Long-term Safety and Efficacy Study of Lebrikizumab (LY36... | NCT04392154

ID	Type	Description
2020-001211-24	EudraCT Number
J2T-DM-KGAA	Other Identifier	Eli Lilly and Company
DRM06-AD07	Other Identifier	Dermira, Inc. (A wholly owned subsidiary of Lilly)

Name	Class
Dermira, Inc.	INDUSTRY

Label	Type	Description	Intervention Names
Lebrikizumab Q2W (Primary Treatment Period)	Experimental	250 milligrams (mg) of Lebrikizumab, subcutaneous injection administered every 4 weeks (Q4W) up to 100 weeks.	Biological: Lebrikizumab
Lebrikizumab Q4W (Primary Treatment Period)	Experimental	250 mg Lebrikizumab, subcutaneous injection administered every 2 weeks (Q2W) up to 100 weeks.	Biological: Lebrikizumab
Open-Label Extension Addendum: Lebrikizumab Q4W	Experimental	250 mg of Lebrikizumab, subcutaneous injection administered every 4 weeks (Q4W) up to 32 weeks.	Biological: Lebrikizumab
Open-Label Extension Addendum: Lebrikizumab Q8W	Experimental	250 mg of Lebrikizumab, subcutaneous injection administered every 8 weeks (Q8W) up to 32 weeks.	Biological: Lebrikizumab

Name	Type	Description	Arm Group Labels	Other Names
Lebrikizumab	Biological	Subcutaneous injection	Lebrikizumab Q2W (Primary Treatment Period) Lebrikizumab Q4W (Primary Treatment Period) Open-Label Extension Addendum: Lebrikizumab Q4W

Measure	Description	Time Frame
Primary Treatment Period: Percentage of Participants Discontinued From Study Treatment Due to Adverse Events	Percentage of participants discontinued from study treatment due to adverse events is reported.	Baseline to Week 100

Measure	Description	Time Frame
Primary Treatment Period: Percentage of Participants With a Response of Investigator Global Assessment (IGA) Score 0 or 1 at Week 100	The IGA measures the investigator's global assessment of the participant's overall severity of their Atopic Dermatitis. The IGA is comprised of a 5-point numeric scale ranging from 0 (clear skin) to 4 (severe disease) and a score is selected using descriptors that best describe the overall appearance of the lesions at a given time point.

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
Pinnacle Research Group, LLC		Anniston	Alabama	36207	United States
Clinical Research Center of Alabama- Birmingham

PubMed Identifier	Type	Citation	Retractions
42315763	Derived	Guttman-Yassky E, Irvine AD, Gooderham M, Weidinger S, Spelman L, Silverberg JI, Crane H, ElMaraghy H, DeLuca-Carter L, Piruzeli MLB, Martimianaki G, Pierce E, Agell H, Thaci D. Three-Year Efficacy and Safety of Lebrikizumab in Patients with Moderate-to-Severe Atopic Dermatitis: A Long-Term Extension (ADjoin). Dermatol Ther (Heidelb). 2026 Jun 19. doi: 10.1007/s13555-026-01810-1. Online ahead of print.
41206702

ID	Title	Description
FG000	Primary Treatment Period: Lebrikizumab Q4W	250 milligrams (mg) of Lebrikizumab, subcutaneous injection administered every 4 weeks (Q4W) up to 100 weeks.
FG001	Primary Treatment Period: Lebrikizumab Q2W

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol: Study Protocol	Dec 14, 2022

