ACT-293987 in Pulmonary Arterial Hypertension | NCT01112306

NCT01112306

ID	Type	Description	Link
2009-014992-31	EudraCT Number

Status Module

Oversight Module

Label	Type	Description	Intervention Names
1	Experimental	ACT-293987, twice daily	Drug: ACT-293987

Name	Type	Description	Arm Group Labels	Other Names
ACT-293987	Drug	Tablets, twice daily	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs) up to 3 Days After Study Intervention Discontinuation	An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. A TEAE is any AE temporally associated with the use of study drug (from study drug initiation until 3 days after study drug discontinuation), whether or not considered related to the study drug.	Up to 3 days after study drug discontinuation (Up to 10.5 years)
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) up to 3 Days After Study Intervention Discontinuation	An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. Those SAEs occurring during study drug administration, that is, between study drug initiation and three days after study drug discontinuation, are defined as treatment-emergent SAEs.	Up to 3 days after study drug discontinuation (Up to 10.5 years)
Number of Participants With TEAEs Leading to Permanent Discontinuation of Study Intervention	An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. A TEAE is any AE temporally associated with the use of study drug (from study drug initiation until 3 days after study drug discontinuation), whether or not considered related to the study drug.	Up to 10.5 years

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Alive Participants	Percentage of alive participants were analyzed using Kaplan-Meier (KM) estimates.	Baseline (Day 1), Months 3, 6, 9, 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

Eligibility Module

Name	Affiliation	Role
Aline Frey	Actelion	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34727317	Derived	Galie N, Gaine S, Channick R, Coghlan JG, Hoeper MM, Lang IM, McLaughlin VV, Lassen C, Rubin LJ, Hsu Schmitz SF, Sitbon O, Tapson VF, Chin KM. Long-Term Survival, Safety and Tolerability with Selexipag in Patients with Pulmonary Arterial Hypertension: Results from GRIPHON and its Open-Label Extension. Adv Ther. 2022 Jan;39(1):796-810. doi: 10.1007/s12325-021-01898-1. Epub 2021 Oct 30.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Selexipag	Participants with pulmonary arterial hypertension (PAH) who completed the double-blind AC-065A302 GRIPHON study (NCT01106014) or experienced a morbidity event in that study, entered in this open label (OL) study. Participants who received selexipag in GRIPHON continued to receive selexipag at the same dose (200 micrograms [mcg], twice daily [bid] up to 1600 mcg bid based on individual maximum tolerated dose) in this OL study. Participants who were on placebo or experienced a morbidity event in GRIPHON entered the titration period of this OL-study and received lowest dose of selexipag (200 mcg, bid) and dose was titrated up to 1600 mcg bid, based on the individual maximum tolerated dose. Each participant received study drug from Day 1 until the earliest of a) selexipag became commercially available in this indication in participant's country, b) sponsor decided to stop current study, or c) participant/investigator decided to discontinue study intervention (up to 10.5 years).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 6, 2019	Aug 24, 2022

Arm/Group Information

ID	Title	Description
BG000	Selexipag	Participants with pulmonary arterial hypertension (PAH) who completed the double-blind AC-065A302 GRIPHON study (NCT01106014) or experienced a morbidity event in that study, entered in this open label (OL) study. Participants who received selexipag in GRIPHON continued to receive selexipag at the same dose (200 micrograms [mcg], twice daily [bid] up to 1600 mcg bid based on individual maximum tolerated dose) in this OL study. Participants who were on placebo or experienced a morbidity event in GRIPHON entered the titration period of this OL-study and received lowest dose of selexipag (200 mcg, bid) and dose was titrated up to 1600 mcg bid, based on the individual maximum tolerated dose. Each participant received study drug from Day 1 until the earliest of a) selexipag became commercially available in this indication in participant's country, b) sponsor decided to stop current study, or c) participant/investigator decided to discontinue study intervention (up to 10.5 years).

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
	BG00047.9± 15.19

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000590
Male	BG000119

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

ASIAN

Title	Measurements
	BG000171

BLACK OR AFRICAN AMERICAN

Title	Measurements
	BG000

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

ARGENTINA

Title	Measurements
	BG00020

AUSTRALIA

Title	Measurements
	BG000

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

Number of Participants With Treatment-emergent Adverse Events (TEAEs) up to 3 Days After Study Intervention Discontinuation

An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. A TEAE is any AE temporally associated with the use of study drug (from study drug initiation until 3 days after study drug discontinuation), whether or not considered related to the study drug.

The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.

