A Study of LY3202626 on Disease Progression in Participan... | NCT02791191

ID	Type	Description	Link
I7X-MC-LLCF	Other Identifier	Eli Lilly and Company

Label	Type	Description	Intervention Names
Dose 1 LY3202626	Experimental	3 mg LY3202626 given orally once daily for 52 weeks.	Drug: LY3202626
Dose 2 LY3202626	Experimental	12 mg LY3202626 given orally once daily for 52 weeks.	Drug: LY3202626
Placebo	Experimental	Placebo given orally once daily for 52 weeks.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
LY3202626	Drug	Administered orally	Dose 1 LY3202626 Dose 2 LY3202626

Measure	Description	Time Frame
Change From Baseline in ¹⁸F-AV-1451 Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at 52 Weeks	The 18F-AV-1451 PET tracer assesses change from baseline in the pharmacodynamic effect of 3 mg and 12 mg doses of LY3202626 in participants with mild Alzheimer's disease (AD), compared with placebo at Week 52.The SUVr of ¹⁸F-AV-1451 was modeled using analysis of covariance (ANCOVA) to include the fixed, categorical effects of treatment dose, and the continuous, fixed covariate of baseline Tau PET SUVr and age at baseline.	Baseline, Week 52

Measure	Description	Time Frame
Percentage of Participants With Emergent Magnetic Resonance Imaging (MRI) Findings	Percentage of participants with treatment-emergent MRI findings at Week 52 are summarized here. The mixed-effect model for repeated measures (MMRM) analysis was adjusted for fixed effects of treatment, visit (categorical covariate), treatment-by-visit interaction, baseline age, baseline score (continuous covariate) and baseline-by-visit interaction.

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Irvine Clinical Research Center		Irvine	California	92614	United States
Sutter Medical Group

Label	URL
Click here for more information about this study: A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia (NAVIGATE-AD)	View source

ID	Title	Description
FG000	3 mg LY3202626	3 mg LY3202626 administered orally once daily for 52 weeks.
FG001	12 mg LY3202626	12 mg LY3202626 administered orally once daily for 52 weeks.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 31, 2018	Nov 16, 2020

