Liraglutide Effect and Action in Diabetes: Evaluation of... | NCT01179048

ID	Type	Description
2009-012201-19	EudraCT Number
U1111-1113-7090	Other Identifier	WHO
CTR20130003	Other Identifier	CFDA

Label	Type	Description	Intervention Names
Liraglutide	Experimental		Drug: liraglutide
Placebo	Placebo Comparator		Drug: placebo

Name	Type	Description	Arm Group Labels	Other Names
liraglutide	Drug	Maximum dose of 1.8 mg liraglutide, injected subcutaneously (under the skin) once daily. Administered in addition to the subject's standard treatment	Liraglutide

Measure	Description	Time Frame
Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)	Time from randomisation to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome). The percentage of subjects experiencing a first event of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome) is presented.	from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)

Measure	Description	Time Frame
Time From Rand. to First Occurrence of an Expanded Composite Cardiovascular Outcome Defined as Either Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, Revascularisation, Hospitalisation for Unstable Angina or for Heart Failure.	Time from randomisation to first occurrence of an expanded composite cardiovascular outcome defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or for heart failure. The percentage of subjects experiencing first occurrence of an expanded composite cardiovascular outcome defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or for heart failure is presented.

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Alabaster	Alabama	35007	United States
Novo Nordisk Investigational Site

PubMed Identifier	Type	Citation	Retractions
30851070	Background	Verma S, Bain SC, Monk Fries T, Mazer CD, Nauck MA, Pratley RE, Rasmussen S, Saevereid HA, Zinman B, Buse JB. Duration of diabetes and cardiorenal efficacy of liraglutide and semaglutide: A post hoc analysis of the LEADER and SUSTAIN 6 clinical trials. Diabetes Obes Metab. 2019 Jul;21(7):1745-1751. doi: 10.1111/dom.13698. Epub 2019 Apr 2.
30900349

Label	URL
Clinical Trials at Novo Nordisk	View source

ID	Title	Description
FG000	Liraglutide	Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0013 events3 affected4,672 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0015 events5 affected4,672 at risk
Abdominal incarcerated hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Abdominal mass	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00020 events20 affected4,668 at risk EG00116 events15 affected4,672 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0012 events2 affected4,672 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0006 events5 affected4,668 at risk EG0014 events4 affected4,672 at risk
Abdominal panniculectomy	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Abdominal strangulated hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Abdominal wall abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events1 affected4,668 at risk EG0015 events4 affected4,672 at risk
Abdominal wound dehiscence	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Abdominoplasty	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Abscess limb	Infections and infestations	MedDRA	Systematic Assessment	EG0005 events5 affected4,668 at risk EG0016 events6 affected4,672 at risk
Abscess neck	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Abscess of salivary gland	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Accelerated hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0014 events4 affected4,672 at risk
Accident	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0005 events5 affected4,668 at risk EG0011 events1 affected4,672 at risk
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Acid peptic disease	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Acquired claw toe	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Acquired oesophageal web	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Acquired phimosis	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Actinic elastosis	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0005 events4 affected4,668 at risk EG0011 events1 affected4,672 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA	Systematic Assessment	EG00041 events37 affected4,668 at risk EG00159 events54 affected4,672 at risk
Acute hepatitis B	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Acute interstitial pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA	Systematic Assessment	EG000124 events108 affected4,668 at risk EG001105 events94 affected4,672 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0017 events7 affected4,672 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0012 events2 affected4,672 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG000176 events155 affected4,668 at risk EG001211 events187 affected4,672 at risk
Acute prerenal failure	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00015 events13 affected4,668 at risk EG00113 events10 affected4,672 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0013 events3 affected4,672 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00023 events22 affected4,668 at risk EG00121 events18 affected4,672 at risk
Acute sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Adams-Stokes syndrome	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0013 events3 affected4,672 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0013 events3 affected4,672 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG00015 events14 affected4,668 at risk EG00111 events11 affected4,672 at risk
Adenocarcinoma of the cervix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0011 events1 affected4,672 at risk
Adhesion	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Adrenal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0012 events2 affected4,672 at risk
Adrenal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0012 events2 affected4,672 at risk
Adverse drug reaction	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Afferent loop syndrome	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Air embolism	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Alcohol abuse	Psychiatric disorders	MedDRA	Systematic Assessment	EG0002 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Alcoholism	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Alopecia areata	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Altered state of consciousness	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Amaurosis	Eye disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Ammonia increased	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Amylase increased	Investigations	MedDRA	Systematic Assessment	EG0005 events5 affected4,668 at risk EG0012 events2 affected4,672 at risk
Amyloidosis	Immune system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG00032 events31 affected4,668 at risk EG00122 events21 affected4,672 at risk
Anaemia macrocytic	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Anaemia megaloblastic	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Anaemia vitamin B12 deficiency	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Anal abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Anal fistula	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Anal skin tags	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Anal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Anaphylactic reaction	Immune system disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Anastomotic ulcer	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Angina pectoris	Cardiac disorders	MedDRA	Systematic Assessment	EG000105 events93 affected4,668 at risk EG001106 events93 affected4,672 at risk
Angina unstable	Cardiac disorders	MedDRA	Systematic Assessment	EG000179 events144 affected4,668 at risk EG001180 events151 affected4,672 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0008 events6 affected4,668 at risk EG0017 events7 affected4,672 at risk
Angiogram peripheral	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Angiomyolipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Angioplasty	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0008 events7 affected4,668 at risk EG00112 events11 affected4,672 at risk
Angle closure glaucoma	Eye disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0016 events5 affected4,672 at risk
Ankle operation	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Anxiety	Psychiatric disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0012 events2 affected4,672 at risk
Aortic aneurysm	Vascular disorders	MedDRA	Systematic Assessment	EG0008 events8 affected4,668 at risk EG0015 events5 affected4,672 at risk
Aortic aneurysm repair	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Aortic aneurysm rupture	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Aortic arteriosclerosis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Aortic bypass	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0012 events1 affected4,672 at risk
Aortic dissection	Vascular disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0010 events0 affected4,672 at risk
Aortic occlusion	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Aortic stenosis	Vascular disorders	MedDRA	Systematic Assessment	EG00011 events11 affected4,668 at risk EG0017 events7 affected4,672 at risk
Aortic surgery	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Aortic valve calcification	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Aortic valve sclerosis	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA	Systematic Assessment	EG0006 events6 affected4,668 at risk EG00110 events10 affected4,672 at risk
Aphakia	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Appendicitis	Infections and infestations	MedDRA	Systematic Assessment	EG0008 events8 affected4,668 at risk EG00111 events11 affected4,672 at risk
Appendicitis perforated	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Arrhythmia	Cardiac disorders	MedDRA	Systematic Assessment	EG00011 events10 affected4,668 at risk EG0015 events5 affected4,672 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Arterial repair	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Arterial restenosis	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Arterial stent insertion	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Arterial therapeutic procedure	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Arteriogram coronary	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0017 events7 affected4,672 at risk
Arteriosclerosis	Vascular disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0015 events5 affected4,672 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA	Systematic Assessment	EG0007 events7 affected4,668 at risk EG00112 events12 affected4,672 at risk
Arteriosclerotic gangrene	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Arteriovenous fistula operation	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0013 events2 affected4,672 at risk
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0014 events1 affected4,672 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Arteriovenous malformation	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00010 events10 affected4,668 at risk EG00114 events13 affected4,672 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00017 events16 affected4,668 at risk EG0015 events5 affected4,672 at risk
Arthritis bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0014 events3 affected4,672 at risk
Arthritis infective	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Arthritis reactive	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Asbestosis	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Ascites	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Asphyxia	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Asthenia	General disorders	MedDRA	Systematic Assessment	EG00010 events9 affected4,668 at risk EG0014 events4 affected4,672 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00014 events12 affected4,668 at risk EG00123 events14 affected4,672 at risk
Asthmatic crisis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Ataxia	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Atherectomy	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0002 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Atrial fibrillation	Cardiac disorders	MedDRA	Systematic Assessment	EG000113 events89 affected4,668 at risk EG001112 events97 affected4,672 at risk
Atrial flutter	Cardiac disorders	MedDRA	Systematic Assessment	EG00020 events17 affected4,668 at risk EG00118 events16 affected4,672 at risk
Atrial septal defect	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Atrial tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0014 events4 affected4,672 at risk
Atrioventricular block	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0014 events4 affected4,672 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA	Systematic Assessment	EG00010 events10 affected4,668 at risk EG0019 events9 affected4,672 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA	Systematic Assessment	EG0005 events5 affected4,668 at risk EG0014 events4 affected4,672 at risk
Atrioventricular dissociation	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Atypical pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Aural polyp	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Autoimmune thyroiditis	Endocrine disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Autoimmune uveitis	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Autonomic nervous system imbalance	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Azotaemia	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0012 events2 affected4,672 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0012 events2 affected4,672 at risk
B-cell unclassifiable lymphoma low grade	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Back disorder	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00014 events14 affected4,668 at risk EG00121 events20 affected4,672 at risk
Bacteraemia	Infections and infestations	MedDRA	Systematic Assessment	EG0005 events5 affected4,668 at risk EG0016 events6 affected4,672 at risk
Bacterial food poisoning	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Bacterial infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Bacterial sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Barrett's oesophagus	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0015 events5 affected4,672 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG00017 events14 affected4,668 at risk EG0017 events7 affected4,672 at risk
