MVA-BN-RSV Vaccine Trial | NCT05238025

Status Module

Label	Type	Description	Intervention Names
Group 1: Single dose MVA-BN-RSV	Experimental	Single dose (Week 0): MVA-BN-RSV virus with a titer of at least 3x10E8 Inf.U/0.5mL (intramuscular vaccination)	Biological: MVA-BN-RSV vaccine
Group 2: Single dose Placebo	Experimental	Single dose of TBS (intramuscular injection; 0.5mL)	Biological: Tris Buffered Saline (TBS)

Name	Type	Description	Arm Group Labels	Other Names
MVA-BN-RSV vaccine	Biological	One injection, suspension for injection, intramuscular use, 0.5mL MVA-BN-RSV virus with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL in a Tris buffer at pH 7.7.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of PCR Confirmed RSV-associated LRTD With at Least 3 Symptoms	RSV-associated lower respiratory tract disease (LRTD) is defined by the presence of clinical evidence of at least 1 sign or symptom of acute respiratory disease (ARD) and at least 3 LRTD signs or symptoms with onset ≥14 days following vaccination until the end of one RSV season (up to 12 months after vaccination), confirmed and documented by a medical professional, together with RSV disease confirmed by polymerase chain reaction (PCR)	From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months
Occurrence of PCR Confirmed RSV-associated LRTD With at Least 2 Symptoms	RSV-associated lower respiratory tract disease (LRTD) is defined by the presence of clinical evidence of at least 1 sign or symptom of acute respiratory disease (ARD) and at least 2 LRTD signs or symptoms with onset ≥14 days following vaccination until the end of one RSV season (up to 12 months after vaccination), confirmed and documented by a medical professional, together with RSV disease confirmed by polymerase chain reaction (PCR)	From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months

Secondary Outcomes

Measure	Description	Time Frame
Occurrence of PCR Confirmed RSV-associated ARD	RSV-associated acute respiratory disease (ARD) is defined by the presence of either one ARD symptom lasting for at least 24 hours or two simultaneously occurring ARD symptoms (irrespective of duration), with onset ≥14 days following vaccination until the end of one RSV season (up to 12 months after vaccination), confirmed and documented by a medical professional, together with RSV disease confirmed by polymerase chain reaction (PCR)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female subjects ≥60 years of age.
Informed Consent signed by the subject.
Subjects may have one or more chronic medical conditions e.g., mild to moderate underlying illnesses such as chronic cardiac diseases and chronic lung disease (asthma and chronic obstructive pulmonary disease [COPD]), congestive heart failure (CHF), hypertension, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, that is clinically stable as assessed by the investigator.
Absence of known, current, and life-limiting diagnoses that render survival to completion of the protocol unlikely.
Ability to comply with trial requirements, which necessitates access to transportation to on-site visits, including symptom visits for a nasopharyngeal swab.
Willingness and ability to utilize an application on a personal device (i.e., smartphone, tablet, etc.) or a provisioned device to record solicited events and record all per protocol required data during the surveillance period.
For women of childbearing potential (WOCBP), agreement to use an acceptable method of contraception during the trial and a negative urine pregnancy test within 24 hours prior to vaccination.

Exclusion Criteria:

History of or current clinical manifestation of any serious medical condition that in the opinion of the investigator would compromise the safety of the subject, confound data interpretation, or would limit the subject's ability to complete the trial.
History of or active autoimmune disease, including diabetes mellitus type I. Vitiligo or hypothyroidism requiring thyroid replacement therapy are not exclusions. Rheumatoid arthritis not requiring immunomodulatory and/or immunosuppressant treatment is not an exclusion.
Known or suspected impairment of immunologic functions, including chronic inflammatory bowel disorders.
Clinically significant mental disorder that would prevent patients from giving informed consent and complying with study procedures (e.g., completion of the electronic diary).
Active or recent (within 6 months before enrollment) history of chronic alcohol abuse.
History of a serious reaction to any prior vaccination or Guillain-Barré syndrome (GBS) within 6 weeks of any prior influenza immunization.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g., tris(hydroxymethyl)-amino methane, chicken embryo fibroblast proteins, gentamycin, ciprofloxacin; this includes:
- Known allergy to eggs or aminoglycosides
- History of anaphylaxis or severe allergic reaction to any vaccine
Any administration or planned administration of:
- A licensed live or vector-based vaccine within 30 days prior to or after trial vaccine administration.
- A licensed inactivated or ribonucleic acid (RNA)-based vaccine within 14 days prior to or after trial vaccine administration.
Previous vaccination with an RSV vaccine, or any planned vaccination with an RSV vaccine other than the trial vaccine.
Planned chronic, systemic administration (defined as more than 14 days) of >10 mg prednisone (or equivalent)/day or any other systemic use of immunemodifying drugs during a period starting from 3 months prior to first administration of the trial vaccine and ending at the End of Study Visit (EOS). The use of topical, inhaled, ophthalmic and nasal glucocorticoids is permitted.
Administration or planned administration of immunoglobulins and/or any blood products during a period starting from 3 months prior to first administration of the trial vaccine and during the trial.
Known uncontrolled coagulation disorder. Anticoagulant treatment under adequate control for cardiovascular prophylaxis or prophylaxis of thromboembolic disease or stroke in the setting of atrial fibrillation are permitted.
Use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days prior to the administration of the trial vaccine, or planned administration of such a drug or vaccine between enrollment in the trial and until the end of the clinical trial including follow-up. [For US Only]
Involvement with this trial as research personnel.

Name	Affiliation	Role
Bernard Hoet, MD	Bavarian Nordic	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
North Alabama Research Center, LLC		Athens	Alabama	35611	United States
Central Alabama Research

PubMed Identifier	Type	Citation	Retractions
39461302	Derived	Jordan E, Jenkins V, Silbernagl G, Chavez MPV, Schmidt D, Schnorfeil F, Schultz S, Chen L, Salgado F, Jacquet JM, Welte T, De Moerlooze L. A multivalent RSV vaccine based on the modified vaccinia Ankara vector shows moderate protection against disease caused by RSV in older adults in a phase 3 clinical study. Vaccine. 2024 Dec 2;42(26):126427. doi: 10.1016/j.vaccine.2024.126427. Epub 2024 Oct 25.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	MVA-BN-RSV	Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection). Group assignment based on the Full Analysis Set, i.e. participants randomized to MVA-BN-RSV and treated (including 8751 participants with a single randomization to MVA-BN-RSV [thereof 4 participants actually received Placebo] and 409 participants [multiple enrollers] with their first randomization to MVA-BN-RSV [thereof 230 participants receiving Placebo as second/later dose])

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Feb 15, 2023

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Occurrence of PCR Confirmed RSV-associated LRTD With at Least 3 Symptoms

RSV-associated lower respiratory tract disease (LRTD) is defined by the presence of clinical evidence of at least 1 sign or symptom of acute respiratory disease (ARD) and at least 3 LRTD signs or symptoms with onset ≥14 days following vaccination until the end of one RSV season (up to 12 months after vaccination), confirmed and documented by a medical professional, together with RSV disease confirmed by polymerase chain reaction (PCR)

Full Analysis Set i.e., all participants who were randomized to any treatment arm and received study vaccine (MVA-BN-RSV or placebo). Participants were analyzed based on the treatment to which they were randomized. Participants who received multiple doses of study vaccine ("multiple enrollers") were included once in this analysis set with group allocation based on their first randomization and with data censored from the time of second randomization.

Posted

Count of Participants

Participants

From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months

ID	Title	Description
OG000	MVA-BN-RSV	Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection)
OG001	Placebo	Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL)

Units	Counts
Participants	OG0009160 OG0019188

Title

Denominators

Categories

Title	Measurements
	OG00012 OG00121

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Vaccine Efficacy	42.9			2-Sided	95	-16.1	71.9					Other	Vaccine Efficacy (VE) is defined as 1 minus the hazard ratio resulting from a Cox proportional hazards regression model stratified by age group. It is demonstrated if the lower limit (LL) of the 2-sided 95% confidence interval (CI) for VE is above 20%

Primary

Occurrence of PCR Confirmed RSV-associated LRTD With at Least 2 Symptoms

RSV-associated lower respiratory tract disease (LRTD) is defined by the presence of clinical evidence of at least 1 sign or symptom of acute respiratory disease (ARD) and at least 2 LRTD signs or symptoms with onset ≥14 days following vaccination until the end of one RSV season (up to 12 months after vaccination), confirmed and documented by a medical professional, together with RSV disease confirmed by polymerase chain reaction (PCR)