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Angina pectoris	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0021 events1 affected133 at risk
Arrhythmia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected55 at risk EG0012 events2 affected127 at risk EG0021 events1 affected133 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Bradycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0012 events2 affected127 at risk EG0020 events0 affected133 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Coronary artery disease	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Left ventricular failure	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Cerumen impaction	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Otorrhoea	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0023 events3 affected133 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0021 events1 affected133 at risk
Goitre	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Hyperparathyroidism secondary	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Hypothyroidism	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Cataract	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected55 at risk EG0011 events1 affected127 at risk EG0022 events1 affected133 at risk
Cataract nuclear	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0021 events1 affected133 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Corneal oedema	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Diplopia	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Dyschromatopsia	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0011 events1 affected127 at risk EG0021 events1 affected133 at risk
Erythropsia	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Eye pain	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0012 events2 affected127 at risk EG0020 events0 affected133 at risk
Eye swelling	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Eyelid cyst	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Eyelid oedema	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Glaucoma	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Lacrimation increased	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Lenticular opacities	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Macular degeneration	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Macular fibrosis	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Macular oedema	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0021 events1 affected133 at risk
Normal tension glaucoma	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Ocular hyperaemia	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Optic disc disorder	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Optic disc haemorrhage	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Photopsia	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0021 events1 affected133 at risk
Posterior capsule opacification	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Retinal drusen	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Retinal haemorrhage	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Visual acuity reduced	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0022 events2 affected133 at risk
Visual impairment	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0012 events2 affected127 at risk EG0020 events0 affected133 at risk
Vitreous detachment	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0012 events2 affected127 at risk EG0021 events1 affected133 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0012 events2 affected127 at risk EG0020 events0 affected133 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Abdominal tenderness	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Aphthous ulcer	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Barrett's oesophagus	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Constipation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected55 at risk EG0015 events5 affected127 at risk EG0022 events1 affected133 at risk
Dental caries	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected55 at risk EG0017 events6 affected127 at risk EG0027 events6 affected133 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0012 events2 affected127 at risk EG0020 events0 affected133 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0012 events2 affected127 at risk EG0021 events1 affected133 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Flatulence	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Functional gastrointestinal disorder	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0012 events2 affected127 at risk EG0022 events2 affected133 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Hyperchlorhydria	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Nausea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0012 events2 affected127 at risk EG0024 events4 affected133 at risk
Oral disorder	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Toothache	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0013 events3 affected127 at risk EG0020 events0 affected133 at risk
Vomiting	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0022 events2 affected133 at risk
Asthenia	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Chest discomfort	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Chest pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0022 events2 affected133 at risk
Chills	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Crying	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Fatigue	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0015 events5 affected127 at risk EG0027 events7 affected133 at risk
Feeling abnormal	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Feeling cold	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Feeling jittery	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Gait disturbance	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0012 events2 affected127 at risk EG0022 events2 affected133 at risk
Influenza like illness	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Injection site rash	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Malaise	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Non-cardiac chest pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0017 events6 affected127 at risk EG0021 events1 affected133 at risk
Oedema	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Oedema peripheral	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0015 events4 affected127 at risk EG0022 events2 affected133 at risk
Pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0013 events2 affected127 at risk EG0020 events0 affected133 at risk
Peripheral swelling	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0012 events2 affected127 at risk EG0020 events0 affected133 at risk
Pyrexia	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0013 events3 affected127 at risk EG0020 events0 affected133 at risk
Unevaluable event	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Vessel puncture site haematoma	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Allergy to animal	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Hypersensitivity	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Mite allergy	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Mycotic allergy	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Seasonal allergy	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0012 events2 affected127 at risk EG0020 events0 affected133 at risk
Acute sinusitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0021 events1 affected133 at risk
Bronchitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected55 at risk EG0011 events1 affected127 at risk EG0023 events3 affected133 at risk
Cellulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Conjunctivitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0021 events1 affected133 at risk
Dermatitis infected	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Diverticulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
External ear cellulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Folliculitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Fungal skin infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Gastroenteritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Hepatitis e	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Herpes zoster	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0011 events1 affected127 at risk EG0021 events1 affected133 at risk
Hordeolum	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected55 at risk EG0010 events0 affected127 at risk EG0022 events2 affected133 at risk
Influenza	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected55 at risk EG0014 events4 affected127 at risk EG0023 events3 affected133 at risk
Laryngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0021 events1 affected133 at risk
Localised infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0021 events1 affected133 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0013 events1 affected127 at risk EG0020 events0 affected133 at risk
Nail bed infection bacterial	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Nasopharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected55 at risk EG00116 events14 affected127 at risk EG0027 events7 affected133 at risk
Onychomycosis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Oral herpes	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0021 events1 affected133 at risk
Otitis externa	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Otitis media	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Pharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0012 events2 affected127 at risk EG0020 events0 affected133 at risk
Rhinitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Sinusitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0011 events1 affected127 at risk EG0021 events1 affected133 at risk
Tinea versicolour	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Tooth infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected55 at risk EG0016 events6 affected127 at risk EG0028 events7 affected133 at risk
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0005 events3 affected55 at risk EG0018 events7 affected127 at risk EG0023 events3 affected133 at risk
Viral infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Back injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Compression fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG00112 events11 affected127 at risk EG0024 events4 affected133 at risk
Eye contusion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected55 at risk EG00112 events8 affected127 at risk EG0029 events8 affected133 at risk
Fracture displacement	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Incision site pain	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0014 events4 affected127 at risk EG0022 events2 affected133 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0012 events2 affected127 at risk EG0020 events0 affected133 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0021 events1 affected133 at risk
Muscle rupture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Post procedural haematuria	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Post procedural swelling	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0023 events3 affected133 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected55 at risk EG0011 events1 affected127 at risk EG0022 events2 affected133 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Synovial rupture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Alanine aminotransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Biopsy skin	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0011 events1 affected127 at risk EG0021 events1 affected133 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Blood cholesterol increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0012 events2 affected127 at risk EG0021 events1 affected133 at risk
Blood creatinine increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0022 events2 affected133 at risk
Blood pressure increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Cardiac murmur	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Colonoscopy	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Cystoscopy	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Electrocardiogram qt prolonged	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0013 events3 affected127 at risk EG0021 events1 affected133 at risk
Fibrin d dimer increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Haemoglobin decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Hepatic enzyme increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0022 events2 affected133 at risk
Low density lipoprotein increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Mammogram abnormal	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Oxygen saturation decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Staphylococcus test positive	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Transaminases increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Tri-iodothyronine decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0012 events2 affected127 at risk EG0021 events1 affected133 at risk
