Study to Evaluate Efficacy, Safety and Immunogenicity of... | NCT01165177

ID	Type	Description	Link
2008-000367-42	EudraCT Number

Label	Type	Description	Intervention Names
GSK1437173A group	Experimental	Subjects will receive Herpes Zoster Vaccine GSK1437173A according to a 0, 2-month schedule	Biological: Herpes Zoster Vaccine GSK1437173A
Placebo group	Placebo Comparator	Subjects will receive NaCl solution placebo according to a 0, 2-month schedule	Biological: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Herpes Zoster Vaccine GSK1437173A	Biological	Intramuscular injection	GSK1437173A group

Measure	Description	Time Frame
Number of Subjects With Confirmed Herpes Zoster (HZ) Cases	Confirmed HZ cases during the study were assessed in the Modified Total Vaccinated Cohort (mTVc)	During the entire study period (3 to 5 year period following Day 0)

Measure	Description	Time Frame
Number of Subjects With Any Episodes of Post-Herpetic Neuralgia (PHN)	The incidence of PHN was calculated using the modified total vaccinated chort.	During the entire study period (3 to 5 year period following Day 0)
Number of Subjects With a Reduction of Duration of Severe 'Worst' HZ-associated Pain

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Mesa	Arizona	85213	United States
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
27626517	Background	Cunningham AL, Lal H, Kovac M, Chlibek R, Hwang SJ, Diez-Domingo J, Godeaux O, Levin MJ, McElhaney JE, Puig-Barbera J, Vanden Abeele C, Vesikari T, Watanabe D, Zahaf T, Ahonen A, Athan E, Barba-Gomez JF, Campora L, de Looze F, Downey HJ, Ghesquiere W, Gorfinkel I, Korhonen T, Leung E, McNeil SA, Oostvogels L, Rombo L, Smetana J, Weckx L, Yeo W, Heineman TC; ZOE-70 Study Group. Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older. N Engl J Med. 2016 Sep 15;375(11):1019-32. doi: 10.1056/NEJMoa1603800.
29529222

Label	URL
IPD for this study will be made available via the Clinical Study Data Request site.	View source

ID	Title	Description
FG000	GSK1437173A Group	Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
FG001	Placebo Group	Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.

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

Number of Subjects With Confirmed Herpes Zoster (HZ) Cases

Confirmed HZ cases during the study were assessed in the Modified Total Vaccinated Cohort (mTVc)

The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.

Posted

Count of Participants

Participants

During the entire study period (3 to 5 year period following Day 0)

ID	Title	Description
OG000	GSK1437173A 50-59 YOA Group	Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
OG001	GSK1437173A 60-69 YOA Group	Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
OG002	GSK1437173A Over 70 YOA Group	Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
OG003	GSK1437173A Overall Ages Group	Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
OG004	Placebo 50-59 YOA Group	Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
OG005	Placebo 60-69 YOA Group	Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
OG006	Placebo Over 70 YOA Group	Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
OG007	Placebo Overall Ages Group	Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.

Units	Counts
Participants	OG0003492 OG0012141 OG0021711 OG003

Title

Denominators

Categories

Title	Measurements
	OG0003 OG0012 OG0021 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 OG004	Comparison of vaccine efficacy in prevention of HZ between GSK1437173A 50-59 YOA group and placebo 50-59 YOA group	Poisson exact test		<0.0001	Two sided exact P-value conditional to number of cases.	Vaccine efficacy	96.6			2-Sided	95	89.6	99.3					Other	Criteria for the vaccine efficacy (VE) objective of herpes zoster subunit (HZ/su) vaccine against herpes zoster (HZ) disease, in the 50-59 YOA strata : The lower limit (LL) of the two-sided 95% confidence interval (CI) of VE had to be above 10%.

Secondary

Number of Subjects With Any Episodes of Post-Herpetic Neuralgia (PHN)

The incidence of PHN was calculated using the modified total vaccinated chort.

Posted

Count of Participants

Participants

During the entire study period (3 to 5 year period following Day 0)

ID	Title	Description
OG000	GSK1437173A 50-59 YOA Group	Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
OG001	GSK1437173A 60-69 YOA Group	Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
OG002	GSK1437173A Over 70 YOA Group	Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
OG003

Secondary

Number of Subjects With a Reduction of Duration of Severe 'Worst' HZ-associated Pain

Severe 'worst' pain was defined as HZ-associated pain rated as 3 or above on the 'worst pain' Zoster Brief Pain Inventory (ZBPI) questionnaire. The outcome assessed the duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period as measured by the ZBPI in subjects with confirmed HZ. This analysis involved any subject reporting clinically significant pain (i.e. pain with a score of 3 or more on a 0-10 point scale) at any time during the study.