Posted

Count of Participants

Participants

From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months

ID	Title	Description
OG000	MVA-BN-RSV	Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection)
OG001	Placebo	Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL)

Secondary

Occurrence of PCR Confirmed RSV-associated ARD

RSV-associated acute respiratory disease (ARD) is defined by the presence of either one ARD symptom lasting for at least 24 hours or two simultaneously occurring ARD symptoms (irrespective of duration), with onset ≥14 days following vaccination until the end of one RSV season (up to 12 months after vaccination), confirmed and documented by a medical professional, together with RSV disease confirmed by polymerase chain reaction (PCR)

Posted

Count of Participants

Participants

From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months

ID	Title	Description
OG000	MVA-BN-RSV	Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection)
OG001	Placebo	Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL)

Secondary

Occurrence of Complications Related to PCR-confirmed RSV Disease

RSV-specific complications include the presence of acute clinical consequences of RSV infection, such as pneumonia (incl. bacterial superinfection), sepsis, positive blood culture, and pneumothorax as well as longer term consequences of RSV-specific symptoms, such as persistent worsening of chronic conditions (e.g. COPD), new onset of persistent medical conditions (e.g. chronically impaired lung function, asthma) or a worsening of the functional status of the patient, e.g. new onset of nursing or assisted living need. RSV disease had to be confirmed by PCR testing.

Posted

Count of Participants

Participants

From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months

ID	Title	Description
OG000	MVA-BN-RSV	Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection)
OG001	Placebo	Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL)

Secondary

Occurrence of Hospitalization Due to Confirmed RSV Disease or Due to Any Complication Related to RSV-confirmed Respiratory Disease

Hospitalization due to PCR confirmed RSV disease and/or any complication related to PCR-confirmed RSV disease. RSV-specific complications include the presence of acute clinical consequences of RSV infection, such as pneumonia (incl. bacterial superinfection), sepsis, positive blood culture, and pneumothorax as well as longer term consequences of RSV-specific symptoms, such as persistent worsening of chronic conditions (e.g. COPD), new onset of persistent medical conditions (e.g. chronically impaired lung function, asthma) or a worsening of the functional status of the patient, e.g. new onset of nursing or assisted living need. RSV disease had to be confirmed by PCR testing.

Posted

Count of Participants

Participants

From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months

ID	Title	Description
OG000	MVA-BN-RSV	Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection)
OG001

Secondary

Occurrence of Severe PCR Confirmed RSV-associated LRTD

Severe RSV-associated LRTD is defined by the presence of clinical evidence of at least 1 sign or symptom of ARD and at least 1 of the following signs or symptoms with onset ≥14 days following vaccination until the end of one RSV season (up to 12 months after vaccination), confirmed and documented by a medical professional, together with RSV disease confirmed by polymerase chain reaction (PCR): 1) hypoxemia (oxygen saturation <92% at rest in conjunction with an at least 3% decrease from baseline); 2) respiratory rate >25 breaths/Min; 3) imaging evidence of new onset of bronchitis, bronchiolitis, or pneumonia

Posted

Count of Participants

Participants

From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months

ID	Title	Description
OG000	MVA-BN-RSV	Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection)
OG001	Placebo

Secondary

Number of Participants With Serious Adverse Events

Number and percentage of study participants reporting any serious adverse events at any time during the trial period.

Safety Set i.e., all participants who received study vaccine (MVA-BN-RSV or placebo). Subjects were analyzed based on the treatment they actually received. Subjects who received multiple doses of study vaccine ("multiple enrollers") were analyzed in the MVA-BN-RSV arm when having received the MVA-BN-RSV vaccine at least once; subjects were analyzed in the placebo arm when having received placebo only.

Posted

Count of Participants

Participants

From vaccination through study termination, up to 16 months

ID	Title	Description
OG000	MVA-BN-RSV	Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection)
OG001	Placebo	Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL)

Units	Counts
Participants

Secondary

Number of Participants With Grade 3 or Higher Adverse Events

Number and percentage of study participants reporting any grade 3 or higher unsolicited adverse events assessed as related to study vaccine

Posted

Count of Participants

Participants

Within 29 days after vaccination

ID	Title	Description
OG000	MVA-BN-RSV	Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection)
OG001	Placebo	Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL)

Units	Counts
Participants

Secondary

Number of Participants With Solicited Local Adverse Events

Number and percentage of study participants reporting injection site reactions (solicited via electronic diaries) within 8 days after vaccination. The number of participants analyzed and the percentages are based on the subset of participants in the Safety Set that completed the electronic diary.