Basal ganglia haemorrhage	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Basal ganglia stroke	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Basosquamous carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Benign anorectal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Benign breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Benign neoplasm of bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Benign neoplasm of prostate	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Benign neoplasm of thyroid gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Benign ovarian tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG00025 events25 affected4,668 at risk EG00123 events23 affected4,672 at risk
Benign soft tissue neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Bile duct stenosis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0015 events1 affected4,672 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0012 events1 affected4,672 at risk
Biliary adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Biliary cirrhosis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Biliary colic	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0005 events5 affected4,668 at risk EG0013 events2 affected4,672 at risk
Biliary fistula	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Biliary sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Biliary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Bipolar disorder	Psychiatric disorders	MedDRA	Systematic Assessment	EG0005 events3 affected4,668 at risk EG0013 events2 affected4,672 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0015 events5 affected4,672 at risk
Bladder cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Bladder cancer stage 0, with cancer in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Bladder cancer stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Bladder diverticulum	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Bladder dysplasia	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Bladder hypertrophy	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Bladder injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Bladder neck obstruction	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0013 events3 affected4,672 at risk
Bladder outlet obstruction	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Bladder prolapse	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0011 events1 affected4,672 at risk
Bladder squamous cell carcinoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Bladder stenosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0015 events5 affected4,672 at risk
Bladder transitional cell carcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Bladder transitional cell carcinoma stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Blepharal papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Blepharitis	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Blindness unilateral	Eye disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Blood alcohol increased	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Blood calcitonin increased	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0013 events3 affected4,672 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Blood creatinine increased	Investigations	MedDRA	Systematic Assessment	EG0006 events6 affected4,668 at risk EG0013 events3 affected4,672 at risk
Blood glucose fluctuation	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Blood glucose increased	Investigations	MedDRA	Systematic Assessment	EG0008 events8 affected4,668 at risk EG00111 events8 affected4,672 at risk
Blood iron decreased	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Blood magnesium decreased	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Blood potassium decreased	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Blood potassium increased	Investigations	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Blood pressure decreased	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Blood pressure fluctuation	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Blood pressure inadequately controlled	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Blood pressure increased	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0013 events3 affected4,672 at risk
Blood pressure systolic increased	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Blood urea increased	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Blood urine present	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Bone neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Bradycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG00011 events11 affected4,668 at risk EG00111 events11 affected4,672 at risk
Brain herniation	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Brain injury	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Brain oedema	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Brain stem infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Breast abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0013 events2 affected4,672 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0006 events6 affected4,668 at risk EG0016 events6 affected4,672 at risk
Breast cancer female	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Breast cancer in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Breast mass	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0012 events2 affected4,672 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Bronchiolitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG00015 events15 affected4,668 at risk EG00125 events24 affected4,672 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Bronchopneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG00013 events11 affected4,668 at risk EG00121 events19 affected4,672 at risk
Bronchopneumopathy	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0006 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Bundle branch block left	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0012 events2 affected4,672 at risk
Bundle branch block right	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Buried penis syndrome	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Burns second degree	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0011 events1 affected4,672 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Calculus bladder	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA	Systematic Assessment	EG00010 events10 affected4,668 at risk EG0019 events9 affected4,672 at risk
Calculus urinary	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0012 events2 affected4,672 at risk
Campylobacter gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Carbon monoxide poisoning	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Carbuncle	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Carcinoid tumour of the small bowel	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Carcinoid tumour pulmonary	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Cardiac ablation	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Cardiac aneurysm	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Cardiac arrest	Cardiac disorders	MedDRA	Systematic Assessment	EG00020 events20 affected4,668 at risk EG00131 events31 affected4,672 at risk
Cardiac death	General disorders	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0016 events6 affected4,672 at risk
Cardiac discomfort	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Cardiac disorder	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Cardiac failure	Cardiac disorders	MedDRA	Systematic Assessment	EG000138 events115 affected4,668 at risk EG001201 events137 affected4,672 at risk
Cardiac failure acute	Cardiac disorders	MedDRA	Systematic Assessment	EG00011 events9 affected4,668 at risk EG00112 events11 affected4,672 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA	Systematic Assessment	EG00028 events28 affected4,668 at risk EG00129 events25 affected4,672 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA	Systematic Assessment	EG000180 events121 affected4,668 at risk EG001176 events129 affected4,672 at risk
Cardiac murmur	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Cardiac pacemaker battery replacement	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Cardiac pacemaker removal	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Cardiac pacemaker replacement	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0013 events3 affected4,672 at risk
Cardiac resynchronisation therapy	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Cardiac stress test abnormal	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Cardiac valve abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Cardiac valve disease	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Cardiac valve replacement complication	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Cardiac valve rupture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Cardiac ventricular thrombosis	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0013 events3 affected4,672 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA	Systematic Assessment	EG00015 events15 affected4,668 at risk EG00115 events13 affected4,672 at risk
Cardiogenic shock	Cardiac disorders	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG00111 events11 affected4,672 at risk
Cardiomegaly	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Cardiomyopathy	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0014 events3 affected4,672 at risk
Cardiopulmonary bypass	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0016 events6 affected4,672 at risk
Cardiorenal syndrome	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Cardiospasm	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Cardiovascular disorder	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Cardiovascular evaluation	Investigations	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0012 events2 affected4,672 at risk
Cardiovascular event prophylaxis	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Cardiovascular insufficiency	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Carotid angioplasty	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0005 events5 affected4,668 at risk EG0010 events0 affected4,672 at risk
Carotid arteriosclerosis	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Carotid artery aneurysm	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Carotid artery bypass	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Carotid artery disease	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Carotid artery occlusion	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0012 events2 affected4,672 at risk
Carotid artery restenosis	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA	Systematic Assessment	EG00030 events28 affected4,668 at risk EG00118 events16 affected4,672 at risk
Carotid artery stent insertion	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0006 events6 affected4,668 at risk EG0012 events2 affected4,672 at risk
Carotid endarterectomy	Surgical and medical procedures	MedDRA	Systematic Assessment	EG00023 events19 affected4,668 at risk EG00114 events14 affected4,672 at risk
Carotid revascularisation	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0006 events6 affected4,668 at risk EG0012 events2 affected4,672 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA	Systematic Assessment	EG0007 events6 affected4,668 at risk EG0014 events4 affected4,672 at risk
Cataract	Eye disorders	MedDRA	Systematic Assessment	EG00029 events24 affected4,668 at risk EG00135 events32 affected4,672 at risk
Cataract operation	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0004 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Cataract operation complication	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Cataract traumatic	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Catheter site haemorrhage	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Catheterisation cardiac	Investigations	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0012 events2 affected4,672 at risk
Cauda equina syndrome	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Cell death	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG00050 events37 affected4,668 at risk EG00161 events54 affected4,672 at risk
Cellulitis gangrenous	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Cellulitis of male external genital organ	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Central nervous system lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Cerebellar haematoma	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Cerebellar infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Cerebellar ischaemia	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Cerebellar tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Cerebral haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Cerebral haematoma	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0015 events5 affected4,672 at risk
Cerebral hypoperfusion	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Cerebral infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG00014 events14 affected4,668 at risk EG00121 events20 affected4,672 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0013 events3 affected4,672 at risk
Cerebral revascularisation	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Cerebral small vessel ischaemic disease	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0010 events0 affected4,672 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA	Systematic Assessment	EG00056 events52 affected4,668 at risk EG00168 events65 affected4,672 at risk
Cerebrovascular insufficiency	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Cervical dysplasia	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Cervical myelopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Cervical polyp	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Cervical radiculopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0013 events3 affected4,672 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Cervicitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Change of bowel habit	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Chest discomfort	General disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0016 events6 affected4,672 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Chest pain	General disorders	MedDRA	Systematic Assessment	EG00056 events53 affected4,668 at risk EG00152 events49 affected4,672 at risk
Chills	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0005 events5 affected4,668 at risk EG0013 events3 affected4,672 at risk
Cholangitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0003 events2 affected4,668 at risk EG0014 events4 affected4,672 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0010 events0 affected4,672 at risk
