Benralizumab Efficacy in Moderate to Very Severe Chronic... | NCT02138916

NCT02138916

Status Module

Name	Class
MedImmune LLC	INDUSTRY

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
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.	From first IP to 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:1.Informed consent. 2.Subjects 40-85 y.o. 3.Moderate to very severe COPD with Post Bronchodilator (BD) FEV1>20% and ≤65%. 4.≥2 moderate or ≥1 severe COPD exacerbation(s) required treatment or hospitalization within 2-52 weeks prior to Visit1. 5. Modified Medical Research Council (mMRC) score ≥1 at Visit 1. 6.Treatment with double or triple therapy throughout the year prior to Visit 1, constant 2 weeks prior to Visit 1. 7.Tobacco history of ≥10 pack-years. 8.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. 9.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. 10.Compliance with maintenance therapy during run-in ≥70%. 11. 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: 1. Clinically important pulmonary disease other than COPD or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.

2. 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.

3. 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.

4. 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.

5. Acute upper or lower respiratory infection requiring antibiotics or antiviral medication within 2 weeks prior to Visit1or during the enrolment and run-in period.

6. Pneumonia within 8 weeks prior to Visit1 or during the enrolment and run-in period.

7. Pregnant, breastfeeding, or lactating women. 8. Risk factors for pneumonia 9. History of anaphylaxis to any other biologic therapy. 10. Long term oxygen therapy with signs and/or symptoms of cor pulmonale, right ventricular failure.

11. Use of immunosuppressive medication within 2 weeks prior to Visit1 and/or during the enrolment and run-in period.

12. Receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to Visit 1.

13. Evidence of active tuberculosis (TB) without an appropriate course of treatment.

14. 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).

15. Asthma as a primary or main diagnosis according to the Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.

16. Previous treatment with benralizumab. 17. Helminth parasitic infection diagnosed within 24 weeks prior to Visit 1.

Name	Affiliation	Role
Gerard Criner, MD	Temple University School of Medicine, 3401 North Broad Street, Suite 745 PP, Philadelphia, PA 19140	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Andalusia	Alabama	36420	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
Clinical Study protocol	View source

Results Section

Participant Flow Module

ID	Title	Description
FG000	Benralizumab 30 mg	Every 8 weeks administered subcutaneously
FG001	Benralizumab 100 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
SAP	No	Yes	No	Statistical Analysis Plan	Apr 23, 2018	Mar 19, 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 with baseline EOS>=220/uL

Posted

Least Squares Mean

95% Confidence Interval

Exacerbations per year

From first IP to week 56

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

Units	Counts
Participants	OG000382 OG001379 OG002359

Title

Denominators

Categories

Title	Measurements
	OG0001.19(1.04 to 1.36) OG0011.03(0.9 to 1.19) OG0021.24(1.08 to 1.42)

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 OG002		Negative binomial	Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.	0.6490		Rate ratio	0.96			2-Sided	95	0.8	1.15					Superiority
OG001 OG002		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 with baseline EOS<220/uL

Posted

Least Squares Mean

95% Confidence Interval

Exacerbations per year

From first IP to week 56

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

Units	Counts
Participants

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 30 mg	Every 8 weeks administered subcutaneously
OG001	Benralizumab 100 mg	Every 8 weeks administered subcutaneously
OG002	Placebo	Every 8 weeks administered subcutaneously

Units	Counts
Participants	OG000

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 30 mg	Every 8 weeks administered subcutaneously
OG001	Benralizumab 100 mg	Every 8 weeks administered subcutaneously
OG002	Placebo	Every 8 weeks administered subcutaneously

Units	Counts
Participants

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 30 mg	Every 8 weeks administered subcutaneously
OG001	Benralizumab 100 mg	Every 8 weeks administered subcutaneously
OG002	Placebo	Every 8 weeks administered subcutaneously

Units	Counts
Participants

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 30 mg	Every 8 weeks administered subcutaneously
OG001	Benralizumab 100 mg	Every 8 weeks administered subcutaneously
OG002	Placebo	Every 8 weeks administered subcutaneously

Units	Counts
Participants

Secondary

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

Change from baseline to week 56 in proportion of nights 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 30 mg	Every 8 weeks administered subcutaneously
OG001	Benralizumab 100 mg	Every 8 weeks administered subcutaneously
OG002	Placebo	Every 8 weeks administered subcutaneously

Units	Counts
Participants	OG000

Secondary

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

Full analysis set, EOS>=220/uL

Posted

Count of Participants

Participants

Immediately following first IP up to week 56

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

Units	Counts

Secondary

Duration of 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 onsidering 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. Calculation of event duration 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 30 mg	Every 8 weeks administered subcutaneously
OG001	Benralizumab 100 mg	Every 8 weeks administered subcutaneously
OG002	Placebo

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 onsidering 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 first IP up to week 56

ID	Title	Description
OG000	Benralizumab 30 mg	Every 8 weeks administered subcutaneously
OG001	Benralizumab 100 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 up to week 56

