A Study of AMR101 to Evaluate Its Ability to Reduce Cardi... | NCT01492361

Label	Type	Description	Intervention Names
AMR101	Experimental	AMR101 (icosapent ethyl) + statin therapy, daily	Drug: AMR101 Drug: Statin therapy
Placebo	Placebo Comparator	Placebo + statin therapy, daily	Drug: Placebo Drug: Statin therapy

Name	Type	Description	Arm Group Labels	Other Names
AMR101	Drug	Parallel Assignment	AMR101	VASCEPA® (icosapent ethyl)

Measure	Description	Time Frame
Composite of CV Death, Nonfatal MI (Including Silent MI), Nonfatal Stroke, Coronary Revascularization, or Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization.	The primary outcome measure was the number of patients with a first occurrence of any component of the composite of CV death, nonfatal MI (including silent MI), nonfatal stroke, coronary revascularization, or unstable angina determined to be caused by myocardial ischemia by invasive / non-invasive testing and requiring emergent hospitalization during the follow-up period.	Total follow-up time of up to approximately 6 years.

Measure	Description	Time Frame
Composite of CV Death, Nonfatal MI (Including Silent MI), or Nonfatal Stroke.	The key secondary outcome measure was the number of patients with a first occurrence of any component of the composite of CV death, nonfatal MI (including silent MI), or nonfatal stroke during the follow-up period.	Total follow-up time of up to approximately 6 years.

Name	Affiliation	Role
Deepak L. Bhatt, MD, MPH	Brigham and Women's Hospital, 75 Francis Street, Boston	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Amarin Investigational Site		Birmingham	Alabama	35205	United States
Amarin Investigational Site

PubMed Identifier	Type	Citation	Retractions
28294373	Background	Bhatt DL, Steg PG, Brinton EA, Jacobson TA, Miller M, Tardif JC, Ketchum SB, Doyle RT Jr, Murphy SA, Soni PN, Braeckman RA, Juliano RA, Ballantyne CM; REDUCE-IT Investigators. Rationale and design of REDUCE-IT: Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial. Clin Cardiol. 2017 Mar;40(3):138-148. doi: 10.1002/clc.22692. Epub 2017 Mar 15.
30415628

ID	Title	Description
FG000	AMR101	AMR101: Parallel Assignment
FG001	Placebo	Placebo: Parallel Assignment

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jul 8, 2016

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG000105 affected4,089 at risk EG001118 affected4,090 at risk
Cellulitis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG00036 affected4,089 at risk EG00128 affected4,090 at risk
Sepsis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG00025 affected4,089 at risk EG00131 affected4,090 at risk
Urinary tract infection	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG00025 affected4,089 at risk EG00122 affected4,090 at risk
Gastroenteritis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG00016 affected4,089 at risk EG00116 affected4,090 at risk
Erysipelas	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG00013 affected4,089 at risk EG0013 affected4,090 at risk
Osteomyelitis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG00012 affected4,089 at risk EG0017 affected4,090 at risk
Septic shock	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG00012 affected4,089 at risk EG0013 affected4,090 at risk
Bronchitis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG00011 affected4,089 at risk EG00110 affected4,090 at risk
Diverticulitis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG00011 affected4,089 at risk EG0019 affected4,090 at risk
Urosepsis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG00011 affected4,089 at risk EG0019 affected4,090 at risk
Appendicitis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0009 affected4,089 at risk EG0016 affected4,090 at risk
Postoperative wound infection	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0008 affected4,089 at risk EG0014 affected4,090 at risk
Pyelonephritis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0007 affected4,089 at risk EG0014 affected4,090 at risk
Gastroenteritis viral	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0005 affected4,089 at risk EG0011 affected4,090 at risk
Arthritis bacterial	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0004 affected4,089 at risk EG0012 affected4,090 at risk
Wound infection	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0004 affected4,089 at risk EG0012 affected4,090 at risk
Bacteraemia	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0014 affected4,090 at risk
Cystitis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0013 affected4,090 at risk
Localised infection	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0013 affected4,090 at risk
Arthritis infective	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0012 affected4,090 at risk
Staphylococcal infection	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0012 affected4,090 at risk
Abscess limb	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0011 affected4,090 at risk
Gangrene	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0011 affected4,090 at risk
Intervertebral discitis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0011 affected4,090 at risk
Laryngitis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0010 affected4,090 at risk
Influenza	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0014 affected4,090 at risk
Pyelonephritis acute	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0014 affected4,090 at risk
Anal abscess	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0012 affected4,090 at risk
Herpes zoster	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0011 affected4,090 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0011 affected4,090 at risk
Liver abscess	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0011 affected4,090 at risk
Appendicitis perforated	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Meningitis bacterial	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Necrotising fasciitis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Parainfluenzae virus infection	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Perirectal abscess	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Pneumococcal sepsis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Pneumonia streptococcal	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0015 affected4,090 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0015 affected4,090 at risk
Endocarditis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0014 affected4,090 at risk
Viral infection	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0013 affected4,090 at risk
Abscess intestinal	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0012 affected4,090 at risk
Clostridium difficile infection	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0012 affected4,090 at risk
Implant site infection	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0012 affected4,090 at risk
Peritonitis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0012 affected4,090 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0012 affected4,090 at risk
Bronchitis viral	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Gastroenteritis rotavirus	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Pneumonia influenzal	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Pneumonia pseudomonal	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Postoperative abscess	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Streptococcal sepsis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Tracheobronchitis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Acquired immunodeficiency syndrome	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Bronchiolitis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Bronchitis bacterial	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Campylobacter gastroenteritis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Catheter site cellulitis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Cellulitis streptococcal	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Cystitis bacterial	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Cystitis escherichia	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Dengue fever	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Device related sepsis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Diabetic foot infection	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Diarrhoea infectious	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Epiglottitis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Gastrointestinal bacterial overgrowth	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Gastrointestinal infection	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Genital infection fungal	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Graft infection	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Groin abscess	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Hepatitis C	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Incision site abscess	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Infected skin ulcer	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Infectious colitis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Infective exacerbation of bronchiectasis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Joint abscess	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Keratitis bacterial	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Latent