Effects of Oral Sildenafil on Mortality in Adults With PAH | NCT02060487

ID	Type	Description	Link
2013-004362-34	EudraCT Number
AFFILIATE	Other Identifier	Alias Study Number

Label	Type	Intervention Names
Low dose	Experimental	Drug: sildenafil citrate
Medium dose	Experimental	Drug: sildenafil citrate
High dose	Experimental	Drug: sildenafil citrate

Name	Type	Description	Arm Group Labels	Other Names
sildenafil citrate	Drug	sildenafil citrate (PDE-5 inhibitor) 5 mg tablet TID until study treatment discontinued or end of study	Low dose

Measure	Description	Time Frame
Overall Survival	In this outcome measure number of deaths during the study were reported.	Day 1 of study treatment up to date of death (within a maximum duration of 2102 days)

Measure	Description	Time Frame
Number of Participants With Clinical Worsening Events	Clinical worsening was defined as all-cause mortality, non-elective hospital stay for worsening pulmonary arterial hypertension (PAH) (including but not limited to right heart failure [RHF], initiation of intravenous (IV) prostanoids, lung transplantation, or septostomy) or disease progression. Disease progression was defined as a reduction from baseline in the 6-Minute Walk Distance (6MWD) test by 15% and worsening functional class from baseline, both confirmed by second test within 2 weeks of study treatment.

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Emory University Investigational Drug Services		Atlanta	Georgia	30322	United States
The Emory Clinic

PubMed Identifier	Type	Citation	Retractions
38752352	Derived	Hoeper MM, Ewert R, Jansa P, Sirenko Y, Skride A, Balagtas C, Hackley S, Vogt S, Abreu P, Haughie S, Hassan T, Oudiz RJ. Randomized, Multicenter Study to Assess the Effects of Different Doses of Sildenafil on Mortality in Adults With Pulmonary Arterial Hypertension. Circulation. 2024 Jun 18;149(25):1949-1959. doi: 10.1161/CIRCULATIONAHA.123.068107. Epub 2024 May 16.

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	Sildenafil 5 mg	Participants received a single tablet of sildenafil at a dose of 5 milligram (mg) along with two tablets of placebo matching 20 mg and 80 mg sildenafil orally thrice daily (TID) until discontinuation of study treatment or end of study. The maximum duration of study treatment was 2080 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 28, 2020	Feb 25, 2022

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0010 affected128 at risk EG0022 affected128 at risk
Blood loss anaemia	Blood and lymphatic system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Hypochromic anaemia	Blood and lymphatic system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0012 affected128 at risk EG0020 affected128 at risk
Atrial flutter	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Cardiac arrest	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0013 affected128 at risk EG0020 affected128 at risk
Cardiac failure	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0009 affected129 at risk EG0018 affected128 at risk EG0023 affected128 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0011 affected128 at risk EG0022 affected128 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 affected129 at risk EG0012 affected128 at risk EG0023 affected128 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0022 affected128 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Cardiovascular insufficiency	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Coronary artery disease	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0012 affected128 at risk EG0020 affected128 at risk
Left ventricular failure	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Pericardial effusion	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Right ventricular failure	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG00011 affected129 at risk EG0014 affected128 at risk EG0022 affected128 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Tachycardia paroxysmal	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0022 affected128 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Gastritis	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Thrombosis mesenteric vessel	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Chest pain	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0012 affected128 at risk EG0021 affected128 at risk
Condition aggravated	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Death	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Disease progression	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0012 affected128 at risk EG0020 affected128 at risk
Exercise tolerance decreased	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
General physical health deterioration	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Oedema	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Peripheral swelling	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Sudden cardiac death	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Sudden death	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Vascular stent stenosis	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Portal vein thrombosis	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Appendicitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0023 affected128 at risk
Bronchitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0012 affected128 at risk EG0023 affected128 at risk
Cellulitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Cystitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Dengue fever	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Diarrhoea infectious	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Encephalitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Endocarditis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Erysipelas	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0012 affected128 at risk EG0020 affected128 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Gangrene	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Gastroenteritis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0011 affected128 at risk EG0022 affected128 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
H1N1 influenza	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Infectious pleural effusion	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Influenza	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Klebsiella bacteraemia	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Leptospirosis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Lung abscess	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Osteomyelitis chronic	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0022 affected128 at risk
Parainfluenzae virus infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Pharyngitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Pneumonia	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0007 affected129 at risk EG0016 affected128 at risk EG0023 affected128 at risk
Pneumonia influenzal	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Postoperative wound infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Respiratory tract infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Sepsis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0012 affected128 at risk EG0021 affected128 at risk
Septic shock	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Sinusitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Staphylococcal infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Viral infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Procedural intestinal perforation	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Haemodynamic test	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Haemoglobin decreased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Weight decreased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Connective tissue disorder	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Oligoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Rheumatic disorder	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Scleroderma	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Gastrointestinal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Myelofibrosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Pleomorphic malignant fibrous histiocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Pleural neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Ataxia	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0012 affected128 at risk EG0020 affected128 at risk