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

Units	Counts
Participants	OG000

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 first IP up to week 56

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

Units	Counts
Participants	OG000

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 first IP up to week 56

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

Units	Counts

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 up to week 56

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

Units	Counts
Participants

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 30 mg	Every 8 weeks administered subcutaneously
OG001	Benralizumab 100 mg	Every 8 weeks administered subcutaneously
OG002	Placebo	Every 8 weeks administered subcutaneously

Units	Counts
Participants	OG000

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 30 mg	Every 8 weeks administered subcutaneously
OG001	Benralizumab 100 mg	Every 8 weeks administered subcutaneously

Units	Counts
Participants	OG000

Secondary

Immunogenicity of Benralizumab

Antidrug 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 30 mg	Every 8 weeks administered subcutaneously
OG001	Benralizumab 100 mg	Every 8 weeks administered subcutaneously
OG002	Placebo	Every 8 weeks administered subcutaneously

Units	Counts
Participants	OG000

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 affected554 at risk EG0010 events0 affected552 at risk EG0023 events2 affected550 at risk
Hypochromic anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected554 at risk EG0011 events1 affected552 at risk EG0024 events4 affected550 at risk
Acute right ventricular failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Angina pectoris	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0013 events3 affected552 at risk EG0020 events0 affected550 at risk
Angina unstable	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected554 at risk EG0012 events2 affected552 at risk EG0022 events2 affected550 at risk
Aortic valve disease	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0004 events4 affected554 at risk EG0018 events8 affected552 at risk EG0022 events2 affected550 at risk
Atrial flutter	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0022 events2 affected550 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0021 events1 affected550 at risk
Cardiac arrest	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Cardiac failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected554 at risk EG0012 events2 affected552 at risk EG0021 events1 affected550 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0012 events1 affected552 at risk EG0021 events1 affected550 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected554 at risk EG0012 events2 affected552 at risk EG0021 events1 affected550 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Cor pulmonale chronic	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Coronary artery disease	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Coronary artery insufficiency	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0023 events3 affected550 at risk
Left ventricular failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Myocardial infarction	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0004 events4 affected554 at risk EG0013 events3 affected552 at risk EG0021 events1 affected550 at risk
Myocarditis	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Exomphalos	Congenital, familial and genetic disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Ascites	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Colitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0012 events2 affected552 at risk EG0021 events1 affected550 at risk
Constipation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected554 at risk EG0012 events1 affected552 at risk EG0020 events0 affected550 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0012 events2 affected552 at risk EG0020 events0 affected550 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Gastritis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events1 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0022 events2 affected550 at risk
Gastrointestinal necrosis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Ileus	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0013 events3 affected552 at risk EG0020 events0 affected550 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Intestinal polyp	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0012 events2 affected552 at risk EG0022 events2 affected550 at risk
Mallory-Weiss syndrome	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Melaena	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Nausea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Oesophageal spasm	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0012 events2 affected552 at risk EG0020 events0 affected550 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Peritoneal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0022 events2 affected550 at risk
Salivary gland calculus	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Chest discomfort	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Death	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0011 events1 affected552 at risk EG0021 events1 affected550 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Non-cardiac chest pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Oedema peripheral	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Sudden cardiac death	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0022 events2 affected550 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Anaphylactic shock	Immune system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Anal abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Appendicitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Arthritis bacterial	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Atypical mycobacterial infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Atypical mycobacterial lower respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Bronchitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0013 events3 affected552 at risk EG0023 events3 affected550 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Cellulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Cellulitis pharyngeal	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Cystitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Disseminated tuberculosis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Diverticulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0023 events2 affected550 at risk
Gastroenteritis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Infectious pleural effusion	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Influenza	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Periorbital cellulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0021 events1 affected550 at risk
Peritonsillar abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00024 events22 affected554 at risk EG00119 events18 affected552 at risk EG00216 events16 affected550 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0005 events5 affected554 at risk EG0019 events8 affected552 at risk EG00210 events10 affected550 at risk
Pneumonia haemophilus	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Pneumonia moraxella	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Pneumonia necrotising	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Pneumonia pseudomonal	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Pneumonia streptococcal	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Pneumonia viral	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0021 events1 affected550 at risk
Pulmonary sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0021 events1 affected550 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Rhinovirus infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0012 events2 affected552 at risk EG0020 events0 affected550 at risk
Septic shock	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Staphylococcal infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0021 events1 affected550 at risk
Urinary tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected554 at risk EG0012 events2 affected552 at risk EG0020 events0 affected550 at risk