Posted

Count of Participants

Participants

Up to 3 days after study drug discontinuation (Up to 10.5 years)

ID	Title	Description
OG000	Selexipag	Participants with pulmonary arterial hypertension (PAH) who completed the double-blind AC-065A302 GRIPHON study (NCT01106014) or experienced a morbidity event in that study, entered in this open label (OL) study. Participants who received selexipag in GRIPHON continued to receive selexipag at the same dose (200 micrograms [mcg], twice daily [bid] up to 1600 mcg bid based on individual maximum tolerated dose) in this OL study. Participants who were on placebo or experienced a morbidity event in GRIPHON entered the titration period of this OL-study and received lowest dose of selexipag (200 mcg, bid) and dose was titrated up to 1600 mcg bid, based on the individual maximum tolerated dose. Each participant received study drug from Day 1 until the earliest of a) selexipag became commercially available in this indication in participant's country, b) sponsor decided to stop current study, or c) participant/investigator decided to discontinue study intervention (up to 10.5 years).

Units	Counts
Participants	OG000709

Title

Denominators

Categories

Title	Measurements
	OG000684

Primary

Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) up to 3 Days After Study Intervention Discontinuation

An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. Those SAEs occurring during study drug administration, that is, between study drug initiation and three days after study drug discontinuation, are defined as treatment-emergent SAEs.

The OL safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set.

Posted

Count of Participants

Participants

Up to 3 days after study drug discontinuation (Up to 10.5 years)

ID	Title	Description
OG000	Selexipag	Participants with pulmonary arterial hypertension (PAH) who completed the double-blind AC-065A302 GRIPHON study (NCT01106014) or experienced a morbidity event in that study, entered in this open label (OL) study. Participants who received selexipag in GRIPHON continued to receive selexipag at the same dose (200 micrograms [mcg], twice daily [bid] up to 1600 mcg bid based on individual maximum tolerated dose) in this OL study. Participants who were on placebo or experienced a morbidity event in GRIPHON entered the titration period of this OL-study and received lowest dose of selexipag (200 mcg, bid) and dose was titrated up to 1600 mcg bid, based on the individual maximum tolerated dose. Each participant received study drug from Day 1 until the earliest of a) selexipag became commercially available in this indication in participant's country, b) sponsor decided to stop current study, or c) participant/investigator decided to discontinue study intervention (up to 10.5 years).

Primary

Number of Participants With TEAEs Leading to Permanent Discontinuation of Study Intervention

Posted

Count of Participants

Participants

Up to 10.5 years

ID	Title	Description
OG000	Selexipag	Participants with pulmonary arterial hypertension (PAH) who completed the double-blind AC-065A302 GRIPHON study (NCT01106014) or experienced a morbidity event in that study, entered in this open label (OL) study. Participants who received selexipag in GRIPHON continued to receive selexipag at the same dose (200 micrograms [mcg], twice daily [bid] up to 1600 mcg bid based on individual maximum tolerated dose) in this OL study. Participants who were on placebo or experienced a morbidity event in GRIPHON entered the titration period of this OL-study and received lowest dose of selexipag (200 mcg, bid) and dose was titrated up to 1600 mcg bid, based on the individual maximum tolerated dose. Each participant received study drug from Day 1 until the earliest of a) selexipag became commercially available in this indication in participant's country, b) sponsor decided to stop current study, or c) participant/investigator decided to discontinue study intervention (up to 10.5 years).

Secondary

Percentage of Alive Participants

Percentage of alive participants were analyzed using Kaplan-Meier (KM) estimates.

Selexipag-treated set (STS): all participants who received at least 1 dose of selexipag in either main study (NCT01106014) or this OL study (NCT01112306). Survival analysis was planned in a subset of STS participants who received selexipag in main study, entered or did not enter this OL study. Here, "n" (number analyzed): participants at risk (alive and on study), analyzed at each specified timepoint.

Posted

Number

95% Confidence Interval

Percentage of participants

Baseline (Day 1), Months 3, 6, 9, 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

ID	Title	Description
OG000	Selexipag	Participants with pulmonary arterial hypertension (PAH) who completed the double-blind AC-065A302 GRIPHON study (NCT01106014) or experienced a morbidity event in that study, entered in this open label (OL) study. Participants who received selexipag in GRIPHON continued to receive selexipag at the same dose (200 micrograms [mcg], twice daily [bid] up to 1600 mcg bid based on individual maximum tolerated dose) in this OL study. Participants who were on placebo or experienced a morbidity event in GRIPHON entered the titration period of this OL-study and received lowest dose of selexipag (200 mcg, bid) and dose was titrated up to 1600 mcg bid, based on the individual maximum tolerated dose. Each participant received study drug from Day 1 until the earliest of a) selexipag became commercially available in this indication in participant's country, b) sponsor decided to stop current study, or c) participant/investigator decided to discontinue study intervention (up to 10.5 years).

