Efficacy and Safety of Benralizumab in Moderate to Very S... | NCT02155660

NCT02155660

Status Module

Name	Class
MedImmune LLC	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Benralizumab Arm A	Experimental	Benralizumab administered subcutaneously	Drug: Benralizumab Arm A
Benralizumab Arm B	Experimental	Benralizumab administered subcutaneously	Drug: Benralizumab Arm B
Benralizumab Arm C	Experimental	Benralizumab administered subcutaneously	Drug: Benralizumab Arm C
Placebo	Placebo Comparator	Placebo administered subcutaneously	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Benralizumab Arm A	Drug	Benralizumab subcutaneously on study week 0 until study week 48 inclusive	Benralizumab Arm A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL	A COPD exacerbation is defined by symptomatic worsening of COPD requiring: Use of systemic corticosteroids for at least 3 days; a single depot injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids; and/or Use of antibiotics; and/or An inpatient hospitalization or death due to COPD Annual COPD exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.	Immediately following the first IP dose through week 56

Secondary Outcomes

Measure	Description	Time Frame
Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS<220/uL	A COPD exacerbation is defined by symptomatic worsening of COPD requiring: Use of systemic corticosteroids for at least 3 days; a single depot injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids; and/or Use of antibiotics; and/or An inpatient hospitalization or death due to COPD Annual COPD exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:.

Informed consent.
Subjects 40-85 y.o.
Moderate to very severe COPD with Post Bronchodilator (BD) FEV1>20% and ≤65%.

-≥2 moderate or ≥1 severe COPD exacerbation(s) required treatment or hospitalization within 2-52 weeks prior to Visit1.
Modified Medical Research Council (mMRC) score ≥1 at Visit 1.
Treatment with double or triple therapy throughout the year prior to Visit 1, constant 2 weeks prior to Visit 1.
Tobacco history of ≥10 pack-years.
Women of childbearing potential must use a highly effective form of birth control from Visit 1 until 16 weeks after their last dose, and negative serum pregnancy test result at Visit 1.
Male subjects who are sexually active must be surgically sterile one year prior to Visit 1 or use an adequate method of contraception from the first Investigational Product (IP) dose until 16 weeks after their last dose.
Compliance with maintenance therapy during run-in ≥70%.
Blood eosinophils due to subject's stratification and cap for blood eosinophil levels.When any eosinophil cohort is full, subjects in the completed cohort will not be randomised and will be withdrawn from the study.

Exclusion criteria:

Clinically important pulmonary disease other than COPD or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
Any disorder or major physical impairment that is not stable by Investigator opinion and/or could affect: - subject safety-study findings or their interpretation or subject's ability to complete the entire study duration.
Unstable ischemic heart disease, arrhythmia, cardiomyopathy, or other relevant cardiovascular disorder that in Investigator's judgment may put the patient at risk or negatively affect the study outcome.
Treatment with systemic corticosteroids and/or antibiotics, and/or hospitalization for a COPD exacerbation within 2 weeks prior to Visit1 or during the enrolment and run-in period.
Acute upper or lower respiratory infection requiring antibiotics within 2 weeks prior to Visit1 or during the enrolment and run-in period.
Pneumonia within 8 weeks prior to Visit1 or during the enrolment and run-in period.
Pregnant, breastfeeding, or lactating women.
Risk factors for pneumonia
History of anaphylaxis to any other biologic therapy.
Long term oxygen therapy with signs and/or symptoms of cor pulmonale, right ventricular failure.
Use of immunosuppressive medication within 2 weeks prior to Visit1 and/or during the enrolment and run-in period.
Receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to Visit 1.
Evidence of active tuberculosis (TB) without an appropriate course of treatment.
Lung volume reduction surgery within the 6 months prior to Visit 1. History of partial or total lung resection (single lobe or segmentectomy is acceptable).
Asthma as a primary or main diagnosis according to the Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.
Previous treatment with benralizumab.
Helminth parasitic infection diagnosed within 24 weeks prior to Visit 1.

