Study to Evaluate Efficacy, Safety and Immunogenicity of... | NCT01165229

ID	Type	Description	Link
2009-015791-94	EudraCT Number

Label	Type	Description	Intervention Names
Zoster vaccine 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	Zoster vaccine group

Measure	Description	Time Frame
Number of Subjects With Any Episodes of Herpes Zoster (HZ)	Confirmed HZ cases during the study in the modified total vaccinated cohort (mTVc).	During the entire study period (3 to 5 year period following Day 0)
Outcome Measure for the Pooled Analysis of Combined Data From Studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229): Number of Subjects With Post-herpetic Neuralgia (PHN)	Incidence of PHN calculated using the mTVc during the entire study period in subjects ≥ 70 years of age (YOA).	During the entire study period (3 to 5 year period following Day 0)
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Confirmed HZ	Occurrence of confirmed HZ during the entire study period in subjects ≥ 70 YOA.	During the entire study period (3 to 5 year period following Day 0)

Measure	Description	Time Frame
Number of Subjects With Post-herpetic Neuralgia (PHN)	PHN cases in the mTVc.	During the entire study period (3 to 5 year period following Day 0)
Number of Days With 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	Zoster-022 GSK1437173A Group	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
FG001	Zoster-022 Placebo Group	Subjects receiving 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 Any Episodes of Herpes Zoster (HZ)

Confirmed HZ cases during the study 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	Zoster-022 GSK1437173A 70-79YOA Group	Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG001	Zoster-022 GSK1437173A >=80YOA Group	Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG002	Zoster-022 GSK1437173A >=70YOA Group	Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG003	Zoster-022 Placebo 70-79YOA Group	Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
OG004	Zoster-022 Placebo >=80YOA Group	Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
OG005	Zoster-022 Placebo >=70YOA Group	Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.

Units	Counts
Participants	OG0005114 OG0011427 OG0026541 OG003

Title

Denominators

Categories

Title	Measurements
	OG00017 OG0016 OG00223 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG003	Comparison of vaccine efficacy in prevention of Herpes Zoster (HZ) disease between Zoster-022 GSK1437173A 70-79 YOA group and Zoster-022 Placebo 70-79 YOA group.	Poisson exact test		<0.0001		Vaccine efficacy	90.02			2-Sided	95	83.54	94.32					Other	The efficacy of Herpes Zoster subunit (HZ/su) vaccine against herpes zoster disease was demonstrated if the lower limit (LL) of the two-sided 95% Confidence Interval (CI) of VE was above 10%.

Primary

Outcome Measure for the Pooled Analysis of Combined Data From Studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229): Number of Subjects With Post-herpetic Neuralgia (PHN)

Incidence of PHN calculated using the mTVc during the entire study period in subjects ≥ 70 years of age (YOA).

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Zoster-022/006 Pooled GSK1437173A 70-79YOA Group	Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG001	Zoster-022/006 Pooled GSK1437173A >=80YOA Group	Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG002	Zoster-022/006 Pooled GSK1437173A >=70YOA Group	Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.

Primary

Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Confirmed HZ

Occurrence of confirmed HZ during the entire study period in subjects ≥ 70 YOA.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Zoster-022/006 Pooled GSK1437173A 70-79YOA Group	Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG001	Zoster-022/006 Pooled GSK1437173A >=80YOA Group	Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG002	Zoster-022/006 Pooled GSK1437173A >=70YOA Group	Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.

Secondary

Number of Subjects With Post-herpetic Neuralgia (PHN)

PHN cases in the mTVc.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Zoster-022 GSK1437173A 70-79YOA Group	Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG001	Zoster-022 GSK1437173A >=80YOA Group	Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG002	Zoster-022 GSK1437173A >=70YOA Group	Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG003

Secondary

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

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 Zoster Brief Pain Inventory (ZBPI) in subjects with confirmed HZ.

Posted

Mean

Standard Deviation

Days

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

ID	Title	Description
OG000	Zoster-022 GSK1437173A 70-79YOA Group	Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG001	Zoster-022 GSK1437173A >=80YOA Group	Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG002	Zoster-022 GSK1437173A >=70YOA Group	Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.

