Care (SOC)	All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Adverse Events as Assessment of Safety and Tolerability of Serelaxin in AHF Patients

Safety Set

Posted

Number

Percentage of participants

Adverse Events (AE): 5 Days / Serious Adverse Events (SAE): 14 days / All cause deaths 30 days

ID	Title	Description
OG000	Serelaxin + Standard of Care	Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.
OG001	Standard of Care (SOC)	All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Health-related Quality of Life Index Value, Assessed by EuroQoL EQ-5D-5L Questionnaire.

EQ-5D-5L is a questionnaire designed to assess health status in adults consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The results were converted into a single index value using UK as the reference country for all countries. Range -0.3 (worst possible state) to 1 (best possible state).

Full Analysis Set (only evaluable patients with non-missing information included)

Posted

Mean

Standard Deviation

units on a scale

Baseline, Day 5, Day 14

ID	Title	Description
OG000	Serelaxin + Standard of Care	Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.
OG001	Standard of Care (SOC)	All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.

Units

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	Serelaxin + Standard of Care	Serelaxin (30 μg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.	63	1,729	214	1,729	637	1,729
EG001	Standard of Care (SOC)	All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.	43	894	107	894	324	894

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0011 affected894 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0006 affected1,729 at risk EG0014 affected894 at risk
Angina pectoris	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0012 affected894 at risk
Angina unstable	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0014 affected894 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0013 affected894 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0006 affected1,729 at risk EG0011 affected894 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0003 affected1,729 at risk EG0010 affected894 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,729 at risk EG0010 affected894 at risk
Bradycardia	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0007 affected1,729 at risk EG0012 affected894 at risk
Bundle branch block left	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Cardiac arrest	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0006 affected1,729 at risk EG0012 affected894 at risk
Cardiac failure	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG00038 affected1,729 at risk EG00126 affected894 at risk
Cardiac failure acute	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0006 affected1,729 at risk EG0012 affected894 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,729 at risk EG0011 affected894 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,729 at risk EG0011 affected894 at risk
Cardiac hypertrophy	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Cardiac ventricular thrombosis	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Cardiogenic shock	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0003 affected1,729 at risk EG0012 affected894 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Cardiorenal syndrome	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Cardiovascular insufficiency	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Coronary artery disease	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0007 affected1,729 at risk EG0014 affected894 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Diastolic dysfunction	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Left ventricular failure	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0011 affected894 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0005 affected1,729 at risk EG0011 affected894 at risk
Myocardial infarction	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,729 at risk EG0013 affected894 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,729 at risk EG0010 affected894 at risk
Myocarditis	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Right ventricular failure	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Sinus arrest	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Stress cardiomyopathy	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Tachycardia	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0005 affected1,729 at risk EG0011 affected894 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0005 affected1,729 at risk EG0012 affected894 at risk
Hypothyroidism	Endocrine disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Glaucoma	Eye disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Abdominal strangulated hernia	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Constipation	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,729 at risk EG0010 affected894 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0003 affected1,729 at risk EG0010 affected894 at risk
Melaena	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Nausea	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Vomiting	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,729 at risk EG0010 affected894 at risk
Death	General disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Fatigue	General disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Hyperthermia	General disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Non-cardiac chest pain	General disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Organ failure	General disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Pyrexia	General disorders	MedDRA (20.0)	Systematic Assessment	EG0004 affected1,729 at risk EG0012 affected894 at risk
Sudden cardiac death	General disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Sudden death	General disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Hepatitis toxic	Hepatobiliary disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,729 at risk EG0010 affected894 at risk
Bacteraemia	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Bronchitis	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0003 affected1,729 at risk EG0011 affected894 at risk
Diverticulitis	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Infection	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Nosocomial infection	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Oropharyngitis fungal	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Parainfluenzae virus infection	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Pneumonia	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG00011 affected1,729 at risk EG0016 affected894 at risk
Pneumonia influenzal	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Respiratory tract infection	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Sepsis	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,729 at risk EG0012 affected894 at risk
Skin bacterial infection	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Staphylococcal infection	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Streptococcal infection	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Tracheobronchitis	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,729 at risk EG0010 affected894 at risk
Urinary tract infection	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0003 affected1,729 at risk EG0014 affected894 at risk
Urosepsis	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,729 at risk EG0010 affected894 at risk
Abdominal injury	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0012 affected894 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Haematuria traumatic	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,729 at risk EG0010 affected894 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Procedural pneumothorax	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,729 at risk EG0010 affected894 at risk