Name	Affiliation	Role
Bartolome R. Celli, MD	Brigham and Women's Hospital, Pulmonary Division, 75 Francis Street, PBB Clinics 3, Boston, MA 02115	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Birmingham	Alabama	35216	United States
Research Site

PubMed Identifier	Type	Citation	Retractions
31575508	Derived	Criner GJ, Celli BR, Singh D, Agusti A, Papi A, Jison M, Makulova N, Shih VH, Brooks L, Barker P, Martin UJ, Newbold P. Predicting response to benralizumab in chronic obstructive pulmonary disease: analyses of GALATHEA and TERRANOVA studies. Lancet Respir Med. 2020 Feb;8(2):158-170. doi: 10.1016/S2213-2600(19)30338-8. Epub 2019 Sep 28.
31112385

Label	URL
Related Info	View source

Results Section

Participant Flow Module

ID	Title	Description
FG000	Benralizumab 10 mg	Every 8 weeks administered subcutaneously
FG001	Benralizumab 30 mg	Every 8 weeks administered subcutaneously

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	Yes	No	No	Study Protocol	Jul 6, 2015	Mar 13, 2019

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

Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL

A COPD exacerbation is defined by symptomatic worsening of COPD requiring:

Use of systemic corticosteroids for at least 3 days; a single depot injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids; and/or
Use of antibiotics; and/or
An inpatient hospitalization or death due to COPD Annual COPD exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.

Full analysis set, baseline EOS>=220/uL

Posted

Least Squares Mean

95% Confidence Interval

Exacerbations per year

Immediately following the first IP dose through week 56

ID	Title	Description
OG000	Benralizumab 10 mg	Every 8 weeks administered subcutaneously
OG001	Benralizumab 30 mg	Every 8 weeks administered subcutaneously
OG002	Benralizumab 100 mg	Every 8 weeks administered subcutaneously
OG003	Placebo	Every 8 weeks administered subcutaneously

Units	Counts
Participants	OG000377 OG001394 OG002386 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000.99(0.87 to 1.13) OG0011.21(1.08 to 1.37) OG0021.09(0.96 to 1.23) OG003

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 OG003		Negative binomial	Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.	0.0638		Rate ratio	0.85			2-Sided	95	0.71	1.01					Superiority
OG001 OG003		Negative binomial

Secondary

Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS<220/uL

A COPD exacerbation is defined by symptomatic worsening of COPD requiring:

Use of systemic corticosteroids for at least 3 days; a single depot injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids; and/or
Use of antibiotics; and/or
An inpatient hospitalization or death due to COPD Annual COPD exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.

Full analysis set, baseline EOS<220/uL

Posted

Least Squares Mean

95% Confidence Interval

Exacerbations per year

Immediately following the first IP dose through week 56

ID	Title	Description
OG000	Benralizumab 10 mg	Every 8 weeks administered subcutaneously
OG001	Benralizumab 30 mg	Every 8 weeks administered subcutaneously
OG002	Benralizumab 100 mg	Every 8 weeks administered subcutaneously

Secondary

Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline EOS>=220/uL

Pre-bronchodilator FEV1 (L) is collected at Weeks 0, 4, 8, 16, 24, 32, 40, 48, and 56. Baseline is the last non-missing value with quality (acceptable or borderline quality grade) prior to the first dose of study treatment.

Full analysis set, baseline EOS>=220/uL

Posted

Mean

Standard Deviation

Liter

First IP up to end of treatment Week 56

ID	Title	Description
OG000	Benralizumab 10 mg	Every 8 weeks administered subcutaneously
OG001	Benralizumab 30 mg	Every 8 weeks administered subcutaneously
OG002	Benralizumab 100 mg	Every 8 weeks administered subcutaneously
OG003	Placebo	Every 8 weeks administered subcutaneously

Secondary

Mean Change From Baseline in SGRQ Total Score for Patients With Baseline EOS>=220/uL

SGRQ is from 50-item PRO instrument. The SGRQ total score is expressed as a percentage of overall impairment, in which 100% means the worst possible health status and 0 indicates the best possible health status.

Full analysis set, baseline EOS>=220/uL

Posted

Mean

Standard Deviation

Percentage

First IP up to Week 56

ID	Title	Description
OG000	Benralizumab 10 mg	Every 8 weeks administered subcutaneously
OG001	Benralizumab 30 mg	Every 8 weeks administered subcutaneously
OG002	Benralizumab 100 mg	Every 8 weeks administered subcutaneously
OG003	Placebo	Every 8 weeks administered subcutaneously

Secondary

Mean Change From Baseline in CAT Total Score for Patients With Baseline EOS>=220/uL

CAT is an 8-item PRO developed to measure the impact of COPD on health status. The instrument uses semantic differential six-point response scales. A CAT total score is the sum of item responses. Score ranges from 0 to 40 with higher scores indicative of greater COPD impact on health status.

Full analysis set, baseline EOS>=220/uL

Posted

Mean

Standard Deviation

Score on a scale

First IP up to Week 56

ID	Title	Description
OG000	Benralizumab 10 mg	Every 8 weeks administered subcutaneously
OG001	Benralizumab 30 mg	Every 8 weeks administered subcutaneously
OG002	Benralizumab 100 mg	Every 8 weeks administered subcutaneously
OG003	Placebo	Every 8 weeks administered subcutaneously

Secondary

Mean Change From Baseline in E-RS: COPD Total Score for Patients With Baseline EOS>=220/uL

The E-RS: COPD is an 11-item PRO developed to evaluate the severity of respiratory symptoms of COPD. Summation of E-RS: COPD item responses produces a total score ranging from 0 to 40, with higher scores indicating greater severity.

Full analysis set, baseline EOS>=220/uL

Posted

Mean

Standard Deviation

Score on a scale

First IP up to Week 56

ID	Title	Description
OG000	Benralizumab 10 mg	Every 8 weeks administered subcutaneously
OG001	Benralizumab 30 mg	Every 8 weeks administered subcutaneously
OG002	Benralizumab 100 mg	Every 8 weeks administered subcutaneously
OG003	Placebo	Every 8 weeks administered subcutaneously

Secondary

Mean Change From Baseline in Total Rescue Medication Use (Number of Puffs Per Day) for Patients With Baseline EOS>=220/uL

The number of rescue medication inhalations and nebulizer treatments taken are recorded by the patient in the eDiary twice daily. Total rescue medication use is the sum of daytime and night-time use.

Full analysis set, baseline EOS>=220/uL

Posted

Mean

Standard Deviation

Puffs/day

First IP up to Week 56

ID	Title	Description
OG000	Benralizumab 10 mg	Every 8 weeks administered subcutaneously
OG001	Benralizumab 30 mg	Every 8 weeks administered subcutaneously
OG002	Benralizumab 100 mg	Every 8 weeks administered subcutaneously
OG003	Placebo	Every 8 weeks administered subcutaneously

Secondary

Mean Change From Baseline in Proportion of Nights With Awakenings Due to Respiratory Symptoms for Patients With Baseline EOS>=220/uL

Change from baseline to Week 56 in proportion of nights with awakenings due to respiratory symptoms.

Full analysis set, baseline EOS>=220/uL

Posted

Mean

Standard Deviation

Proportion of nights

First IP up to Week 56

ID	Title	Description
OG000	Benralizumab 10 mg	Every 8 weeks administered subcutaneously
OG001	Benralizumab 30 mg	Every 8 weeks administered subcutaneously
OG002	Benralizumab 100 mg	Every 8 weeks administered subcutaneously
OG003	Placebo	Every 8 weeks administered subcutaneously

Units	Counts

Secondary

Number of Participants by Number of COPD Exacerbations Based on EXACT-PRO for Patients With Baseline EOS>=220/uL

The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while considering their experiences "today". The daily EXACT-PRO total score is recorded and has a range of 0-100 with higher scores indicative of greater severity. COPD exacerbation event frequency is calculated based on comparison of the baseline score with daily total scores. An increase of EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicates a COPD exacerbation event has occurred.

Full analysis set, EOS>=220/uL

Posted

Count of Participants

Participants

Immediately following first IP up to week 56

ID	Title	Description
OG000	Benralizumab 10 mg	Every 8 weeks administered subcutaneously
OG001	Benralizumab 30 mg	Every 8 weeks administered subcutaneously
OG002	Benralizumab 100 mg	Every 8 weeks administered subcutaneously

Secondary

Severity of EXACT-PRO for Patients With Baseline EOS>=220/uL

Full analysis set, baseline EOS>=220/uL

Posted

Mean

Standard Deviation

Score on a scale

Immediately following first IP up to week 56

ID	Title	Description
OG000	Benralizumab 10 mg	Every 8 weeks administered subcutaneously
OG001	Benralizumab 30 mg	Every 8 weeks administered subcutaneously
OG002	Benralizumab 100 mg	Every 8 weeks administered subcutaneously
OG003	Placebo	Every 8 weeks administered subcutaneously

Secondary

Duration of COPD Exacerbation Based on EXACT-PRO Score for Patients With Baseline EOS>=220/uL

The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while considering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. COPD exacerbation event frequency is identified by comparing the baseline score with daily total scores. An increase in EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicate an event has occurred. Event duration is calculated after identification of the following five parameters: 1) onset; 2) three-day rolling average; 3) maximum observed value; 4) threshold for improvement; and 5) recovery. That is, duration of the exacerbation is the time elapse between onset and recovery of the event.

Full analysis set, baseline EOS>=220/uL

Posted

Mean

Standard Deviation

Days

Immediately following first IP up to week 56

ID	Title	Description
OG000	Benralizumab 10 mg	Every 8 weeks administered subcutaneously
OG001	Benralizumab 30 mg	Every 8 weeks administered subcutaneously
OG002	Benralizumab 100 mg

Secondary

Annual EXACT-PRO Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL

The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while considering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Event frequency is calculated by comparing the baseline with daily total scores. An increase in EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicate an event has occurred. Annual EXACT-PRO exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.

Full analysis set, baseline EOS>=220/uL

Posted

Least Squares Mean

95% Confidence Interval

Exacerbations per year

Immediately following the first IP dose through week 56

ID	Title	Description
OG000	Benralizumab 10 mg	Every 8 weeks administered subcutaneously
OG001	Benralizumab 30 mg	Every 8 weeks administered subcutaneously
OG002

Secondary

Number of Participants Having at Least 1 COPD Exacerbation for Patients With Baseline EOS>=220/uL

A COPD exacerbation is defined by symptomatic worsening COPD requiring systemic corticosteroids, antibiotics, or an inpatient hospitalization/death due to COPD.

Full analysis set, baseline EOS>=220/uL

Posted

Count of Participants

Participants

Immediately following first IP dose up to week 56

ID	Title	Description
OG000	Benralizumab 10 mg	Every 8 weeks administered subcutaneously
OG001	Benralizumab 30 mg	Every 8 weeks administered subcutaneously
OG002	Benralizumab 100 mg	Every 8 weeks administered subcutaneously
OG003	Placebo	Every 8 weeks administered subcutaneously

Secondary

Time to First COPD Exacerbation

Time to first COPD exacerbation is from the randomization date to the first occurrence of COPD exacerbation.

Full analysis set, baseline EOS>=220/uL

Posted

Median

95% Confidence Interval

Days

Immediately following IP dose to Week 56

ID	Title	Description
OG000	Benralizumab 10 mg	Every 8 weeks administered subcutaneously
OG001	Benralizumab 30 mg	Every 8 weeks administered subcutaneously
OG002	Benralizumab 100 mg	Every 8 weeks administered subcutaneously
OG003	Placebo	Every 8 weeks administered subcutaneously

Units	Counts
Participants

Secondary

Annual COPD Exacerbation Rate Associated With ER or Hospitalization Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL

Annual COPD exacerbations rate that result in ER or hospitalization is calculated by number of exacerbations resulting ER or hospitalization divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.

Full analysis set, baseline EOS>=220/uL

Posted

Least Squares Mean

95% Confidence Interval

Exacerbations per year

Immediately following the first IP dose through week 56

ID	Title	Description
OG000	Benralizumab 10 mg	Every 8 weeks administered subcutaneously
OG001	Benralizumab 30 mg	Every 8 weeks administered subcutaneously
OG002	Benralizumab 100 mg	Every 8 weeks administered subcutaneously
OG003	Placebo	Every 8 weeks administered subcutaneously

Secondary

Number of Participants Had COPD-related Healthcare Encounter for Patient With Baseline EOS>=220/uL

Types of healthcare encounter: Hospitalisations (inc. intensive care and/or general care), Emergency department visits, Unscheduled outpatients visits, Home visits, Telephone calls, and ambulance transports.

Full analysis set, baseline EOS>=220/uL

Posted

Count of Participants

Participants

Immediately following first IP dose up to Week 56

ID	Title	Description
OG000	Benralizumab 10 mg	Every 8 weeks administered subcutaneously
OG001	Benralizumab 30 mg	Every 8 weeks administered subcutaneously
OG002	Benralizumab 100 mg	Every 8 weeks administered subcutaneously
OG003	Placebo	Every 8 weeks administered subcutaneously

Secondary

Duration of Study Treatment Administration

Duration of study treatment is calculated from first dose date to last dose date + 1 day.

Safety analysis set

Posted

Mean

Standard Deviation

Days

From first dose date to last dose date, 48 weeks per protocol.

ID	Title	Description
OG000	Benralizumab 10 mg	Every 8 weeks administered subcutaneously
OG001	Benralizumab 30 mg	Every 8 weeks administered subcutaneously
OG002	Benralizumab 100 mg	Every 8 weeks administered subcutaneously
OG003	Placebo	Every 8 weeks administered subcutaneously

Units	Counts
Participants

Secondary

Serum Concentration of Benralizumab

PK serum samples were collected pre-dose at each visit.

PK analysis set

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Pre-first dose and pre-dose at end of treatment (week 56).

ID	Title	Description
OG000	Benralizumab 10 mg	Every 8 weeks administered subcutaneously
OG001	Benralizumab 30 mg	Every 8 weeks administered subcutaneously
OG002	Benralizumab 100 mg	Every 8 weeks administered subcutaneously

Units	Counts
Participants	OG000

Secondary

Immunogenicity of Benralizumab

Anti-drug antibody (ADA) responses such as ADA prevalence, ADA incidence, ADA persistently positive counts, etc. were presented.

Safety analysis set. For each parameter, the number of subjects at risk is to be analyzed.

Posted

Count of Participants

Participants

Pre-treatment until end of follow-up, week 60 per protocol.

ID	Title	Description
OG000	Benralizumab 10 mg	Every 8 weeks administered subcutaneously
OG001	Benralizumab 30 mg	Every 8 weeks administered subcutaneously
OG002	Benralizumab 100 mg	Every 8 weeks administered subcutaneously
OG003	Placebo	Every 8 weeks administered subcutaneously

Units	Counts

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0012 events2 affected563 at risk EG0020 events0 affected562 at risk EG0031 events1 affected568 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Polycythaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0011 events1 affected563 at risk EG0021 events1 affected562 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected561 at risk EG0017 events7 affected563 at risk EG0021 events1 affected562 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0003 events2 affected561 at risk EG0011 events1 affected563 at risk EG0021 events1 affected562 at risk EG003
Angina unstable	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected561 at risk EG0012 events2 affected563 at risk EG0021 events1 affected562 at risk EG003
Aortic valve incompetence	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected561 at risk EG0013 events1 affected563 at risk EG0021 events1 affected562 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Atrioventricular block	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0012 events2 affected563 at risk EG0023 events3 affected562 at risk EG003
Cardiac failure acute	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Cardiac failure chronic	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected561 at risk EG0013 events2 affected563 at risk EG0025 events4 affected562 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0011 events1 affected563 at risk EG0021 events1 affected562 at risk EG003
Cor pulmonale	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected561 at risk EG0011 events1 affected563 at risk EG0023 events3 affected562 at risk EG003
Right ventricular failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0012 events2 affected563 at risk EG0020 events0 affected562 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Ventricular fibrillation	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Vertigo positional	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Retinal artery embolism	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Abdominal incarcerated hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Chronic gastritis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0021 events1 affected562 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0012 events2 affected563 at risk EG0020 events0 affected562 at risk EG003
Colitis ulcerative	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Colonic pseudo-obstruction	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Diverticular perforation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Diverticulum	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Duodenitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Femoral hernia strangulated	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Gastrointestinal polyp haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0022 events1 affected562 at risk EG003
Incarcerated inguinal hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0012 events2 affected563 at risk EG0020 events0 affected562 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Intestinal perforation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Large intestine perforation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Lumbar hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Oesophageal hypomotility	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Chest pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Death	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Oedema	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0012 events2 affected563 at risk EG0020 events0 affected562 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Food allergy	Immune system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Abdominal abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Acute sinusitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Appendicitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0012 events2 affected563 at risk EG0021 events1 affected562 at risk EG003
Bronchitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0014 events4 affected563 at risk EG0021 events1 affected562 at risk EG003
Bronchitis bacterial	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Bursitis infective	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Catheter site cellulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Cellulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected561 at risk EG0012 events2 affected563 at risk EG0020 events0 affected562 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Cystitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Diarrhoea infectious	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0011 events1 affected563 at risk EG0021 events1 affected562 at risk EG003
Erysipelas	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Hepatitis C	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0022 events2 affected562 at risk EG003
Infectious colitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Influenza	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Intestinal sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Labyrinthitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Laryngitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Localised infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Lung abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Lung infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0022 events2 affected562 at risk EG003
Peritonitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00020 events19 affected561 at risk EG00125 events22 affected563 at risk EG00210 events9 affected562 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0005 events5 affected561 at risk EG0017 events5 affected563 at risk EG0022 events2 affected562 at risk EG003
Pneumonia mycoplasmal	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Post procedural infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Pseudomembranous colitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Pseudomonas bronchitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Pulmonary sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0012 events2 affected563 at risk EG0021 events1 affected562 at risk EG003
Pulmonary tuberculosis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Septic shock	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Sinusitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Tracheobronchitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Tuberculosis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0011 events1 affected563 at risk EG0021 events1 affected562 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0014 events2 affected563 at risk EG0020 events0 affected562 at risk EG003
Urosepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Abdominal injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Carbon monoxide poisoning	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Forearm fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Hand fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Open fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Traumatic fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Traumatic haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Anticoagulation drug level above therapeutic	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Electrocardiogram T wave inversion	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
False positive tuberculosis test	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
International normalised ratio increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Oxygen saturation decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Alcohol intolerance	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Cachexia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Malnutrition	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Psoriatic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Trigger finger	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Abdominal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0011 events1 affected563 at risk EG0021 events1 affected562 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Brain cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Brain neoplasm benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Breast cancer female	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Colorectal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Follicular thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Laryngeal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Lip and/or oral cavity cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0012 events2 affected563 at risk EG0021 events1 affected562 at risk EG003