Dizziness	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Guillain-Barre syndrome	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Migraine	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Presyncope	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Sciatica	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Syncope	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Device dislocation	Product Issues	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Delusion	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG0004 affected129 at risk EG0011 affected128 at risk EG0022 affected128 at risk
Renal failure	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Ovarian cyst ruptured	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Alveolitis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 affected129 at risk EG0011 affected128 at risk EG0024 affected128 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Hyperventilation	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0012 affected128 at risk EG0020 affected128 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0022 affected128 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG00017 affected129 at risk EG00110 affected128 at risk EG0028 affected128 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0012 affected128 at risk EG0021 affected128 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0014 affected128 at risk EG0022 affected128 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Systemic sclerosis pulmonary	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0022 affected128 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Vocal cord dysfunction	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Hypersensitivity vasculitis	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0012 affected128 at risk EG0020 affected128 at risk
Vasculitic rash	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Drug therapy	Surgical and medical procedures	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Hospitalisation	Surgical and medical procedures	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Lung transplant	Surgical and medical procedures	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Aortic stenosis	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Hypertension	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0010 affected128 at risk EG0022 affected128 at risk
Shock	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Varicose ulceration	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 23.1	Non-systematic Assessment	EG0005 affected129 at risk EG0013 affected128 at risk EG00211 affected128 at risk
Bicytopenia	Blood and lymphatic system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Blood loss anaemia	Blood and lymphatic system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Cytopenia	Blood and lymphatic system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Heparin-induced thrombocytopenia	Blood and lymphatic system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Hypothrombinaemia	Blood and lymphatic system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Increased tendency to bruise	Blood and lymphatic system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0010 affected128 at risk EG0023 affected128 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0012 affected128 at risk EG0021 affected128 at risk
Lymphocytosis	Blood and lymphatic system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Macrocytosis	Blood and lymphatic system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Polycythaemia	Blood and lymphatic system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Splenomegaly	Blood and lymphatic system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0012 affected128 at risk EG0023 affected128 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Angina pectoris	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0014 affected128 at risk EG0022 affected128 at risk
Arrhythmia	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0013 affected128 at risk EG0022 affected128 at risk
Atrial flutter	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Atrial thrombosis	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Bradycardia	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Cardiac failure	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 affected129 at risk EG0010 affected128 at risk EG0023 affected128 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Cardiac ventricular thrombosis	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Extrasystoles	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Palpitations	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0005 affected129 at risk EG0015 affected128 at risk EG0026 affected128 at risk
Pericardial effusion	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Right ventricular dysfunction	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Right ventricular failure	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 affected129 at risk EG0012 affected128 at risk EG0020 affected128 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0012 affected128 at risk EG0020 affected128 at risk
Tachycardia	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0012 affected128 at risk EG0025 affected128 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0022 affected128 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Atrial septal defect	Congenital, familial and genetic disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0012 affected128 at risk EG0021 affected128 at risk
Thyroid malformation	Congenital, familial and genetic disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Cerumen impaction	Ear and labyrinth disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Ear congestion	Ear and labyrinth disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Ear haemorrhage	Ear and labyrinth disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0013 affected128 at risk EG0021 affected128 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Mixed deafness	Ear and labyrinth disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0014 affected128 at risk EG0021 affected128 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0014 affected128 at risk EG0022 affected128 at risk
Autoimmune thyroiditis	Endocrine disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Cushing's syndrome	Endocrine disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Hypothyroidism	Endocrine disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0014 affected128 at risk EG0022 affected128 at risk
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Primary hypothyroidism	Endocrine disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Thyroid mass	Endocrine disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Asthenopia	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Astigmatism	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Blepharitis	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Cataract	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0004 affected129 at risk EG0010 affected128 at risk EG0022 affected128 at risk
Chalazion	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Chromatopsia	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0022 affected128 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Cornea verticillata	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Corneal oedema	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Corneal opacity	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Dacryostenosis acquired	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Dark circles under eyes	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Diplopia	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Dry eye	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Dyschromatopsia	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Eye disorder	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Eye haemorrhage	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Eye inflammation	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Eye irritation	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Eye pain	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0023 affected128 at risk