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0017 events6 affected1,012 at risk EG0020 events0 affected52 at risk EG0030 events0 affected51 at risk
Anaemia macrocytic	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Eosinophilia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG00112 events10 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG00110 events9 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0014 events4 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Lymphocytosis	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Neutrophilia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Normocytic anaemia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Splenomegaly	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Thrombocytosis	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Palpitations	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0013 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Dermoid cyst	Congenital, familial and genetic disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0014 events4 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Ear pruritus	Ear and labyrinth disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Androgen deficiency	Endocrine disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Glucocorticoid deficiency	Endocrine disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0013 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Polycystic ovarian syndrome	Endocrine disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Thyroid cyst	Endocrine disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Allergic keratitis	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Astigmatism	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Blepharitis	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0015 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Blepharitis allergic	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Cataract	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0013 events3 affected1,012 at risk EG0021 events1 affected52 at risk EG003
Chalazion	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Conjunctival irritation	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Conjunctivitis allergic	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0004 events4 affected141 at risk EG00139 events29 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Corneal neovascularisation	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Dry eye	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0015 events5 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Eczema eyelids	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Erythema of eyelid	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Eye irritation	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0013 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Eye pruritus	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0014 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Eye swelling	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Eyelid oedema	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Glaucoma	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Keratitis	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Keratoconus	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Myopia	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Ocular hyperaemia	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Periorbital dermatitis	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Scleritis	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Vernal keratoconjunctivitis	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0014 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Vision blurred	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0014 events4 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Visual impairment	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Vitreous detachment	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Vitreous floaters	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Xerophthalmia	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0017 events7 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0013 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Coeliac disease	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0014 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Dental caries	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0013 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG00115 events13 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0014 events4 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0021 events1 affected52 at risk EG003
Gastritis erosive	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0016 events5 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0013 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Intestinal vascular disorder	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Large intestine polyp	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0013 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Malpositioned teeth	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0019 events9 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Odynophagia	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Rectal polyp	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Stress ulcer	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Tooth impacted	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0015 events5 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0015 events5 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Asthenia	General disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Chest discomfort	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0013 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Chest pain	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0013 events3 affected1,012 at risk EG0021 events1 affected52 at risk EG003
Fatigue	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG00110 events9 affected1,012 at risk EG0020 events0 affected52 at risk EG003
General physical health deterioration	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Influenza like illness	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0013 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Injection site bruising	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Injection site haematoma	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Injection site pain	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Injection site pruritus	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Injection site rash	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Injection site reaction	General disorders	MedDRA 28.0	Systematic Assessment	EG0002 events1 affected141 at risk EG00132 events12 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Injection site swelling	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Malaise	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Pain	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Peripheral swelling	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Pyrexia	General disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0013 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Swelling face	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Vaccination site pain	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG00116 events8 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Vaccination site reaction	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Vascular stent stenosis	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Alcoholic liver disease	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Gallbladder disorder	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Gallbladder polyp	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Hepatic steatosis	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0017 events7 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Hepatomegaly	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Jaundice	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Metabolic dysfunction-associated liver disease	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Metabolic dysfunction-associated steatohepatitis	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Allergy to animal	Immune system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Allergy to arthropod bite	Immune system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Allergy to venom	Immune system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Dust allergy	Immune system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Food allergy	Immune system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0016 events5 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0013 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Multiple allergies	Immune system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG00110 events9 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Abscess of eyelid	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Acarodermatitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Acute sinusitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Alveolar osteitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Appendicitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Ascariasis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Bacterial vaginosis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0003 events2 affected141 at risk EG0014 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Blastocystis infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Body tinea	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Bronchitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG00111 events11 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Bronchitis bacterial	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Campylobacter gastroenteritis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Cellulitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0015 events5 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Cellulitis staphylococcal	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Chlamydial infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Chronic sinusitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0004 events3 affected141 at risk EG00145 events39 affected1,012 at risk EG0022 events1 affected52 at risk EG003
Conjunctivitis bacterial	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected141 at risk EG0014 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Conjunctivitis viral	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0002 events1 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Coronavirus infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0014 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Covid-19	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG00029 events26 affected141 at risk EG001172 events159 affected1,012 at risk EG0021 events1 affected52 at risk EG003
Cystitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0015 events4 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Cystitis bacterial	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0013 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Ear infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected141 at risk EG0016 events4 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Eczema infected	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Enterobiasis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Erythrasma	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Eye infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Folliculitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0003 events1 affected141 at risk EG00112 events11 affected1,012 at risk EG0021 events1 affected52 at risk EG003
Furuncle	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG00116 events13 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0014 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Gastrointestinal infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0015 events5 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Gastrointestinal viral infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Genital herpes	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Genital herpes simplex	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0013 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Genital infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Giardiasis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Gingivitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Helicobacter gastritis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Helicobacter infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Herpes simplex	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0003 events2 affected141 at risk EG00115 events10 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Herpes virus infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG00115 events11 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Hordeolum	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0017 events5 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Impetigo	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0003 events2 affected141 at risk EG00110 events8 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Infected bite	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Infected cyst	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Infected dermal cyst	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Infectious mononucleosis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Influenza	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG00112 events12 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Infusion site cellulitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Labyrinthitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Laryngitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Latent tuberculosis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Localised infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0021 events1 affected52 at risk EG003
Malassezia infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Molluscum contagiosum	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Nail infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Nasal herpes	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0015 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG00014 events13 affected141 at risk EG001165 events115 affected1,012 at risk EG0022 events2 affected52 at risk EG003
Norovirus infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Oesophageal candidiasis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Onychomycosis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Oral herpes	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0003 events2 affected141 at risk EG00146 events30 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Orchitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Otitis externa	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0014 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Otitis media	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0015 events4 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Otitis media acute	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Paronychia	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Periodontitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0017 events6 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Pharyngitis bacterial	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Pharyngitis streptococcal	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0015 events5 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Pneumonia	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0013 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Pulpitis dental	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Rhinitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Rhinovirus infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Scarlet fever	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Sinusitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0004 events4 affected141 at risk EG00115 events15 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Skin bacterial infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0013 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Skin candida	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Skin infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0013 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Staphylococcal skin infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0013 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Tinea capitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Tinea cruris	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Tinea pedis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Tinea versicolour	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0015 events5 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Tonsillitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Tooth abscess	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0012 events2 affected1,012 at risk EG0021 events1 affected52 at risk EG003