Safety Set i.e., all participants who received study vaccine (MVA-BN-RSV or placebo). Subjects were analyzed based on the treatment they actually received. Subjects who received multiple doses of study vaccine ("multiple enrollers") were analyzed in the MVA-BN-RSV arm when having received the MVA-BN-RSV vaccine at least once; participants were analyzed in the placebo arm when having received placebo only.

Posted

Count of Participants

Participants

Within 8 days after vaccination

ID	Title	Description
OG000	MVA-BN-RSV	Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection)
OG001	Placebo	Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL)

Units	Counts

Secondary

Number of Participants With Solicited Systemic Adverse Events

Number and percentage of study participants reporting systemic reactions (solicited via electronic diaries) within 8 days after vaccination. The number of participants analyzed and the percentages are based on the subset of participants in the Safety Set that completed the electronic diary.

Safety Set i.e., all participants who received study vaccine (MVA-BN-RSV or placebo). Subjects were analyzed based on the treatment they actually received. Subjects who received multiple doses of study vaccine ("multiple enrollers") were analyzed in the MVA-BN-RSV arm when having received the MVA-BN-RSV vaccine at least once; participants were analyzed in the placebo arm when having received placebo only.

Posted

Count of Participants

Participants

Within 8 days after vaccination

ID	Title	Description
OG000	MVA-BN-RSV	Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection)
OG001	Placebo	Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL)

Units	Counts

Secondary

Number of Participants With Unsolicited Adverse Events

Number and percentage of study participants reporting any unsolicited adverse events within 29 days after vaccination.

Posted

Count of Participants

Participants

Within 29 days after vaccination

ID	Title	Description
OG000	MVA-BN-RSV	Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection)
OG001	Placebo	Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL)

Units	Counts
Participants

Secondary

RSV-specific T-cell Responses

RSV-specific T-cell responses measured 1 week post vaccination in a subset of the study population

Not Posted

1 week after vaccination

Participants

Secondary

RSV-specific Serum IgG Antibody Titers

Geometric Mean Titers (GMTs) based on RSV-specific Immunoglobulin G (IgG) Enzyme-linked Immunosorbent Assay (ELISA)

Immunogenicity Analysis Set, a subset of the Full Analysis Set, including participants at designated clinical trial sites who signed the informed consent form for collection of serum samples. Number of participants analyzed represent the participants with antibody titer results available at the respective time point.

Posted

Geometric Mean

95% Confidence Interval

Titer

2 weeks after vaccination

ID	Title	Description
OG000	MVA-BN-RSV	Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection)
OG001	Placebo	Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL)

Units	Counts
Participants	OG000

Secondary

RSV-specific Serum Neutralizing Antibody Titers (Subtype A)

Geometric Mean Titers (GMTs) based on RSV-specific Plaque Reduction Neutralization Test (PRNT; against subtype A). Results below the lower limit of quantitation (LLOQ) are included with a value of 1/2 LLOQ

Posted

Geometric Mean

95% Confidence Interval

Titer

2 weeks after vaccination

ID	Title	Description
OG000	MVA-BN-RSV	Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection)
OG001	Placebo	Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL)

Units	Counts
Participants

Secondary

RSV-specific Serum Neutralizing Antibody Titers (Subtype B)

Geometric Mean Titers (GMTs) based on RSV-specific Plaque Reduction Neutralization Test (PRNT; against subtype B). Results below the lower limit of quantitation (LLOQ) are included with a value of 1/2 LLOQ

Posted

Geometric Mean

95% Confidence Interval

Titer

2 weeks after vaccination

ID	Title	Description
OG000	MVA-BN-RSV	Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection)
OG001	Placebo	Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL)