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	Selexipag	Participants with pulmonary arterial hypertension (PAH) who completed the double-blind AC-065A302 GRIPHON study (NCT01106014) or experienced a morbidity event in that study, entered in this open label (OL) study. Participants who received selexipag in GRIPHON continued to receive selexipag at the same dose (200 micrograms [mcg], twice daily [bid] up to 1600 mcg bid based on individual maximum tolerated dose) in this OL study. Participants who were on placebo or experienced a morbidity event in GRIPHON entered the titration period of this OL-study and received lowest dose of selexipag (200 mcg, bid) and dose was titrated up to 1600 mcg bid, based on the individual maximum tolerated dose. Each participant received study drug from Day 1 until the earliest of a) selexipag became commercially available in this indication in participant's country, b) sponsor decided to stop current study, or c) participant/investigator decided to discontinue study intervention (up to 10.5 years).	186	709	420	709	598	709

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0009 affected709 at risk
Anaemia Vitamin B12 Deficiency	Blood and lymphatic system disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Blood Loss Anaemia	Blood and lymphatic system disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Bone Marrow Failure	Blood and lymphatic system disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Disseminated Intravascular Coagulation	Blood and lymphatic system disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Immune Thrombocytopenic Purpura	Blood and lymphatic system disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Iron Deficiency Anaemia	Blood and lymphatic system disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Lymphadenopathy Mediastinal	Blood and lymphatic system disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Pseudolymphoma	Blood and lymphatic system disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Acute Coronary Syndrome	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0004 affected709 at risk
Acute Right Ventricular Failure	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG00011 affected709 at risk
Angina Pectoris	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Aortic Valve Stenosis	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Arrhythmia	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG00017 affected709 at risk
Atrial Flutter	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0008 affected709 at risk
Atrial Tachycardia	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Atrioventricular Block	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Atrioventricular Block Complete	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0003 affected709 at risk
Atrioventricular Block Second Degree	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Cardiac Arrest	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG00013 affected709 at risk
Cardiac Failure	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0008 affected709 at risk
Cardiac Failure Acute	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Cardiac Failure Chronic	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0004 affected709 at risk
Cardio-Respiratory Arrest	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0005 affected709 at risk
Cardiogenic Shock	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0009 affected709 at risk
Cardiopulmonary Failure	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0008 affected709 at risk
Cardiorenal Syndrome	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Cardiovascular Insufficiency	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Chronic Left Ventricular Failure	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Chronic Right Ventricular Failure	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Cor Pulmonale	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Cor Pulmonale Acute	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Left Ventricular Failure	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0004 affected709 at risk
Myocardial Infarction	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Pericardial Effusion	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Right Ventricular Dysfunction	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Right Ventricular Failure	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG00093 affected709 at risk
Supraventricular Tachycardia	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0004 affected709 at risk
Tricuspid Valve Incompetence	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Ventricular Tachyarrhythmia	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Dermoid Cyst	Congenital, familial and genetic disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Haemorrhagic Arteriovenous Malformation	Congenital, familial and genetic disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Vertigo	Ear and labyrinth disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Adrenocortical Insufficiency Acute	Endocrine disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Basedow's Disease	Endocrine disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Hyperthyroidism	Endocrine disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Thyroiditis Subacute	Endocrine disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Astigmatism	Eye disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Diabetic Retinopathy	Eye disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Glaucoma	Eye disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Abdominal Distension	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Abdominal Hernia	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0004 affected709 at risk
Abdominal Pain Lower	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Abdominal Wall Haematoma	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Ascites	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0006 affected709 at risk
Chronic Gastritis	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Colitis	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Constipation	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG00012 affected709 at risk
Diverticular Perforation	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Gastric Ulcer	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Gastritis Haemorrhagic	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0009 affected709 at risk
Gastrointestinal Motility Disorder	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Haematemesis	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Ileus Paralytic	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Intestinal Haemorrhage	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Large Intestinal Haemorrhage	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Large Intestine Polyp	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Melaena	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Obstructive Pancreatitis	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Oesophageal Haemorrhage	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Pancreatitis Acute	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Upper Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0003 affected709 at risk
Catheter Site Erythema	General disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Catheter Site Thrombosis	General disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Chest Discomfort	General disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Chest Pain	General disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0007 affected709 at risk
Death	General disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0003 affected709 at risk