Eye pruritus	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Eye swelling	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Foreign body sensation in eyes	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Glaucoma	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0022 affected128 at risk
Hypermetropia	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Keratitis	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Lacrimation increased	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Macular degeneration	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Maculopathy	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Ocular hyperaemia	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Periorbital pain	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Periorbital swelling	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0012 affected128 at risk EG0021 affected128 at risk
Photophobia	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Photopsia	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Pterygium	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0022 affected128 at risk
Retinal vascular disorder	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0012 affected128 at risk EG0021 affected128 at risk
Swelling of eyelid	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Vision blurred	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 affected129 at risk EG0012 affected128 at risk EG0022 affected128 at risk
Visual impairment	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0012 affected128 at risk EG0024 affected128 at risk
Visual snow syndrome	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Xerophthalmia	Eye disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0012 affected128 at risk EG0022 affected128 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0005 affected129 at risk EG0015 affected128 at risk EG0024 affected128 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0006 affected129 at risk EG0017 affected128 at risk EG00211 affected128 at risk
Abdominal symptom	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Angular cheilitis	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Ascites	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 affected129 at risk EG0012 affected128 at risk EG0021 affected128 at risk
Barrett's oesophagus	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Colitis	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Constipation	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0005 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Dental necrosis	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG00013 affected129 at risk EG00117 affected128 at risk EG00220 affected128 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0013 affected128 at risk EG0023 affected128 at risk
Duodenal bulb deformity	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Duodenal vascular ectasia	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Duodenogastric reflux	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0006 affected129 at risk EG00110 affected128 at risk EG00210 affected128 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Enteritis	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Eructation	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Flatulence	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0012 affected128 at risk EG0020 affected128 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0023 affected128 at risk
Frequent bowel movements	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Gastric disorder	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0013 affected128 at risk EG0021 affected128 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Gastritis	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 affected129 at risk EG0012 affected128 at risk EG0023 affected128 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0012 affected128 at risk EG0024 affected128 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Gingival hypertrophy	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Gingival pain	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0022 affected128 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0022 affected128 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Intestinal polyp	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0022 affected128 at risk
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Nausea	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG00016 affected129 at risk EG00112 affected128 at risk EG0028 affected128 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Oesophageal disorder	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0022 affected128 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Tongue erythema	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Tongue ulceration	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Toothache	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0005 affected129 at risk EG0015 affected128 at risk EG0023 affected128 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Varices oesophageal	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0007 affected129 at risk EG00110 affected128 at risk EG0027 affected128 at risk
Asthenia	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 affected129 at risk EG0017 affected128 at risk EG0022 affected128 at risk
Catheter site erythema	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Chest discomfort	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 affected129 at risk EG0013 affected128 at risk EG0020 affected128 at risk
Chest pain	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0007 affected129 at risk EG00115 affected128 at risk EG00213 affected128 at risk
Chills	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0011 affected128 at risk EG0025 affected128 at risk
Crying	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Cyst	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Disease progression	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Face oedema	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Facial pain	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Fatigue	General disorders	MedDRA 23.1	Non-systematic Assessment	EG00011 affected129 at risk EG00110 affected128 at risk EG0029 affected128 at risk
Feeling cold	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Feeling hot	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Gait disturbance	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
General physical health deterioration	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Generalised oedema	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Ill-defined disorder	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0012 affected128 at risk EG0020 affected128 at risk
Inflammation	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Influenza like illness	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Infusion site pain	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Injection site hypersensitivity	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Malaise	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0012 affected128 at risk EG0021 affected128 at risk
Mucosal dryness	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Oedema	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 affected129 at risk EG0012 affected128 at risk EG0023 affected128 at risk
Oedema peripheral	General disorders	MedDRA 23.1	Non-systematic Assessment	EG00014 affected129 at risk EG00117 affected128 at risk EG0028 affected128 at risk
Pain	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0011 affected128 at risk EG0023 affected128 at risk
