Clinical Study to Assess the Long-term Safety and Tolerab... | NCT00667823

NCT00667823

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
ACT-064992	Experimental	ACT-064992	Drug: Macitentan

Name	Type	Description	Arm Group Labels	Other Names
Macitentan	Drug	Tablet, oral administration, 10 mg dose once daily	ACT-064992

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to 28 Days After Study Treatment Discontinuation	An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAE are defined as AEs with onset during the treatment period or that are a consequence of a pre-existing condition that has worsened since baseline.	Up to 28 days after study treatment discontinuation (Up to 12 years)
Number of Participants With Death up to 28 Days After Study Treatment Discontinuation	Number of participants with deaths up to 28 days after study treatment discontinuation were reported.	Up to 28 days after study treatment discontinuation (Up to 12 years)
Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) up to 28 Days After Study Treatment Discontinuation	An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAE are defined as AEs with onset during the treatment period or that are a consequence of a pre-existing condition that has worsened since baseline. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically significant, or requires intervention to prevent at least one of the outcomes listed above.	Up to 28 days after study treatment discontinuation (Up to 12 years)
Number of Participants With AEs Leading to Permanent Discontinuation of Study Treatment	Number of participants with AEs leading to permanent discontinuation of study treatment were reported. An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35249-0001	United States
Arizona Pulmonary Specialists

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35819570	Derived	Souza R, Delcroix M, Galie N, Jansa P, Mehta S, Pulido T, Rubin L, Sastry BKS, Simonneau G, Sitbon O, Torbicki A, Boyanova N, Chamitava L, Stein C, Channick RN. Long-Term Safety, Tolerability and Survival in Patients with Pulmonary Arterial Hypertension Treated with Macitentan: Results from the SERAPHIN Open-Label Extension. Adv Ther. 2022 Sep;39(9):4374-4390. doi: 10.1007/s12325-022-02199-x. Epub 2022 Jul 12.
29501590

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Macitentan 10 mg	Participants with symptomatic pulmonary arterial hypertension (PAH) who completed or have experienced a morbidity/clinical worsening of PAH in the study AC-055-302 (NCT00660179) and opted to continue this open label extension (OLE) study received macitentan oral tablet, 10 milligrams (mg) once daily from Day 1 up to end of study (up to 12 years) which depends on following a). transition to commercially available macitentan in the participant's country b). the sponsor decided to stop the OL study, and c). the participant's or investigators or sponsors decision to discontinue study treatment.

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	Jul 17, 2020	Dec 2, 2021

Arm/Group Information

ID	Title	Description
BG000	Macitentan 10 mg	Participants with symptomatic pulmonary arterial hypertension (PAH) who completed or have experienced a morbidity/clinical worsening of PAH in the study AC-055-302 (NCT00660179) and opted to continue this open label extension (OLE) study received macitentan oral tablet, 10 milligrams (mg) once daily from Day 1 up to end of study (up to 12 years) which depends on following a). transition to commercially available macitentan in the participant's country b). the sponsor decided to stop the OL study, and c). the participant's or investigators or sponsors decision to discontinue study treatment.

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
	BG00047.7± 15.67

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000440
Male	BG000110

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Asian

Title	Measurements
	BG000165

Other

Title	Measurements
	BG000

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

ARGENTINA

Title	Measurements
	BG00032

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 28 Days After Study Treatment Discontinuation

The safety analysis set (SAF) included all participants who received at least 1 dose of macitentan 10 milligrams (mg).

Posted

Count of Participants

Participants

Up to 28 days after study treatment discontinuation (Up to 12 years)

ID	Title	Description
OG000	Macitentan 10 mg	Participants with symptomatic pulmonary arterial hypertension (PAH) who completed or have experienced a morbidity/clinical worsening of PAH in the study AC-055-302 (NCT00660179) and opted to continue this open label extension (OLE) study received macitentan oral tablet, 10 milligrams (mg) once daily from Day 1 up to end of study (up to 12 years) which depends on following a). transition to commercially available macitentan in the participant's country b). the sponsor decided to stop the OL study, and c). the participant's or investigators or sponsors decision to discontinue study treatment.

Units	Counts
Participants	OG000550

Title

Denominators

Categories

Title	Measurements
	OG000527

Primary

Number of Participants With Death up to 28 Days After Study Treatment Discontinuation

Number of participants with deaths up to 28 days after study treatment discontinuation were reported.

The SAF included all participants who received at least 1 dose of macitentan 10 mg.