Posted

Count of Participants

Participants

During the entire study period (3 to 5 year period following Day 0)

ID	Title	Description
OG000	GSK1437173A 50-59 YOA Group	Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
OG001	GSK1437173A 60-69 YOA Group	Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
OG002

Secondary

Number of Subjects With Confirmed HZ Episode Related Mortality

The analysis focused on the number of subjects who died due to HZ

Posted

Count of Participants

Participants

During the entire study period (3 to 5 year period following Day 0)

ID	Title	Description
OG000	GSK1437173A 50-59 YOA Group	Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
OG001	GSK1437173A 60-69 YOA Group	Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
OG002	GSK1437173A Over 70 YOA Group	Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
OG003	GSK1437173A Overall Ages Group

Secondary

Number of Subjects With HZ Related Complications

The analysis focused on the incidence of HZ complications in subjects with confirmed HZ

Posted

Count of Participants

Participants

During the entire study period (3 to 5 year period following Day 0)

ID	Title	Description
OG000	GSK1437173A 50-59 YOA Group	Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
OG001	GSK1437173A 60-69 YOA Group	Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
OG002	GSK1437173A Over 70 YOA Group	Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
OG003	GSK1437173A Overall Ages Group

Secondary

Number of Subjects With Confirmed HZ Episode Related Hospitalizations

The analysis focused on confirmed HZ episode related hospitalizations.

Posted

Count of Participants

Participants

During the entire study period (3 to 5 year period following Day 0)

ID	Title	Description
OG000	GSK1437173A 50-59 YOA Group	Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
OG001	GSK1437173A 60-69 YOA Group	Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
OG002	GSK1437173A Over 70 YOA Group	Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
OG003	GSK1437173A Overall Ages Group

Secondary

Number of Subjects With a Confirmed HZ Episode Having a Reduction of Duration of Pain Medication Associated With HZ

The analysis focused on patients who experienced a reduction in duration of pain medication administered for HZ in subjects with confirmed HZ.

Posted

Count of Participants

Participants

During the entire study period (3 to 5 year period following Day 0)

ID	Title	Description
OG000	GSK1437173A 50-59 YOA Group	Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
OG001	GSK1437173A 60-69 YOA Group	Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
OG002	GSK1437173A Over 70 YOA Group	Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.

Secondary

Number of Subjects With a Confirmed HZ Episode Taking Pain Medication Associated With HZ

The analysis focused on subjects taking pain medication due to HZ

Posted

Count of Participants

Participants

During the entire study period (3 to 5 year period following Day 0)

ID	Title	Description
OG000	GSK1437173A 50-59 YOA Group	Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
OG001	GSK1437173A 60-69 YOA Group	Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
OG002	GSK1437173A Over 70 YOA Group	Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
OG003

Secondary

Number of Days With Severe 'Worst' HZ-associated Pain.

Severe 'worst' pain was defined as HZ-associated pain rated as 3 or above on the 'worst pain' ZBPI questionnaire. This Outcome Measure was only assessed participants with confirmed HZ. This analysis involved any subject reporting ZBPI clinically significant pain (i.e. pain with a score of 3 or more on a 0-10 point scale) at any time during the study.

Posted

Mean

Standard Deviation

Days

During the entire study period (3 to 5 year period following Day 0)

ID	Title	Description
OG000	GSK1437173A 50-59 YOA Group	Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
OG001	GSK1437173A 60-69 YOA Group	Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
OG002	GSK1437173A Over 70 YOA Group	Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.

Secondary

Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations

The analysis focused on confirmed HZ episode related hospitalizations and deaths.

Posted

Count of Participants

Participants

During the entire study period (3 to 5 year period following Day 0)

ID	Title	Description
OG000	GSK1437173A 50-59 YOA Group	Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
OG001	GSK1437173A 60-69 YOA Group	Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
OG002	GSK1437173A Over 70 YOA Group	Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
OG003

Secondary

Number of Subjects With HZ Related Complications, by Complication Type

Complication types included HZ vasculitis, Disseminated Disease, Ophtalmic Disease, Neurologic Disease, Visceral Disease and Stroke. This Outcome Measure was only assessed participants with confirmed HZ.

Posted

Count of Participants

Participants

During the entire study period (3 to 5 year period following Day 0)

ID	Title	Description
OG000	GSK1437173A 50-59 YOA Group	Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
OG001	GSK1437173A 60-69 YOA Group	Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
OG002	GSK1437173A Over 70 YOA Group	Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.

Secondary

Distribution of Pain Medication Associated With HZ

The distribution of pain medication included 1 to 3 or more separate medications. This Outcome Measure was only assessed on participants with confirmed HZ.

Posted

Count of Participants

Participants

During the entire study period (3 to 5 year period following Day 0)

ID	Title	Description
OG000	GSK1437173A 50-59 YOA Group	Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
OG001	GSK1437173A 60-69 YOA Group	Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
OG002	GSK1437173A Over 70 YOA Group	Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.

Secondary

Number of Days of Pain Medication Associated With HZ

The analysis was performed on subjects with a confirmed HZ episode

Posted

Mean

Standard Deviation

Days

During the entire study period (3 to 5 year period following Day 0)

ID	Title	Description
OG000	GSK1437173A 50-59 YOA Group	Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
OG001	GSK1437173A 60-69 YOA Group	Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
OG002	GSK1437173A Over 70 YOA Group	Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
OG003	GSK1437173A Overall Ages Group

Secondary

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.