tuberculosis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Lower respiratory tract infection viral	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Mastitis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Meningitis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Mycobacterial infection	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Parotitis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Peritonitis bacterial	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Pharyngolaryngeal abscess	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Pilonidal cyst	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Pneumonia bacterial	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Post procedural infection	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Rectal abscess	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Respiratory tract infection	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Shunt infection	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Skin infection	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Subacute endocarditis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Systemic candida	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Tick-borne fever	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Viral sepsis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Vulval cellulitis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Wound sepsis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Infection	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Orchitis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Rotavirus infection	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Abdominal abscess	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Abdominal infection	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Abdominal wall abscess	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Bacterial sepsis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Biliary abscess	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Breast abscess	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Bursitis infective	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Cholecystitis infective	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Device related infection	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Diverticulitis intestinal haemorrhagic	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Enterococcal bacteraemia	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Epididymitis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Gas gangrene	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
H1N1 influenza	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Helicobacter gastritis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Hepatitis viral	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Klebsiella infection	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Listeriosis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Neutropenic sepsis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Oral candidiasis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Osteomyelitis acute	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Otitis media acute	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Parasitic gastroenteritis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Pelvic abscess	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Pharyngeal abscess	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Pneumonia respiratory syncytial viral	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Pneumonia viral	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Post procedural cellulitis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Pseudomembranous colitis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Pseudomonas infection	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Pyelocystitis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Rhinovirus infection	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Sepsis syndrome	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Sialoadenitis	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Streptococcal infection	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Tooth abscess	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Wound abscess	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Wound infection staphylococcal	Infections and infestations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG00026 affected4,089 at risk EG00126 affected4,090 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG00014 affected4,089 at risk EG0018 affected4,090 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG00010 affected4,089 at risk EG0016 affected4,090 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0008 affected4,089 at risk EG00114 affected4,090 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0008 affected4,089 at risk EG0019 affected4,090 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0008 affected4,089 at risk EG0019 affected4,090 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0007 affected4,089 at risk EG0014 affected4,090 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0006 affected4,089 at risk EG0016 affected4,090 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0006 affected4,089 at risk EG0014 affected4,090 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0006 affected4,089 at risk EG0014 affected4,090 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0005 affected4,089 at risk EG0015 affected4,090 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0005 affected4,089 at risk EG0014 affected4,090 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0005 affected4,089 at risk EG0012 affected4,090 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0004 affected4,089 at risk EG0016 affected4,090 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0004 affected4,089 at risk EG0015 affected4,090 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0004 affected4,089 at risk EG0013 affected4,090 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0004 affected4,089 at risk EG0013 affected4,090 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0004 affected4,089 at risk EG0013 affected4,090 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0012 affected4,090 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0012 affected4,090 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0011 affected4,090 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0011 affected4,090 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0010 affected4,090 at risk
Non-small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0010 affected4,090 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0016 affected4,090 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0013 affected4,090 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0012 affected4,090 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0012 affected4,090 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0012 affected4,090 at risk
Prostate cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0012 affected4,090 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0012 affected4,090 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0012 affected4,090 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0011 affected4,090 at risk
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0011 affected4,090 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0011 affected4,090 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0011 affected4,090 at risk
Parathyroid tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0011 affected4,090 at risk
Renal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0011 affected4,090 at risk
Bladder cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Breast cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Metastatic renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0014 affected4,090 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0013 affected4,090 at risk
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0013 affected4,090 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0012 affected4,090 at risk