Airway burns	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Arterial bypass occlusion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Asbestosis	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Dural tear	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0012 events2 affected552 at risk EG0020 events0 affected550 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Fractured coccyx	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Skin flap necrosis	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Subarachnoid haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0012 events1 affected552 at risk EG0021 events1 affected550 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Vascular bypass dysfunction	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Vascular procedure complication	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Electrocardiogram ST-T change	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0022 events2 affected550 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0021 events1 affected550 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0012 events1 affected552 at risk EG0021 events1 affected550 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0011 events1 affected552 at risk EG0021 events1 affected550 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0021 events1 affected550 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0021 events1 affected550 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0022 events2 affected550 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Benign lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Glioblastoma multiforme	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Haemangioma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Laryngeal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0022 events2 affected550 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Non-small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Non-small cell lung cancer stage IIIB	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected554 at risk EG0011 events1 affected552 at risk EG0022 events2 affected550 at risk
Prostate cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0012 events2 affected552 at risk EG0020 events0 affected550 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0021 events1 affected550 at risk
Tonsil cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0022 events2 affected550 at risk
Cerebral infarction	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Dizziness	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0021 events1 affected550 at risk
Facial paralysis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Hyperaesthesia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Monoparesis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Polyneuropathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Radicular syndrome	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Radiculopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Sciatica	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Seizure	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Sinus headache	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Stupor	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Syncope	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Thrombotic stroke	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0012 events2 affected552 at risk EG0020 events0 affected550 at risk
Anxiety	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0022 events1 affected550 at risk
Anxiety disorder	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Depression	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Mental status changes	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0021 events1 affected550 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0022 events2 affected550 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0011 events1 affected552 at risk EG0021 events1 affected550 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG000145 events97 affected554 at risk EG001101 events78 affected552 at risk EG002142 events100 affected550 at risk
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Lung consolidation	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Pickwickian syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected554 at risk EG0011 events1 affected552 at risk EG0026 events5 affected550 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0011 events1 affected552 at risk EG0025 events4 affected550 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0023 events3 affected550 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Dermatomyositis	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Erythema nodosum	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Skin laxity	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk
Arterial haemorrhage	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0023 events3 affected550 at risk
Hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0021 events1 affected550 at risk
Hypertensive crisis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Hypotension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0012 events2 affected552 at risk EG0020 events0 affected550 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0010 events0 affected552 at risk EG0022 events2 affected550 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected554 at risk EG0011 events1 affected552 at risk EG0020 events0 affected550 at risk
Peripheral venous disease	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected554 at risk EG0010 events0 affected552 at risk EG0020 events0 affected550 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00019 events17 affected554 at risk EG00119 events19 affected552 at risk EG00217 events15 affected550 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00018 events17 affected554 at risk EG00118 events15 affected552 at risk EG0027 events6 affected550 at risk
Nausea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00017 events13 affected554 at risk EG00122 events18 affected552 at risk EG00215 events13 affected550 at risk
Oedema peripheral	General disorders	MedDRA 20.0	Systematic Assessment	EG00013 events11 affected554 at risk EG00128 events26 affected552 at risk EG00211 events11 affected550 at risk
Bronchitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00074 events59 affected554 at risk EG001113 events84 affected552 at risk EG002121 events80 affected550 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00076 events50 affected554 at risk EG00147 events32 affected552 at risk EG00239 events29 affected550 at risk
Oral candidiasis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00021 events17 affected554 at risk EG00118 events13 affected552 at risk EG00216 events15 affected550 at risk
Respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00010 events10 affected554 at risk EG00114 events11 affected552 at risk EG00226 events18 affected550 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00021 events15 affected554 at risk EG00118 events12 affected552 at risk EG00223 events19 affected550 at risk
Sinusitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00016 events13 affected554 at risk EG00122 events17 affected552 at risk EG00222 events20 affected550 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00087 events69 affected554 at risk EG001104 events74 affected552 at risk EG00297 events65 affected550 at risk
Urinary tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00027 events23 affected554 at risk EG00130 events22 affected552 at risk EG00222 events15 affected550 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG000126 events83 affected554 at risk EG001134 events95 affected552 at risk EG00298 events66 affected550 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG00023 events21 affected554 at risk EG00130 events25 affected552 at risk EG00219 events19 affected550 at risk
Headache	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG00029 events21 affected554 at risk EG00130 events26 affected552 at risk EG00221 events20 affected550 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG00018 events16 affected554 at risk EG00120 events14 affected552 at risk EG00230 events21 affected550 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG00030 events24 affected554 at risk EG00119 events17 affected552 at risk EG00237 events23 affected550 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG00015 events14 affected554 at risk EG00121 events18 affected552 at risk EG00217 events13 affected550 at risk
Hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG00019 events19 affected554 at risk EG00119 events19 affected552 at risk EG00219 events18 affected550 at risk

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 30 mg	Every 8 weeks administered subcutaneously
BG001	Benralizumab 100 mg	Every 8 weeks administered subcutaneously
BG002	Placebo	Every 8 weeks administered subcutaneously
BG003	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	Benralizumab 30 mg	Every 8 weeks administered subcutaneously	15	554	151	554	293	554
EG001	Benralizumab 100 mg	Every 8 weeks administered subcutaneously	11	552	177	552	318	552
EG002	Placebo	Every 8 weeks administered subcutaneously	13	550	176	550	282	550