Posted

Count of Participants

Participants

Up to 28 days after study treatment discontinuation (Up to 12 years)

ID	Title	Description
OG000	Macitentan 10 mg	Participants with symptomatic pulmonary arterial hypertension (PAH) who completed or have experienced a morbidity/clinical worsening of PAH in the study AC-055-302 (NCT00660179) and opted to continue this open label extension (OLE) study received macitentan oral tablet, 10 milligrams (mg) once daily from Day 1 up to end of study (up to 12 years) which depends on following a). transition to commercially available macitentan in the participant's country b). the sponsor decided to stop the OL study, and c). the participant's or investigators or sponsors decision to discontinue study treatment.

Units	Counts
Participants	OG000

Primary

Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) up to 28 Days After Study Treatment Discontinuation

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAE are defined as AEs with onset during the treatment period or that are a consequence of a pre-existing condition that has worsened since baseline. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically significant, or requires intervention to prevent at least one of the outcomes listed above.

The SAF included all participants who received at least 1 dose of macitentan 10 mg.

Posted

Count of Participants

Participants

Up to 28 days after study treatment discontinuation (Up to 12 years)

ID	Title	Description
OG000	Macitentan 10 mg	Participants with symptomatic pulmonary arterial hypertension (PAH) who completed or have experienced a morbidity/clinical worsening of PAH in the study AC-055-302 (NCT00660179) and opted to continue this open label extension (OLE) study received macitentan oral tablet, 10 milligrams (mg) once daily from Day 1 up to end of study (up to 12 years) which depends on following a). transition to commercially available macitentan in the participant's country b). the sponsor decided to stop the OL study, and c). the participant's or investigators or sponsors decision to discontinue study treatment.

Primary

Number of Participants With AEs Leading to Permanent Discontinuation of Study Treatment

Number of participants with AEs leading to permanent discontinuation of study treatment were reported. An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

The safety analysis set (SAF) included all participants who received at least 1 dose of macitentan 10 mg.

Posted

Count of Participants

Participants

Up to 28 days after study treatment discontinuation (Up to12 years)

ID	Title	Description
OG000	Macitentan 10 mg	Participants with symptomatic pulmonary arterial hypertension (PAH) who completed or have experienced a morbidity/clinical worsening of PAH in the study AC-055-302 (NCT00660179) and opted to continue this open label extension (OLE) study received macitentan oral tablet, 10 milligrams (mg) once daily from Day 1 up to end of study (up to 12 years) which depends on following a). transition to commercially available macitentan in the participant's country b). the sponsor decided to stop the OL study, and c). the participant's or investigators or sponsors decision to discontinue study treatment.

Units	Counts
Participants

Primary

Number of Participants With Treatment Emergent Abnormal Liver Tests up to 28 Days After Study Treatment Discontinuation

Number of participants with treatment-emergent abnormal liver tests: Alanine aminotransferase (ALT) greater than (>) 3*upper limit of normal (ULN) or aspartate aminotransferase (AST) >3* ULN, ALT >5* ULN or AST >5*ULN, ALT >8*ULN or AST >8*ULN, total bilirubin (TBIL) >2*ULN, ALT >3*ULN or AST >3*ULN and TBIL >2*ULN at any time were reported.

The SAF included all participants who received at least 1 dose of macitentan 10 mg.

Posted

Count of Participants

Participants

Up to 28 days after study treatment discontinuation (Up to12 years)

ID	Title	Description
OG000	Macitentan 10 mg	Participants with symptomatic pulmonary arterial hypertension (PAH) who completed or have experienced a morbidity/clinical worsening of PAH in the study AC-055-302 (NCT00660179) and opted to continue this open label extension (OLE) study received macitentan oral tablet, 10 milligrams (mg) once daily from Day 1 up to end of study (up to 12 years) which depends on following a). transition to commercially available macitentan in the participant's country b). the sponsor decided to stop the OL study, and c). the participant's or investigators or sponsors decision to discontinue study treatment.

Units	Counts
Participants

Primary

Number of Participants With Treatment Emergent Hemoglobin Abnormality up to 28 Days After Study Treatment Discontinuation

Number of participants with treatment-emergent hemoglobin (HGB) abnormality up to 28 days after study treatment discontinuation were reported. Participants assessed for different categories of HGB were <=80 grams/Liter (g/L), <=100g/L, decrease from baseline >=20 g/L, and decrease from baseline >=50 g/L.

The SAF included all participants who received at least 1 dose of macitentan 10 mg.