Bone cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Colon cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Metastases to peritoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Metastatic carcinoma of the bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Mucinous adenocarcinoma of appendix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Thyroid cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Anal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Benign neoplasm of thyroid gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Breast cancer male	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Cervix neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Cholesteatoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Colorectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Endometrial cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Extranodal marginal zone B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Gastrointestinal stromal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Iris melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Large cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Large intestine benign neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Leiomyosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Lung adenocarcinoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Lung carcinoma cell type unspecified recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Malignant glioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Metastases to abdominal cavity	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Metastases to chest wall	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Metastases to kidney	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Metastatic gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Metastatic squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Nasal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Oesophageal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Oropharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Ovarian epithelial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Ovarian granulosa-theca cell tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Pituitary tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Pleural mesothelioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Salivary gland adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Small intestine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Testis cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Transitional cell cancer of the renal pelvis and ureter	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Tumour ulceration	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Breast cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Acute lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Adenoid cystic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Adrenal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Adrenal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Anal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Bladder cancer stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Central nervous system neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Colorectal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Duodenal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Endometrial cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Gastric adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Gastric cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Gastric neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Gastrointestinal tract adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Hepatic cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Lip and/or oral cavity cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Lung adenocarcinoma stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Malignant mesenteric neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Mucoepidermoid carcinoma of salivary gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Neuroendocrine carcinoma of the skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Neuroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Nodular melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Non-small cell lung cancer stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Non-small cell lung cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Oesophageal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Ovarian cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Ovarian epithelial cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Ovarian neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Penile cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Prostate cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Rectal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Refractory anaemia with ringed sideroblasts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Refractory cytopenia with unilineage dysplasia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Retroperitoneal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Schwannoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Squamous cell carcinoma of pharynx	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Throat cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Tongue cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Tonsil cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Transitional cell carcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Urethral cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Angina pectoris	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG00048 affected4,089 at risk EG00148 affected4,090 at risk
Angina unstable	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG00041 affected4,089 at risk EG00153 affected4,090 at risk
Atrial fibrillation	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG00021 affected4,089 at risk EG00117 affected4,090 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG00019 affected4,089 at risk EG00113 affected4,090 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG00010 affected4,089 at risk EG0017 affected4,090 at risk
Coronary artery disease	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0009 affected4,089 at risk EG00116 affected4,090 at risk
Cardiac failure	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0007 affected4,089 at risk EG0018 affected4,090 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0006 affected4,089 at risk EG0014 affected4,090 at risk
Myocardial infarction	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0004 affected4,089 at risk EG00112 affected4,090 at risk
Cardiac arrest	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0004 affected4,089 at risk EG0019 affected4,090 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0004 affected4,089 at risk EG0014 affected4,090 at risk
Cardiomyopathy	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0004 affected4,089 at risk EG0012 affected4,090 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0004 affected4,089 at risk EG0012 affected4,090 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0013 affected4,090 at risk
Arrhythmia	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0012 affected4,090 at risk
Palpitations	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0011 affected4,090 at risk
Cardiac failure acute	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0010 affected4,090 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0010 affected4,090 at risk
Cardiogenic shock	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0013 affected4,090 at risk
Pericarditis	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0013 affected4,090 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0011 affected4,090 at risk
Left ventricular failure	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0014 affected4,090 at risk
Atrial flutter	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0013 affected4,090 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0012 affected4,090 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0012 affected4,090 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0012 affected4,090 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0012 affected4,090 at risk
Bradycardia	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Bundle branch block left	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Cardiac valve disease	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Cor pulmonale chronic	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Pleuropericarditis	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Ventricular parasystole	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0014 affected4,090 at risk
Cardiac tamponade	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0013 affected4,090 at risk
Arteriospasm coronary	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Pericardial effusion	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Silent myocardial infarction	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Aortic valve disease	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Aortic valve disease mixed	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Cardiac ventricular thrombosis	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Coronary artery dissection	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Microvascular coronary artery disease	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Pericardial haemorrhage	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Stress cardiomyopathy	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Tachycardia paroxysmal	Cardiac disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG00026 affected4,089 at risk EG00120 affected4,090 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG00016 affected4,089 at risk EG00112 affected4,090 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG00011 affected4,089 at risk EG0018 affected4,090 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG00010 affected4,089 at risk EG0016 affected4,090 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0007 affected4,089 at risk EG0014 affected4,090 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0007 affected4,089 at risk EG0014 affected4,090 at risk
Constipation	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0006 affected4,089 at risk EG0018 affected4,090 at risk