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	MVA-BN-RSV	Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection). Group assignment based on actual treatment, i.e. participants treated with MVA-BN-RSV (including 8747 Single Enroller participants randomized to MVA-BN-RSV and treated with MVA-BN-RSV + 1 Single Enroller participant randomized to Placebo and treated with MVA-BN-RSV + 179 Multiple Enroller participants randomized to MVA-BN-RSV (first randomization) and treated with MVA-BN-RSV only + 230 Multiple Enroller participants randomized to MVA-BN-RSV (first randomization) and treated with at least one dose of Placebo + 232 Multiple Enroller participants randomized to Placebo (first randomization) and treated with at least one dose of MVA-BN-RSV).	41	9,389	517	9,389	82	9,389
EG001	Placebo	Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL). Group assignment based on actual treatment, i.e. participants treated with Placebo (including 8770 Single Enroller participants randomized to Placebo and treated with Placebo + 4 Single Enroller participants randomized to MVA-BN-RSV and treated with Placebo + 185 Multiple Enroller participants randomized to Placebo (first randomization) and treated with Placebo only (at least 2 doses and up to 4 doses) + 232 Multiple Enroller participants randomized to Placebo (first randomization) and treated with at least one dose of MVA-BN-RSV).	34	9,191	422	9,191	82	9,191

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG00037 affected9,389 at risk EG00123 affected9,191 at risk
Sepsis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG00012 affected9,389 at risk EG0019 affected9,191 at risk
Cellulitis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG00010 affected9,389 at risk EG0016 affected9,191 at risk
COVID-19	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0009 affected9,389 at risk EG0015 affected9,191 at risk
Urinary tract infection	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0009 affected9,389 at risk EG0017 affected9,191 at risk
Diverticulitis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0006 affected9,389 at risk EG0011 affected9,191 at risk
Arthritis infective	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0005 affected9,389 at risk EG0011 affected9,191 at risk
Appendicitis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0004 affected9,389 at risk EG0013 affected9,191 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0004 affected9,389 at risk EG0011 affected9,191 at risk
Influenza	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0003 affected9,389 at risk EG0012 affected9,191 at risk
Pyelonephritis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0003 affected9,389 at risk EG0010 affected9,191 at risk
Septic shock	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0003 affected9,389 at risk EG0014 affected9,191 at risk
Abscess limb	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0010 affected9,191 at risk
Atypical pneumonia	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0010 affected9,191 at risk
Cystitis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0012 affected9,191 at risk
Localised infection	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0011 affected9,191 at risk
Metapneumovirus pneumonia	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0010 affected9,191 at risk
Osteomyelitis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0011 affected9,191 at risk
Sinusitis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0010 affected9,191 at risk
Abdominal wall abscess	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Abscess intestinal	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0011 affected9,191 at risk
Arthritis bacterial	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Bacterial infection	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Campylobacter infection	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Cellulitis staphylococcal	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Clostridium difficile infection	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Complicated appendicitis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Endocarditis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Epididymitis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Fournier's gangrene	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0011 affected9,191 at risk
Gangrene	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0011 affected9,191 at risk
Hepatitis A	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Large intestine infection	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0012 affected9,191 at risk
Norovirus infection	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Pneumonia influenzal	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Pneumonia respiratory syncytial viral	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Postoperative wound infection	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0011 affected9,191 at risk
Staphylococcal infection	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0012 affected9,191 at risk
Urosepsis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0011 affected9,191 at risk
Wound infection	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0011 affected9,191 at risk
Bronchitis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0013 affected9,191 at risk
Cholecystitis infective	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Erysipelas	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
External ear cellulitis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Fungaemia	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Gastroenteritis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Incision site abscess	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Infected bite	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Kidney infection	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Pelvic abscess	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Peritonitis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Pneumococcal bacteraemia	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Post procedural infection	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Pyelonephritis acute	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Rhinovirus infection	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0012 affected9,191 at risk
Scrotal cellulitis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Skin bacterial infection	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Streptococcal sepsis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Vestibular neuronitis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Vulval abscess	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG00021 affected9,389 at risk EG00114 affected9,191 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG00015 affected9,389 at risk EG0016 affected9,191 at risk
Myocardial infarction	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG00011 affected9,389 at risk EG00113 affected9,191 at risk
Angina pectoris	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0009 affected9,389 at risk EG0016 affected9,191 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0008 affected9,389 at risk EG0013 affected9,191 at risk
Cardiac arrest	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0006 affected9,389 at risk EG0011 affected9,191 at risk
Cardiac failure	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0006 affected9,389 at risk EG0012 affected9,191 at risk
Coronary artery disease	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0006 affected9,389 at risk EG0016 affected9,191 at risk
Cardiac failure acute	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0003 affected9,389 at risk EG0013 affected9,191 at risk
Arrhythmia	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0010 affected9,191 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0011 affected9,191 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0012 affected9,191 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Arrhythmic storm	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Atrioventricular block	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Bradycardia	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0012 affected9,191 at risk
Bundle branch block left	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0011 affected9,191 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Palpitations	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Pericarditis	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0011 affected9,191 at risk
Sinus arrest	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Sinus bradycardia	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0012 affected9,191 at risk
Stress cardiomyopathy	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0011 affected9,191 at risk
Angina unstable	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0014 affected9,191 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Cardiomyopathy	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Cardiovascular disorder	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Pericardial effusion	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0013 affected9,191 at risk
Pulseless electrical activity	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG00015 affected9,389 at risk EG00111 affected9,191 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG00012 affected9,389 at risk EG0016 affected9,191 at risk
Syncope	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0009 affected9,389 at risk EG0018 affected9,191 at risk
Encephalopathy	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0003 affected9,389 at risk EG0011 affected9,191 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0011 affected9,191 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0010 affected9,191 at risk
Dizziness	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0011 affected9,191 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0012 affected9,191 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0011 affected9,191 at risk
Myelopathy	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0011 affected9,191 at risk
Presyncope	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0010 affected9,191 at risk
Alcoholic seizure	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Altered state of consciousness	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Amnesia	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Ataxia	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Basal ganglia stroke	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Carotid artery occlusion	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0011 affected9,191 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0012 affected9,191 at risk
Cerebrospinal fluid leakage	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Cervical radiculopathy	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Embolic stroke	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Epilepsy	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Facial paresis	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Headache	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Loss of consciousness	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Monoplegia	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Paralysis	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Seizure	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0013 affected9,191 at risk