Posted

Count of Participants

Participants

Up to 28 days after treatment discontinuation (Up to 12 years)

ID	Title	Description
OG000	Macitentan 10 mg	Participants with symptomatic pulmonary arterial hypertension (PAH) who completed or have experienced a morbidity/clinical worsening of PAH in the study AC-055-302 (NCT00660179) and opted to continue this open label extension (OLE) study received macitentan oral tablet, 10 milligrams (mg) once daily from Day 1 up to end of study (up to 12 years) which depends on following a). transition to commercially available macitentan in the participant's country b). the sponsor decided to stop the OL study, and c). the participant's or investigators or sponsors decision to discontinue study treatment.

Units	Counts
Participants

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	Macitentan 10 mg	Participants with symptomatic pulmonary arterial hypertension (PAH) who completed or have experienced a morbidity/clinical worsening of PAH in the study AC-055-302 (NCT00660179) and opted to continue this open label extension (OLE) study received macitentan oral tablet, 10 milligrams (mg) once daily from Day 1 up to end of study (up to 12 years) which depends on following a). transition to commercially available macitentan in the participant's country b). the sponsor decided to stop the OL study, and c). the participant's or investigators or sponsors decision to discontinue study treatment.	182	550	354	550	476	550

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00027 affected550 at risk
Autoimmune Haemolytic Anaemia	Blood and lymphatic system disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Hypercoagulation	Blood and lymphatic system disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Iron Deficiency Anaemia	Blood and lymphatic system disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0003 affected550 at risk
Acute Coronary Syndrome	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Acute Right Ventricular Failure	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00011 affected550 at risk
Angina Pectoris	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Arrhythmia	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0003 affected550 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0007 affected550 at risk
Atrial Flutter	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0008 affected550 at risk
Bradycardia	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Cardiac Arrest	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0009 affected550 at risk
Cardiac Disorder	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Cardiac Failure	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0007 affected550 at risk
Cardiac Failure Acute	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Cardiac Failure Chronic	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0006 affected550 at risk
Cardio-Respiratory Arrest	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0004 affected550 at risk
Cardiogenic Shock	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0009 affected550 at risk
Cardiopulmonary Failure	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Cardiorenal Syndrome	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Chronic Right Ventricular Failure	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Cyanosis	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Left Ventricular Dysfunction	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Left Ventricular Failure	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Myocardial Infarction	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0004 affected550 at risk
Myocardial Ischaemia	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Palpitations	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0003 affected550 at risk
Pericardial Effusion	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Right Ventricular Dysfunction	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Right Ventricular Failure	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00072 affected550 at risk
Stress Cardiomyopathy	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Supraventricular Tachycardia	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Ventricular Fibrillation	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Ventricular Tachycardia	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Vertigo Positional	Ear and labyrinth disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Cataract	Eye disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Abdominal Distension	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0003 affected550 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Anal Fistula	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Ascites	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Colitis	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0003 affected550 at risk
Duodenal Perforation	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Enterocolitis Haemorrhagic	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Gastritis	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Gastritis Erosive	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Gastroduodenitis	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Gastrointestinal Disorder	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0003 affected550 at risk
Gastrointestinal Necrosis	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Haematemesis	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Hiatus Hernia	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Ileus Paralytic	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Intestinal Pseudo-Obstruction	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Lower Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Pancreatitis Acute	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Pancreatitis Relapsing	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Peptic Ulcer	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Umbilical Hernia	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0003 affected550 at risk
Upper Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0006 affected550 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Cardiac Death	General disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Chest Discomfort	General disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0003 affected550 at risk
Chest Pain	General disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00011 affected550 at risk
Death	General disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0005 affected550 at risk
Drug Ineffective	General disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Fatigue	General disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
General Physical Health Deterioration	General disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Influenza Like Illness	General disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Infusion Site Pain	General disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Multiple Organ Dysfunction Syndrome	General disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0004 affected550 at risk
Oedema Peripheral	General disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Peripheral Swelling	General disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Pyrexia	General disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0004 affected550 at risk
Sudden Cardiac Death	General disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0003 affected550 at risk
Sudden Death	General disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00011 affected550 at risk
Vascular Stent Thrombosis	General disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Bile Duct Stone	Hepatobiliary disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Cholecystitis Acute	Hepatobiliary disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Hepatic Function Abnormal	Hepatobiliary disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Hepatic Steatosis	Hepatobiliary disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Drug Hypersensitivity	Immune system disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Abscess Limb	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Appendicitis	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0003 affected550 at risk