Peripheral swelling	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0007 affected129 at risk EG0016 affected128 at risk EG0025 affected128 at risk
Pyrexia	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 affected129 at risk EG0019 affected128 at risk EG0029 affected128 at risk
Swelling	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Swelling face	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Ulcer	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Vessel puncture site bruise	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Vessel puncture site haematoma	General disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Biliary dilatation	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Biliary dyskinesia	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Cardiac cirrhosis	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Cholecystocholangitis	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 affected129 at risk EG0012 affected128 at risk EG0021 affected128 at risk
Congestive hepatopathy	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Hepatomegaly	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Hepatosplenomegaly	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 affected129 at risk EG0014 affected128 at risk EG0020 affected128 at risk
Liver disorder	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Ocular icterus	Hepatobiliary disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Allergy to arthropod bite	Immune system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0022 affected128 at risk
Food allergy	Immune system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Hypersensitivity	Immune system disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0012 affected128 at risk EG0021 affected128 at risk
Multiple allergies	Immune system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Seasonal allergy	Immune system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0022 affected128 at risk
Secondary immunodeficiency	Immune system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Abdominal abscess	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Acute sinusitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0023 affected128 at risk
Bacterial disease carrier	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Bacterial infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Bacterial rhinitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Bronchitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00011 affected129 at risk EG00111 affected128 at risk EG0028 affected128 at risk
Bronchitis viral	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
COVID-19	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Cellulitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0003 affected129 at risk EG0012 affected128 at risk EG0021 affected128 at risk
Chronic sinusitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Chronic tonsillitis 0 0	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Conjunctivitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0005 affected129 at risk EG0011 affected128 at risk EG0026 affected128 at risk
Cystitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0003 affected129 at risk EG0012 affected128 at risk EG0020 affected128 at risk
Device related infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Device related sepsis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Diverticulitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Ear infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0004 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Enteritis infectious	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Erysipelas	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Eye infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Gastric infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Gastroenteritis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0004 affected129 at risk EG0011 affected128 at risk EG0023 affected128 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0012 affected128 at risk EG0020 affected128 at risk
Gastrointestinal candidiasis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Gastrointestinal viral infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Genital infection female	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Gingivitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Groin abscess	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Helicobacter gastritis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Helicobacter infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Hepatitis B	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Herpes simplex	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0022 affected128 at risk
Herpes virus infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Herpes zoster	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Hordeolum	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Incision site abscess	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Influenza	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0006 affected129 at risk EG0018 affected128 at risk EG00211 affected128 at risk
Joint abscess	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Laryngitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0012 affected128 at risk EG0022 affected128 at risk
Localised infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0022 affected128 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Nasopharyngitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00019 affected129 at risk EG00116 affected128 at risk EG00219 affected128 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Onychomycosis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Oral candidiasis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0022 affected128 at risk
Oral fungal infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Oral herpes	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Otitis media	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Otitis media chronic	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Paronychia	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Periodontitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Pharyngitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0023 affected128 at risk
Pharyngitis bacterial	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Pneumonia	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0005 affected129 at risk EG0013 affected128 at risk EG0025 affected128 at risk
Pulpitis dental	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Pyelonephritis chronic	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Respiratory tract infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0005 affected129 at risk EG0014 affected128 at risk EG0026 affected128 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0004 affected129 at risk EG0015 affected128 at risk EG0028 affected128 at risk
Rhinitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0005 affected129 at risk EG0015 affected128 at risk EG0021 affected128 at risk
Salpingo-oophoritis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Sinusitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0003 affected129 at risk EG0013 affected128 at risk EG00210 affected128 at risk
Skin infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Tinea pedis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Tongue fungal infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Tonsillitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0013 affected128 at risk EG0021 affected128 at risk
Tonsillitis bacterial	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Tooth abscess	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Tracheitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Tracheobronchitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG00016 affected129 at risk EG0018 affected128 at risk EG00213 affected128 at risk
Urinary tract infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0004 affected129 at risk EG0011 affected128 at risk EG0025 affected128 at risk