Colitis	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0006 affected4,089 at risk EG0016 affected4,090 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0005 affected4,089 at risk EG0016 affected4,090 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0005 affected4,089 at risk EG0016 affected4,090 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0005 affected4,089 at risk EG0014 affected4,090 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0005 affected4,089 at risk EG0011 affected4,090 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0005 affected4,089 at risk EG0011 affected4,090 at risk
Ileus	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0004 affected4,089 at risk EG0015 affected4,090 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0004 affected4,089 at risk EG0015 affected4,090 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0004 affected4,089 at risk EG0015 affected4,090 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0004 affected4,089 at risk EG0012 affected4,090 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0004 affected4,089 at risk EG0010 affected4,090 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0017 affected4,090 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0016 affected4,090 at risk
Melaena	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0014 affected4,090 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0013 affected4,090 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0013 affected4,090 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0012 affected4,090 at risk
Ascites	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0011 affected4,090 at risk
Diverticulum	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0011 affected4,090 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0011 affected4,090 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0011 affected4,090 at risk
Haematemesis	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0010 affected4,090 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0015 affected4,090 at risk
Obstructive pancreatitis	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0014 affected4,090 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0013 affected4,090 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0012 affected4,090 at risk
Anal fistula	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0011 affected4,090 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0011 affected4,090 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0011 affected4,090 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Enteritis	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Retroperitoneal fibrosis	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG00110 affected4,090 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0013 affected4,090 at risk
Haematochezia	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0012 affected4,090 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Large intestinal haemorrhage	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Peritoneal disorder	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Appendix disorder	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Duodenogastric reflux	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Gastric antral vascular ectasia	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Gastrointestinal angiodysplasia haemorrhagic	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Gastrointestinal pain	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Intra-abdominal haemorrhage	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Mallory-Weiss syndrome	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Pancreatic cyst	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Pancreatitis haemorrhagic	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Peptic ulcer haemorrhage	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Peritoneal adhesions	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Pharyngo-oesophageal diverticulum	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Proctitis ulcerative	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Rectal prolapse	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Subileus	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Thrombosis mesenteric vessel	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Volvulus	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Gastritis	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0016 affected4,090 at risk
Dysphagia	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Food poisoning	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Gastrointestinal obstruction	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Abdominal adhesions	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Abdominal hernia obstructive	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Duodenal perforation	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Duodenitis haemorrhagic	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Enterovesical fistula	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Gastric perforation	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Gastroduodenitis	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Gastrointestinal angiodysplasia	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Mesenteric arterial occlusion	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Mouth haemorrhage	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Oesophageal food impaction	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Oesophageal haemorrhage	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Oesophageal pain	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Pancreatic mass	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Portal hypertensive gastropathy	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Rectal polyp	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Strangulated umbilical hernia	Gastrointestinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG00081 affected4,089 at risk EG00173 affected4,090 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG00017 affected4,089 at risk EG00111 affected4,090 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG00016 affected4,089 at risk EG0017 affected4,090 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG00011 affected4,089 at risk EG0015 affected4,090 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG00010 affected4,089 at risk EG00112 affected4,090 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG00010 affected4,089 at risk EG00110 affected4,090 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0007 affected4,089 at risk EG0019 affected4,090 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0006 affected4,089 at risk EG0016 affected4,090 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0006 affected4,089 at risk EG0011 affected4,090 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0005 affected4,089 at risk EG0013 affected4,090 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0005 affected4,089 at risk EG0012 affected4,090 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0013 affected4,090 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0012 affected4,090 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0014 affected4,090 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0013 affected4,090 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0012 affected4,090 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0011 affected4,090 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0014 affected4,090 at risk
Vertebral foraminal stenosis	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0012 affected4,090 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Pseudarthrosis	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Intervertebral disc compression	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Knee deformity	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Mandibular mass	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Rheumatic fever	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Soft tissue mass	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Sympathetic posterior cervical syndrome	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0015 affected4,090 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0013 affected4,090 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Back disorder	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Coccydynia	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Gouty tophus	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Temporomandibular joint syndrome	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG00033 affected4,089 at risk EG00134 affected4,090 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG00019 affected4,089 at risk EG00118 affected4,090 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG00016 affected4,089 at risk EG00115 affected4,090 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG00016 affected4,089 at risk EG00113 affected4,090 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG00014 affected4,089 at risk EG00122 affected4,090 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0009 affected4,089 at risk EG0015 affected4,090 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0007 affected4,089 at risk EG00111 affected4,090 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0007 affected4,089 at risk EG0014 affected4,090 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0007 affected4,089 at risk EG0014 affected4,090 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0004 affected4,089 at risk EG0012 affected4,090 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0004 affected4,089 at risk EG0011 affected4,090 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0017 affected4,090 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0015 affected4,090 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0012 affected4,090 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0011 affected4,090 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0012 affected4,090 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0012 affected4,090 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0011 affected4,090 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0014 affected4,090 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0012 affected4,090 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0012 affected4,090 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Pharyngeal mass	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Pneumomediastinum	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Status asthmaticus	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0014 affected4,090 at risk