Secondary

Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations

The number of subjects with confirmed HZ related mortality and hospitalizations were tabulated.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Zoster-022 GSK1437173A 70-79YOA Group	Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG001	Zoster-022 GSK1437173A >=80YOA Group	Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG002	Zoster-022 GSK1437173A >=70YOA Group	Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.

Secondary

Number of Subjects With Overall Mortality and HZ-related Mortality

The number of subjects with overall mortality and HZ related mortality were tabulated. Evaluation of VE in the reduction of overall and HZ related mortality as per study objective was not performed due to low number of events reported.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Zoster-022 GSK1437173A 70-79YOA Group	Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG001	Zoster-022 GSK1437173A >=80YOA Group	Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG002	Zoster-022 GSK1437173A >=70YOA Group	Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.

Secondary

Number of Subjects With Confirmed HZ Episode Related Hospitalizations

Incidence of overall and HZ-related hospitalizations 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	Zoster-022 GSK1437173A 70-79YOA Group	Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG001	Zoster-022 GSK1437173A >=80YOA Group	Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG002	Zoster-022 GSK1437173A >=70YOA Group	Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.

Secondary

Number of Subjects With HZ Related Complications

Incidence of HZ complications during the study 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	Zoster-022 GSK1437173A 70-79YOA Group	Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG001	Zoster-022 GSK1437173A >=80YOA Group	Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG002	Zoster-022 GSK1437173A >=70YOA Group	Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.

Secondary

Number of Subjects Receiving Pain Medication Associated With HZ

Incidence of use of pain medications throughout the study

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Zoster-022 GSK1437173A 70-79YOA Group	Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG001	Zoster-022 GSK1437173A >=80YOA Group	Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG002	Zoster-022 GSK1437173A >=70YOA Group	Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG003

Secondary

Number of Days With Pain Medication Associated With HZ

Incidence of reduction of duration of pain medication associated with HZ throughout the study.

Posted

Mean

Standard Deviation

Days

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

ID	Title	Description
OG000	Zoster-022 GSK1437173A 70-79YOA Group	Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG001	Zoster-022 GSK1437173A >=80YOA Group	Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG002	Zoster-022 GSK1437173A >=70YOA Group	Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.

Secondary

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Occurrence, intensity of each solicited local symptom within 7 days (Days 0-6) after each vaccination, in subjects included in the 7-day diary card subset; 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 everyday normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

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

Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses

ID	Title	Description
OG000	Zoster-022 GSK1437173A Group	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG001	Zoster-022 Placebo Group	Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.

Secondary

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

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

Posted

Count of Participants

Participants

Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses

ID	Title	Description
OG000	Zoster-022 GSK1437173A Group	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG001	Zoster-022 Placebo Group	Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.

Secondary

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

Occurrence, intensity and relationship to vaccination of unsolicited AEs during 30 days (Days 0-29) after each vaccination, 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 the 30 days (Days 0-29) after each vaccination

ID	Title	Description
OG000	Zoster-022 GSK1437173A Group	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG001	Zoster-022 Placebo Group	Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.

Secondary

Number of Subjects With Any and Related Serious Adverse Events (SAEs)

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

From Month 0 to Month 14

ID	Title	Description
OG000	Zoster-022 GSK1437173A Group	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG001	Zoster-022 Placebo Group	Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.

Units	Counts
Participants	OG000

Secondary

Number of Subjects With Fatal Serious Adverse Events (SAEs)

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	Zoster-022 GSK1437173A Group	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG001	Zoster-022 Placebo Group	Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.

Units	Counts
Participants	OG000

Secondary

Number of Subjects With SAEs Related to Study Participation or Concomitant GSK Medication

The number of subjects with SAEs related to study participation or concomitant GSK medication were tabulated

The analysis was based on 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	Zoster-022 GSK1437173A Group	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG001	Zoster-022 Placebo Group	Subjects receiving 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) during the entire study period 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	Zoster-022 GSK1437173A Group	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG001	Zoster-022 Placebo Group	Subjects receiving 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 Medically Attended Visits

Occurrence and relationship to vaccination of medically attended visits other than routine health care visits, from Month 0 to Month 8 in all subjects. Medically attended visits were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any medically attended visits= Occurrence of any medically attended visits regardless of intensity grade or relation to 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

From Month 0 to Month 8 post-vaccination

ID	Title	Description
OG000	Zoster-022 GSK1437173A Group	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG001	Zoster-022 Placebo Group	Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.