Tooth infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0014 events4 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Toxocariasis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Tracheitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG00011 events7 affected141 at risk EG00163 events49 affected1,012 at risk EG0021 events1 affected52 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected141 at risk EG00135 events30 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Vaginal infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Viral infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Viral pharyngitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Vulvovaginal candidiasis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Wound infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Abdominal wall wound	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Animal bite	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0014 events4 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0014 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Chemical burn of skin	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0013 events3 affected1,012 at risk EG0021 events1 affected52 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0013 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Corneal abrasion	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Epicondylitis	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Eyelid abrasion	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0016 events5 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Foreign body in ear	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Foreign body in eye	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Hand fracture	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0013 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0014 events4 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Joint injury	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0017 events7 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Lip injury	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0016 events5 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0015 events5 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Nail injury	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Post-traumatic neck syndrome	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Procedural dizziness	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0012 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0014 events4 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0021 events1 affected52 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Scar	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0016 events5 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Sports injury	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Sunburn	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0013 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Superficial injury of eye	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Suture rupture	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Tendon injury	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0013 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Tooth fracture	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Traumatic pain	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Vaccination complication	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG00110 events5 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG00118 events17 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0018 events7 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Bilirubin urine	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Bilirubin urine present	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Blood bicarbonate decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Blood cholesterol increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0014 events4 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Blood creatinine increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Blood glucose decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Blood immunoglobulin e increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Blood iron decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0013 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Blood potassium increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Blood pressure diastolic increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Blood pressure increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0013 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Blood testosterone decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Blood thyroid stimulating hormone increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Blood uric acid increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Cardiac murmur	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Double stranded dna antibody positive	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Eosinophil count increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0017 events6 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected141 at risk EG0017 events7 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Glucose urine present	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Haematocrit decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Haemoglobin urine present	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0015 events4 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Heart rate increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Helicobacter test positive	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0013 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Intraocular pressure increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Liver function test abnormal	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Liver function test increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Lymphocyte morphology abnormal	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Mean cell haemoglobin concentration decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Mean cell haemoglobin decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Mean cell volume decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Mean cell volume increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Platelet count decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0014 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Platelet count increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Protein urine present	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Red blood cell morphology abnormal	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Sars-cov-2 test positive	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Treponema test positive	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Tri-iodothyronine free increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Urine ketone body present	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Weight decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Weight increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected141 at risk EG0015 events5 affected1,012 at risk EG0020 events0 affected52 at risk EG003
White blood cell count decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
White blood cell count increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
White blood cells urine positive	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0013 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0013 events3 affected1,012 at risk EG0021 events1 affected52 at risk EG003
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Food intolerance	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0018 events7 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Haemochromatosis	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Histamine intolerance	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0013 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0013 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Lactose intolerance	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Obesity	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0014 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Periarthritis calcarea	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Vitamin d deficiency	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG00119 events15 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected141 at risk EG00117 events14 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Hypercreatinaemia	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0015 events5 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0016 events4 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0015 events4 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Scoliosis	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Spondylitis	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Tenosynovitis stenosans	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Anogenital warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0013 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Benign neoplasm of thyroid gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Fibroadenoma of breast	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Ovarian germ cell teratoma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Pyogenic granuloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0013 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0017 events7 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Dementia	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Disturbance in attention	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Dizziness	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0013 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Facial paralysis	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Headache	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0004 events4 affected141 at risk EG00133 events25 affected1,012 at risk EG0021 events1 affected52 at risk EG003
Hypogeusia	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Migraine	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0015 events4 affected1,012 at risk EG0021 events1 affected52 at risk EG003
Migraine with aura	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Nerve compression	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Occipital neuralgia	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Parkinson's disease	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Parosmia	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Piriformis syndrome	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Post herpetic neuralgia	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Presyncope	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Radiculopathy	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Seizure	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Syncope	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0016 events5 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Tension headache	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Vith nerve paralysis	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Anembryonic gestation	Pregnancy, puerperium and perinatal conditions	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Morning sickness	Pregnancy, puerperium and perinatal conditions	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Uterine hypertonus	Pregnancy, puerperium and perinatal conditions	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Alcohol abuse	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG00111 events11 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Apathy	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Attention deficit hyperactivity disorder	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0021 events1 affected52 at risk EG003
Autism spectrum disorder	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Bipolar i disorder	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Depression	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG00110 events10 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0017 events7 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Libido decreased	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Major depression	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Mania	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Mixed anxiety and depressive disorder	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Sleep disorder due to general medical condition, insomnia type	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Bladder obstruction	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Glycosuria	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0016 events5 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Nephropathy toxic	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Abnormal uterine bleeding	Reproductive system and breast disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Breast mass	Reproductive system and breast disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG00126 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Fibrocystic breast disease	Reproductive system and breast disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Heavy menstrual bleeding	Reproductive system and breast disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Menopausal symptoms	Reproductive system and breast disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Menstruation irregular	Reproductive system and breast disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0013 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Prostatitis	Reproductive system and breast disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Testicular cyst	Reproductive system and breast disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Vaginal discharge	Reproductive system and breast disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Allergic cough	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0016 events6 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG00113 events12 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0016 events4 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0013 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0016 events6 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0015 events4 affected1,012 at risk EG0021 events1 affected52 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0017 events5 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0013 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Tonsillar hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG00119 events17 affected1,012 at risk EG0021 events1 affected52 at risk EG003
Acne varioliformis	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0018 events4 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0017 events7 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Alopecia areata	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0015 events5 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Androgenetic alopecia	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Chronic cutaneous lupus erythematosus	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Cutaneous calcification	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Dandruff	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0014 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0013 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG00012 events9 affected141 at risk EG001102 events70 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected141 at risk EG0015 events5 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Dermatitis psoriasiform	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0002 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Diffuse alopecia	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0013 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Eczema nummular	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Guttate psoriasis	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0013 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Intertrigo	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Keloid scar	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Keratosis pilaris	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Lichen striatus	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Lichenoid keratosis	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Mechanical urticaria	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Milia	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Nail bed inflammation	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Nail dystrophy	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Papule	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Parapsoriasis	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Perioral dermatitis	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Photodermatosis	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Pityriasis rosea	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0018 events8 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Pruritus allergic	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0013 events3 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Rosacea	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0019 events6 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0003 events1 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG00111 events11 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Urticaria chronic	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Urticaria contact	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Arteriosclerosis	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Essential hypertension	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Haematoma	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Hypertension	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG00115 events15 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Raynaud's phenomenon	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0012 events2 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Thrombosis	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Venous thrombosis	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0011 events1 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Accessory navicular syndrome	Congenital, familial and genetic disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Nasal obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected1,012 at risk EG0021 events1 affected52 at risk EG003
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected1,012 at risk EG0020 events0 affected52 at risk EG003
Ingrown hair	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected1,012 at risk EG0021 events1 affected52 at risk EG003
Rash vesicular	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected141 at risk EG0010 events0 affected1,012 at risk EG0021 events1 affected52 at risk EG003