Weight decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected55 at risk EG0011 events1 affected127 at risk EG0023 events3 affected133 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0013 events3 affected127 at risk EG0021 events1 affected133 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected55 at risk EG0012 events2 affected127 at risk EG0021 events1 affected133 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Gout	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0021 events1 affected133 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Vitamin d deficiency	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected55 at risk EG0014 events4 affected127 at risk EG0028 events8 affected133 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0012 events2 affected127 at risk EG0020 events0 affected133 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0012 events2 affected127 at risk EG0021 events1 affected133 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Joint space narrowing	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0012 events2 affected127 at risk EG0020 events0 affected133 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0021 events1 affected133 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0012 events2 affected127 at risk EG0021 events1 affected133 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0023 events3 affected133 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0011 events1 affected127 at risk EG0021 events1 affected133 at risk
Scoliosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0021 events1 affected133 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0012 events2 affected127 at risk EG0020 events0 affected133 at risk
Acrochordon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0021 events1 affected133 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Dysplastic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0024 events4 affected133 at risk
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0022 events2 affected133 at risk
Amyloid related imaging abnormality-oedema/effusion	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Aphasia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0013 events3 affected127 at risk EG0020 events0 affected133 at risk
Ataxia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Balance disorder	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0021 events1 affected133 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Cerebellar infarction	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Cerebellar microhaemorrhage	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Cerebellar syndrome	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Cerebral microhaemorrhage	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0022 events2 affected133 at risk
Corticobasal degeneration	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Dementia alzheimer's type	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Dizziness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected55 at risk EG0013 events3 affected127 at risk EG0024 events4 affected133 at risk
Dizziness postural	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Dysgeusia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Essential tremor	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Extrapyramidal disorder	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Head discomfort	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected55 at risk EG0014 events4 affected127 at risk EG0022 events2 affected133 at risk
Hypersomnia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Hypogeusia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Lethargy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0012 events2 affected127 at risk EG0020 events0 affected133 at risk
Loss of consciousness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Memory impairment	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0012 events2 affected127 at risk EG0020 events0 affected133 at risk
Migraine	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Nervous system disorder	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Paraesthesia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Poor quality sleep	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Presyncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0012 events2 affected127 at risk EG0022 events2 affected133 at risk
Somnolence	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Superficial siderosis of central nervous system	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Syncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0022 events2 affected133 at risk
Thalamic infarction	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Tremor	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0013 events3 affected127 at risk EG0020 events0 affected133 at risk
Vertebral artery stenosis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Abnormal dreams	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0014 events3 affected127 at risk EG0022 events2 affected133 at risk
Affect lability	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Agitation	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected55 at risk EG0011 events1 affected127 at risk EG0023 events3 affected133 at risk
Anxiety	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected55 at risk EG0014 events4 affected127 at risk EG0020 events0 affected133 at risk
Confusional state	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0004 events3 affected55 at risk EG0013 events3 affected127 at risk EG0021 events1 affected133 at risk
Delusion	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0021 events1 affected133 at risk
Depressed mood	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Depression	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected55 at risk EG0013 events3 affected127 at risk EG0024 events3 affected133 at risk
Disorientation	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0012 events1 affected127 at risk EG0020 events0 affected133 at risk
Emotional distress	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Generalised anxiety disorder	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Hallucination	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0016 events6 affected127 at risk EG0022 events2 affected133 at risk
Hallucination, auditory	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Hallucination, visual	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0014 events4 affected127 at risk EG0020 events0 affected133 at risk
Hypnopompic hallucination	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Insomnia	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Mania	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Mental status changes	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Mood altered	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Mood swings	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Nightmare	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0015 events4 affected127 at risk EG0020 events0 affected133 at risk
Psychotic disorder	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Sleep disorder	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Tension	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Dysuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Haematuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Hypertonic bladder	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Lower urinary tract symptoms	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0013 events3 affected127 at risk EG0021 events1 affected133 at risk
Renal cyst	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Renal mass	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Breast cyst	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Breast mass	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Breast pain	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Genital rash	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected55 at risk EG0015 events5 affected127 at risk EG0023 events2 affected133 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected55 at risk EG0012 events2 affected127 at risk EG0020 events0 affected133 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0022 events1 affected133 at risk
Lower respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0011 events1 affected127 at risk EG0021 events1 affected133 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0013 events3 affected127 at risk EG0020 events0 affected133 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0013 events3 affected127 at risk EG0024 events3 affected133 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0012 events1 affected127 at risk EG0021 events1 affected133 at risk
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected55 at risk EG0011 events1 affected127 at risk EG0021 events1 affected133 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0012 events2 affected127 at risk EG0020 events0 affected133 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Eczema asteatotic	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Hair colour changes	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0022 events2 affected133 at risk
Idiopathic guttate hypomelanosis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Leukoderma	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0012 events2 affected127 at risk EG0021 events1 affected133 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0012 events1 affected127 at risk EG0023 events1 affected133 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0011 events1 affected127 at risk EG0022 events2 affected133 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Skin hypopigmentation	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0021 events1 affected133 at risk
Solar lentigo	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0023 events1 affected133 at risk
Splinter haemorrhages	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Telangiectasia	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Orthosis user	Social circumstances	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Walking aid user	Social circumstances	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Blepharectomy	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Bursa removal	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Cataract operation	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0023 events2 affected133 at risk
Catheter placement	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Chest tube insertion	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Cochlea implant	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Coronary artery bypass	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Dental implantation	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Endodontic procedure	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Internal fixation of fracture	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Intraocular lens implant	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Lens capsulotomy	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Medical device removal	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Micrographic skin surgery	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Nasal operation	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Open reduction of fracture	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Papilloma excision	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Skin neoplasm excision	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0012 events2 affected127 at risk EG0020 events0 affected133 at risk
Spinal fusion surgery	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Tooth extraction	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0012 events2 affected127 at risk EG0021 events1 affected133 at risk
Transurethral prostatectomy	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Vertebroplasty	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Aortic disorder	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Arteriosclerosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Flushing	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Haematoma	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0022 events2 affected133 at risk
Hot flush	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Hypotension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0012 events2 affected127 at risk EG0020 events0 affected133 at risk
Orthostatic hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0015 events5 affected127 at risk EG0021 events1 affected133 at risk
Supine hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D024801	Tauopathies
D019636	Neurodegenerative Diseases
D019965	Neurocognitive Disorders
D001523	Mental Disorders