Cholecystectomy	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG00011 events11 affected4,668 at risk EG00112 events12 affected4,672 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG00035 events35 affected4,668 at risk EG00119 events18 affected4,672 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0008 events8 affected4,668 at risk EG0015 events5 affected4,672 at risk
Cholecystitis infective	Infections and infestations	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0011 events1 affected4,672 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG00045 events44 affected4,668 at risk EG00130 events30 affected4,672 at risk
Cholera	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Cholestasis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Cholesteatoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Cholesterol granuloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Chondrosarcoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Chondrosarcoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Chordae tendinae rupture	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0014 events4 affected4,672 at risk
Chronic hepatic failure	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Chronic hepatitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Chronic inflammatory demyelinating polyradiculoneuropathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA	Systematic Assessment	EG00060 events52 affected4,668 at risk EG00155 events52 affected4,672 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0013 events3 affected4,672 at risk
Chronic lymphocytic leukaemia stage 1	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Chronic myelomonocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00068 events50 affected4,668 at risk EG00182 events59 affected4,672 at risk
Chronic pigmented purpura	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Chronic spontaneous urticaria	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Circulatory collapse	Vascular disorders	MedDRA	Systematic Assessment	EG0005 events4 affected4,668 at risk EG0016 events6 affected4,672 at risk
Cirrhosis alcoholic	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Citrobacter sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0006 events6 affected4,668 at risk EG0013 events3 affected4,672 at risk
Clostridium colitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA	Systematic Assessment	EG0006 events6 affected4,668 at risk EG0013 events3 affected4,672 at risk
Clostridium difficile infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Coarctation of the aorta	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Cognitive disorder	Nervous system disorders	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0014 events3 affected4,672 at risk
Colitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0009 events9 affected4,668 at risk EG0014 events4 affected4,672 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG00014 events13 affected4,668 at risk EG00118 events16 affected4,672 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0016 events6 affected4,672 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0011 events1 affected4,672 at risk
Colon cancer stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Colonic pseudo-obstruction	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Colonoscopy	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Colonoscopy normal	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Colorectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Colostomy closure	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Coma	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0013 events2 affected4,672 at risk
Compartment syndrome	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Completed suicide	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0014 events4 affected4,672 at risk
Complications of transplanted kidney	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0015 events5 affected4,672 at risk
Confusional state	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0019 events9 affected4,672 at risk
Congenital cystic kidney disease	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0013 events3 affected4,672 at risk
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00011 events11 affected4,668 at risk EG0017 events7 affected4,672 at risk
Contrast media allergy	Immune system disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0010 events0 affected4,672 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0012 events2 affected4,672 at risk
Cor pulmonale	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events1 affected4,672 at risk
Cor pulmonale acute	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Cor pulmonale chronic	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Corneal erosion	Eye disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Coronary angioplasty	Surgical and medical procedures	MedDRA	Systematic Assessment	EG00056 events46 affected4,668 at risk EG00142 events39 affected4,672 at risk
Coronary arterial stent insertion	Surgical and medical procedures	MedDRA	Systematic Assessment	EG000117 events110 affected4,668 at risk EG001136 events112 affected4,672 at risk
Coronary artery bypass	Surgical and medical procedures	MedDRA	Systematic Assessment	EG00086 events84 affected4,668 at risk EG001105 events102 affected4,672 at risk
Coronary artery disease	Cardiac disorders	MedDRA	Systematic Assessment	EG00077 events73 affected4,668 at risk EG00189 events87 affected4,672 at risk
Coronary artery insufficiency	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0012 events2 affected4,672 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA	Systematic Assessment	EG00016 events16 affected4,668 at risk EG00110 events10 affected4,672 at risk
Coronary artery reocclusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0005 events5 affected4,668 at risk EG00110 events10 affected4,672 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA	Systematic Assessment	EG00020 events20 affected4,668 at risk EG00136 events35 affected4,672 at risk
Coronary ostial stenosis	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Coronary revascularisation	Surgical and medical procedures	MedDRA	Systematic Assessment	EG000144 events120 affected4,668 at risk EG001157 events132 affected4,672 at risk
Coronary vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0013 events3 affected4,672 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Cryptogenic cirrhosis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Culture urine positive	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Cushing's syndrome	Endocrine disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Cyst	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Cystitis	Infections and infestations	MedDRA	Systematic Assessment	EG0007 events7 affected4,668 at risk EG0011 events1 affected4,672 at risk
Cystocele	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Dacryocystitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Deafness bilateral	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Deafness unilateral	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Death	General disorders	MedDRA	Systematic Assessment	EG00055 events55 affected4,668 at risk EG00147 events47 affected4,672 at risk
Decreased activity	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0011 events1 affected4,672 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Deep brain stimulation	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Deep vein thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG00023 events20 affected4,668 at risk EG00111 events10 affected4,672 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00030 events30 affected4,668 at risk EG00122 events22 affected4,672 at risk
Delayed recovery from anaesthesia	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Delirium	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0013 events3 affected4,672 at risk
Dementia	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0013 events3 affected4,672 at risk
Dementia Alzheimer's type	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Dementia with Lewy bodies	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Dengue fever	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Dependence on respirator	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Depression	Psychiatric disorders	MedDRA	Systematic Assessment	EG00011 events9 affected4,668 at risk EG0017 events7 affected4,672 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Dermoid cyst	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Device battery issue	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Device dislocation	General disorders	MedDRA	Systematic Assessment	EG0003 events2 affected4,668 at risk EG0015 events4 affected4,672 at risk
Device leakage	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Device malfunction	General disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0015 events5 affected4,672 at risk
Device occlusion	General disorders	MedDRA	Systematic Assessment	EG0003 events2 affected4,668 at risk EG0013 events3 affected4,672 at risk
Device related infection	Infections and infestations	MedDRA	Systematic Assessment	EG0005 events5 affected4,668 at risk EG0015 events3 affected4,672 at risk
Device related sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG00112 events11 affected4,672 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00028 events25 affected4,668 at risk EG00147 events43 affected4,672 at risk
Diabetic blindness	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Diabetic complication	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG00088 events66 affected4,668 at risk EG00194 events80 affected4,672 at risk
Diabetic foot infection	Infections and infestations	MedDRA	Systematic Assessment	EG00012 events11 affected4,668 at risk EG00111 events9 affected4,672 at risk
Diabetic gangrene	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00012 events11 affected4,668 at risk EG0018 events7 affected4,672 at risk
Diabetic mononeuropathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0007 events6 affected4,668 at risk EG00111 events11 affected4,672 at risk
Diabetic neuropathic ulcer	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA	Systematic Assessment	EG00010 events9 affected4,668 at risk EG00112 events7 affected4,672 at risk
Diabetic retinal oedema	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Diabetic retinopathy	Eye disorders	MedDRA	Systematic Assessment	EG0009 events9 affected4,668 at risk EG00115 events15 affected4,672 at risk
Diabetic ulcer	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0004 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Diabetic vascular disorder	Vascular disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Dialysis related complication	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00014 events14 affected4,668 at risk EG00111 events11 affected4,672 at risk
Diarrhoea infectious	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Diastasis recti abdominis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Dilatation atrial	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Diplopia	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Disorientation	Psychiatric disorders	MedDRA	Systematic Assessment	EG0002 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0014 events4 affected4,672 at risk
Diverticulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0008 events7 affected4,668 at risk EG00113 events13 affected4,672 at risk
Diverticulitis intestinal haemorrhagic	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Diverticulum	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0017 events7 affected4,672 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0011 events1 affected4,672 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0012 events1 affected4,672 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG00012 events12 affected4,668 at risk EG0016 events6 affected4,672 at risk
Drowning	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Drug hypersensitivity	Immune system disorders	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0011 events1 affected4,672 at risk
Drug interaction	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Drug withdrawal syndrome	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Dry gangrene	Vascular disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Duodenal perforation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Duodenal polyp	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0008 events8 affected4,668 at risk EG0016 events6 affected4,672 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0015 events5 affected4,672 at risk
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Duodenitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0012 events2 affected4,672 at risk
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0010 events0 affected4,672 at risk
Dysarthria	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Dysentery	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Dyskinesia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events1 affected4,672 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0013 events3 affected4,672 at risk
Dysphagia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00021 events20 affected4,668 at risk EG00136 events32 affected4,672 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0006 events6 affected4,668 at risk EG0017 events7 affected4,672 at risk
Dysuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0013 events3 affected4,672 at risk
ECG signs of myocardial ischaemia	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Ear infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Ejection fraction decreased	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Electric shock	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Electrocardiogram QT prolonged	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0013 events3 affected4,672 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Embolic cerebral infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Embolic stroke	Nervous system disorders	MedDRA	Systematic Assessment	EG0006 events5 affected4,668 at risk EG0011 events1 affected4,672 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0013 events3 affected4,672 at risk
Encephalopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Endarterectomy	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0013 events3 affected4,672 at risk
Endocarditis	Infections and infestations	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0014 events4 affected4,672 at risk
Endocarditis enterococcal	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Endocarditis staphylococcal	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Endophthalmitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Enteritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0013 events3 affected4,672 at risk