Units	Counts

Secondary

Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Overall Number of Subjects With PHN in Subjects ≥ 50 YOA

Incidence of PHN calculated using the mTVc during the entire study period in subjects ≥ 50 YOA.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Zoster-022/006 Pooled GSK1437173A 50-59 YOA Group	Subjects between 50 and 59 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG001	Zoster-022/006 Pooled GSK1437173A 60-69 YOA Group	Subjects between 60 and 69 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG002	Zoster-022/006 Pooled GSK1437173A 70-79 YOA Group	Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.

Secondary

Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With a Reduction of PHN Incidence in Subjects ≥ 50 YOA With Confirmed HZ

Occurrence of PHN during the entire study period in all 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	Zoster-022/006 Pooled GSK1437173A 50-59 YOA Group	Subjects between 50 and 59 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG001	Zoster-022/006 Pooled GSK1437173A 60-69 YOA Group	Subjects between 60 and 69 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG002	Zoster-022/006 Pooled GSK1437173A 70-79 YOA Group	Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.

Secondary

Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With at Least One Day of Severe 'Worst' HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ.

The duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period was measured by the ZBPI in subjects ≥ 70 YOA 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	Zoster-022/006 Pooled GSK1437173A 70-79 YOA Group	Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG001	Zoster-022/006 Pooled GSK1437173A >=80 YOA Group	Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG002	Zoster-022/006 Pooled GSK1437173A >=70 YOA Group

Secondary

Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Duration of Severe 'Worst' HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ.

Duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period was measured by the ZBPI in subjects ≥ 70 YOA with confirmed HZ.

Posted

Mean

Standard Deviation

Days

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

ID	Title	Description
OG000	Zoster-022/006 Pooled GSK1437173A 70-79 YOA Group	Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG001	Zoster-022/006 Pooled GSK1437173A >=80 YOA Group	Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG002	Zoster-022/006 Pooled GSK1437173A >=70 YOA Group

Secondary

Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Occurrence, intensity of each solicited local symptom within 7 days (Days 0-6) after each vaccination, in subjects ≥ 70 YOA. Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

Posted

Count of Participants

Participants

Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses

ID	Title	Description
OG000	Zoster-022/006 Pooled GSK1437173A Group	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG001	Zoster-022/006 Pooled Placebo Group	Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.

Secondary

Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. 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.

Posted

Count of Participants

Participants

Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses

ID	Title	Description
OG000	Zoster-022/006 Pooled GSK1437173A Group	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG001	Zoster-022/006 Pooled Placebo Group	Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.

Secondary

Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any,Grade 3 and Related Unsolicited AEs in Subjects ≥ 70 YOA

Occurrence, intensity and relationship to vaccination of unsolicited AEs during 30 days (Days 0-29) after each vaccination, according to the MedDRA classification, in subjects ≥ 70 YOA.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.

The analysis was based on the total vaccinated cohort, which included all vaccinated subjects with study vaccine or placebo administered.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Zoster-022/006 Pooled GSK1437173A Group	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG001	Zoster-022/006 Pooled Placebo Group

Secondary

Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related SAEs

Occurrence and relationship to vaccination of all SAEs from Month 0 to Month 14 in subjects ≥ 70 YOA. Related SAEs also included any SAEs related to study participation or concurrent GSK medication/vaccine.

The analysis was based on the total vaccinated cohort, which included all vaccinated subjects with study vaccine or placebo administered.

Posted

Count of Participants

Participants

From Month 0 to Month 14

ID	Title	Description
OG000	Zoster-022/006 Pooled GSK1437173A Group	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG001	Zoster-022/006 Pooled Placebo Group	Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.

Units	Counts
Participants

Secondary

Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Fatal SAEs

Fatal SAEs during the entire study period in subjects ≥ 70 YOA.