Speech disorder	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Bell's palsy	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Cervical spinal cord paralysis	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Dysarthria	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Facial paralysis	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Lacunar stroke	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Migraine	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Mononeuropathy	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Normal pressure hydrocephalus	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Paraesthesia	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Partial seizures	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Sciatica	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Spinal claudication	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0012 affected9,191 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0005 affected9,389 at risk EG0011 affected9,191 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0004 affected9,389 at risk EG0010 affected9,191 at risk
Colitis	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0004 affected9,389 at risk EG0012 affected9,191 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0004 affected9,389 at risk EG0012 affected9,191 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0010 affected9,191 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0012 affected9,191 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0010 affected9,191 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0011 affected9,191 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0012 affected9,191 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0010 affected9,191 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0010 affected9,191 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0010 affected9,191 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0010 affected9,191 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Abdominal incarcerated hernia	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0011 affected9,191 at risk
Constipation	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Diaphragmatic hernia	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Enteritis	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0011 affected9,191 at risk
Gastritis	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Gastrointestinal obstruction	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Haematemesis	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Haematochezia	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0011 affected9,191 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0012 affected9,191 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Oesophageal ulcer haemorrhage	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Proctitis ulcerative	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Vomiting	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0013 affected9,191 at risk
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0012 affected9,191 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Enterovesical fistula	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0013 affected9,191 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Ileus	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Nausea	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0012 affected9,191 at risk
Obstructive pancreatitis	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0012 affected9,191 at risk
Volvulus of small bowel	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG00013 affected9,389 at risk EG00118 affected9,191 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG00010 affected9,389 at risk EG0012 affected9,191 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0009 affected9,389 at risk EG0018 affected9,191 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0005 affected9,389 at risk EG00113 affected9,191 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0003 affected9,389 at risk EG0011 affected9,191 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0003 affected9,389 at risk EG0011 affected9,191 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0010 affected9,191 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0012 affected9,191 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0011 affected9,191 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0012 affected9,191 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Asthma-chronic obstructive pulmonary disease overlap syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Obstructive sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Pulmonary artery occlusion	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Pulmonary thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG00014 affected9,389 at risk EG00124 affected9,191 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0004 affected9,389 at risk EG0012 affected9,191 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0004 affected9,389 at risk EG0012 affected9,191 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0011 affected9,191 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0011 affected9,191 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0011 affected9,191 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0012 affected9,191 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0010 affected9,191 at risk
Spinal retrolisthesis	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0010 affected9,191 at risk
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0011 affected9,191 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0011 affected9,191 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Fracture pain	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Intervertebral disc compression	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0011 affected9,191 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Scoliosis	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Soft tissue swelling	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0012 affected9,191 at risk
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0012 affected9,191 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Vertebral osteophyte	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0005 affected9,389 at risk EG0014 affected9,191 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0005 affected9,389 at risk EG0011 affected9,191 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0005 affected9,389 at risk EG0016 affected9,191 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0003 affected9,389 at risk EG0012 affected9,191 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0010 affected9,191 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0010 affected9,191 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0012 affected9,191 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0011 affected9,191 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Neck injury	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Periprosthetic fracture	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0011 affected9,191 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0011 affected9,191 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0015 affected9,191 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Splenic injury	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0011 affected9,191 at risk
Tendon injury	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0011 affected9,191 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0013 affected9,191 at risk
Burns second degree	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0014 affected9,191 at risk
Extradural haematoma	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0014 affected9,191 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0012 affected9,191 at risk
Gastrointestinal injury	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Procedural intestinal perforation	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Spinal column injury	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Stoma site haemorrhage	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0012 affected9,191 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0012 affected9,191 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0003 affected9,389 at risk EG0011 affected9,191 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0011 affected9,191 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0010 affected9,191 at risk
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0010 affected9,191 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0012 affected9,191 at risk
Throat cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0010 affected9,191 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Benign renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Bladder cancer stage 0, with cancer in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Bone cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0011 affected9,191 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Gastrointestinal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Lung carcinoma cell type unspecified recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0013 affected9,191 at risk
Malignant peritoneal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Mantle cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Metastases to abdominal wall	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0013 affected9,191 at risk
Prostate cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Schwannoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Tonsil cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Bone cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Brain cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Cardiac myxoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Central nervous system lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0012 affected9,191 at risk
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Lung carcinoma cell type unspecified stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Marginal zone lymphoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Oesophageal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Oncocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Salivary gland neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Testis cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Non-cardiac chest pain	General disorders	MedDRA (25.0)	Systematic Assessment	EG00011 affected9,389 at risk EG0013 affected9,191 at risk
Death	General disorders	MedDRA (25.0)	Systematic Assessment	EG0009 affected9,389 at risk EG0017 affected9,191 at risk
Chest discomfort	General disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0010 affected9,191 at risk
Chest pain	General disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0013 affected9,191 at risk
Gait disturbance	General disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0010 affected9,191 at risk