Enterobacter pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Enterococcal infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0012 events2 affected4,672 at risk
Enterocutaneous fistula	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Enterovesical fistula	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Epididymitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Epididymitis ureaplasmal	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Epilepsy	Nervous system disorders	MedDRA	Systematic Assessment	EG0005 events4 affected4,668 at risk EG0013 events2 affected4,672 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0008 events8 affected4,668 at risk EG0013 events3 affected4,672 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0010 events0 affected4,672 at risk
Erosive oesophagitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Erysipelas	Infections and infestations	MedDRA	Systematic Assessment	EG00011 events10 affected4,668 at risk EG00116 events14 affected4,672 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Escherichia pyelonephritis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Eustachian tube dysfunction	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Extradural abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Extranodal marginal zone B-cell lymphoma (MALT type)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Extrasystoles	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Extremity necrosis	Vascular disorders	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0011 events1 affected4,672 at risk
Eye haemorrhage	Eye disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Eye infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Eyelid ptosis	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Faecal incontinence	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Faecalith	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Faecaloma	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0004 events3 affected4,668 at risk EG0010 events0 affected4,672 at risk
Fall	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG00094 events84 affected4,668 at risk EG00183 events81 affected4,672 at risk
Fat embolism	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Femoral artery occlusion	Vascular disorders	MedDRA	Systematic Assessment	EG0007 events6 affected4,668 at risk EG0015 events5 affected4,672 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0014 events4 affected4,672 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0006 events6 affected4,668 at risk EG0016 events6 affected4,672 at risk
Fibrillary glomerulonephritis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0010 events0 affected4,672 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0008 events8 affected4,668 at risk EG0016 events4 affected4,672 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Focal segmental glomerulosclerosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Follicle centre lymphoma, follicular grade I, II, III stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Follicle centre lymphoma, follicular grade I, II, III stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Food poisoning	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0014 events4 affected4,672 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Fracture displacement	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Fracture nonunion	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Frostbite	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Gait disturbance	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Gallbladder abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Gallbladder adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Gallbladder disorder	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events1 affected4,672 at risk
Gallbladder empyema	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Gallbladder perforation	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Gallbladder polyp	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Gangrene	Infections and infestations	MedDRA	Systematic Assessment	EG00013 events10 affected4,668 at risk EG00114 events12 affected4,672 at risk
Gas gangrene	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Gastric antral vascular ectasia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Gastric banding	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Gastric bypass	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Gastric cancer stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0013 events3 affected4,672 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0016 events6 affected4,672 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0005 events5 affected4,668 at risk EG0010 events0 affected4,672 at risk
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Gastritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00016 events15 affected4,668 at risk EG00114 events13 affected4,672 at risk
Gastritis bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG00110 events10 affected4,672 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Gastroduodenitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG00034 events33 affected4,668 at risk EG00131 events31 affected4,672 at risk
Gastroenteritis bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Gastroenteritis salmonella	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Gastroenteritis viral	Infections and infestations	MedDRA	Systematic Assessment	EG0009 events9 affected4,668 at risk EG0014 events4 affected4,672 at risk
Gastrointestinal angiodysplasia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0013 events2 affected4,672 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00017 events14 affected4,668 at risk EG00127 events21 affected4,672 at risk
Gastrointestinal hypomotility	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Gastrointestinal necrosis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Gastrointestinal polyp haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Gastrointestinal tract adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Gastrointestinal ulcer haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Gastrointestinal viral infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00011 events11 affected4,668 at risk EG00112 events12 affected4,672 at risk
Gastroplasty	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
General physical health deterioration	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0013 events3 affected4,672 at risk
Generalised oedema	General disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0012 events2 affected4,672 at risk
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Genital prolapse	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Giant cell tumour of tendon sheath	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Gingivitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Glaucoma	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0013 events3 affected4,672 at risk
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Glioblastoma multiforme	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Glomerular filtration rate decreased	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Glomerulonephritis membranous	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Glomerulosclerosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Glomus tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Glycosylated haemoglobin increased	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Goitre	Endocrine disorders	MedDRA	Systematic Assessment	EG0008 events8 affected4,668 at risk EG0015 events5 affected4,672 at risk
Gout	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0008 events4 affected4,668 at risk EG0016 events6 affected4,672 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Granuloma	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Granulomatosis with polyangiitis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Groin abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Guillain-Barre syndrome	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Gun shot wound	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Haemangioma of bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events1 affected4,672 at risk
Haemangioma of spleen	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Haematemesis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Haematochezia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0015 events5 affected4,672 at risk
Haematoma	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Haematoma infection	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Haematospermia	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Haematuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0007 events7 affected4,668 at risk EG0012 events2 affected4,672 at risk
Haemoglobin decreased	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0011 events1 affected4,672 at risk
Haemorrhage	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA	Systematic Assessment	EG0006 events6 affected4,668 at risk EG0014 events3 affected4,672 at risk
Haemorrhage subcutaneous	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Haemorrhage urinary tract	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0015 events4 affected4,672 at risk
Haemorrhagic cerebral infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA	Systematic Assessment	EG00010 events10 affected4,668 at risk EG00113 events13 affected4,672 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0014 events4 affected4,672 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Hairy cell leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Hamartoma	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0014 events4 affected4,672 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0017 events7 affected4,672 at risk
Heart rate decreased	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Heart rate increased	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Heat exhaustion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Helicobacter gastritis	Infections and infestations	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0011 events1 affected4,672 at risk
Helicobacter infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Hemiparesis	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Hemiplegia	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0011 events1 affected4,672 at risk
Hepatic cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0016 events6 affected4,672 at risk
Hepatic cyst	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0010 events0 affected4,672 at risk
Hepatic enzyme increased	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Hepatic lesion	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0010 events0 affected4,672 at risk
Hepatitis acute	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0005 events5 affected4,668 at risk EG0014 events4 affected4,672 at risk
Hepatomegaly	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Hepatopulmonary syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Hepatorenal syndrome	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Hernia	General disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Herpes virus infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Herpes zoster	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0016 events6 affected4,672 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0006 events5 affected4,668 at risk EG0014 events4 affected4,672 at risk
Hospitalisation	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Human bite	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Human ehrlichiosis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0014 events3 affected4,672 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Hydrocephalus	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0006 events5 affected4,668 at risk EG0012 events2 affected4,672 at risk
Hyperaesthesia	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Hypercorticoidism	Endocrine disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00035 events34 affected4,668 at risk EG00152 events49 affected4,672 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00010 events9 affected4,668 at risk EG00115 events15 affected4,672 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Hyperosmolar hyperglycaemic state	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0016 events6 affected4,672 at risk
Hyperparathyroidism primary	Endocrine disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Hypersensitivity	Immune system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG00036 events32 affected4,668 at risk EG00127 events25 affected4,672 at risk
Hypertensive cardiomyopathy	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Hypertensive crisis	Vascular disorders	MedDRA	Systematic Assessment	EG00018 events14 affected4,668 at risk EG00113 events12 affected4,672 at risk
Hypertensive emergency	Vascular disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Hypertensive encephalopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0013 events3 affected4,672 at risk
Hyperthyroidism	Endocrine disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Hypertrophic cardiomyopathy	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Hypoaesthesia	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Hypoaldosteronism	Endocrine disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Hypochromic anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00060 events44 affected4,668 at risk EG00192 events75 affected4,672 at risk
Hypoglycaemic coma	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Hypoglycaemic seizure	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Hypoglycaemic unconsciousness	Nervous system disorders	MedDRA	Systematic Assessment	EG00024 events21 affected4,668 at risk EG00128 events28 affected4,672 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0008 events7 affected4,668 at risk EG0017 events7 affected4,672 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0016 events6 affected4,672 at risk
Hypopharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG00018 events18 affected4,668 at risk EG00117 events16 affected4,672 at risk
Hypothermia	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Hypothyroidism	Endocrine disorders	MedDRA	Systematic Assessment	EG0006 events6 affected4,668 at risk EG0010 events0 affected4,672 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0013 events3 affected4,672 at risk
Hypovolaemic shock	Vascular disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0015 events5 affected4,672 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0005 events5 affected4,668 at risk EG0013 events3 affected4,672 at risk