Blood bilirubin increased	Investigations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Blood creatinine increased	Investigations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0011 affected894 at risk
Electrocardiogram T wave inversion	Investigations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Haemoglobin decreased	Investigations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Heart rate decreased	Investigations	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
International normalised ratio decreased	Investigations	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
International normalised ratio increased	Investigations	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Liver function test increased	Investigations	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Oxygen saturation decreased	Investigations	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,729 at risk EG0010 affected894 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Gout	Metabolism and nutrition disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Hyperammonaemia	Metabolism and nutrition disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0012 affected894 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0012 affected894 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Chest wall haematoma	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Brain oedema	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0011 affected894 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Epilepsy	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,729 at risk EG0010 affected894 at risk
Hypercapnic coma	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0003 affected1,729 at risk EG0014 affected894 at risk
Loss of consciousness	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Seizure	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Status epilepticus	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Agitation	Psychiatric disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Confusional state	Psychiatric disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,729 at risk EG0010 affected894 at risk
Delirium	Psychiatric disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,729 at risk EG0010 affected894 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (20.0)	Systematic Assessment	EG0009 affected1,729 at risk EG0014 affected894 at risk
Acute prerenal failure	Renal and urinary disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Anuria	Renal and urinary disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,729 at risk EG0010 affected894 at risk
Haematuria	Renal and urinary disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Nephropathy	Renal and urinary disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Nephropathy toxic	Renal and urinary disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0011 affected894 at risk
Prerenal failure	Renal and urinary disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Renal failure	Renal and urinary disorders	MedDRA (20.0)	Systematic Assessment	EG0006 affected1,729 at risk EG0013 affected894 at risk
Renal impairment	Renal and urinary disorders	MedDRA (20.0)	Systematic Assessment	EG0004 affected1,729 at risk EG0015 affected894 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0011 affected894 at risk
Urinary retention	Renal and urinary disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (20.0)	Systematic Assessment	EG0006 affected1,729 at risk EG0011 affected894 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0011 affected894 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0011 affected894 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,729 at risk EG0013 affected894 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0011 affected894 at risk
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0012 affected894 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (20.0)	Systematic Assessment	EG0003 affected1,729 at risk EG0012 affected894 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (20.0)	Systematic Assessment	EG0006 affected1,729 at risk EG0010 affected894 at risk
Dermatitis exfoliative	Skin and subcutaneous tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Left atrial appendage occlusion	Surgical and medical procedures	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Aortic stenosis	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Arterial disorder	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Arterial stenosis	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Arteriosclerosis	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Arteriovenous fistula	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Circulatory collapse	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Femoral artery aneurysm	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Haematoma	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Hypertension	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,729 at risk EG0011 affected894 at risk
Hypertensive crisis	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected1,729 at risk EG0010 affected894 at risk
Hypotension	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG0007 affected1,729 at risk EG0012 affected894 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected1,729 at risk EG0010 affected894 at risk
Peripheral ischaemia	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk
Shock haemorrhagic	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected1,729 at risk EG0011 affected894 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (20.0)	Systematic Assessment	EG00049 affected1,729 at risk EG0019 affected894 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG00034 affected1,729 at risk EG00123 affected894 at risk
Cardiac failure	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG00081 affected1,729 at risk EG00156 affected894 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG00028 affected1,729 at risk EG00112 affected894 at risk
Constipation	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG00074 affected1,729 at risk EG00132 affected894 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG00029 affected1,729 at risk EG00121 affected894 at risk
Nausea	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG00040 affected1,729 at risk EG00117 affected894 at risk
Pyrexia	General disorders	MedDRA (20.0)	Systematic Assessment	EG00024 affected1,729 at risk EG00121 affected894 at risk
Bronchitis	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG00024 affected1,729 at risk EG00114 affected894 at risk
Urinary tract infection	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG00056 affected1,729 at risk EG00126 affected894 at risk
Blood pressure systolic decreased	Investigations	MedDRA (20.0)	Systematic Assessment	EG00049 affected1,729 at risk EG0012 affected894 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA (20.0)	Systematic Assessment	EG00047 affected1,729 at risk EG00135 affected894 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (20.0)	Systematic Assessment	EG000119 affected1,729 at risk EG00173 affected894 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG00028 affected1,729 at risk EG00111 affected894 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG00033 affected1,729 at risk EG0018 affected894 at risk
Headache	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG00045 affected1,729 at risk EG00118 affected894 at risk
Anxiety	Psychiatric disorders	MedDRA (20.0)	Systematic Assessment	EG00027 affected1,729 at risk EG00116 affected894 at risk
Insomnia	Psychiatric disorders	MedDRA (20.0)	Systematic Assessment	EG00058 affected1,729 at risk EG00121 affected894 at risk
Renal failure	Renal and urinary disorders	MedDRA (20.0)	Systematic Assessment	EG00018 affected1,729 at risk EG00118 affected894 at risk
Renal impairment	Renal and urinary disorders	MedDRA (20.0)	Systematic Assessment	EG00030 affected1,729 at risk EG00118 affected894 at risk
Hypotension	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG00048 affected1,729 at risk EG00118 affected894 at risk

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation