B-Enhancement of HBV Vaccination in Persons Living With H... | NCT04193189

ID	Type	Description	Link
38569	Registry Identifier	DAIDS-ES Registry Number

Name	Class
Dynavax Technologies Corporation	INDUSTRY

Label	Type	Description	Intervention Names
Group A, 2-CpG: HEPLISAV-B (two injections)	Experimental	Participants were prescribed 0.5 mL of HEPLISAV-B (hepatitis B vaccine with a cytosine phosphoguanine adjuvant) by intramuscular (IM) injection at Weeks 0 and 4.	Biological: HEPLISAV-B
Group A, 3-CpG: HEPLISAV-B (three injections)	Experimental	Participants were prescribed 0.5 mL of HEPLISAV-B (hepatitis B vaccine with a cytosine phosphoguanine adjuvant) by IM injection at Weeks 0, 4, and 24.	Biological: HEPLISAV-B
Group A, 3-alum: ENGERIX-B (three injections)	Active Comparator	Participants were prescribed 1 mL of ENGERIX-B (conventional hepatitis B vaccine with an aluminum hydroxide adjuvant) by IM injection at Weeks 0, 4, and 24.	Biological: ENGERIX-B
Group B: HEPLISAV-B (three injections)	Experimental	Participants were prescribed 0.5 mL of HEPLISAV-B (hepatitis B vaccine with a cytosine phosphoguanine adjuvant) by IM injection at Weeks 0, 4, and 24.	Biological: HEPLISAV-B

Name	Type	Description	Arm Group Labels	Other Names
HEPLISAV-B	Biological	Administered by IM injection	Group A, 2-CpG: HEPLISAV-B (two injections) Group A, 3-CpG: HEPLISAV-B (three injections) Group B: HEPLISAV-B (three injections)

Measure	Description	Time Frame
Percentage of Participants With Primary Seroprotection Response	Primary seroprotection response was defined as antibody titer against hepatitis B surface antigen (anti-HBs) ≥10 mIU/mL at 8 weeks after 2-dose vaccination series and at 4 weeks after 3-dose vaccination series. If the completion of the vaccine series was delayed (a delay of ≤4 weeks was allowed), the trial protocol specified obtaining an antibody result at 8 weeks for the 2-dose series or at 4 weeks for the 3-dose series after vaccine completion for use in the primary outcome analysis. The study was designed separately for the two study populations (Groups A and B), and the analysis was conducted separately, as prespecified in the study protocol and Statistical Analysis Plan (SAP). In Group A, two-sided 97.5% confidence intervals (CI) were specified for the SPR differences between study arms (presented in the Statistical Analyses sections below). In Group B, two-sided 95% Wilson CI around the single-arm estimate was specified (presented in the Data Table below).	Week 12 in Group A 2-CpG, Week 28 in Group A 3-CpG and 3-alum and in Group B
Percentage of Participants With Adverse Events (AEs)	The protocol required reporting of (1) Grade ≥2 AEs, (2) AEs that led to a change in study treatment regardless of grade, (3) AEs meeting serious AE (SAE) definition or expedited AE (EAE) reporting requirement, (4) Grade ≥1 local and systemic injection reactions within 7 days of any study vaccine injection, (5) medically attended adverse events (MAAE) regardless of grade, and (6) potential immune-mediated AEs regardless of grade. Grading was per DAIDS AE Grading Table (Version 2.1): Grade 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening) and 5 (death). DAIDS EAE Manual (V1.0) was used. Wilson method was used for confidence intervals.	From study entry to study discontinuation (Week 72 or premature discontinuation)

Measure	Description	Time Frame
Percentage of Participants With Seroprotection Response	Seroprotection response (SPR) was defined as antibody titer against hepatitis B surface antigen (anti-HBs) ≥10 mIU/mL. Study visit weeks are according to protocol-specified visit windows; anti-HBs results outside visit windows were not included. These are snapshots at scheduled visits irrespective of delayed vaccinations, unlike the visits defined in Primary Outcome 1. The study was designed separately for the two study populations (Groups A and B), and the analysis was conducted separately, as prespecified in the study protocol and Statistical Analysis Plan (SAP). In Group A, two-sided 97.5% confidence intervals (CI) were specified for the SPR differences between study arms (presented in the Statistical Analyses sections below). In Group B, two-sided 95% Wilson CIs around the single-arm estimates were specified (presented in the Data Table below).

Measure	Description	Time Frame
Percentage of Participants With Primary Seroprotection Response by Sex	Subgroup analysis of the primary seroprotection response outcome measure (as described in the Primary Outcome Measure 1 above) by sex. Descriptive summary of the SPR by subgroups; the study was not powered for testing the success of HEPLISAV-B vaccination within subgroups.	Week 12 in Group A 2-CpG, Week 28 in Group A 3-CpG and 3-alum and in Group B

Name	Affiliation	Role
Kenneth E. Sherman, MD, PhD	Cincinnati CRS	Study Chair
Kristen Marks, MD	Weill Cornell Chelsea CRS	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Alabama CRS		Birmingham	Alabama	35222	United States
UCLA CARE Center CRS

PubMed Identifier	Type	Citation	Retractions
37017075	Result	Marks KM, Kang M, Umbleja T, Avihingsanon A, Sugandhavesa P, Cox AL, Vigil K, Perazzo H, Price JC, Katsidzira L, Vernon C, Alston-Smith B, Sherman KE; ACTG 5379 Study Team. Immunogenicity and Safety of Hepatitis B Virus (HBV) Vaccine With a Toll-Like Receptor 9 Agonist Adjuvant in HBV Vaccine-Naive People With Human Immunodeficiency Virus. Clin Infect Dis. 2023 Aug 14;77(3):414-418. doi: 10.1093/cid/ciad201.
39616603

Label	URL
Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017	View source

ID	Title	Description
FG000	Group A: 2-CpG	Participants were prescribed 0.5 mL of HEPLISAV-B (hepatitis B vaccine with a cytosine phosphoguanine adjuvant) by intramuscular injection at Weeks 0 and 4.
FG001	Group A: 3-CpG

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_ICF	Yes	No	Yes	Study Protocol and Informed Consent Form: V3.0	Dec 13, 2022

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected187 at risk EG0011 affected188 at risk EG0021 affected186 at risk EG0030 affected74 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0011 affected188 at risk EG0022 affected186 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Pernicious anaemia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Polycythaemia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Atrioventricular block second degree	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Extrasystoles	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Heart failure with preserved ejection fraction	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Palpitations	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Cerumen impaction	Ear and labyrinth disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Ear congestion	Ear and labyrinth disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0012 affected188 at risk EG0020 affected186 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0011 affected188 at risk EG0021 affected186 at risk EG003
Hypoacusis	Ear and labyrinth disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Inner ear inflammation	Ear and labyrinth disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Tympanic membrane perforation	Ear and labyrinth disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Thyroid mass	Endocrine disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Blindness transient	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Cataract	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Chalazion	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Conjunctivitis allergic	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Eye irritation	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Eye pruritus	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Eyelid margin crusting	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Lacrimation increased	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Ocular hyperaemia	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0011 affected188 at risk EG0021 affected186 at risk EG003
Photopsia	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Pterygium	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Vision blurred	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Vitreous floaters	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Abdominal mass	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected187 at risk EG0013 affected188 at risk EG0024 affected186 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0012 affected188 at risk EG0021 affected186 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0003 affected187 at risk EG0012 affected188 at risk EG0020 affected186 at risk EG003
Abdominal tenderness	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Anal fissure	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Anal fistula	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Anal pruritus	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Anogenital dysplasia	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Anorectal discomfort	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Aphthous ulcer	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Change of bowel habit	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Cheilitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Chronic gastritis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0022 affected186 at risk EG003
Dental caries	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0012 affected188 at risk EG0020 affected186 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected187 at risk EG0013 affected188 at risk EG0026 affected186 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected187 at risk EG0010 affected188 at risk EG0022 affected186 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Food poisoning	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected187 at risk EG0012 affected188 at risk EG0021 affected186 at risk EG003
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Gastrointestinal pain	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0013 affected188 at risk EG0021 affected186 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0003 affected187 at risk EG0012 affected188 at risk EG0021 affected186 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Lip swelling	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0004 affected187 at risk EG0014 affected188 at risk EG0024 affected186 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Peptic ulcer	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Proctitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0015 affected188 at risk EG0020 affected186 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0003 affected187 at risk EG0012 affected188 at risk EG0023 affected186 at risk EG003
Asthenia	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Chest discomfort	General disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Chest pain	General disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected187 at risk EG0013 affected188 at risk EG0024 affected186 at risk EG003
Chills	General disorders	MedDRA 27.1	Systematic Assessment	EG0003 affected187 at risk EG0011 affected188 at risk EG0022 affected186 at risk EG003
Chronic fatigue syndrome	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Facial pain	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Fatigue	General disorders	MedDRA 27.1	Systematic Assessment	EG00027 affected187 at risk EG00133 affected188 at risk EG00233 affected186 at risk EG003
Feeling hot	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Gait disturbance	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Hypothermia	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0012 affected188 at risk EG0021 affected186 at risk EG003
Influenza like illness	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Injection site erythema	General disorders	MedDRA 27.1	Systematic Assessment	EG0009 affected187 at risk EG00115 affected188 at risk EG00216 affected186 at risk EG003
Injection site induration	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Injection site joint pain	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Injection site pain	General disorders	MedDRA 27.1	Systematic Assessment	EG00047 affected187 at risk EG00175 affected188 at risk EG00241 affected186 at risk EG003
Injection site swelling	General disorders	MedDRA 27.1	Systematic Assessment	EG00014 affected187 at risk EG00114 affected188 at risk EG00215 affected186 at risk EG003
Malaise	General disorders	MedDRA 27.1	Systematic Assessment	EG00022 affected187 at risk EG00134 affected188 at risk EG00226 affected186 at risk EG003
Mass	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Oedema peripheral	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Pain	General disorders	MedDRA 27.1	Systematic Assessment	EG0003 affected187 at risk EG0012 affected188 at risk EG0026 affected186 at risk EG003
Peripheral swelling	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0011 affected188 at risk EG0023 affected186 at risk EG003
Pyrexia	General disorders	MedDRA 27.1	Systematic Assessment	EG0009 affected187 at risk EG00111 affected188 at risk EG0029 affected186 at risk EG003
Vaccination site joint pain	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Vaccination site pain	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Vessel puncture site pain	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Allergy to chemicals	Immune system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Abscess limb	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Acute sinusitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Anal chlamydia infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0022 affected186 at risk EG003
Atypical pneumonia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Bacterial diarrhoea	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Bacterial vaginosis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Bronchitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
COVID-19	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG00014 affected187 at risk EG00112 affected188 at risk EG00214 affected186 at risk EG003
Cellulitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0012 affected188 at risk EG0020 affected186 at risk EG003
Cellulitis staphylococcal	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Cervicitis gonococcal	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0021 affected186 at risk EG003
Cystitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Dengue fever	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Dermatophytosis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Diarrhoea infectious	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0021 affected186 at risk EG003
Endometritis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Epididymitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Folliculitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Fungal foot infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Furuncle	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0013 affected188 at risk EG0020 affected186 at risk EG003
Genital herpes simplex	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Groin infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Helicobacter gastritis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Hepatitis C	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Herpes simplex	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0012 affected188 at risk EG0020 affected186 at risk EG003
Hordeolum	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Infective exacerbation of bronchiectasis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Influenza	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Latent syphilis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0022 affected186 at risk EG003
Latent tuberculosis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Localised infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0011 affected188 at risk EG0021 affected186 at risk EG003
Malaria	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Monkeypox	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0022 affected186 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0004 affected187 at risk EG0013 affected188 at risk EG0024 affected186 at risk EG003
Neurosyphilis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Onychomycosis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0012 affected188 at risk EG0020 affected186 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0022 affected186 at risk EG003
Oropharyngeal gonococcal infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Otitis externa	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Otitis media	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Parasitic gastroenteritis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Paronychia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Pelvic abscess	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Pelvic inflammatory disease	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Pharyngeal chlamydia infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Pharyngitis streptococcal	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Plasmodium falciparum infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Pneumonia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Proctitis chlamydial	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0021 affected186 at risk EG003
Proctitis gonococcal	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 affected187 at risk EG0013 affected188 at risk EG0022 affected186 at risk EG003
Pulmonary tuberculosis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Purulent discharge	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Respiratory syncytial virus infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Rhinitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Secondary syphilis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0011 affected188 at risk EG0021 affected186 at risk EG003
Sepsis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Sexually transmitted disease	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Sinusitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0003 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Sinusitis bacterial	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Staphylococcal skin infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Strongyloidiasis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Suspected COVID-19	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Syphilis genital	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Tinea cruris	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Tinea pedis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0011 affected188 at risk EG0021 affected186 at risk EG003
Tonsillitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0012 affected188 at risk EG0022 affected186 at risk EG003
Tooth abscess	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Tooth infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 affected187 at risk EG0012 affected188 at risk EG0020 affected186 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0008 affected187 at risk EG00111 affected188 at risk EG0027 affected186 at risk EG003
Urethritis chlamydial	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Urethritis gonococcal	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0012 affected188 at risk EG0022 affected186 at risk EG003
Vaginal infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Vaginitis gardnerella	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Viral infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0021 affected186 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Vulval abscess	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Vulvovaginal candidiasis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Wound infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Animal bite	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Avulsion fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0002 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0012 affected188 at risk EG0020 affected186 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Hand fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Immunisation reaction	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0011 affected188 at risk EG0021 affected186 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0021 affected186 at risk EG003
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0021 affected186 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0021 affected186 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Pelvic bone injury	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Shoulder fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0011 affected188 at risk EG0022 affected186 at risk EG003
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Traumatic pain	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0013 affected188 at risk EG0021 affected186 at risk EG003
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Wound	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Wound secretion	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0013 affected188 at risk EG0020 affected186 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0003 affected187 at risk EG0014 affected188 at risk EG0022 affected186 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0002 affected187 at risk EG0013 affected188 at risk EG0025 affected186 at risk EG003
Bilirubin conjugated increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0022 affected186 at risk EG003
Blood cholesterol increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0022 affected186 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0012 affected188 at risk EG0022 affected186 at risk EG003
Blood creatinine increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0007 affected187 at risk EG0013 affected188 at risk EG0025 affected186 at risk EG003
Blood glucose decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Blood glucose increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0006 affected187 at risk EG0017 affected188 at risk EG00210 affected186 at risk EG003
Blood phosphorus decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0002 affected187 at risk EG0012 affected188 at risk EG0021 affected186 at risk EG003
Blood pressure increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0002 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Blood sodium decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0011 affected188 at risk EG0021 affected186 at risk EG003
Blood sodium increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Blood triglycerides increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
CD4 lymphocytes decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0022 affected186 at risk EG003
Carbon dioxide decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0002 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Creatinine renal clearance decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0006 affected187 at risk EG0016 affected188 at risk EG0025 affected186 at risk EG003
Glomerular filtration rate decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0004 affected187 at risk EG0017 affected188 at risk EG0028 affected186 at risk EG003
Glomerular filtration rate increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0002 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Haemoglobin	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0014 affected188 at risk EG0028 affected186 at risk EG003
Heart rate increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Lipase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Low density lipoprotein increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0003 affected187 at risk EG0010 affected188 at risk EG0022 affected186 at risk EG003
Platelet count decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0022 affected186 at risk EG003
Transaminases increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Treponema test positive	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Weight decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0014 affected188 at risk EG0023 affected186 at risk EG003
White blood cell count decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Abnormal loss of weight	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0004 affected187 at risk EG0014 affected188 at risk EG0025 affected186 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected187 at risk EG0012 affected188 at risk EG0024 affected186 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Insulin resistance	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Obesity	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Vitamin B12 deficiency	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0012 affected188 at risk EG0021 affected186 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0005 affected187 at risk EG0018 affected188 at risk EG0027 affected186 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0004 affected187 at risk EG00110 affected188 at risk EG0025 affected186 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Fracture malunion	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0012 affected188 at risk EG0020 affected186 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0021 affected186 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG00017 affected187 at risk EG00133 affected188 at risk EG00225 affected186 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected187 at risk EG0014 affected188 at risk EG0023 affected186 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected187 at risk EG0011 affected188 at risk EG0021 affected186 at risk EG003
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0004 affected187 at risk EG0014 affected188 at risk EG0026 affected186 at risk EG003
Patellofemoral pain syndrome	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Psoriatic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0012 affected188 at risk EG0020 affected186 at risk EG003
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Tenosynovitis stenosans	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Torticollis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Trigger finger	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0022 affected186 at risk EG003
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Cervical radiculopathy	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Dizziness	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0006 affected187 at risk EG0012 affected188 at risk EG0022 affected186 at risk EG003
Epilepsy	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Headache	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG00030 affected187 at risk EG00138 affected188 at risk EG00232 affected186 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0022 affected186 at risk EG003
Lumbar radiculopathy	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Migraine	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Myelopathy	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Nerve compression	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0021 affected186 at risk EG003
Post herpetic neuralgia	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Post-traumatic headache	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Radicular pain	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Sciatica	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0012 affected188 at risk EG0020 affected186 at risk EG003
Seizure	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Sinus headache	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Syncope	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Tardive dyskinesia	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Tremor	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Alcohol abuse	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected187 at risk EG0011 affected188 at risk EG0021 affected186 at risk EG003
Bipolar II disorder	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Depression	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Libido decreased	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Major depression	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Psychotic disorder	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0021 affected186 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Hypertonic bladder	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Nocturia	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Urethral pain	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Urethral spasm	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Urinary hesitation	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Urinary tract obstruction	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Atrophic vulvovaginitis	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Bartholin's cyst	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Breast mass	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Dyspareunia	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0021 affected186 at risk EG003
Genital odour	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Heavy menstrual bleeding	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Menopausal symptoms	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Scrotal mass	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Uterine spasm	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Vaginal discharge	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0014 affected188 at risk EG0021 affected186 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Vulval ulceration	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Vulvovaginal pain	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Vulvovaginal pruritus	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Vulvovaginal swelling	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Asthma late onset	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0012 affected188 at risk EG0021 affected186 at risk EG003
Childhood asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG00012 affected187 at risk EG0017 affected188 at risk EG0029 affected186 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected187 at risk EG0011 affected188 at risk EG0021 affected186 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected187 at risk EG0010 affected188 at risk EG0022 affected186 at risk EG003
Nasal septum ulceration	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Oropharyngeal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0006 affected187 at risk EG0016 affected188 at risk EG0022 affected186 at risk EG003
Paranasal sinus discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Pharyngeal cyst	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected187 at risk EG0012 affected188 at risk EG0020 affected186 at risk EG003
Respiratory symptom	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0004 affected187 at risk EG0014 affected188 at risk EG0024 affected186 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Tonsillar erythema	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Tonsillar exudate	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Tonsillar hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Upper respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Vocal cord thickening	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0012 affected188 at risk EG0020 affected186 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Brachioradial pruritus	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Cold sweat	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0022 affected186 at risk EG003
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Dyshidrotic eczema	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Eczema asteatotic	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Intertrigo	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Keratosis pilaris	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0004 affected187 at risk EG0013 affected188 at risk EG0025 affected186 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0021 affected186 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Sebaceous hyperplasia	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Skin hypopigmentation	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Abortion induced	Surgical and medical procedures	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Cardiac ablation	Surgical and medical procedures	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Female sterilisation	Surgical and medical procedures	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Nerve block	Surgical and medical procedures	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Tooth extraction	Surgical and medical procedures	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0012 affected188 at risk EG0020 affected186 at risk EG003
Hot flush	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Hypertension	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0005 affected187 at risk EG0011 affected188 at risk EG0024 affected186 at risk EG003
Hypotension	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Pelvic venous thrombosis	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Peripheral artery stenosis	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Vasoconstriction	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003

ID	Title	Description
BG000	Group A: 2-CpG	Participants were prescribed 0.5 mL of HEPLISAV-B (hepatitis B vaccine with a cytosine phosphoguanine adjuvant) by intramuscular injection at Weeks 0 and 4.
BG001	Group A: 3-CpG	Participants were prescribed 0.5 mL of HEPLISAV-B (hepatitis B vaccine with a cytosine phosphoguanine adjuvant) by intramuscular injection at Weeks 0, 4, and 24.
BG002	Group A: 3-alum	Participants were prescribed 1 mL of ENGERIX-B (conventional 3-dose hepatitis B vaccine with an aluminum hydroxide adjuvant) by intramuscular injection at Weeks 0, 4, and 24.
BG003	Group B	Participants were prescribed 0.5 mL of HEPLISAV-B (hepatitis B vaccine with a cytosine phosphoguanine adjuvant) by intramuscular injection at Weeks 0, 4, and 24.
BG004	Total	Total of all reporting groups

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D016180	Lentivirus Infections
D012192	Retroviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases
D018347	Hepadnaviridae Infections
D004266	DNA Virus Infections
D006525	Hepatitis, Viral, Human
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases

ID	Term
C000726347	Heplisav-B
C075654	Engerix-B

Title	Measurements
<5 mIU/mL	OG00016 OG0019 OG00252 OG0037
5-9 mIU/mL	OG0003 OG0017 OG00210 OG0032
10-99 mIU/mL	OG00033 OG00137 OG00236 OG00324
100-1000 mIU/mL	OG00072 OG00168 OG00246 OG00328
>1000 mIU/mL	OG00051 OG00153 OG00229 OG0038