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0015 events4 affected4,672 at risk
IIIrd nerve disorder	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Ileal gangrene	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Ileus	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0017 events7 affected4,672 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Iliac artery occlusion	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Ill-defined disorder	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Imaging procedure	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Immune thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0006 events5 affected4,668 at risk EG0011 events1 affected4,672 at risk
Impaired healing	General disorders	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0012 events2 affected4,672 at risk
Implantable defibrillator insertion	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0015 events5 affected4,672 at risk
Implantable defibrillator replacement	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Incarcerated hernia	General disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Incarcerated hiatus hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Incarcerated inguinal hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Incarcerated umbilical hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Incision site infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0013 events3 affected4,672 at risk
Incorrect dose administered	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Infected bites	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Infected dermal cyst	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Infected skin ulcer	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0015 events4 affected4,672 at risk
Infection	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0017 events7 affected4,672 at risk
Infectious colitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Infectious pleural effusion	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Infective exacerbation of bronchiectasis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA	Systematic Assessment	EG0004 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Inflammation	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Inflammation of wound	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Inflammatory bowel disease	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Inflammatory marker increased	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0018 events8 affected4,672 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00015 events12 affected4,668 at risk EG00114 events14 affected4,672 at risk
Inguinal hernia repair	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Insulin-requiring type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Intercostal neuralgia	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Intermittent claudication	Vascular disorders	MedDRA	Systematic Assessment	EG0007 events5 affected4,668 at risk EG0013 events3 affected4,672 at risk
Internal carotid artery kinking	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Internal haemorrhage	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
International normalised ratio decreased	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
International normalised ratio increased	Investigations	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0016 events6 affected4,672 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0011 events1 affected4,672 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0014 events4 affected4,672 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Intervertebral disc displacement	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00014 events13 affected4,668 at risk EG00127 events23 affected4,672 at risk
Intervertebral discitis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Intestinal infarction	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0012 events2 affected4,672 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0019 events7 affected4,672 at risk
Intestinal polyp	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Intracranial lipoma	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Intraductal papillary mucinous neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0013 events3 affected4,672 at risk
Invasive breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG00011 events11 affected4,668 at risk EG0019 events9 affected4,672 at risk
Invasive lobular breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Iridocyclitis	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Iritis	Eye disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0013 events3 affected4,672 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0009 events9 affected4,668 at risk EG00113 events13 affected4,672 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0013 events2 affected4,672 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0019 events9 affected4,672 at risk
Ischaemic cerebral infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 events2 affected4,668 at risk EG0014 events4 affected4,672 at risk
Ischaemic heart disease prophylaxis	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Ischaemic hepatitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Ischaemic stroke	Nervous system disorders	MedDRA	Systematic Assessment	EG00054 events50 affected4,668 at risk EG00159 events54 affected4,672 at risk
Jaundice	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Joint arthroplasty	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0005 events4 affected4,668 at risk EG0016 events2 affected4,672 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0013 events2 affected4,672 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Keloid scar	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Keratoacanthoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Ketoacidosis	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Kidney infection	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Klebsiella bacteraemia	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Klebsiella sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Knee operation	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Labile hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Lacunar infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0007 events6 affected4,668 at risk EG0018 events8 affected4,672 at risk
Large cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Large granular lymphocytosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Large intestinal ulcer	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Large intestine benign neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00016 events16 affected4,668 at risk EG00118 events13 affected4,672 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Laryngeal cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Laryngeal dysplasia	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Laryngeal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Laryngeal stenosis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Laryngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA	Systematic Assessment	EG0005 events5 affected4,668 at risk EG00110 events10 affected4,672 at risk
Left ventricular end-diastolic pressure increased	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Left ventricular failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0017 events7 affected4,672 at risk
Left ventricular hypertrophy	Cardiac disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0013 events3 affected4,672 at risk
Legionella infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Leriche syndrome	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Lethargy	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Lichen sclerosus	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Limb traumatic amputation	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Lip squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Lipase increased	Investigations	MedDRA	Systematic Assessment	EG00011 events11 affected4,668 at risk EG0013 events3 affected4,672 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Lipoma excision	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Liposarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Liposarcoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Liver abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0012 events2 affected4,672 at risk
Liver disorder	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Liver function test abnormal	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Lividity	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0002 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Lobar pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG00016 events15 affected4,668 at risk EG00115 events15 affected4,672 at risk
Local swelling	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Localised infection	Infections and infestations	MedDRA	Systematic Assessment	EG0009 events7 affected4,668 at risk EG0018 events8 affected4,672 at risk
Loss of consciousness	Nervous system disorders	MedDRA	Systematic Assessment	EG0006 events5 affected4,668 at risk EG0017 events7 affected4,672 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0011 events1 affected4,672 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0013 events3 affected4,672 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG00016 events15 affected4,668 at risk EG00115 events15 affected4,672 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0011 events1 affected4,672 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00012 events11 affected4,668 at risk EG0019 events9 affected4,672 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0006 events6 affected4,668 at risk EG0013 events3 affected4,672 at risk
Lung adenocarcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0013 events3 affected4,672 at risk
Lung adenocarcinoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0012 events2 affected4,672 at risk
Lung carcinoma cell type unspecified stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Lung infection	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0015 events5 affected4,672 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG00110 events9 affected4,672 at risk
Lung squamous cell carcinoma stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Lung squamous cell carcinoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Lymphocele	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Lymphoedema	Vascular disorders	MedDRA	Systematic Assessment	EG0002 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Macular fibrosis	Eye disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0014 events4 affected4,672 at risk
Macular oedema	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Macular rupture	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Major depression	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0015 events4 affected4,672 at risk
Malaise	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0013 events3 affected4,672 at risk
Malignant glioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Malignant hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0013 events3 affected4,672 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0008 events8 affected4,668 at risk EG0016 events6 affected4,672 at risk
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Malignant neoplasm of pleura	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Mallory-Weiss syndrome	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Mania	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Mass	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Mastitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Mastoiditis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Mechanical ileus	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Mediastinitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Medical device battery replacement	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Medical device change	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Medical device complication	General disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Medullary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Melaena	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Melanocytic hyperplasia	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Memory impairment	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0012 events2 affected4,672 at risk
Meningioma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Meningitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Meningitis pneumococcal	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Meniscal degeneration	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0014 events4 affected4,672 at risk
Mental disorder	Psychiatric disorders	MedDRA	Systematic Assessment	EG0002 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Mental status changes	Psychiatric disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0014 events3 affected4,672 at risk
Mesangioproliferative glomerulonephritis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Mesenteric artery embolism	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Mesothelioma malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Metabolic disorder	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0006 events6 affected4,668 at risk EG0010 events0 affected4,672 at risk
Metabolic syndrome	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0013 events1 affected4,672 at risk
Metaplasia	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Metapneumovirus infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0012 events2 affected4,672 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0006 events5 affected4,668 at risk EG0014 events4 affected4,672 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0012 events2 affected4,672 at risk
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Metastases to peritoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Metastatic bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Metastatic malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0012 events2 affected4,672 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Metastatic renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Metastatic squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Microalbuminuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Microangiopathy	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Microvascular coronary artery disease	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Migraine	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0014 events4 affected4,672 at risk
Mitral valve calcification	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG00110 events10 affected4,672 at risk