Bronchial fistula	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Nasal turbinate hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Tracheal mass	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Fall	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG00016 affected4,089 at risk EG00115 affected4,090 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0009 affected4,089 at risk EG0015 affected4,090 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0008 affected4,089 at risk EG0018 affected4,090 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0006 affected4,089 at risk EG0013 affected4,090 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0005 affected4,089 at risk EG0013 affected4,090 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0005 affected4,089 at risk EG0013 affected4,090 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0005 affected4,089 at risk EG0012 affected4,090 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0004 affected4,089 at risk EG00110 affected4,090 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0004 affected4,089 at risk EG0015 affected4,090 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0004 affected4,089 at risk EG0014 affected4,090 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0004 affected4,089 at risk EG0011 affected4,090 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0014 affected4,090 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0014 affected4,090 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0010 affected4,090 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0010 affected4,090 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0013 affected4,090 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0012 affected4,090 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0012 affected4,090 at risk
Ligament injury	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0011 affected4,090 at risk
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0011 affected4,090 at risk
Subarachnoid haemorrhage	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0011 affected4,090 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0011 affected4,090 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0011 affected4,090 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0011 affected4,090 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Muscle rupture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Postoperative fever	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Postoperative hernia	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0013 affected4,090 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0012 affected4,090 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0012 affected4,090 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Fractured sacrum	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Post procedural discharge	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Post procedural swelling	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Wound	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Avulsion fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Bone fragmentation	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Cartilage injury	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Dislocation of sternum	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Foreign body in gastrointestinal tract	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Incarcerated incisional hernia	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Muscle injury	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Periprosthetic fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Post laminectomy syndrome	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Post procedural pulmonary embolism	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Postoperative adhesion	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Postoperative renal failure	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Postoperative thrombosis	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Radiation oesophagitis	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Spinal cord injury	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Traumatic liver injury	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0013 affected4,090 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Stomal hernia	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Axillary nerve injury	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Back injury	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Carbon monoxide poisoning	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Compression fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Heat stroke	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Oesophageal injury	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Poisoning deliberate	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Post procedural haematuria	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Procedural hypertension	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Pubis fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Radiation injury	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Sciatic nerve injury	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Skull fractured base	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Spinal column injury	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Stress fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Traumatic renal injury	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Ureteric anastomosis complication	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Urethral injury	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Chest pain	General disorders	MedDRA Version 20.1	Systematic Assessment	EG00066 affected4,089 at risk EG00166 affected4,090 at risk
Non-cardiac chest pain	General disorders	MedDRA Version 20.1	Systematic Assessment	EG00049 affected4,089 at risk EG00152 affected4,090 at risk
Asthenia	General disorders	MedDRA Version 20.1	Systematic Assessment	EG0006 affected4,089 at risk EG0018 affected4,090 at risk
Malaise	General disorders	MedDRA Version 20.1	Systematic Assessment	EG0005 affected4,089 at risk EG0013 affected4,090 at risk
Pyrexia	General disorders	MedDRA Version 20.1	Systematic Assessment	EG0004 affected4,089 at risk EG0015 affected4,090 at risk
Oedema peripheral	General disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0012 affected4,090 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0011 affected4,090 at risk
General physical health deterioration	General disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0017 affected4,090 at risk
Chest discomfort	General disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0014 affected4,090 at risk
Fatigue	General disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0012 affected4,090 at risk
Cyst	General disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Impaired healing	General disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Adverse drug reaction	General disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Chills	General disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Complication associated with device	General disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Drowning	General disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Gait disturbance	General disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Generalised oedema	General disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Peripheral swelling	General disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Swelling	General disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Ulcer	General disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Ulcer haemorrhage	General disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Vascular stent restenosis	General disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Exercise tolerance decreased	General disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0013 affected4,090 at risk
Incarcerated hernia	General disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Polyp	General disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Catheter site haemorrhage	General disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Death	General disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Pain	General disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Pelvic mass	General disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Suprapubic pain	General disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG00047 affected4,089 at risk EG00134 affected4,090 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG00013 affected4,089 at risk EG00112 affected4,090 at risk