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Metastatic malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Neuroendocrine carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Oesophageal adenocarcinoma stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0012 events2 affected563 at risk EG0020 events0 affected562 at risk EG003
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Polycythaemia vera	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0022 events2 affected562 at risk EG003
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Squamous cell carcinoma of the cervix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Sweat gland tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Transitional cell cancer of the renal pelvis and ureter	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Carotid arteriosclerosis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Cerebellar haemorrhage	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0014 events4 affected563 at risk EG0021 events1 affected562 at risk EG003
Cervical myelopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Cognitive disorder	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Dementia Alzheimer's type	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Dizziness	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0022 events2 affected562 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0021 events1 affected562 at risk EG003
Haemorrhagic stroke	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0022 events2 affected562 at risk EG003
Hepatic encephalopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Intercostal neuralgia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Intracranial aneurysm	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0011 events1 affected563 at risk EG0023 events1 affected562 at risk EG003
Lumbosacral radiculopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Multiple sclerosis relapse	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Myoclonus	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Seizure	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Syncope	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Thrombotic cerebral infarction	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected561 at risk EG0011 events1 affected563 at risk EG0021 events1 affected562 at risk EG003
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Alcohol abuse	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Alcoholism	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Bipolar disorder	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Delirium	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Depression	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Major depression	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Post-traumatic stress disorder	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0004 events4 affected561 at risk EG0010 events0 affected563 at risk EG0022 events2 affected562 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Renal infarct	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Ureterolithiasis	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Acquired hydrocele	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0011 events1 affected563 at risk EG0022 events2 affected562 at risk EG003
Pelvic prolapse	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Prostatitis	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected561 at risk EG0011 events1 affected563 at risk EG0024 events4 affected562 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG000129 events92 affected561 at risk EG001136 events107 affected563 at risk EG002106 events80 affected562 at risk EG003
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0023 events2 affected562 at risk EG003
Cystic lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0006 events6 affected561 at risk EG0010 events0 affected563 at risk EG0023 events3 affected562 at risk EG003
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0012 events2 affected563 at risk EG0020 events0 affected562 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected561 at risk EG0012 events2 affected563 at risk EG0021 events1 affected562 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Henoch-Schonlein purpura	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Accelerated hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0011 events1 affected563 at risk EG0021 events1 affected562 at risk EG003
Aortic dissection	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Aortic stenosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0021 events1 affected562 at risk EG003
Arteriosclerosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Circulatory collapse	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0011 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Haematoma	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0022 events2 affected562 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003
Hypotension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0012 events1 affected563 at risk EG0020 events0 affected562 at risk EG003
Hypovolaemic shock	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0021 events1 affected562 at risk EG003
Penetrating aortic ulcer	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected561 at risk EG0010 events0 affected563 at risk EG0020 events0 affected562 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Oedema peripheral	General disorders	MedDRA 20.0	Systematic Assessment	EG00017 events15 affected561 at risk EG0019 events9 affected563 at risk EG00218 events17 affected562 at risk EG00310 events9 affected568 at risk
Bronchitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00094 events66 affected561 at risk EG001100 events70 affected563 at risk EG00287 events63 affected562 at risk EG003
Influenza	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00011 events11 affected561 at risk EG00122 events20 affected563 at risk EG00215 events15 affected562 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00027 events26 affected561 at risk EG00129 events22 affected563 at risk EG00216 events15 affected562 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00025 events21 affected561 at risk EG00113 events12 affected563 at risk EG00220 events15 affected562 at risk EG003
Sinusitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00018 events15 affected561 at risk EG00119 events13 affected563 at risk EG00221 events15 affected562 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG000109 events68 affected561 at risk EG00198 events71 affected563 at risk EG00292 events67 affected562 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00034 events24 affected561 at risk EG00126 events24 affected563 at risk EG00232 events28 affected562 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00073 events61 affected561 at risk EG00168 events47 affected563 at risk EG00292 events60 affected562 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG00011 events11 affected561 at risk EG00112 events12 affected563 at risk EG00220 events17 affected562 at risk EG003
Headache	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG00020 events19 affected561 at risk EG00117 events16 affected563 at risk EG00234 events27 affected562 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG00010 events8 affected561 at risk EG00113 events10 affected563 at risk EG00224 events20 affected562 at risk EG003
Hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG00022 events17 affected561 at risk EG00117 events16 affected563 at risk EG00212 events12 affected562 at risk EG003

ID	Term
D008173	Lung Diseases, Obstructive
D029424	Pulmonary Disease, Chronic Obstructive
D008171	Lung Diseases
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases

ID	Term
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	Benralizumab 10 mg	Every 8 weeks administered subcutaneously
BG001	Benralizumab 30 mg	Every 8 weeks administered subcutaneously
BG002	Benralizumab 100 mg	Every 8 weeks administered subcutaneously
BG003	Placebo	Every 8 weeks administered subcutaneously
BG004	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Benra 10 mg	Every 8 weeks administered subcutaneously	17	561	144	561	251	561
EG001	Benra 30 mg	Every 8 weeks administered subcutaneously	21	563	177	563	233	563
EG002	Benra 100 mg	Every 8 weeks administered subcutaneously	17	562	127	562	238	562
EG003	Placebo	Every 8 weeks administered subcutaneously	19	568	158	568	260	568