Vaginal infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Varicella	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Viral infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0004 affected129 at risk EG0015 affected128 at risk EG0023 affected128 at risk
Viral rhinitis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0012 affected128 at risk EG0020 affected128 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0012 affected128 at risk EG0021 affected128 at risk
Arthropod sting	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Back injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Burn oral cavity	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0022 affected128 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0012 affected128 at risk EG0021 affected128 at risk
Endotracheal intubation complication	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Epicondylitis	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Exposure via breast milk	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0004 affected129 at risk EG0012 affected128 at risk EG0023 affected128 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0012 affected128 at risk EG0021 affected128 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Muscle injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Muscle rupture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Nasal injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Oral contusion	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0012 affected128 at risk EG0021 affected128 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Scar	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Tooth fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Alanine aminotransferase increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0012 affected128 at risk EG0020 affected128 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Blood albumin abnormal	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Blood bilirubin increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0003 affected129 at risk EG0013 affected128 at risk EG0023 affected128 at risk
Blood cholesterol increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Blood creatinine increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Blood glucose decreased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Blood iron decreased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Blood potassium abnormal	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Blood pressure decreased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0022 affected128 at risk
Blood pressure diastolic decreased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Blood pressure increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0003 affected129 at risk EG0011 affected128 at risk EG0022 affected128 at risk
Blood pressure measurement	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Blood urea increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Blood uric acid increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0012 affected128 at risk EG0022 affected128 at risk
Body temperature increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0012 affected128 at risk EG0021 affected128 at risk
Breath sounds abnormal	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Colonoscopy	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Endoscopy	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Fibrin D dimer increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Haemodynamic test	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0012 affected128 at risk EG0020 affected128 at risk
Heart rate	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Heart rate decreased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Heart rate increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Heart sounds abnormal	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Liver function test abnormal	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Oxygen saturation decreased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Platelet count decreased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Protein total abnormal	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
SARS-CoV-2 test positive	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Staphylococcus test positive	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Transaminases increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Troponin increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Ultrasound scan	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Venous pressure jugular increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Vitamin D decreased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Walking distance test abnormal	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Weight decreased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0004 affected129 at risk EG0011 affected128 at risk EG0022 affected128 at risk
Weight increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
White blood cell count increased	Investigations	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0022 affected128 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Calcium deficiency	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0012 affected128 at risk EG0022 affected128 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0012 affected128 at risk EG0020 affected128 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0011 affected128 at risk EG0022 affected128 at risk
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Gout	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0012 affected128 at risk EG0021 affected128 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0014 affected128 at risk EG0020 affected128 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 affected129 at risk EG0011 affected128 at risk EG0023 affected128 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG00010 affected129 at risk EG0016 affected128 at risk EG0025 affected128 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Impaired fasting glucose	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Insulin resistance	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0013 affected128 at risk EG0022 affected128 at risk
Mineral metabolism disorder	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0012 affected128 at risk EG0020 affected128 at risk
Steroid diabetes	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG00014 affected129 at risk EG00113 affected128 at risk EG00215 affected128 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 affected129 at risk EG0013 affected128 at risk EG0020 affected128 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG00016 affected129 at risk EG00110 affected128 at risk EG00214 affected128 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0012 affected128 at risk EG0021 affected128 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0022 affected128 at risk
Limb mass	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Metatarsalgia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Muscle contracture	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0004 affected129 at risk EG0013 affected128 at risk EG0023 affected128 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0012 affected128 at risk EG0020 affected128 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Musculoskeletal disorder	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0004 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0004 affected129 at risk EG00110 affected128 at risk EG00212 affected128 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0013 affected128 at risk EG0024 affected128 at risk
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0012 affected128 at risk EG0023 affected128 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0011 affected128 at risk EG0024 affected128 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0006 affected129 at risk EG00114 affected128 at risk EG0026 affected128 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 affected129 at risk EG0013 affected128 at risk EG0021 affected128 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Sclerodactylia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Scleroderma	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Sjogren's syndrome	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Spinal disorder	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0013 affected128 at risk EG0020 affected128 at risk