The analysis was performed on the total vaccinated cohort - Diary Card, which was a subset of subjects from the total vaccinated cohort, who completed diary cards with any solicited symptoms during the 7 days (Day 0 to Day 6) post vaccination period.

Posted

Count of Participants

Participants

During the 7-day (Days 0-6) post-vaccination period

ID	Title	Description
OG000	GSK1437173A Group	Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
OG001	Placebo Group	Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.

Units	Counts
Participants

Secondary

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Assessed solicited general symptoms were fatigue, GI (gastrointestinal) symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), fever [defined as oral, axillary, rectal or tympanic temperature equal to or above 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = temperature> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

The analysis was performed on the TVc - Diary Card, which was a subset of subjects from the TVc, who completed diary cards with any solicited symptoms during the 7 days (Day 0 to Day 6) post vaccination period.

Posted

Count of Participants

Participants

Within the 7-day (Days 0-6) post-vaccination period

ID	Title	Description
OG000	GSK1437173A Group	Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
OG001	Placebo Group	Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.

Secondary

Number of Subjects With Any and Grade 3 Symptoms (Solicited and Unsolicited)

Number of subjects with any and grade 3 solicited and unsolicited symptoms were tabulated

Posted

Count of Participants

Participants

Within the 7-day (Days 0-6) post-vaccination period

ID	Title	Description
OG000	GSK1437173A Group	Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
OG001	Placebo Group	Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.

Units	Counts
Participants	OG000

Secondary

Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)

Occurrence and relationship to vaccination of any potential immune-mediated diseases (pIMDs) in all subjects

This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.

Posted

Count of Participants

Participants

During the entire study period (3 to 5 year period following Day 0)

ID	Title	Description
OG000	GSK1437173A Group	Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
OG001	Placebo Group	Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.

Units	Counts
Participants	OG000

Secondary

Number of Subjects With AEs With Any and Related Medically Attended Visit

Occurrence and relationship to vaccination of medically attended visits (defined as hospitalizations, emergency room visits or visits to or from medical personnel), other than routine health care visits in all subjects.

This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.

Posted

Count of Participants

Participants

From Month 0 to Month 8 post-vaccination

ID	Title	Description
OG000	GSK1437173A Group	Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
OG001	Placebo Group	Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.

Units	Counts
Participants	OG000

Secondary

Number of Subjects With Unsolicited Adverse Events (AEs)

Occurrence, intensity and relationship to vaccination of unsolicited AEs, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification in all subjects An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.

Posted

Count of Participants

Participants

Within 30 days (Days 0 - 29) after each vaccination

ID	Title	Description
OG000	GSK1437173A Group	Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
OG001	Placebo Group	Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.

Secondary

Number of Subjects With Serious Adverse Events (SAEs)

Occurrence and relationship to vaccination of all SAEs in all subjects. Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.

Posted

Count of Participants

Participants

Within the 30-day (Days 0-29) post-vaccination period, up to Month 14 and up to study end (3 to 5 year period following Day 0)

ID	Title	Description
OG000	GSK1437173A Group	Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
OG001	Placebo Group	Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.

Units	Counts
Participants

Secondary

Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine

The number of subjects with SAEs related to study participation or to a concurrent GSK medication/vaccine were tabulated

The analysis was based on TVC, which included all subjects with at least one dose of the study vaccine or place administered.

Posted

Count of Participants

Participants

During the entire study period (3 to 5 year period following Day 0)

ID	Title	Description
OG000	GSK1437173A Group	Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
OG001	Placebo Group	Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.

Units	Counts
Participants	OG000

Secondary

Number of Subjects With Fatal SAEs

Number of subjects with fatal SAEs during the entire study period were tabulated

This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.

Posted

Count of Participants

Participants

During the entire study period (3 to 5 years following day 0)

ID	Title	Description
OG000	GSK1437173A Group	Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
OG001	Placebo Group	Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0006 events6 affected7,695 at risk EG0014 events4 affected7,710 at risk
Anaemia vitamin b12 deficiency	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0010 events0 affected7,710 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Heparin-induced thrombocytopenia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Hypochromic anaemia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Immune thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0011 events1 affected7,710 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0003 events2 affected7,695 at risk EG0011 events1 affected7,710 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Lymphadenopathy mediastinal	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Splenic haemorrhage	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Splenic infarction	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected7,695 at risk EG0012 events2 affected7,710 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0008 events8 affected7,695 at risk EG00119 events19 affected7,710 at risk
Angina pectoris	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0004 events3 affected7,695 at risk EG0013 events3 affected7,710 at risk
Angina unstable	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0014 events4 affected7,710 at risk
Aortic valve disease	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0012 events2 affected7,710 at risk
Arrhythmia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0006 events6 affected7,695 at risk EG0010 events0 affected7,710 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG00023 events19 affected7,695 at risk EG0016 events6 affected7,710 at risk
Atrial flutter	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected7,695 at risk EG0014 events4 affected7,710 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Atrioventricular block	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0012 events2 affected7,710 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0010 events0 affected7,710 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Bradycardia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0012 events2 affected7,710 at risk
Cardiac arrest	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0008 events8 affected7,695 at risk EG0018 events8 affected7,710 at risk
Cardiac failure	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG00021 events20 affected7,695 at risk EG00127 events24 affected7,710 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0013 events3 affected7,710 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0011 events1 affected7,710 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG00015 events14 affected7,695 at risk EG00110 events10 affected7,710 at risk
Cardiac valve disease	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0010 events0 affected7,710 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0012 events2 affected7,710 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0011 events1 affected7,710 at risk
Cardiomyopathy alcoholic	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Cardiovascular deconditioning	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Cardiovascular insufficiency	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Cor pulmonale	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Coronary artery disease	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG00011 events11 affected7,695 at risk EG00119 events17 affected7,710 at risk
Coronary artery insufficiency	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected7,695 at risk EG0010 events0 affected7,710 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0010 events0 affected7,710 at risk
Left ventricular failure	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0010 events0 affected7,710 at risk
Mitral valve prolapse	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Mitral valve stenosis	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Myocardial infarction	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG00028 events28 affected7,695 at risk EG00127 events27 affected7,710 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0007 events7 affected7,695 at risk EG00111 events11 affected7,710 at risk
Palpitations	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Pericardial effusion	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Pericarditis	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Right ventricular failure	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0010 events0 affected7,710 at risk
Stress cardiomyopathy	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0011 events1 affected7,710 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0010 events0 affected7,710 at risk
Tachycardia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Cystic fibrosis	Congenital, familial and genetic disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Hernia congenital	Congenital, familial and genetic disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Hypertrophic cardiomyopathy	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Odontogenic cyst	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Deafness neurosensory	Ear and labyrinth disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Motion sickness	Ear and labyrinth disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected7,695 at risk EG0013 events3 affected7,710 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Basedow's disease	Endocrine disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Goitre	Endocrine disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Hypopituitarism	Endocrine disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Thyroiditis subacute	Endocrine disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Amaurosis fugax	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Cataract	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0015 events5 affected7,710 at risk
Eyelid ptosis	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Glaucoma	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Lens dislocation	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Macular cyst	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Macular hole	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Neovascular age-related macular degeneration	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Retinal artery occlusion	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Retinal detachment	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0014 events4 affected7,710 at risk
Retinal tear	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Vitreous detachment	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Vitreous haemorrhage	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0012 events2 affected7,710 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Abdominal strangulated hernia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Ascites	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Colitis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0013 events3 affected7,710 at risk
Constipation	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0012 events2 affected7,710 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected7,695 at risk EG0011 events1 affected7,710 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0011 events1 affected7,710 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Duodenal perforation	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Duodenitis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Enteritis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0012 events2 affected7,710 at risk
Enterovesical fistula	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Functional gastrointestinal disorder	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Gastric mucosal lesion	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0013 events3 affected7,710 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0012 events2 affected7,710 at risk
Gastritis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0005 events5 affected7,695 at risk EG0014 events4 affected7,710 at risk
Gastritis alcoholic	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Gastrointestinal angiodysplasia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0014 events4 affected7,710 at risk
Gastrointestinal polyp haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0012 events2 affected7,710 at risk
Gingival disorder	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0014 events4 affected7,710 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0013 events3 affected7,710 at risk
Ileus	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0013 events3 affected7,710 at risk
Incarcerated umbilical hernia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0018 events8 affected7,710 at risk
Intestinal congestion	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0013 events3 affected7,710 at risk
Intestinal polyp	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0012 events2 affected7,710 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0014 events4 affected7,710 at risk
Mallory-weiss syndrome	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Melaena	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Nausea	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0010 events0 affected7,710 at risk
Pancreatic cyst	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Pancreatic fistula	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected7,695 at risk EG0010 events0 affected7,710 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0005 events5 affected7,695 at risk EG0017 events6 affected7,710 at risk
Pancreatitis necrotising	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Peptic ulcer perforation	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0010 events0 affected7,710 at risk
Periodontal disease	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Peritoneal cyst	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Peritoneal haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Pneumoperitoneum	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Portal hypertensive gastropathy	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Rectal polyp	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0013 events3 affected7,710 at risk
Splenic artery aneurysm	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Subileus	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Thrombosis mesenteric vessel	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0011 events1 affected7,710 at risk
Volvulus	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Vomiting	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Asthenia	General disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0010 events0 affected7,710 at risk
Chest discomfort	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Chest pain	General disorders	MedDRA 10.0	Systematic Assessment	EG00012 events12 affected7,695 at risk EG00112 events10 affected7,710 at risk
Death	General disorders	MedDRA 10.0	Systematic Assessment	EG00011 events11 affected7,695 at risk EG00115 events15 affected7,710 at risk
Device dislocation	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Device failure	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Drowning	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Drug withdrawal syndrome	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
General physical health deterioration	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Gravitational oedema	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Hernia	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Impaired healing	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Influenza like illness	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Malaise	General disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0010 events0 affected7,710 at risk
Multi-organ failure	General disorders	MedDRA 10.0	Systematic Assessment	EG0006 events6 affected7,695 at risk EG0012 events2 affected7,710 at risk