Arthritis Bacterial	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Atypical Pneumonia	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Bronchitis	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0009 affected550 at risk
Bronchitis Viral	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Candida Sepsis	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Cellulitis	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0004 affected550 at risk
Device Related Infection	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Endocarditis	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Erysipelas	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Gastroenteritis	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0004 affected550 at risk
Gastroenteritis Bacterial	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Gastroenteritis Norovirus	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Gastroenteritis Salmonella	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Herpes Zoster	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Hiv Infection	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Infected Skin Ulcer	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Infective Exacerbation of Chronic Obstructive Airways Disease	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Influenza	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0005 affected550 at risk
Joint Tuberculosis	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Laryngitis Bacterial	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Localised Infection	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Lower Respiratory Tract Infection	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0008 affected550 at risk
Lung Infection	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0008 affected550 at risk
Meningitis	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Peritonitis	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Pneumococcal Sepsis	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Pneumonia	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG00040 affected550 at risk
Pneumonia Influenzal	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Pneumonia Klebsiella	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Pneumonia Streptococcal	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Postoperative Wound Infection	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Pulmonary Sepsis	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Pulmonary Tuberculosis	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Pyelonephritis	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Pyelonephritis Acute	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0003 affected550 at risk
Respiratory Tract Infection Viral	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Salmonella Sepsis	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Sepsis	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0004 affected550 at risk
Septic Shock	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0006 affected550 at risk
Staphylococcal Bacteraemia	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Subcutaneous Abscess	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Tuberculosis	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0008 affected550 at risk
Urinary Tract Infection	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0003 affected550 at risk
Urosepsis	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Viral Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Accidental Overdose	Injury, poisoning and procedural complications	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Acetabulum Fracture	Injury, poisoning and procedural complications	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Ankle Fracture	Injury, poisoning and procedural complications	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Brain Contusion	Injury, poisoning and procedural complications	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Fall	Injury, poisoning and procedural complications	MedDRA Version 21.0	Non-systematic Assessment	EG0005 affected550 at risk
Femoral Neck Fracture	Injury, poisoning and procedural complications	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Femur Fracture	Injury, poisoning and procedural complications	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Foot Fracture	Injury, poisoning and procedural complications	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Humerus Fracture	Injury, poisoning and procedural complications	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Perineal Injury	Injury, poisoning and procedural complications	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Post Procedural Haematoma	Injury, poisoning and procedural complications	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Post Procedural Haemorrhage	Injury, poisoning and procedural complications	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Radius Fracture	Injury, poisoning and procedural complications	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Spinal Compression Fracture	Injury, poisoning and procedural complications	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Subarachnoid Haemorrhage	Injury, poisoning and procedural complications	MedDRA Version 21.0	Non-systematic Assessment	EG0003 affected550 at risk
Subdural Haematoma	Injury, poisoning and procedural complications	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Thermal Burn	Injury, poisoning and procedural complications	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Thoracic Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Toxicity to Various Agents	Injury, poisoning and procedural complications	MedDRA Version 21.0	Non-systematic Assessment	EG0003 affected550 at risk
Traumatic Haematoma	Injury, poisoning and procedural complications	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Traumatic Haemorrhage	Injury, poisoning and procedural complications	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Ulna Fracture	Injury, poisoning and procedural complications	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Upper Limb Fracture	Injury, poisoning and procedural complications	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Anticoagulation Drug Level above Therapeutic	Investigations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Blood Bilirubin Increased	Investigations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Catheterisation Cardiac	Investigations	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Computerised Tomogram Abnormal	Investigations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
International Normalised Ratio Increased	Investigations	MedDRA Version 21.0	Non-systematic Assessment	EG0003 affected550 at risk
Investigation	Investigations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Liver Function Test Increased	Investigations	MedDRA Version 21.0	Non-systematic Assessment	EG0003 affected550 at risk
Oxygen Saturation Decreased	Investigations	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0004 affected550 at risk
Electrolyte Imbalance	Metabolism and nutrition disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Fluid Overload	Metabolism and nutrition disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0004 affected550 at risk
Fluid Retention	Metabolism and nutrition disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Gout	Metabolism and nutrition disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0004 affected550 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0005 affected550 at risk
Metabolic Acidosis	Metabolism and nutrition disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Intervertebral Disc Degeneration	Musculoskeletal and connective tissue disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Joint Swelling	Musculoskeletal and connective tissue disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Mixed Connective Tissue Disease	Musculoskeletal and connective tissue disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Polymyositis	Musculoskeletal and connective tissue disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Rheumatoid Arthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Scleroderma	Musculoskeletal and connective tissue disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0003 affected550 at risk
Spinal Column Stenosis	Musculoskeletal and connective tissue disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Systemic Lupus Erythematosus	Musculoskeletal and connective tissue disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0005 affected550 at risk
Systemic Scleroderma	Musculoskeletal and connective tissue disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Anogenital Warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Bladder Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Brain Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Cardiac Valve Fibroelastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Colon Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Intraductal Proliferative Breast Lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Invasive Ductal Breast Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Metastases to Lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Metastatic Uterine Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Nasopharyngeal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Ovarian Adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Ovarian Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Rectosigmoid Cancer Recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Richter's Syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Squamous Cell Carcinoma of Lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Squamous Cell Carcinoma of the Cervix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Uterine Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Uterine Leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Amnesia	Nervous system disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Brain Oedema	Nervous system disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Cerebellar Infarction	Nervous system disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Dizziness	Nervous system disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Headache	Nervous system disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Hepatic Encephalopathy	Nervous system disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Ischaemic Stroke	Nervous system disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Loss of Consciousness	Nervous system disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Polyneuropathy	Nervous system disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Radiculopathy	Nervous system disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Syncope	Nervous system disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00020 affected550 at risk
Abortion Missed	Pregnancy, puerperium and perinatal conditions	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Abortion Spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Device Dislocation	Product Issues	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Device Malfunction	Product Issues	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Anxiety	Psychiatric disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Anxiety Disorder	Psychiatric disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Completed Suicide	Psychiatric disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Confusional State	Psychiatric disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Depression	Psychiatric disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Mental Status Changes	Psychiatric disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Acute Kidney Injury	Renal and urinary disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0008 affected550 at risk
Calculus Urinary	Renal and urinary disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Chronic Kidney Disease	Renal and urinary disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Cystitis Haemorrhagic	Renal and urinary disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Lupus Nephritis	Renal and urinary disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Neurogenic Bladder	Renal and urinary disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Pollakiuria	Renal and urinary disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Prerenal Failure	Renal and urinary disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Renal Colic	Renal and urinary disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0003 affected550 at risk
Renal Failure	Renal and urinary disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Renal Impairment	Renal and urinary disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Menometrorrhagia	Reproductive system and breast disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Ovarian Cyst	Reproductive system and breast disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0004 affected550 at risk
Ovarian Cyst Ruptured	Reproductive system and breast disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Ovarian Cyst Torsion	Reproductive system and breast disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Pelvic Haematoma	Reproductive system and breast disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Uterine Haemorrhage	Reproductive system and breast disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Vaginal Haemorrhage	Reproductive system and breast disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Acute Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0004 affected550 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Bronchitis Chronic	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Chronic Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00016 affected550 at risk
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0005 affected550 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0008 affected550 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0003 affected550 at risk
Nasal Polyps	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Organising Pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0003 affected550 at risk
Pulmonary Arterial Hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG000123 affected550 at risk
Pulmonary Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00010 affected550 at risk
Pulmonary Fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Pulmonary Haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Pulmonary Hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0006 affected550 at risk
Pulmonary Hypertensive Crisis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0003 affected550 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0005 affected550 at risk
Respiratory Tract Haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Photosensitivity Reaction	Skin and subcutaneous tissue disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Rash Pruritic	Skin and subcutaneous tissue disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Aortic Surgery	Surgical and medical procedures	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Bunion Operation	Surgical and medical procedures	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Chemotherapy	Surgical and medical procedures	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Cholecystectomy	Surgical and medical procedures	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Gastric Polypectomy	Surgical and medical procedures	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Hysterectomy	Surgical and medical procedures	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Lung Transplant	Surgical and medical procedures	MedDRA Version 21.0	Non-systematic Assessment	EG0007 affected550 at risk