Mitral valve replacement	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Mitral valve stenosis	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Mononeuropathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Mucinous breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Mucosal inflammation	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Multi-organ failure	General disorders	MedDRA	Systematic Assessment	EG0007 events7 affected4,668 at risk EG0019 events9 affected4,672 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Multiple system atrophy	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Muscle rupture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0007 events7 affected4,668 at risk EG0019 events9 affected4,672 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0005 events5 affected4,668 at risk EG0012 events2 affected4,672 at risk
Myasthenia gravis	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Myelopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Myocardial fibrosis	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG00071 events68 affected4,668 at risk EG00189 events84 affected4,672 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA	Systematic Assessment	EG00027 events27 affected4,668 at risk EG00135 events33 affected4,672 at risk
Myocardial necrosis marker increased	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Myocarditis	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Myxofibrosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Nail bed inflammation	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Nasopharyngeal polyp	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0009 events8 affected4,668 at risk EG0019 events9 affected4,672 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Necrobiosis lipoidica diabeticorum	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Necrosis	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Necrosis ischaemic	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Necrotising fasciitis	Infections and infestations	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0010 events0 affected4,672 at risk
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Neoplasm of appendix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Neoplasm skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Nephritis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG00027 events26 affected4,668 at risk EG00122 events21 affected4,672 at risk
Nephropathy	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0006 events6 affected4,668 at risk EG00115 events13 affected4,672 at risk
Nephropathy toxic	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Nerve compression	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Nervous system disorder	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Neuralgia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Neuritis cranial	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Neurodermatitis	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Neuroendocrine carcinoma of the skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Neurogenic shock	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Neuropathic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Neuropathic ulcer	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0010 events0 affected4,672 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0011 events1 affected4,672 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Neutropenic sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Nocturia	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Nodal rhythm	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0012 events2 affected4,672 at risk
Non-Hodgkin's lymphoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Non-Hodgkin's lymphoma stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Non-cardiac chest pain	General disorders	MedDRA	Systematic Assessment	EG00052 events45 affected4,668 at risk EG00173 events63 affected4,672 at risk
Non-cardiogenic pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0012 events2 affected4,672 at risk
Non-small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Non-small cell lung cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Normal pressure hydrocephalus	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Normochromic normocytic anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Obesity	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0008 events8 affected4,668 at risk EG00111 events11 affected4,672 at risk
Obesity surgery	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Obstruction gastric	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Obstructive uropathy	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Oedema	General disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG0006 events6 affected4,668 at risk EG00110 events9 affected4,672 at risk
Oedematous pancreatitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Oesophageal achalasia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Oesophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0010 events0 affected4,672 at risk
Oesophageal adenocarcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Oesophageal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Oesophageal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0013 events3 affected4,672 at risk
Oesophageal squamous cell carcinoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Oesophagitis ulcerative	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Open angle glaucoma	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Optic ischaemic neuropathy	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0013 events3 affected4,672 at risk
Optic nerve infarction	Eye disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Oral candidiasis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Orchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0012 events2 affected4,672 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Oropharyngeal cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Orthostatic hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG00010 events10 affected4,668 at risk EG0018 events8 affected4,672 at risk
Orthostatic intolerance	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Osteitis deformans	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00080 events75 affected4,668 at risk EG00169 events64 affected4,672 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Osteolysis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Osteomyelitis	Infections and infestations	MedDRA	Systematic Assessment	EG00027 events21 affected4,668 at risk EG00130 events23 affected4,672 at risk
Osteomyelitis acute	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Osteomyelitis chronic	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0013 events2 affected4,672 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0013 events3 affected4,672 at risk
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Otitis externa	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Otitis media	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Otitis media chronic	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Ovarian cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Ovarian epithelial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Ovarian epithelial cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Pain	General disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0013 events3 affected4,672 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0007 events7 affected4,668 at risk EG0011 events1 affected4,672 at risk
Palpitations	Cardiac disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0014 events4 affected4,672 at risk
Pancreas divisum	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Pancreas infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0017 events7 affected4,672 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0012 events2 affected4,672 at risk
Pancreatic carcinoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Pancreatic cyst	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0012 events2 affected4,672 at risk
Pancreatic disorder	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Pancreatic enzymes increased	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Pancreatic mass	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Pancreatic pseudocyst	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00020 events18 affected4,668 at risk EG00111 events10 affected4,672 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00014 events14 affected4,668 at risk EG00122 events19 affected4,672 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0012 events2 affected4,672 at risk
Pancreatitis relapsing	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Papillary cystadenoma lymphomatosum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Papillary serous endometrial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0005 events4 affected4,668 at risk EG0013 events3 affected4,672 at risk
Papilloedema	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Parainfluenzae virus infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Paranasal cyst	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Paraplegia	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Parapsoriasis	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Parathyroid tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0012 events2 affected4,672 at risk
Parathyroidectomy	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Paratracheal lymphadenopathy	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Parkinson's disease	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Parkinsonism	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Parotitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Partial seizures	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Pelvi-ureteric obstruction	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Pelvic floor repair	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Pelvic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Pemphigoid	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Penetrating atherosclerotic ulcer	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Penile infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0014 events4 affected4,672 at risk
Percutaneous coronary intervention	Surgical and medical procedures	MedDRA	Systematic Assessment	EG00071 events59 affected4,668 at risk EG00166 events57 affected4,672 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0005 events5 affected4,668 at risk EG0010 events0 affected4,672 at risk
Pericardial cyst	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Pericardial effusion	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0013 events3 affected4,672 at risk
Pericardial haemorrhage	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Pericarditis	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0015 events5 affected4,672 at risk
Pericarditis uraemic	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Perichondritis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA	Systematic Assessment	EG00027 events24 affected4,668 at risk EG00138 events34 affected4,672 at risk
Peripheral arterial reocclusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Peripheral artery angioplasty	Surgical and medical procedures	MedDRA	Systematic Assessment	EG00025 events20 affected4,668 at risk EG00129 events27 affected4,672 at risk
Peripheral artery bypass	Surgical and medical procedures	MedDRA	Systematic Assessment	EG00012 events11 affected4,668 at risk EG00119 events14 affected4,672 at risk
Peripheral artery restenosis	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0014 events3 affected4,672 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA	Systematic Assessment	EG0009 events8 affected4,668 at risk EG00119 events12 affected4,672 at risk
Peripheral artery stent insertion	Surgical and medical procedures	MedDRA	Systematic Assessment	EG00010 events7 affected4,668 at risk EG00110 events9 affected4,672 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0005 events4 affected4,668 at risk EG0015 events4 affected4,672 at risk
Peripheral circulatory failure	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Peripheral endarterectomy	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0007 events6 affected4,668 at risk EG0012 events2 affected4,672 at risk
Peripheral ischaemia	Vascular disorders	MedDRA	Systematic Assessment	EG00014 events13 affected4,668 at risk EG00112 events11 affected4,672 at risk
Peripheral nerve lesion	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Peripheral revascularisation	Surgical and medical procedures	MedDRA	Systematic Assessment	EG00033 events29 affected4,668 at risk EG00147 events36 affected4,672 at risk
Peripheral swelling	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0013 events3 affected4,672 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA	Systematic Assessment	EG00011 events10 affected4,668 at risk EG0019 events8 affected4,672 at risk
Peripheral venous disease	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Peritoneal adhesions	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Peritoneal haematoma	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Peritonitis	Infections and infestations	MedDRA	Systematic Assessment	EG0006 events5 affected4,668 at risk EG0019 events6 affected4,672 at risk
Peritonitis bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0011 events1 affected4,672 at risk
Peritonsillar abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Peroneal nerve palsy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Personality disorder	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Petit mal epilepsy	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Peyronie's disease	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Pharyngeal cyst	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Pharyngeal inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Pharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Phimosis	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Phlebitis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Phlebosclerosis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Phyllodes tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Pilonidal cyst	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Pituitary tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0015 events5 affected4,672 at risk
Plasmacytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Plasmodium falciparum infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG00118 events15 affected4,672 at risk