Non-cardiac chest pain	General disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0011 events1 affected7,710 at risk
Pain	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0012 events2 affected7,710 at risk
Peripheral swelling	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Polyp	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Pyrexia	General disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0011 events1 affected7,710 at risk
Strangulated hernia	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Sudden cardiac death	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0013 events3 affected7,710 at risk
Sudden death	General disorders	MedDRA 10.0	Systematic Assessment	EG0005 events5 affected7,695 at risk EG0017 events7 affected7,710 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Bile duct stenosis	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0013 events3 affected7,710 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0005 events5 affected7,695 at risk EG0016 events6 affected7,710 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0006 events6 affected7,695 at risk EG0014 events4 affected7,710 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0007 events7 affected7,695 at risk EG00110 events10 affected7,710 at risk
Fatty liver alcoholic	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Gallbladder polyp	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Biliary dyskinesia	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Hypersensitivity	Immune system disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0011 events1 affected7,710 at risk
Sarcoidosis	Immune system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Abdominal infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Abdominal sepsis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Abscess neck	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Anal abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Appendiceal abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Appendicitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0016 events6 affected7,710 at risk
Appendicitis perforated	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Atypical pneumonia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Bacteraemia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Bacterial infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0012 events2 affected7,710 at risk
Bacteriuria	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Biliary sepsis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Breast abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Bronchitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0014 events4 affected7,710 at risk
Bronchitis bacterial	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Bronchopneumonia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0010 events0 affected7,710 at risk
Candiduria	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Catheter site infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Cellulitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0008 events8 affected7,695 at risk EG0016 events6 affected7,710 at risk
Cellulitis orbital	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Cellulitis streptococcal	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Chronic sinusitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0010 events0 affected7,710 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0013 events3 affected7,710 at risk
Cystitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Cystitis klebsiella	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Dengue fever	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Diabetic gangrene	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Diverticulitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected7,695 at risk EG0017 events6 affected7,710 at risk
Encephalomyelitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Endocarditis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Endometritis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Erysipelas	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0013 events3 affected7,710 at risk
Fungaemia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Gangrene	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0010 events0 affected7,710 at risk
Gastroenteritis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0004 events3 affected7,695 at risk EG0014 events4 affected7,710 at risk
Gastroenteritis caliciviral	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Gastroenteritis clostridial	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Gastroenteritis salmonella	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0010 events0 affected7,710 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Helicobacter gastritis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Hepatitis a	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Herpes zoster	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Infected dermal cyst	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Infected skin ulcer	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Infectious colitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Influenza	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Klebsiella sepsis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Labyrinthitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Leptospirosis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Liver abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Lobar pneumonia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0012 events2 affected7,710 at risk
Localised infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0016 events6 affected7,710 at risk
Lung infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Lymph node tuberculosis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Meningitis pneumococcal	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Mycobacterial infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Nasal abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Nasopharyngitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Neuroborreliosis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Osteomyelitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0005 events4 affected7,695 at risk EG0012 events2 affected7,710 at risk
Osteomyelitis chronic	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Otitis media chronic	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Periodontitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Peritonitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0012 events2 affected7,710 at risk
Peritonsillar abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Pertussis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Pharyngitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Pneumonia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG00041 events40 affected7,695 at risk EG00128 events26 affected7,710 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Pneumonia mycoplasmal	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0010 events0 affected7,710 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Post procedural infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0013 events3 affected7,710 at risk
Pseudomembranous colitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0011 events1 affected7,710 at risk
Pyelonephritis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0006 events6 affected7,695 at risk EG0013 events3 affected7,710 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0012 events2 affected7,710 at risk
Respiratory tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0012 events2 affected7,710 at risk
Sepsis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0007 events7 affected7,695 at risk EG00114 events13 affected7,710 at risk
Septic shock	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0014 events4 affected7,710 at risk
Serratia infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Shigella infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Sinusitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Sinusitis fungal	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Soft tissue infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Staphylococcal infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0011 events1 affected7,710 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Subdiaphragmatic abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Superinfection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Testicular abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Toxic shock syndrome	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Tracheobronchitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Tularaemia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0012 events2 affected7,710 at risk
Upper respiratory tract infection bacterial	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0010 events0 affected7,710 at risk
Urethritis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Urinary tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG00010 events10 affected7,695 at risk EG00110 events10 affected7,710 at risk
Urosepsis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0013 events3 affected7,710 at risk
Vestibular neuronitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Viral sepsis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Visceral leishmaniasis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Wound infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0010 events0 affected7,710 at risk
Wound infection pseudomonas	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Wound infection staphylococcal	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Accident	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Anastomotic leak	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Aneurysm perforation	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0007 events7 affected7,695 at risk EG0014 events4 affected7,710 at risk
Burns second degree	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Burns third degree	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Cataract operation complication	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Chemical poisoning	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0010 events0 affected7,710 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Comminuted fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0012 events2 affected7,710 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0010 events0 affected7,710 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0012 events2 affected7,710 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Electrical burn	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Eye penetration	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0011 events1 affected7,710 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0012 events2 affected7,710 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0005 events5 affected7,695 at risk EG0015 events4 affected7,710 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0007 events7 affected7,695 at risk EG0013 events3 affected7,710 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0010 events0 affected7,710 at risk
Flail chest	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Fractured sacrum	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Gun shot wound	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0012 events2 affected7,710 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0014 events4 affected7,710 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0016 events6 affected7,710 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0012 events2 affected7,710 at risk
Incarcerated incisional hernia	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0011 events1 affected7,710 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0014 events4 affected7,710 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0012 events2 affected7,710 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0013 events3 affected7,710 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0011 events1 affected7,710 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0012 events2 affected7,710 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0013 events3 affected7,710 at risk