Title	Measurements
<5 mIU/mL	OG0008 OG0016 OG00247 OG0034
5-9 mIU/mL	OG0003 OG0016 OG0029 OG0030
10-99 mIU/mL	OG00039 OG00138 OG00242 OG00319
100-1000 mIU/mL	OG00076 OG00171 OG00250 OG00338
>1000 mIU/mL	OG00046 OG00148 OG00219 OG00311

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Group A: 2-CpG	Participants were prescribed 0.5 mL of HEPLISAV-B (hepatitis B vaccine with a cytosine phosphoguanine adjuvant) by intramuscular injection at Weeks 0 and 4.	1	187	12	187	133	187
EG001	Group A: 3-CpG	Participants were prescribed 0.5 mL of HEPLISAV-B (hepatitis B vaccine with a cytosine phosphoguanine adjuvant) by intramuscular injection at Weeks 0, 4, and 24.	1	188	15	188	146	188
EG002	Group A: 3-alum	Participants were prescribed 1 mL of ENGERIX-B (conventional 3-dose hepatitis B vaccine with an aluminum hydroxide adjuvant) by intramuscular injection at Weeks 0, 4, and 24.	0	186	11	186	134	186
EG003	Group B	Participants were prescribed 0.5 mL of HEPLISAV-B (hepatitis B vaccine with a cytosine phosphoguanine adjuvant) by intramuscular injection at Weeks 0, 4, and 24.	0	74	4	74	64	74

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Blood loss anaemia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG0030 affected74 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Cardiac failure acute	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Anal fissure	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Chest pain	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Abscess limb	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Appendicitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
COVID-19	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Cellulitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0011 affected188 at risk EG0021 affected186 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Plasmodium falciparum infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Pneumonia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Pulmonary tuberculosis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Sepsis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Craniofacial fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Spinal column injury	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Histiocytic necrotising lymphadenitis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0022 affected186 at risk EG003
Headache	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Hemiplegic migraine	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Syncope	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Abortion incomplete	Pregnancy, puerperium and perinatal conditions	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Depression	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Intentional self-injury	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0001 affected187 at risk EG0010 affected188 at risk EG0020 affected186 at risk EG003
Bartholin's cyst	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0020 affected186 at risk EG003
Asthma late onset	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0011 affected188 at risk EG0021 affected186 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 affected187 at risk EG0010 affected188 at risk EG0021 affected186 at risk EG003

Title	Measurements
<5 mIU/mL	OG0006 OG0015 OG00250 OG0031
5-9 mIU/mL	OG0002 OG0013 OG00213 OG0030
10-99 mIU/mL	OG00031 OG00127 OG00250 OG00314
100-1000 mIU/mL	OG00085 OG00179 OG00242 OG00334
>1000 mIU/mL	OG00038 OG00149 OG0029 OG00319

Title	Measurements
<5 mIU/mL	OG0006 OG0011 OG00225 OG0030
5-9 mIU/mL	OG0006 OG0010 OG0027 OG0030
10-99 mIU/mL	OG00029 OG0016 OG00228 OG0032
100-1000 mIU/mL	OG00081 OG00128 OG00243 OG0039
>1000 mIU/mL	OG00041 OG001127 OG00257 OG00357

Title	Measurements
<5 mIU/mL	OG0012 OG00231 OG0030
5-9 mIU/mL	OG0010 OG00210 OG0030
10-99 mIU/mL	OG0018 OG00227 OG0032
100-1000 mIU/mL	OG00139 OG00247 OG00311
>1000 mIU/mL	OG001112 OG00246 OG00356

Title	Measurements
<5 mIU/mL	OG0013 OG00245 OG0030
5-9 mIU/mL	OG0011 OG00211 OG0031
10-99 mIU/mL	OG00115 OG00232 OG0035
100-1000 mIU/mL	OG00170 OG00248 OG00325
>1000 mIU/mL	OG00179 OG00224 OG00339

Title	Measurements
<5 mIU/mL	OG00012
5-9 mIU/mL	OG0005
10-99 mIU/mL	OG00039
100-1000 mIU/mL	OG00084
>1000 mIU/mL	OG00022

Title	Measurements
<5 mIU/mL	OG00016 OG0015 OG00253 OG0031
5-9 mIU/mL	OG0006 OG0010 OG00212 OG0031
10-99 mIU/mL	OG00045 OG00125 OG00232 OG00310
100-1000 mIU/mL	OG00077 OG00176 OG00239 OG00332
>1000 mIU/mL	OG00015 OG00155 OG00217 OG00327