Renal failure	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG00011 affected4,089 at risk EG0016 affected4,090 at risk
Haematuria	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0008 affected4,089 at risk EG0014 affected4,090 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0006 affected4,089 at risk EG0017 affected4,090 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0006 affected4,089 at risk EG0014 affected4,090 at risk
Urinary retention	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0005 affected4,089 at risk EG0014 affected4,090 at risk
Renal impairment	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0005 affected4,089 at risk EG0011 affected4,090 at risk
Renal cyst	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0004 affected4,089 at risk EG0010 affected4,090 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0012 affected4,090 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0011 affected4,090 at risk
Calculus urinary	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0013 affected4,090 at risk
Renal colic	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0013 affected4,090 at risk
End stage renal disease	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0011 affected4,090 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Bladder outlet obstruction	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0012 affected4,090 at risk
Stress urinary incontinence	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0012 affected4,090 at risk
Bladder neck obstruction	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Nephropathy	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Urinary bladder haemorrhage	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Bladder stenosis	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Incontinence	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Renal artery fibromuscular dysplasia	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Renal disorder	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Renal injury	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Ureteric dilatation	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Urethral meatus stenosis	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Calculus bladder	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0014 affected4,090 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0014 affected4,090 at risk
Acute prerenal failure	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Bladder dysfunction	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Bladder prolapse	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Dysuria	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Hypertonic bladder	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Nephropathy toxic	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Renal haemorrhage	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Stag horn calculus	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Urinary bladder polyp	Renal and urinary disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Syncope	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG00028 affected4,089 at risk EG00131 affected4,090 at risk
Dizziness	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG00011 affected4,089 at risk EG00110 affected4,090 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0008 affected4,089 at risk EG0013 affected4,090 at risk
Encephalopathy	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0007 affected4,089 at risk EG0012 affected4,090 at risk
Presyncope	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0006 affected4,089 at risk EG0016 affected4,090 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0015 affected4,090 at risk
Headache	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0014 affected4,090 at risk
Seizure	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0014 affected4,090 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0013 affected4,090 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0011 affected4,090 at risk
Cervical radiculopathy	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0011 affected4,090 at risk
Ataxia	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Dementia	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Epilepsy	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0013 affected4,090 at risk
Neuralgia	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0012 affected4,090 at risk
Aphasia	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Cerebral infarction	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Dementia Alzheimer's type	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Facial paralysis	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Hydrocephalus	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Hypertensive encephalopathy	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Transient global amnesia	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Unresponsive to stimuli	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Brain injury	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Carotid artery occlusion	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Cerebrospinal fluid leakage	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Cognitive disorder	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Dural arteriovenous fistula	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Haemorrhagic transformation stroke	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Hypoaesthesia	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
IIIrd nerve paralysis	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Intracranial mass	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Ischaemic stroke	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Migraine	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Nerve compression	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Neurodegenerative disorder	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Neurological symptom	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Pseudoradicular syndrome	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Quadriplegia	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Radicular syndrome	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Sensory ganglionitis	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Speech disorder	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Trigeminal nerve disorder	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Vasogenic cerebral oedema	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Vocal cord paralysis	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Hemiparesis	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0015 affected4,090 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Loss of consciousness	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Sciatica	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Acute disseminated encephalomyelitis	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Altered state of consciousness	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Amyotrophic lateral sclerosis	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Autonomic nervous system imbalance	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Carotid artery disease	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Demyelinating polyneuropathy	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Hypoglycaemic coma	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Hypoglycaemic encephalopathy	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Hypoglycaemic unconsciousness	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Multiple sclerosis	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Multiple sclerosis relapse	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Myelopathy	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Paraesthesia	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Polyneuropathy	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Reversible ischaemic neurological deficit	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Spinal cord herniation	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Status epilepticus	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Trigeminal neuralgia	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Vascular dementia	Nervous system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA Version 20.1	Systematic Assessment	EG00016 affected4,089 at risk EG00111 affected4,090 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA Version 20.1	Systematic Assessment	EG00015 affected4,089 at risk EG00114 affected4,090 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA Version 20.1	Systematic Assessment	EG00011 affected4,089 at risk EG0018 affected4,090 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 20.1	Systematic Assessment	EG00010 affected4,089 at risk EG0018 affected4,090 at risk