Muscle rupture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Nerve root injury cervical	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Open fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0010 events0 affected7,710 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Pneumothorax traumatic	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Poisoning	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0012 events2 affected7,710 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0011 events1 affected7,710 at risk
Pubis fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0007 events7 affected7,695 at risk EG0017 events7 affected7,710 at risk
Respiratory fume inhalation disorder	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0011 events1 affected7,710 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0015 events5 affected7,710 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Snake bite	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0010 events0 affected7,710 at risk
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0011 events1 affected7,710 at risk
Spinal cord injury	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Splenic rupture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Sternal fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0011 events1 affected7,710 at risk
Spinal cord injury cervical	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Tendon injury	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0010 events0 affected7,710 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0011 events1 affected7,710 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0004 events3 affected7,695 at risk EG0011 events1 affected7,710 at risk
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Traumatic shock	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected7,695 at risk EG0011 events1 affected7,710 at risk
Vascular pseudoaneurysm ruptured	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0012 events2 affected7,710 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Anticoagulation drug level above therapeutic	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Blood heavy metal increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Haemoglobin decreased	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected7,695 at risk EG0012 events2 affected7,710 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0012 events2 affected7,710 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Gout	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Hyperammonaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0012 events2 affected7,710 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0011 events1 affected7,710 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0010 events0 affected7,710 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0011 events1 affected7,710 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0012 events2 affected7,710 at risk
Ketoacidosis	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0012 events2 affected7,710 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0014 events4 affected7,710 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0010 events0 affected7,710 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0011 events1 affected7,710 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Fasciitis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0012 events2 affected7,710 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0017 events7 affected7,710 at risk
Joint destruction	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0008 events8 affected7,695 at risk EG00111 events11 affected7,710 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Osteolysis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected7,695 at risk EG0010 events0 affected7,710 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0012 events2 affected7,710 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0012 events2 affected7,710 at risk
Soft tissue mass	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0012 events2 affected7,710 at risk
Spinal disorder	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0013 events3 affected7,710 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0010 events0 affected7,710 at risk
Still's disease adult onset	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Abdominal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Acute leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0012 events2 affected7,710 at risk
Acute promyelocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0012 events2 affected7,710 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0011 events1 affected7,710 at risk
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Adult t-cell lymphoma/leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Angioimmunoblastic t-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected7,695 at risk EG0011 events1 affected7,710 at risk
Benign neoplasm of bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Benign neoplasm of orbit	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Benign neoplasm of thyroid gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Benign renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Benign soft tissue neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Bile duct adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Bile duct cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0015 events5 affected7,710 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0014 events4 affected7,710 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Brain cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Brain neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0012 events2 affected7,710 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0008 events8 affected7,695 at risk EG0016 events6 affected7,710 at risk
Breast cancer female	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Breast cancer in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0012 events2 affected7,710 at risk
Bronchial neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Carcinoid tumour of the small bowel	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Cervix carcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0013 events3 affected7,710 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0010 events0 affected7,710 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0007 events7 affected7,695 at risk EG00111 events11 affected7,710 at risk
Diffuse large b-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Extranodal marginal zone b-cell lymphoma (malt type)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Fallopian tube cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Gallbladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected7,695 at risk EG0014 events4 affected7,710 at risk
Gastrointestinal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Glioblastoma multiforme	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Glioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Glomus tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected7,695 at risk EG0011 events1 affected7,710 at risk
Hepatic cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Hepatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0012 events2 affected7,710 at risk
Hypopharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0012 events2 affected7,710 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0005 events5 affected7,695 at risk EG0014 events4 affected7,710 at risk
Invasive papillary breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0010 events0 affected7,710 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Laryngeal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Lip and/or oral cavity cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Lip squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0012 events2 affected7,710 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected7,695 at risk EG0013 events3 affected7,710 at risk
Lung adenocarcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0012 events2 affected7,710 at risk
Lung adenocarcinoma stage i	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0011 events1 affected7,710 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG00011 events11 affected7,695 at risk EG0016 events6 affected7,710 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0014 events4 affected7,710 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0011 events1 affected7,710 at risk
Malignant neoplasm of pleura metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Malignant neoplasm of unknown primary site	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Meningioma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0013 events3 affected7,710 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0013 events3 affected7,710 at risk
Metastases to lymph	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0012 events2 affected7,710 at risk
Metastases to peritoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0010 events0 affected7,710 at risk
Metastases to pleura	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Metastatic carcinoma of the bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Metastatic malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Metastatic squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0003 events2 affected7,695 at risk EG0010 events0 affected7,710 at risk
Nasopharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Neoplasm skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Neuroendocrine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Oesophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Oesophageal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0010 events0 affected7,710 at risk
Ovarian fibroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Ovarian neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0006 events6 affected7,695 at risk EG0019 events8 affected7,710 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0012 events2 affected7,710 at risk
Pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Phaeochromocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0012 events2 affected7,710 at risk
Pleural mesothelioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0007 events7 affected7,695 at risk EG0019 events9 affected7,710 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0010 events0 affected7,710 at risk
Prostate cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Rectal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0012 events2 affected7,710 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0013 events3 affected7,710 at risk
Renal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0012 events2 affected7,710 at risk
Renal oncocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Small intestine adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Spinal cord neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Squamous cell carcinoma of the oral cavity	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Testicular neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Thyroid adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Tongue neoplasm malignant stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0012 events2 affected7,710 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Vulval cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Amyotrophic lateral sclerosis	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0011 events1 affected7,710 at risk
Aphasia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Basal ganglia haemorrhage	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Basal ganglia infarction	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Brain injury	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Carotid artery disease	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Carotid artery thrombosis	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0014 events4 affected7,710 at risk