Pleural mesothelioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Pneumococcal sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG000154 events133 affected4,668 at risk EG001157 events141 affected4,672 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0007 events7 affected4,668 at risk EG0017 events6 affected4,672 at risk
Pneumonia bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0013 events3 affected4,672 at risk
Pneumonia influenzal	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Pneumonia legionella	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Pneumonia pseudomonal	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Pneumonia viral	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Pneumopericardium	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Polycythaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0014 events4 affected4,672 at risk
Polyneuropathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0012 events2 affected4,672 at risk
Polyp	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Polyuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Portal hypertension	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Portal vein thrombosis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Post herpetic neuralgia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Post laminectomy syndrome	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Post procedural cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Post procedural fistula	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0010 events0 affected4,672 at risk
Post procedural haematuria	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0014 events3 affected4,672 at risk
Post procedural hypothyroidism	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Post procedural infection	Infections and infestations	MedDRA	Systematic Assessment	EG0006 events6 affected4,668 at risk EG0013 events3 affected4,672 at risk
Post procedural myocardial infarction	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0016 events6 affected4,672 at risk
Post procedural pulmonary embolism	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Post procedural sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Post procedural stroke	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Post-traumatic headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Post-traumatic pain	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Postoperative abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Postoperative fever	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Postoperative hernia	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Postoperative respiratory failure	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Postoperative thoracic procedure complication	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0003 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Postoperative thrombosis	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Postoperative wound complication	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0011 events1 affected4,672 at risk
Postoperative wound infection	Infections and infestations	MedDRA	Systematic Assessment	EG0009 events9 affected4,668 at risk EG0016 events6 affected4,672 at risk
Postural orthostatic tachycardia syndrome	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Presyncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0007 events6 affected4,668 at risk EG0016 events6 affected4,672 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Procedural intestinal perforation	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Proctitis ulcerative	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Prophylaxis against dehydration	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG00024 events24 affected4,668 at risk EG00139 events39 affected4,672 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0014 events4 affected4,672 at risk
Prostate cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Prostate cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Prostatic abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Prostatic dysplasia	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0002 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Prostatic specific antigen increased	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0007 events7 affected4,668 at risk EG0012 events2 affected4,672 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0011 events1 affected4,672 at risk
Proteinuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0013 events3 affected4,672 at risk
Pseudomembranous colitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Psoas abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0012 events1 affected4,672 at risk
Pulmonary cavitation	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00021 events21 affected4,668 at risk EG00126 events24 affected4,672 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 events1 affected4,668 at risk EG0014 events3 affected4,672 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0015 events4 affected4,672 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0018 events6 affected4,672 at risk
Pulmonary mycosis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00022 events17 affected4,668 at risk EG00125 events21 affected4,672 at risk
Pulmonary sarcoidosis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Pulmonary sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0013 events3 affected4,672 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Pyelonephritis	Infections and infestations	MedDRA	Systematic Assessment	EG0009 events9 affected4,668 at risk EG00112 events10 affected4,672 at risk
Pyelonephritis acute	Infections and infestations	MedDRA	Systematic Assessment	EG0009 events6 affected4,668 at risk EG0016 events6 affected4,672 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG0006 events5 affected4,668 at risk EG0016 events6 affected4,672 at risk
Pyuria	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Radiation pneumonitis	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Radiculopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Reactive gastropathy	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Rectal abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0006 events6 affected4,668 at risk EG0013 events3 affected4,672 at risk
Rectal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0013 events3 affected4,672 at risk
Rectal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Rectal cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0007 events6 affected4,668 at risk EG0016 events5 affected4,672 at risk
Rectal polyp	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0012 events2 affected4,672 at risk
Rectal prolapse	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Red blood cell sedimentation rate increased	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Reflux gastritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Rehabilitation therapy	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Renal artery arteriosclerosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Renal artery occlusion	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0013 events3 affected4,672 at risk
Renal artery stent placement	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0013 events3 affected4,672 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Renal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Renal cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0015 events5 affected4,672 at risk
Renal cell carcinoma stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Renal colic	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0011 events1 affected4,672 at risk
Renal cyst	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0005 events5 affected4,668 at risk EG00111 events11 affected4,672 at risk
Renal failure	Renal and urinary disorders	MedDRA	Systematic Assessment	EG00021 events20 affected4,668 at risk EG00133 events31 affected4,672 at risk
Renal function test	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Renal haemorrhage	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Renal impairment	Renal and urinary disorders	MedDRA	Systematic Assessment	EG00014 events14 affected4,668 at risk EG00110 events10 affected4,672 at risk
Renal infarct	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Renal injury	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Renal pain	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Renal revascularisation surgery	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0015 events5 affected4,672 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0005 events5 affected4,668 at risk EG0010 events0 affected4,672 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00020 events18 affected4,668 at risk EG00121 events19 affected4,672 at risk
Respiratory fume inhalation disorder	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG00110 events7 affected4,672 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Restless legs syndrome	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Restrictive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Retinal aneurysm	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Retinal artery embolism	Eye disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Retinal artery occlusion	Eye disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Retinal degeneration	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Retinal detachment	Eye disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Retinal haemorrhage	Eye disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Retinal infarction	Eye disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Retinal vascular occlusion	Eye disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Retinal vein occlusion	Eye disorders	MedDRA	Systematic Assessment	EG0004 events3 affected4,668 at risk EG0010 events0 affected4,672 at risk
Retinal vein thrombosis	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Retinopathy	Eye disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0015 events4 affected4,672 at risk
Retinopathy haemorrhagic	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Retinopathy proliferative	Eye disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Retroperitoneal mass	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Reversible ischaemic neurological deficit	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Rhinitis hypertrophic	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Rhythm idioventricular	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0014 events4 affected4,672 at risk
Right ventricular failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG00023 events20 affected4,668 at risk EG00116 events16 affected4,672 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0005 events5 affected4,668 at risk EG0017 events7 affected4,672 at risk
Sacroiliitis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Salivary gland mass	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Salivary gland neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Salmonella sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Salmonellosis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Sarcoidosis	Immune system disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Scapula fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Sciatica	Nervous system disorders	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0013 events3 affected4,672 at risk
Scrotal abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0010 events0 affected4,672 at risk
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Seizure	Nervous system disorders	MedDRA	Systematic Assessment	EG0007 events7 affected4,668 at risk EG0016 events6 affected4,672 at risk
Seizure like phenomena	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG00050 events48 affected4,668 at risk EG00136 events34 affected4,672 at risk
Sepsis syndrome	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Septic shock	Infections and infestations	MedDRA	Systematic Assessment	EG0009 events8 affected4,668 at risk EG00113 events13 affected4,672 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Serotonin syndrome	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Serum ferritin decreased	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Shock	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Shock haemorrhagic	Vascular disorders	MedDRA	Systematic Assessment	EG0005 events5 affected4,668 at risk EG0010 events0 affected4,672 at risk
Short-bowel syndrome	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Shunt occlusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Silent myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Single functional kidney	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Sinus arrest	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Sinus bradycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0016 events6 affected4,672 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA	Systematic Assessment	EG00010 events10 affected4,668 at risk EG0019 events9 affected4,672 at risk
Sinus polyp	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Sinus tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Skeletal injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Skin graft	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG00010 events10 affected4,668 at risk EG00115 events15 affected4,672 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0009 events9 affected4,668 at risk EG0017 events7 affected4,672 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0012 events2 affected4,672 at risk
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0011 events1 affected4,672 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00012 events10 affected4,668 at risk EG00123 events5 affected4,672 at risk
Small intestine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Small intestine carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Social stay hospitalisation	Social circumstances	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Soft tissue infection	Infections and infestations	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0010 events0 affected4,672 at risk
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Somatisation disorder	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Spinal claudication	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0007 events7 affected4,668 at risk EG00110 events10 affected4,672 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0013 events3 affected4,672 at risk