Obesity	Metabolism and nutrition disorders	MedDRA Version 20.1	Systematic Assessment	EG0009 affected4,089 at risk EG0015 affected4,090 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA Version 20.1	Systematic Assessment	EG0005 affected4,089 at risk EG0013 affected4,090 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA Version 20.1	Systematic Assessment	EG0005 affected4,089 at risk EG0010 affected4,090 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA Version 20.1	Systematic Assessment	EG0004 affected4,089 at risk EG0011 affected4,090 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0016 affected4,090 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0013 affected4,090 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0014 affected4,090 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0013 affected4,090 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0013 affected4,090 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0011 affected4,090 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0011 affected4,090 at risk
Gout	Metabolism and nutrition disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Hyperglycaemic hyperosmolar nonketotic syndrome	Metabolism and nutrition disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Shock hypoglycaemic	Metabolism and nutrition disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Diabetic metabolic decompensation	Metabolism and nutrition disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Hyperosmolar state	Metabolism and nutrition disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Hypertensive crisis	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG00015 affected4,089 at risk EG00111 affected4,090 at risk
Hypertension	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG00012 affected4,089 at risk EG00116 affected4,090 at risk
Hypotension	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0009 affected4,089 at risk EG00111 affected4,090 at risk
Deep vein thrombosis	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0005 affected4,089 at risk EG0018 affected4,090 at risk
Aortic stenosis	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0004 affected4,089 at risk EG00110 affected4,090 at risk
Orthostatic hypotension	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0004 affected4,089 at risk EG0015 affected4,090 at risk
Aortic aneurysm	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0011 affected4,090 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0013 affected4,090 at risk
Hypovolaemic shock	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0011 affected4,090 at risk
Accelerated hypertension	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Shock haemorrhagic	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Peripheral ischaemia	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0013 affected4,090 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0012 affected4,090 at risk
Aortic aneurysm rupture	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Haematoma	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Hypertensive emergency	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Intermittent claudication	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Shock	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Angiodysplasia	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Arteriovenous fistula	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Circulatory collapse	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Embolism arterial	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Extravasation blood	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Iliac artery occlusion	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Malignant hypertension	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Peripheral embolism	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Renovascular hypertension	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Vena cava thrombosis	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Blood pressure fluctuation	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Extremity necrosis	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Leriche syndrome	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Temporal arteritis	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Thrombophlebitis	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Thrombosis	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Vasculitis	Vascular disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA Version 20.1	Systematic Assessment	EG00015 affected4,089 at risk EG00118 affected4,090 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA Version 20.1	Systematic Assessment	EG00015 affected4,089 at risk EG0017 affected4,090 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA Version 20.1	Systematic Assessment	EG0009 affected4,089 at risk EG0017 affected4,090 at risk
Cholangitis	Hepatobiliary disorders	MedDRA Version 20.1	Systematic Assessment	EG0004 affected4,089 at risk EG0011 affected4,090 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0012 affected4,090 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0010 affected4,090 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Ischaemic hepatitis	Hepatobiliary disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Alcoholic liver disease	Hepatobiliary disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Cryptogenic cirrhosis	Hepatobiliary disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Gallbladder polyp	Hepatobiliary disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Gallbladder disorder	Hepatobiliary disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Gallbladder enlargement	Hepatobiliary disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Biliary colic	Hepatobiliary disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Biliary dilatation	Hepatobiliary disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Cholestasis	Hepatobiliary disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Liver disorder	Hepatobiliary disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Non-alcoholic steatohepatitis	Hepatobiliary disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA Version 20.1	Systematic Assessment	EG00022 affected4,089 at risk EG00120 affected4,090 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA Version 20.1	Systematic Assessment	EG0004 affected4,089 at risk EG0013 affected4,090 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA Version 20.1	Systematic Assessment	EG0004 affected4,089 at risk EG0011 affected4,090 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0010 affected4,090 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Lymphoid tissue hyperplasia	Blood and lymphatic system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Normocytic anaemia	Blood and lymphatic system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Thrombotic microangiopathy	Blood and lymphatic system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Autoimmune haemolytic anaemia	Blood and lymphatic system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Splenic infarction	Blood and lymphatic system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Immune thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Pernicious anaemia	Blood and lymphatic system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Splenomegaly	Blood and lymphatic system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA Version 20.1	Systematic Assessment	EG00018 affected4,089 at risk EG00111 affected4,090 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA Version 20.1	Systematic Assessment	EG0006 affected4,089 at risk EG0013 affected4,090 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0012 affected4,090 at risk
Adnexa uteri mass	Reproductive system and breast disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Genital haemorrhage	Reproductive system and breast disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Pelvic prolapse	Reproductive system and breast disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Peyronie's disease	Reproductive system and breast disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Prostatism	Reproductive system and breast disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Vaginal prolapse	Reproductive system and breast disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Endometrial hypoplasia	Reproductive system and breast disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Female genital tract fistula	Reproductive system and breast disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Ovarian cyst ruptured	Reproductive system and breast disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Seminal vesicular cyst	Reproductive system and breast disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Testicular cyst	Reproductive system and breast disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Delirium	Psychiatric disorders	MedDRA Version 20.1	Systematic Assessment	EG0005 affected4,089 at risk EG0012 affected4,090 at risk
Suicide attempt	Psychiatric disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0011 affected4,090 at risk
Mental status changes	Psychiatric disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0013 affected4,090 at risk
Depression	Psychiatric disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0012 affected4,090 at risk
Anxiety	Psychiatric disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Panic attack	Psychiatric disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Alcohol abuse	Psychiatric disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0013 affected4,090 at risk