ID	Title	Description
BG000	3 mg LY3202626	3 mg LY3202626 administered orally once daily for 52 weeks.
BG001	12 mg LY3202626	12 mg LY3202626 administered orally once daily for 52 weeks.
BG002	Placebo	Placebo administered orally once daily for 52 weeks.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	3 mg LY3202626	3 mg LY3202626 administered orally once daily for 52 weeks.	55	10	55	46	55
EG001	12 mg LY3202626	12 mg LY3202626 administered orally once daily for 52 weeks	127	8	127	97	127
EG002	Placebo	Placebo administered orally once daily for 52 weeks.	133	10	133	91	133

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Angina pectoris	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Coronary artery disease	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Chest discomfort	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Gait disturbance	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0012 events2 affected127 at risk EG0020 events0 affected133 at risk
Pyrexia	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Cystitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Influenza	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Pyuria	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Confusion postoperative	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0011 events1 affected127 at risk EG0021 events1 affected133 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Syncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0021 events1 affected133 at risk
Transient global amnesia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected127 at risk EG0020 events0 affected133 at risk
Device breakage	Product Issues	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Aggression	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected127 at risk EG0021 events1 affected133 at risk
Suicide attempt	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk
Urinary retention	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0003 events1 affected55 at risk EG0010 events0 affected127 at risk EG0020 events0 affected133 at risk