Spinal cord injury thoracic	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Spinal decompression	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Spinal instability	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0009 events9 affected4,668 at risk EG0018 events8 affected4,672 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Splenic embolism	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Splenic infarction	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Splenic rupture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Splenomegaly	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0011 events1 affected4,672 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0012 events2 affected4,672 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0015 events5 affected4,672 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0008 events7 affected4,668 at risk EG0012 events2 affected4,672 at risk
Squamous cell carcinoma of the cervix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0005 events4 affected4,668 at risk EG0010 events0 affected4,672 at risk
Squamous cell carcinoma of the oral cavity	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Squamous cell carcinoma of the tongue	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Squamous cell carcinoma of the vulva	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Stab wound	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Staphylococcal infection	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0015 events5 affected4,672 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0010 events0 affected4,672 at risk
Staphylococcal skin infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Status asthmaticus	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Status epilepticus	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Steal syndrome	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Stent placement	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0014 events4 affected4,672 at risk
Stent-graft endoleak	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Sternal fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Streptococcal infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Stress cardiomyopathy	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Stress urinary incontinence	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0013 events3 affected4,672 at risk
Subclavian artery stenosis	Vascular disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Subcutaneous abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Subcutaneous haematoma	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0006 events5 affected4,668 at risk EG00110 events10 affected4,672 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Subgaleal haematoma	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Sudden cardiac death	General disorders	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0016 events6 affected4,672 at risk
Sudden death	General disorders	MedDRA	Systematic Assessment	EG00011 events11 affected4,668 at risk EG00117 events17 affected4,672 at risk
Sudden hearing loss	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Suicidal ideation	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Suicide attempt	Psychiatric disorders	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0012 events2 affected4,672 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0009 events9 affected4,668 at risk EG0019 events7 affected4,672 at risk
Swollen tongue	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Syncope	Nervous system disorders	MedDRA	Systematic Assessment	EG00043 events39 affected4,668 at risk EG00127 events26 affected4,672 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0012 events2 affected4,672 at risk
Systolic dysfunction	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0013 events3 affected4,672 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0014 events4 affected4,672 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0010 events0 affected4,672 at risk
Tension headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Testicular abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Testicular cyst	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Testicular mass	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Testicular necrosis	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Thalamic infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0010 events0 affected4,672 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Thrombectomy	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0015 events4 affected4,672 at risk
Thromboangiitis obliterans	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events1 affected4,672 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Thrombophlebitis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA	Systematic Assessment	EG0004 events3 affected4,668 at risk EG0010 events0 affected4,672 at risk
Thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0002 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Thrombosis in device	General disorders	MedDRA	Systematic Assessment	EG0002 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Thrombotic cerebral infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Thrombotic stroke	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0010 events0 affected4,672 at risk
Thyroid C-cell hyperplasia	Endocrine disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Thyroid adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0013 events3 affected4,672 at risk
Thyroiditis	Endocrine disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Thyroiditis subacute	Endocrine disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Tonsil cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Tonsillitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Tooth abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0015 events5 affected4,672 at risk
Tooth infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Tooth socket haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Toxic epidermal necrolysis	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Toxic nodular goitre	Endocrine disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0011 events1 affected4,672 at risk
Tracheitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0013 events2 affected4,672 at risk
Tracheo-oesophageal fistula	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Tracheobronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0014 events3 affected4,672 at risk
Tracheostomy malfunction	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA	Systematic Assessment	EG00057 events52 affected4,668 at risk EG00173 events68 affected4,672 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0008 events8 affected4,668 at risk EG0013 events3 affected4,672 at risk
Transitional cell carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Transplant evaluation	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Traumatic arthritis	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Traumatic arthrosis	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Traumatic ulcer	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0014 events4 affected4,672 at risk
Trigger finger	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Troponin increased	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Tuberculosis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Tuberculosis of genitourinary system	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0013 events3 affected4,672 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Ulcerative keratitis	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Ulnocarpal abutment syndrome	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0006 events6 affected4,668 at risk EG0014 events4 affected4,672 at risk
Unresponsive to stimuli	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Upper airway obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0006 events6 affected4,668 at risk EG0018 events8 affected4,672 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0013 events3 affected4,672 at risk
Uraemic encephalopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Ureteral necrosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Ureteral polyp	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0017 events6 affected4,672 at risk
Urinary bladder polyp	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0012 events2 affected4,672 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0011 events1 affected4,672 at risk
Urinary retention	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0008 events8 affected4,668 at risk EG00113 events12 affected4,672 at risk
Urinary retention postoperative	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG00051 events47 affected4,668 at risk EG00179 events71 affected4,672 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0013 events3 affected4,672 at risk
Urinary tract neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Urine albumin/creatinine ratio increased	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Urosepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0008 events8 affected4,668 at risk EG00119 events17 affected4,672 at risk
Urticaria papular	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0013 events3 affected4,672 at risk
Uterine leiomyosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0016 events6 affected4,672 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0010 events0 affected4,672 at risk
VIIth nerve paralysis	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0016 events5 affected4,672 at risk
Vaginal abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Vaginal fistula	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0012 events2 affected4,672 at risk
Vaginal prolapse	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Varicose vein	Vascular disorders	MedDRA	Systematic Assessment	EG0002 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Vascular dementia	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Vascular graft	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0017 events6 affected4,672 at risk
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0003 events2 affected4,668 at risk EG0012 events2 affected4,672 at risk
Vascular operation	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Vascular stent insertion	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Vasculitis necrotising	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Venous thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0010 events0 affected4,672 at risk
Ventricular dyssynchrony	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA	Systematic Assessment	EG0005 events5 affected4,668 at risk EG0013 events3 affected4,672 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA	Systematic Assessment	EG0004 events4 affected4,668 at risk EG0016 events6 affected4,672 at risk
Ventricular hypokinesia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Ventricular tachyarrhythmia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG00029 events18 affected4,668 at risk EG00111 events8 affected4,672 at risk
Vertebral artery stenosis	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Vertebral foraminal stenosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0014 events3 affected4,672 at risk
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0013 events3 affected4,672 at risk
Vertigo	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0006 events6 affected4,668 at risk EG00110 events10 affected4,672 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0003 events3 affected4,668 at risk EG0011 events1 affected4,672 at risk
Vestibular disorder	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Vestibular neuronitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0013 events3 affected4,672 at risk
Viral infection	Infections and infestations	MedDRA	Systematic Assessment	EG0005 events5 affected4,668 at risk EG0012 events2 affected4,672 at risk
Viral myocarditis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Viral pharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Viral sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Vision blurred	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0013 events3 affected4,672 at risk
Visual impairment	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Vitamin B12 deficiency	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Vitreous adhesions	Eye disorders	MedDRA	Systematic Assessment	EG0002 events2 affected4,668 at risk EG0010 events0 affected4,672 at risk
Vitreous haemorrhage	Eye disorders	MedDRA	Systematic Assessment	EG0006 events6 affected4,668 at risk EG0015 events5 affected4,672 at risk
Vocal cord neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Vocal cord paralysis	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Vocal cord polyp	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Volvulus	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0008 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00020 events17 affected4,668 at risk EG00111 events11 affected4,672 at risk
Vulval neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Walking disability	Social circumstances	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Weight decreased	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0013 events3 affected4,672 at risk
Weight increased	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Wolff-Parkinson-White syndrome	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Wound	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0004 events1 affected4,668 at risk EG0012 events2 affected4,672 at risk
Wound decomposition	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Wound haemorrhage	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Wound infection	Infections and infestations	MedDRA	Systematic Assessment	EG0006 events6 affected4,668 at risk EG0010 events0 affected4,672 at risk
Wound infection staphylococcal	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0011 events1 affected4,672 at risk
Wound necrosis	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Wound sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Wrist surgery	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk
Wrong drug administered	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected4,668 at risk EG0010 events0 affected4,672 at risk
Zygomycosis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected4,668 at risk EG0011 events1 affected4,672 at risk

ID	Term
D003920	Diabetes Mellitus
D003924	Diabetes Mellitus, Type 2

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D052216	Glucagon-Like Peptide 1
D004763	Glucagon-Like Peptides
D052336	Proglucagon
D005768	Gastrointestinal Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

ID	Title	Description
BG000	Liraglutide	Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
BG001	Placebo	Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Liraglutide	Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.			2,320	4,668	684	4,668
EG001	Placebo	Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.			2,354	4,672	210	4,672