Malaise	General disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0011 affected9,191 at risk
Peripheral swelling	General disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0011 affected9,191 at risk
Pyrexia	General disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0011 affected9,191 at risk
Asthenia	General disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0013 affected9,191 at risk
Cardiac death	General disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Cyst	General disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Drug withdrawal syndrome	General disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Injection site erythema	General disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Injection site pruritus	General disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Oedema peripheral	General disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Sudden cardiac death	General disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Calcinosis	General disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Dysplasia	General disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Fatigue	General disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Pain	General disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (25.0)	Systematic Assessment	EG0006 affected9,389 at risk EG0013 affected9,191 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (25.0)	Systematic Assessment	EG0004 affected9,389 at risk EG0010 affected9,191 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (25.0)	Systematic Assessment	EG0004 affected9,389 at risk EG0012 affected9,191 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (25.0)	Systematic Assessment	EG0003 affected9,389 at risk EG0012 affected9,191 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0010 affected9,191 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0013 affected9,191 at risk
Hyperglycaemic hyperosmolar nonketotic syndrome	Metabolism and nutrition disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0010 affected9,191 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0012 affected9,191 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0010 affected9,191 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0010 affected9,191 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Gout	Metabolism and nutrition disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG0005 affected9,389 at risk EG0014 affected9,191 at risk
Hypertensive crisis	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG0004 affected9,389 at risk EG0011 affected9,191 at risk
Aortic stenosis	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0011 affected9,191 at risk
Hypertension	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0011 affected9,191 at risk
Hypertensive emergency	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0011 affected9,191 at risk
Hypotension	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0016 affected9,191 at risk
Thrombosis	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0011 affected9,191 at risk
Arterial occlusive disease	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Arteriosclerosis	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Bleeding varicose vein	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Extremity necrosis	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Haematoma	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0012 affected9,191 at risk
Internal haemorrhage	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Ischaemia	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Malignant hypertension	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0011 affected9,191 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Shock haemorrhagic	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Aortic aneurysm	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Aortic aneurysm rupture	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Aortic dissection	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Circulatory collapse	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Pelvic venous thrombosis	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Peripheral ischaemia	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Venous thrombosis limb	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Depression	Psychiatric disorders	MedDRA (25.0)	Systematic Assessment	EG0005 affected9,389 at risk EG0013 affected9,191 at risk
Mental status changes	Psychiatric disorders	MedDRA (25.0)	Systematic Assessment	EG0004 affected9,389 at risk EG0011 affected9,191 at risk
Anxiety	Psychiatric disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0011 affected9,191 at risk
Suicidal ideation	Psychiatric disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0010 affected9,191 at risk
Suicide attempt	Psychiatric disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0010 affected9,191 at risk
Alcohol use disorder	Psychiatric disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Bipolar disorder	Psychiatric disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Confusional state	Psychiatric disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Delirium	Psychiatric disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Depression suicidal	Psychiatric disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Mental disorder	Psychiatric disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Schizophrenia	Psychiatric disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Substance use disorder	Psychiatric disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Alcohol abuse	Psychiatric disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Disorientation	Psychiatric disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (25.0)	Systematic Assessment	EG0007 affected9,389 at risk EG0012 affected9,191 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (25.0)	Systematic Assessment	EG0004 affected9,389 at risk EG0016 affected9,191 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0011 affected9,191 at risk
End stage renal disease	Renal and urinary disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Mixed incontinence	Renal and urinary disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Renal failure	Renal and urinary disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0011 affected9,191 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Urinary retention	Renal and urinary disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Bladder spasm	Renal and urinary disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Urinary bladder polyp	Renal and urinary disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA (25.0)	Systematic Assessment	EG0005 affected9,389 at risk EG0011 affected9,191 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (25.0)	Systematic Assessment	EG0003 affected9,389 at risk EG0012 affected9,191 at risk
Biliary colic	Hepatobiliary disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0011 affected9,191 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0013 affected9,191 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Bile duct stenosis	Hepatobiliary disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Biliary obstruction	Hepatobiliary disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0012 affected9,191 at risk
Hepatic lesion	Hepatobiliary disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Hepatitis alcoholic	Hepatobiliary disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected9,389 at risk EG0014 affected9,191 at risk
Blood loss anaemia	Blood and lymphatic system disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Immune thrombocytopenia	Blood and lymphatic system disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0012 affected9,191 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0012 affected9,191 at risk
Endometrial thickening	Reproductive system and breast disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Female genital tract fistula	Reproductive system and breast disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Diplopia	Eye disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Lens dislocation	Eye disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Macular oedema	Eye disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Glaucoma	Eye disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Visual impairment	Eye disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0012 affected9,191 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Gastrointestinal stoma output increased	Investigations	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
SARS-CoV-2 test positive	Investigations	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0011 affected9,191 at risk
Blood magnesium decreased	Investigations	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Blood potassium increased	Investigations	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Cardiac murmur	Investigations	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Heart rate increased	Investigations	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Heart rate irregular	Investigations	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Hepatic enzyme increased	Investigations	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Device dislocation	Product Issues	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Device failure	Product Issues	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Device loosening	Product Issues	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0012 affected9,191 at risk
Transient acantholytic dermatosis	Skin and subcutaneous tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Goitre	Endocrine disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected9,389 at risk EG0010 affected9,191 at risk
Gallbladder operation	Surgical and medical procedures	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Hip surgery	Surgical and medical procedures	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk
Inguinal hernia repair	Surgical and medical procedures	MedDRA (25.0)	Systematic Assessment	EG0000 affected9,389 at risk EG0011 affected9,191 at risk

ID	Term
D018186	Pneumovirus Infections
D018184	Paramyxoviridae Infections
D018701	Mononegavirales Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D007239	Infections

ID	Title	Description
BG000	MVA-BN-RSV	Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection)
BG001	Placebo	Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL)
BG002	Total	Total of all reporting groups