Oophorectomy	Surgical and medical procedures	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Osteosynthesis	Surgical and medical procedures	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Therapy Cessation	Surgical and medical procedures	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Transfusion	Surgical and medical procedures	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Accelerated Hypertension	Vascular disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Aneurysm Ruptured	Vascular disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Aortic Aneurysm	Vascular disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Aortic Aneurysm Rupture	Vascular disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Circulatory Collapse	Vascular disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected550 at risk
Haematoma	Vascular disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Hypertension	Vascular disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Hypotension	Vascular disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0003 affected550 at risk
Hypovolaemic Shock	Vascular disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk
Venous Thrombosis Limb	Vascular disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected550 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00080 affected550 at risk
Iron Deficiency Anaemia	Blood and lymphatic system disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00014 affected550 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00022 affected550 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00036 affected550 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00024 affected550 at risk
Palpitations	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00034 affected550 at risk
Right Ventricular Failure	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00024 affected550 at risk
Tachycardia	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00022 affected550 at risk
Hypothyroidism	Endocrine disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00021 affected550 at risk
Abdominal Distension	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00014 affected550 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00012 affected550 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00022 affected550 at risk
Constipation	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00020 affected550 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00059 affected550 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00013 affected550 at risk
Gastritis	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00011 affected550 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00021 affected550 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00028 affected550 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00024 affected550 at risk
Chest Pain	General disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00035 affected550 at risk
Fatigue	General disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00019 affected550 at risk
Oedema Peripheral	General disorders	MedDRA Version 21.0	Non-systematic Assessment	EG000105 affected550 at risk
Pyrexia	General disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00025 affected550 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00026 affected550 at risk
Bronchitis	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG00078 affected550 at risk
Cellulitis	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG00011 affected550 at risk
Cystitis	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG00011 affected550 at risk
Gastroenteritis	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG00016 affected550 at risk
Influenza	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG00017 affected550 at risk
Laryngitis	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG00011 affected550 at risk
Lower Respiratory Tract Infection	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG00012 affected550 at risk
Nasopharyngitis	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG000105 affected550 at risk
Pharyngitis	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG00028 affected550 at risk
Pneumonia	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG00029 affected550 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG00031 affected550 at risk
Respiratory Tract Infection Viral	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG00023 affected550 at risk
Rhinitis	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG00016 affected550 at risk
Sinusitis	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG00018 affected550 at risk
Tooth Abscess	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG00011 affected550 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG000121 affected550 at risk
Urinary Tract Infection	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG00046 affected550 at risk
Ligament Sprain	Injury, poisoning and procedural complications	MedDRA Version 21.0	Non-systematic Assessment	EG00011 affected550 at risk
Alanine Aminotransferase Increased	Investigations	MedDRA Version 21.0	Non-systematic Assessment	EG00022 affected550 at risk
Aspartate Aminotransferase Increased	Investigations	MedDRA Version 21.0	Non-systematic Assessment	EG00020 affected550 at risk
Blood Bilirubin Increased	Investigations	MedDRA Version 21.0	Non-systematic Assessment	EG00016 affected550 at risk
Blood Creatinine Increased	Investigations	MedDRA Version 21.0	Non-systematic Assessment	EG00012 affected550 at risk
Haemoglobin Decreased	Investigations	MedDRA Version 21.0	Non-systematic Assessment	EG00013 affected550 at risk
Liver Function Test Increased	Investigations	MedDRA Version 21.0	Non-systematic Assessment	EG00015 affected550 at risk
Weight Decreased	Investigations	MedDRA Version 21.0	Non-systematic Assessment	EG00019 affected550 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00018 affected550 at risk
Gout	Metabolism and nutrition disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00016 affected550 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00011 affected550 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00016 affected550 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00015 affected550 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00039 affected550 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00033 affected550 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00033 affected550 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00015 affected550 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00012 affected550 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00021 affected550 at risk
Dizziness	Nervous system disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00055 affected550 at risk
Headache	Nervous system disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00063 affected550 at risk
Syncope	Nervous system disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00040 affected550 at risk
Anxiety	Psychiatric disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00013 affected550 at risk
Depression	Psychiatric disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00012 affected550 at risk
Insomnia	Psychiatric disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00036 affected550 at risk
Acute Kidney Injury	Renal and urinary disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00014 affected550 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00074 affected550 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00054 affected550 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00027 affected550 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00018 affected550 at risk
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00014 affected550 at risk
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00018 affected550 at risk
Pulmonary Arterial Hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00047 affected550 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00016 affected550 at risk
Skin Ulcer	Skin and subcutaneous tissue disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00013 affected550 at risk
Hypotension	Vascular disorders	MedDRA Version 21.0	Non-systematic Assessment	EG00020 affected550 at risk

Certain Agreements

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