ID	Term
D003876	Dermatitis, Atopic
D004485	Eczema
D003872	Dermatitis
D012871	Skin Diseases

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D017437	Skin and Connective Tissue Diseases
D017443	Skin Diseases, Eczematous
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

ID	Title	Description
BG000	Primary Treatment Period: Lebrikizumab Q4W	250 mg of Lebrikizumab, subcutaneous injection administered every 4 weeks (Q4W) up to 100 weeks.
BG001	Primary Treatment Period: Lebrikizumab Q2W	250 mg Lebrikizumab, subcutaneous injection administered every 2 weeks (Q2W) up to 100 weeks.
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	Primary Treatment Period: Lebrikizumab Q4W	250 mg of Lebrikizumab, subcutaneous injection administered every 4 weeks (Q4W) up to 100 weeks.	0	141	5	141	89	141
EG001	Primary Treatment Period: Lebrikizumab Q2W	250 mg Lebrikizumab, subcutaneous injection administered every 2 weeks (Q2W) up to 100 weeks.	2	1,012	45	1,012	638	1,012
EG002	Open-Label Extension Addendum: Lebrikizumab Q4W	250 mg of Lebrikizumab, subcutaneous injection administered every 4 weeks (Q4W) up to 32 weeks.	0	52	0	52	17	52
EG003	Open-Label Extension Addendum: Lebrikizumab Q8W	250 mg of Lebrikizumab, subcutaneous injection administered every 8 weeks (Q8W) up to 32 weeks.	0	51	0	51	13	51