Drowning	General disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Drug Ineffective	General disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Drug Interaction	General disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Euthanasia	General disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Fatigue	General disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Gait Disturbance	General disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Generalised Oedema	General disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Multiple Organ Dysfunction Syndrome	General disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0008 affected709 at risk
Oedema Peripheral	General disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0004 affected709 at risk
Organ Failure	General disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Peripheral Swelling	General disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Pyrexia	General disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0005 affected709 at risk
Sudden Cardiac Death	General disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0003 affected709 at risk
Sudden Death	General disorders	MedDRA Version 22.0	Non-systematic Assessment	EG00014 affected709 at risk
Systemic Inflammatory Response Syndrome	General disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Withdrawal Syndrome	General disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Bile Duct Stone	Hepatobiliary disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Cardiac Cirrhosis	Hepatobiliary disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Cholecystitis Acute	Hepatobiliary disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Cirrhosis Alcoholic	Hepatobiliary disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Drug-Induced Liver Injury	Hepatobiliary disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Hepatic Failure	Hepatobiliary disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Jaundice	Hepatobiliary disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Amyloidosis	Immune system disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Abscess Bacterial	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Abscess Limb	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Actinomycotic Pulmonary Infection	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Anal Abscess	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Appendicitis	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0003 affected709 at risk
Appendicitis Perforated	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Atypical Pneumonia	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Bacterial Abdominal Infection	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Bacterial Sepsis	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Bronchitis	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG00011 affected709 at risk
Cellulitis	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0006 affected709 at risk
Clostridium Difficile Colitis	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Colonic Abscess	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Complicated Appendicitis	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Corona Virus Infection	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0004 affected709 at risk
Cystitis	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Dengue Fever	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Disseminated Tuberculosis	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Empyema	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Endocarditis	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Enterobacter Sepsis	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Erysipelas	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Escherichia Sepsis	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Escherichia Urinary Tract Infection	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Gastroenteritis	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0003 affected709 at risk
Gastroenteritis Clostridial	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Gastroenteritis Norovirus	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Gastrointestinal Infection	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
H1n1 Influenza	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Haematoma Infection	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Haemorrhagic Pneumonia	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Herpes Zoster	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Infection	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Infective Tenosynovitis	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Influenza	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Lower Respiratory Tract Infection	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0008 affected709 at risk
Lung Infection	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0005 affected709 at risk
Nasopharyngitis	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Osteomyelitis	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Otitis Media Bacterial	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Peritonitis	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0003 affected709 at risk
Peritonitis Bacterial	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Pneumonia	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG00050 affected709 at risk
Pneumonia Bacterial	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Pneumonia Viral	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0003 affected709 at risk
Postoperative Wound Infection	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Pyelonephritis	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Pyelonephritis Acute	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Pyoderma	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0004 affected709 at risk
Rhinitis	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Sepsis	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG00010 affected709 at risk
Septic Shock	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0003 affected709 at risk
Sialoadenitis	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Soft Tissue Infection	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Staphylococcal Sepsis	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Tracheobronchitis	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0004 affected709 at risk
Urinary Tract Infection	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0004 affected709 at risk
Viral Infection	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Viral Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Wound Infection	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Accident	Injury, poisoning and procedural complications	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Anaesthetic Complication	Injury, poisoning and procedural complications	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Ankle Fracture	Injury, poisoning and procedural complications	MedDRA Version 22.0	Non-systematic Assessment	EG0003 affected709 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Fall	Injury, poisoning and procedural complications	MedDRA Version 22.0	Non-systematic Assessment	EG0008 affected709 at risk