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Systemic scleroderma	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0012 affected128 at risk EG0020 affected128 at risk
Temporomandibular joint syndrome	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Trigger finger	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Undifferentiated connective tissue disease	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
B-cell lymphoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Benign pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Haemangioma of bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Haemangioma of liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Myelofibrosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Myeloproliferative neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Polycythaemia vera	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Rectal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0022 affected128 at risk
Ageusia	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Amnesia	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Anosmia	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Aphasia	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0012 affected128 at risk EG0020 affected128 at risk
Balance disorder	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Burning sensation	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0022 affected128 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Cerebral atrophy	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Cervical radiculopathy	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Cognitive disorder	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0022 affected128 at risk
Dizziness	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG00012 affected129 at risk EG00115 affected128 at risk EG00218 affected128 at risk
Dizziness exertional	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0012 affected128 at risk EG0020 affected128 at risk
Encephalopathy	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Epilepsy	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Head discomfort	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0012 affected128 at risk EG0020 affected128 at risk
Headache	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG00026 affected129 at risk EG00145 affected128 at risk EG00233 affected128 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0013 affected128 at risk EG0022 affected128 at risk
Hypotonia	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Intercostal neuralgia	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Lethargy	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Loss of consciousness	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Migraine	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Neuralgia	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Neuritis	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Paraesthesia	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0013 affected128 at risk EG0022 affected128 at risk
Postictal paralysis	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Presyncope	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0014 affected128 at risk EG0021 affected128 at risk
Radiculopathy	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Sciatica	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Sensory loss	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Sinus headache	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Somnolence	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 affected129 at risk EG0015 affected128 at risk EG0020 affected128 at risk
Syncope	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0004 affected129 at risk EG0014 affected128 at risk EG0024 affected128 at risk
Tension headache	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Tremor	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0023 affected128 at risk
Trigeminal neuralgia	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Trigeminal neuritis	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Vascular encephalopathy	Nervous system disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Device breakage	Product Issues	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Device fastener issue	Product Issues	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Anxiety	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 affected129 at risk EG0012 affected128 at risk EG0021 affected128 at risk
Apathy	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Confusional state	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Depressed mood	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Depression	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0013 affected128 at risk EG0021 affected128 at risk
Emotional disorder	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Initial insomnia	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Insomnia	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0004 affected129 at risk EG0015 affected128 at risk EG0022 affected128 at risk
Mental disorder	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Mood altered	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Mood swings	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Nervousness	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Sleep disorder	Psychiatric disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0013 affected128 at risk EG0021 affected128 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Azotaemia	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Dysuria	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Haematuria	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0012 affected128 at risk EG0020 affected128 at risk
Proteinuria	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Pyelocaliectasis	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Renal cyst	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0011 affected128 at risk EG0023 affected128 at risk
Renal failure	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0022 affected128 at risk
Renal impairment	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0022 affected128 at risk
Urinary retention	Renal and urinary disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Amenorrhoea	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Breast cyst	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Breast inflammation	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Breast mass	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Breast pain	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Dysfunctional uterine bleeding	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Gynaecomastia	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Menstrual disorder	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Priapism	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0022 affected128 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Vulvovaginal pruritus	Reproductive system and breast disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Alveolitis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0022 affected128 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0022 affected128 at risk
Bronchopneumopathy	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Catarrh	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0022 affected128 at risk
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG00014 affected129 at risk EG00111 affected128 at risk EG00212 affected128 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG00012 affected129 at risk EG00116 affected128 at risk EG00211 affected128 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0013 affected128 at risk EG0020 affected128 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG00011 affected129 at risk EG00113 affected128 at risk EG00213 affected128 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0013 affected128 at risk EG0021 affected128 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Hyperventilation	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0013 affected128 at risk EG0020 affected128 at risk
Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Increased upper airway secretion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0008 affected129 at risk EG0014 affected128 at risk EG0025 affected128 at risk
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0016 affected128 at risk EG0022 affected128 at risk
Paranasal sinus discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Pharyngeal swelling	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0012 affected128 at risk EG0021 affected128 at risk
Prolonged expiration	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG00010 affected129 at risk EG0017 affected128 at risk EG0024 affected128 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Pulmonary vascular disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0012 affected128 at risk EG0020 affected128 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0012 affected128 at risk EG0020 affected128 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0014 affected128 at risk EG0023 affected128 at risk
Rhonchi	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Sinonasal obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0022 affected128 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0022 affected128 at risk
Vasomotor rhinitis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Vocal cord polyp	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0013 affected128 at risk EG0020 affected128 at risk
Chronic spontaneous urticaria	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0023 affected128 at risk
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Eczema nummular	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0014 affected128 at risk EG0024 affected128 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0012 affected128 at risk EG0020 affected128 at risk
Hypersensitivity vasculitis	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0004 affected129 at risk EG0013 affected128 at risk EG0023 affected128 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 affected129 at risk EG0011 affected128 at risk EG0022 affected128 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Skin burning sensation	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0011 affected128 at risk EG0022 affected128 at risk
Telangiectasia	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Vitiligo	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Yellow skin	Skin and subcutaneous tissue disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Cancer surgery	Surgical and medical procedures	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Cardiac ablation	Surgical and medical procedures	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Cataract operation	Surgical and medical procedures	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0023 affected128 at risk
Dental operation	Surgical and medical procedures	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Haematoma evacuation	Surgical and medical procedures	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Myomectomy	Surgical and medical procedures	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Tooth extraction	Surgical and medical procedures	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Tooth repair	Surgical and medical procedures	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Vascular operation	Surgical and medical procedures	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Aortic stenosis	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0022 affected128 at risk
Cyanosis	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0021 affected128 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Flushing	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0006 affected129 at risk EG0013 affected128 at risk EG0024 affected128 at risk
Haematoma	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Haemorrhage	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Hot flush	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0013 affected128 at risk EG0022 affected128 at risk
Hyperaemia	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Hypertension	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0016 affected128 at risk EG0025 affected128 at risk
Hypertensive crisis	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0003 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Hypotension	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0009 affected129 at risk EG0016 affected128 at risk EG0027 affected128 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Labile blood pressure	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Lymphoedema	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Neovascularisation	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Pelvic venous thrombosis	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Peripheral venous disease	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Phlebitis	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0002 affected129 at risk EG0011 affected128 at risk EG0020 affected128 at risk
Raynaud's phenomenon	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Thrombophlebitis	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected128 at risk
Varicose vein	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk
Vasodilatation	Vascular disorders	MedDRA 23.1	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected128 at risk

ID	Title	Description
BG000	Sildenafil 5 mg	Participants received a single tablet of sildenafil at a dose of 5 mg along with two tablets of placebo matching 20 mg and 80 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 2080 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.
BG001	Sildenafil 20 mg	Participants received a single tablet of sildenafil at a dose of 20 mg along with two tablets of placebo matching 5 mg and 80 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 1984 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.
BG002	Sildenafil 80 mg	Participants received a single tablet of sildenafil at a dose of 20 mg along with two tablets of placebo matching 5 mg and 80 mg sildenafil orally TID on day 1 for 2 weeks and then titrated up to 80 mg at week 2 along with two tablets of placebo matching 5 mg and 20 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 2073 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.
BG003	Total	Total of all reporting groups

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006973	Hypertension
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D013450	Sulfones
D013457	Sulfur Compounds
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Sildenafil 5 mg	Participants received a single tablet of sildenafil at a dose of 5 mg along with two tablets of placebo matching 20 mg and 80 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 2080 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.	34	129	66	129	108	129
EG001	Sildenafil 20 mg	Participants received a single tablet of sildenafil at a dose of 20 mg along with two tablets of placebo matching 5 mg and 80 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 1984 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.	25	128	49	128	107	128
EG002	Sildenafil 80 mg	Participants received a single tablet of sildenafil at a dose of 20 mg along with two tablets of placebo matching 5 mg and 80 mg sildenafil orally TID on day 1 for 2 weeks and then titrated up to 80 mg at week 2 along with two tablets of placebo matching 5 mg and 20 mg sildenafil orally TID until discontinuation of study treatment or end of study. The maximum duration of study treatment was 2073 days approximately. Participants were followed up for at least 28 days after last dose of study treatment.	19	128	51	128	111	128

ID	Term
D000081029	Pulmonary Arterial Hypertension
D006976	Hypertension, Pulmonary