Completed suicide	Psychiatric disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0012 affected4,090 at risk
Suicidal ideation	Psychiatric disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0012 affected4,090 at risk
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Confusional state	Psychiatric disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Aggression	Psychiatric disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Agitated depression	Psychiatric disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Delirium tremens	Psychiatric disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Major depression	Psychiatric disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Schizoaffective disorder	Psychiatric disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Acute psychosis	Psychiatric disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Alcoholism	Psychiatric disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Bipolar disorder	Psychiatric disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Mania	Psychiatric disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Psychotic disorder	Psychiatric disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Schizophrenia	Psychiatric disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0005 affected4,089 at risk EG0013 affected4,090 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0012 affected4,090 at risk
Diabetic ulcer	Skin and subcutaneous tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0011 affected4,090 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Granuloma annulare	Skin and subcutaneous tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Panniculitis	Skin and subcutaneous tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0010 affected4,090 at risk
Implantable defibrillator insertion	Surgical and medical procedures	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0011 affected4,090 at risk
Lung lobectomy	Surgical and medical procedures	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Aortic valve replacement	Surgical and medical procedures	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Artificial urinary sphincter implant	Surgical and medical procedures	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Hospitalisation	Surgical and medical procedures	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Polypectomy	Surgical and medical procedures	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Rotator cuff repair	Surgical and medical procedures	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Shoulder operation	Surgical and medical procedures	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Stem cell transplant	Surgical and medical procedures	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Transurethral prostatectomy	Surgical and medical procedures	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Cardiac ablation	Surgical and medical procedures	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Spinal operation	Surgical and medical procedures	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Endotracheal intubation	Surgical and medical procedures	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Gastric bypass	Surgical and medical procedures	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Large intestinal polypectomy	Surgical and medical procedures	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Transurethral bladder resection	Surgical and medical procedures	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Troponin increased	Investigations	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0013 affected4,090 at risk
Arteriogram coronary	Investigations	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0011 affected4,090 at risk
Ejection fraction decreased	Investigations	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0011 affected4,090 at risk
Blood pressure increased	Investigations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0012 affected4,090 at risk
Blood glucose increased	Investigations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Weight decreased	Investigations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Biopsy pleura	Investigations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Prostatic specific antigen increased	Investigations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Transaminases increased	Investigations	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Influenza A virus test positive	Investigations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0013 affected4,090 at risk
Alanine aminotransferase increased	Investigations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Anticoagulation drug level above therapeutic	Investigations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Blood pressure difference of extremities	Investigations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Cardiac murmur	Investigations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Ejection fraction abnormal	Investigations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Electrocardiogram T wave abnormal	Investigations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Influenza virus test positive	Investigations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Lipase increased	Investigations	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Cataract	Eye disorders	MedDRA Version 20.1	Systematic Assessment	EG0004 affected4,089 at risk EG0015 affected4,090 at risk
Retinal detachment	Eye disorders	MedDRA Version 20.1	Systematic Assessment	EG0003 affected4,089 at risk EG0010 affected4,090 at risk
Eyelid ptosis	Eye disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Retinal haemorrhage	Eye disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Diplopia	Eye disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Eye swelling	Eye disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Retinal vein thrombosis	Eye disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Retinal artery occlusion	Eye disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Chalazion	Eye disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Visual impairment	Eye disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Vertigo	Ear and labyrinth disorders	MedDRA Version 20.1	Systematic Assessment	EG0005 affected4,089 at risk EG0018 affected4,090 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0015 affected4,090 at risk
Vestibular disorder	Ear and labyrinth disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0012 affected4,090 at risk
Ear pain	Ear and labyrinth disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Inner ear disorder	Ear and labyrinth disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Sudden hearing loss	Ear and labyrinth disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Device malfunction	Product Issues	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0012 affected4,090 at risk
Device breakage	Product Issues	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0012 affected4,090 at risk
Device dislocation	Product Issues	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0012 affected4,090 at risk
Device failure	Product Issues	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0012 affected4,090 at risk
Device occlusion	Product Issues	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Thyroid mass	Endocrine disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Hyperthyroidism	Endocrine disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Goitre	Endocrine disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0014 affected4,090 at risk
Addison's disease	Endocrine disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Hypothyroidism	Endocrine disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Toxic nodular goitre	Endocrine disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Anaphylactic shock	Immune system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0012 affected4,090 at risk
Hypersensitivity	Immune system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0011 affected4,090 at risk
Allergy to arthropod sting	Immune system disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk
Anaphylactic reaction	Immune system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Sarcoidosis	Immune system disorders	MedDRA Version 20.1	Systematic Assessment	EG0000 affected4,089 at risk EG0011 affected4,090 at risk
Hypertrophic cardiomyopathy	Congenital, familial and genetic disorders	MedDRA Version 20.1	Systematic Assessment	EG0002 affected4,089 at risk EG0010 affected4,090 at risk
Pancreas divisum	Congenital, familial and genetic disorders	MedDRA Version 20.1	Systematic Assessment	EG0001 affected4,089 at risk EG0010 affected4,090 at risk

ID	Term
D002318	Cardiovascular Diseases
D003324	Coronary Artery Disease
D017202	Myocardial Ischemia
D003327	Coronary Disease
D006331	Heart Diseases
D054058	Acute Coronary Syndrome
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D000787	Angina Pectoris
D002637	Chest Pain
D015228	Hypertriglyceridemia
D050171	Dyslipidemias

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D006949	Hyperlipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Title	Description
BG000	AMR101	AMR101: Parallel Assignment
BG001	Placebo	Placebo: Parallel Assignment
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	AMR101	AMR101: Parallel Assignment	274	4,089	1,252	4,089	3,268	4,089
EG001	Placebo	Placebo: Parallel Assignment	310	4,090	1,254	4,090	3,248	4,090