Femoral Neck Fracture	Injury, poisoning and procedural complications	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Fractured Sacrum	Injury, poisoning and procedural complications	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Head Injury	Injury, poisoning and procedural complications	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Humerus Fracture	Injury, poisoning and procedural complications	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Intentional Overdose	Injury, poisoning and procedural complications	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Jaw Fracture	Injury, poisoning and procedural complications	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Joint Dislocation	Injury, poisoning and procedural complications	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Pelvic Fracture	Injury, poisoning and procedural complications	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Poisoning	Injury, poisoning and procedural complications	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Post Procedural Haemorrhage	Injury, poisoning and procedural complications	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Radius Fracture	Injury, poisoning and procedural complications	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Reactive Gastropathy	Injury, poisoning and procedural complications	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Rib Fracture	Injury, poisoning and procedural complications	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Road Traffic Accident	Injury, poisoning and procedural complications	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Skin Laceration	Injury, poisoning and procedural complications	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Soft Tissue Injury	Injury, poisoning and procedural complications	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Spinal Compression Fracture	Injury, poisoning and procedural complications	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Spinal Fracture	Injury, poisoning and procedural complications	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Subcutaneous Haematoma	Injury, poisoning and procedural complications	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Toxicity to Various Agents	Injury, poisoning and procedural complications	MedDRA Version 22.0	Non-systematic Assessment	EG0003 affected709 at risk
Traumatic Haematoma	Injury, poisoning and procedural complications	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Upper Limb Fracture	Injury, poisoning and procedural complications	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Vascular Pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Activated Partial Thromboplastin Time Prolonged	Investigations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Anticoagulation Drug Level above Therapeutic	Investigations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Biopsy Kidney	Investigations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Blood Uric Acid Increased	Investigations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Catheterisation Cardiac	Investigations	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Haemoglobin Decreased	Investigations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
International Normalised Ratio Increased	Investigations	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Investigation	Investigations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
N-Terminal Prohormone Brain Natriuretic Peptide Increased	Investigations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Precancerous Cells Present	Investigations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Prothrombin Time Prolonged	Investigations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Transplant Evaluation	Investigations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Weight Decreased	Investigations	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Fluid Overload	Metabolism and nutrition disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0003 affected709 at risk
Fluid Retention	Metabolism and nutrition disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Fracture Malunion	Musculoskeletal and connective tissue disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Haematoma Muscle	Musculoskeletal and connective tissue disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Mixed Connective Tissue Disease	Musculoskeletal and connective tissue disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Rheumatoid Arthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Still's Disease	Musculoskeletal and connective tissue disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Systemic Lupus Erythematosus	Musculoskeletal and connective tissue disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Systemic Scleroderma	Musculoskeletal and connective tissue disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Adenocarcinoma of Colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Benign Salivary Gland Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Breast Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Breast Cancer Recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Carcinoid Tumour of the Stomach	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Endometrial Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Endometrial Cancer Stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Extranodal Marginal Zone B-Cell Lymphoma (Malt Type)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Hepatocellular Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Infected Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Lung Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Lung Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Metastases to the Mediastinum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Nodal Marginal Zone B-Cell Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Ovarian Germ Cell Teratoma Benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Papillary Thyroid Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Uterine Leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Carotid Artery Occlusion	Nervous system disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Cerebral Infarction	Nervous system disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Headache	Nervous system disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0004 affected709 at risk
Intracranial Haematoma	Nervous system disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Ischaemic Stroke	Nervous system disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Presyncope	Nervous system disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0003 affected709 at risk
Seizure	Nervous system disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Syncope	Nervous system disorders	MedDRA Version 22.0	Non-systematic Assessment	EG00018 affected709 at risk
Transient Ischaemic Attack	Nervous system disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Vocal Cord Paralysis	Nervous system disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Abortion Missed	Pregnancy, puerperium and perinatal conditions	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Abortion Spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA Version 22.0	Non-systematic Assessment	EG0005 affected709 at risk
Acute Psychosis	Psychiatric disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Anxiety	Psychiatric disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Drug Dependence	Psychiatric disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Major Depression	Psychiatric disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Suicide Attempt	Psychiatric disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Acute Kidney Injury	Renal and urinary disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0006 affected709 at risk
Chronic Kidney Disease	Renal and urinary disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0003 affected709 at risk
Cystitis Haemorrhagic	Renal and urinary disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Glomerulonephritis Chronic	Renal and urinary disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Haematuria	Renal and urinary disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Ischaemic Nephropathy	Renal and urinary disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Lupus Nephritis	Renal and urinary disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Proteinuria	Renal and urinary disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Renal Failure	Renal and urinary disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0004 affected709 at risk