Cerebral infarction	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0008 events8 affected7,695 at risk EG0017 events6 affected7,710 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0012 events2 affected7,710 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG00019 events19 affected7,695 at risk EG00112 events12 affected7,710 at risk
Cerebrovascular disorder	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Cerebrovascular insufficiency	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Chronic inflammatory demyelinating polyradiculoneuropathy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Coma	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Dementia alzheimer's type	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Demyelinating polyneuropathy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0002 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Dizziness	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0014 events4 affected7,710 at risk
Encephalopathy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Epilepsy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0014 events4 affected7,710 at risk
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Guillain-barre syndrome	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Haemorrhagic transformation stroke	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Headache	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected7,695 at risk EG0010 events0 affected7,710 at risk
Hemiparesis	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Hydrocephalus	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0013 events3 affected7,710 at risk
Ivth nerve paralysis	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Lacunar infarction	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Loss of consciousness	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0012 events2 affected7,710 at risk
Migraine	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Mononeuritis	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Myasthenia gravis	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Myelopathy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Nerve compression	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Nervous system disorder	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Neuritis cranial	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Paraesthesia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Paraneoplastic neurological syndrome	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Post polio syndrome	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Presyncope	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Radiculopathy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0012 events2 affected7,710 at risk
Reversible ischaemic neurological deficit	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Ruptured cerebral aneurysm	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Sciatica	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0011 events1 affected7,710 at risk
Seizure	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0013 events3 affected7,710 at risk
Spinal claudication	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0014 events4 affected7,710 at risk
Syncope	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0008 events8 affected7,695 at risk EG0018 events8 affected7,710 at risk
Transient global amnesia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0008 events8 affected7,695 at risk EG0017 events6 affected7,710 at risk
Trigeminal neuralgia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Vascular encephalopathy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Vasculitis cerebral	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Viith nerve paralysis	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Abnormal behaviour	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Adjustment disorder	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Completed suicide	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected7,695 at risk EG0014 events4 affected7,710 at risk
Delirium	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Delirium febrile	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Depression	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0014 events4 affected7,710 at risk
Generalised anxiety disorder	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Korsakoff's syndrome	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Major depression	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Mental status changes	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Psychotic disorder	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0013 events3 affected7,710 at risk
Somatoform disorder	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0010 events0 affected7,710 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Suicide attempt	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected7,695 at risk EG0010 events0 affected7,710 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0008 events8 affected7,695 at risk EG0014 events4 affected7,710 at risk
Azotaemia	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Bladder prolapse	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Calculus bladder	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected7,695 at risk EG0010 events0 affected7,710 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0016 events6 affected7,710 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0010 events0 affected7,710 at risk
Haematuria	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0012 events2 affected7,710 at risk
Renal artery arteriosclerosis	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Renal artery occlusion	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Renal colic	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Renal cyst	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0012 events2 affected7,710 at risk
Renal failure	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0013 events3 affected7,710 at risk
Renal impairment	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Stress urinary incontinence	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0010 events0 affected7,710 at risk
Urethral polyp	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Urinary retention	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0014 events4 affected7,710 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0012 events2 affected7,710 at risk
Cystocele	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0010 events0 affected7,710 at risk
Endometrial hypertrophy	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Fibrocystic breast disease	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Rectocele	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Uterine enlargement	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Uterovaginal prolapse	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0012 events2 affected7,710 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0013 events3 affected7,710 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0006 events6 affected7,695 at risk EG0017 events5 affected7,710 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0009 events8 affected7,695 at risk EG00110 events8 affected7,710 at risk
Dyspnoea	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0010 events0 affected7,710 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0010 events0 affected7,710 at risk
Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0010 events0 affected7,710 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Nasal turbinate hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Paranasal cyst	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Pickwickian syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Pleural calcification	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0014 events4 affected7,710 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0012 events2 affected7,710 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0014 events4 affected7,710 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Pulmonary bulla	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0006 events6 affected7,695 at risk EG00113 events13 affected7,710 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0011 events1 affected7,710 at risk
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0007 events7 affected7,695 at risk EG00112 events12 affected7,710 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Leukoplakia	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected7,695 at risk EG0010 events0 affected7,710 at risk
Cardiac pacemaker replacement	Surgical and medical procedures	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Aneurysm	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Angiodysplasia	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Aortic aneurysm	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0013 events3 affected7,710 at risk
Aortic dilatation	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Aortic dissection	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Aortic rupture	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Aortic stenosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0013 events3 affected7,710 at risk
Arterial disorder	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Arterial thrombosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Arteriosclerosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0012 events2 affected7,710 at risk
Bleeding varicose vein	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Circulatory collapse	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0013 events3 affected7,710 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected7,695 at risk EG0015 events5 affected7,710 at risk
Diabetic vascular disorder	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Essential hypertension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Haematoma	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0013 events3 affected7,710 at risk
Haemodynamic instability	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Haemorrhage	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Hypertension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0008 events8 affected7,695 at risk EG00111 events10 affected7,710 at risk
Hypertensive crisis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0013 events3 affected7,710 at risk
Hypertensive emergency	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Hypotension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0012 events2 affected7,710 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0013 events3 affected7,710 at risk
Intermittent claudication	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0012 events2 affected7,710 at risk
Orthostatic hypertension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0013 events2 affected7,710 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0014 events4 affected7,710 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0010 events0 affected7,710 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Peripheral embolism	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0011 events1 affected7,710 at risk
Peripheral venous disease	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0010 events0 affected7,710 at risk
Polyarteritis nodosa	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Superior vena cava syndrome	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0011 events1 affected7,710 at risk
Temporal arteritis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Thrombophlebitis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected7,695 at risk EG0010 events0 affected7,710 at risk
Varicose ulceration	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected7,695 at risk EG0010 events0 affected7,710 at risk
Varicose vein	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected7,695 at risk EG0012 events1 affected7,710 at risk

ID	Term
D000073618	Varicella Zoster Virus Infection
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections

ID	Title	Description
BG000	GSK1437173A Group	Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
BG001	Placebo Group	Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	GSK1437173A Group	Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.	11	7,695	727	7,695	5,586	7,695
EG001	Placebo Group	Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.	15	7,710	731	7,710	1,893	7,710

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG000967 events792 affected7,695 at risk EG001449 events389 affected7,710 at risk
Chills	General disorders	MedDRA 10.0	Systematic Assessment	EG0001,860 events1,464 affected7,695 at risk EG001314 events276 affected7,710 at risk
Fatigue	General disorders	MedDRA 10.0	Systematic Assessment	EG0003,111 events2,211 affected7,695 at risk EG001961 events770 affected7,710 at risk
Injection site erythema	General disorders	MedDRA 10.0	Systematic Assessment	EG000636 events493 affected7,695 at risk EG00111 events10 affected7,710 at risk
Injection site pain	General disorders	MedDRA 10.0	Systematic Assessment	EG0002,090 events1,390 affected7,695 at risk EG001118 events104 affected7,710 at risk
Injection site swelling	General disorders	MedDRA 10.0	Systematic Assessment	EG000515 events401 affected7,695 at risk EG0016 events6 affected7,710 at risk
Pain	General disorders	MedDRA 10.0	Systematic Assessment	EG0006,064 events3,575 affected7,695 at risk EG001627 events505 affected7,710 at risk
Pyrexia	General disorders	MedDRA 10.0	Systematic Assessment	EG0001,839 events1,498 affected7,695 at risk EG001176 events168 affected7,710 at risk
Swelling	General disorders	MedDRA 10.0	Systematic Assessment	EG0001,573 events1,154 affected7,695 at risk EG00148 events46 affected7,710 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0003,234 events2,277 affected7,695 at risk EG001704 events571 affected7,710 at risk
Headache	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0003,044 events2,167 affected7,695 at risk EG0011,198 events929 affected7,710 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0002,408 events1,690 affected7,695 at risk EG00175 events69 affected7,710 at risk