Renal Haematoma	Renal and urinary disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Renal Impairment	Renal and urinary disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Tubulointerstitial Nephritis	Renal and urinary disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Urinary Retention	Renal and urinary disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Uterine Haemorrhage	Reproductive system and breast disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Vaginal Haemorrhage	Reproductive system and breast disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Acute Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0005 affected709 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Chronic Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG00018 affected709 at risk
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG00010 affected709 at risk
Hypersensitivity Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0004 affected709 at risk
Lower Respiratory Tract Inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Lupus Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Pleuritic Pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Pulmonary Alveolar Haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Pulmonary Arterial Hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG000169 affected709 at risk
Pulmonary Artery Aneurysm	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Pulmonary Artery Dilatation	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0008 affected709 at risk
Pulmonary Hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Pulmonary Mass	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Respiratory Distress	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0004 affected709 at risk
Skin Necrosis	Skin and subcutaneous tissue disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Skin Ulcer	Skin and subcutaneous tissue disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Balloon Atrial Septostomy	Surgical and medical procedures	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Benign Breast Lump Removal	Surgical and medical procedures	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Breast Conserving Surgery	Surgical and medical procedures	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Cardiac Pacemaker Insertion	Surgical and medical procedures	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Coronary Angioplasty	Surgical and medical procedures	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Coronary Arterial Stent Insertion	Surgical and medical procedures	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Drug Therapy	Surgical and medical procedures	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Fasciotomy	Surgical and medical procedures	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Gastric Bypass	Surgical and medical procedures	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Heart and Lung Transplant	Surgical and medical procedures	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Hip Arthroplasty	Surgical and medical procedures	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Knee Operation	Surgical and medical procedures	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Lung Transplant	Surgical and medical procedures	MedDRA Version 22.0	Non-systematic Assessment	EG0005 affected709 at risk
Nephrectomy	Surgical and medical procedures	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Ovarian Cystectomy	Surgical and medical procedures	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Packed Red Blood Cell Transfusion	Surgical and medical procedures	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Percutaneous Coronary Intervention	Surgical and medical procedures	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Rehabilitation Therapy	Surgical and medical procedures	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Transfusion	Surgical and medical procedures	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Varicose Vein Operation	Surgical and medical procedures	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Vascular Operation	Surgical and medical procedures	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Circulatory Collapse	Vascular disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0002 affected709 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0003 affected709 at risk
Hypotension	Vascular disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0006 affected709 at risk
Hypovolaemic Shock	Vascular disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Orthostatic Hypotension	Vascular disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Peripheral Arterial Occlusive Disease	Vascular disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Peripheral Ischaemia	Vascular disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Superior Vena Cava Perforation	Vascular disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Vasculitis	Vascular disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk
Venous Thrombosis Limb	Vascular disorders	MedDRA Version 22.0	Non-systematic Assessment	EG0001 affected709 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 22.0	Non-systematic Assessment	EG00065 affected709 at risk
Palpitations	Cardiac disorders	MedDRA Version 22.0	Non-systematic Assessment	EG00043 affected709 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG000209 affected709 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG000135 affected709 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG00074 affected709 at risk
Fatigue	General disorders	MedDRA Version 22.0	Non-systematic Assessment	EG00044 affected709 at risk
Oedema Peripheral	General disorders	MedDRA Version 22.0	Non-systematic Assessment	EG00090 affected709 at risk
Bronchitis	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG00059 affected709 at risk
Nasopharyngitis	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG00088 affected709 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG00084 affected709 at risk
Urinary Tract Infection	Infections and infestations	MedDRA Version 22.0	Non-systematic Assessment	EG00042 affected709 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 22.0	Non-systematic Assessment	EG00044 affected709 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 22.0	Non-systematic Assessment	EG00065 affected709 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA Version 22.0	Non-systematic Assessment	EG00068 affected709 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 22.0	Non-systematic Assessment	EG00078 affected709 at risk
Pain in Jaw	Musculoskeletal and connective tissue disorders	MedDRA Version 22.0	Non-systematic Assessment	EG000130 affected709 at risk
Dizziness	Nervous system disorders	MedDRA Version 22.0	Non-systematic Assessment	EG00071 affected709 at risk
Headache	Nervous system disorders	MedDRA Version 22.0	Non-systematic Assessment	EG000328 affected709 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG00080 affected709 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG00076 affected709 at risk
Pulmonary Arterial Hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Non-systematic Assessment	EG00068 affected709 at risk
Flushing	Vascular disorders	MedDRA Version 22.0	Non-systematic Assessment	EG00049 affected709 at risk
Hypotension	Vascular disorders	MedDRA Version 22.0	Non-systematic Assessment	EG00038 affected709 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Mobile	Alabama		United States

ID	Term
D006976	Hypertension, Pulmonary
D008171	Lung Diseases
D012140	Respiratory Tract Diseases