The analysis was based on the total vaccinated cohort, which included all vaccinated subjects with 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	Zoster-022/006 Pooled GSK1437173A Group	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG001	Zoster-022/006 Pooled Placebo Group	Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.

Units	Counts
Participants	OG000

Secondary

Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related pIMDs

Occurrence and relationship to vaccination of any pIMDs during the entire study period in subjects ≥ 70 YOA.

The analysis was based on the total vaccinated cohort, which included all vaccinated subjects with 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	Zoster-022/006 Pooled GSK1437173A Group	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG001	Zoster-022/006 Pooled Placebo Group	Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.

Units	Counts
Participants	OG000

Secondary

Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related Medically Attended Visits

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, from Month 0 to Month 8 in subjects ≥ 70 YOA.

The analysis was based on the total vaccinated cohort, which included all vaccinated subjects with study vaccine or placebo administered.

Posted

Count of Participants

Participants

From Month 0 to Month 8 post-vaccination

ID	Title	Description
OG000	Zoster-022/006 Pooled GSK1437173A Group	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
OG001	Zoster-022/006 Pooled Placebo Group	Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.

Units	Counts
Participants

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 affected6,950 at risk EG00115 events13 affected6,950 at risk
Anaemia vitamin b12 deficiency	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Hypersplenism	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Immune thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0005 events5 affected6,950 at risk EG0014 events4 affected6,950 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Nephrogenic anaemia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Normochromic normocytic anaemia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Pernicious anaemia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0013 events3 affected6,950 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0016 events4 affected6,950 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG00022 events21 affected6,950 at risk EG00129 events28 affected6,950 at risk
Angina pectoris	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG00013 events13 affected6,950 at risk EG0016 events6 affected6,950 at risk
Angina unstable	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0007 events7 affected6,950 at risk EG0017 events7 affected6,950 at risk
Aortic valve disease	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0013 events3 affected6,950 at risk
Arrhythmia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0005 events5 affected6,950 at risk EG0019 events9 affected6,950 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0013 events3 affected6,950 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG00045 events40 affected6,950 at risk EG00156 events54 affected6,950 at risk
Atrial flutter	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0006 events6 affected6,950 at risk EG0015 events5 affected6,950 at risk
Atrioventricular block	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0014 events4 affected6,950 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected6,950 at risk EG0012 events2 affected6,950 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0013 events3 affected6,950 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Bradycardia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected6,950 at risk EG0018 events8 affected6,950 at risk
Cardiac arrest	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG00023 events23 affected6,950 at risk EG00117 events17 affected6,950 at risk
Cardiac disorder	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Cardiac failure	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG00052 events51 affected6,950 at risk EG00162 events57 affected6,950 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0016 events6 affected6,950 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG00023 events23 affected6,950 at risk EG00137 events33 affected6,950 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Cardiac valve disease	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0011 events1 affected6,950 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0015 events5 affected6,950 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0006 events6 affected6,950 at risk EG0012 events2 affected6,950 at risk
Cardiomegaly	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0012 events2 affected6,950 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Chronotropic incompetence	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0011 events1 affected6,950 at risk
Cor pulmonale	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Coronary artery disease	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG00029 events28 affected6,950 at risk EG00125 events25 affected6,950 at risk
Coronary artery insufficiency	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0016 events6 affected6,950 at risk
Diastolic dysfunction	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Extrasystoles	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Heart valve incompetence	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0014 events4 affected6,950 at risk
Left ventricular failure	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Left ventricular hypertrophy	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0013 events3 affected6,950 at risk
Myocardial infarction	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG00043 events41 affected6,950 at risk EG00145 events45 affected6,950 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0006 events5 affected6,950 at risk EG00116 events16 affected6,950 at risk
Palpitations	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0013 events3 affected6,950 at risk
Pericarditis	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Right ventricular failure	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0011 events1 affected6,950 at risk
Sinus arrest	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0005 events5 affected6,950 at risk EG0016 events6 affected6,950 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0010 events0 affected6,950 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Tachycardia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0012 events2 affected6,950 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0013 events3 affected6,950 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0018 events6 affected6,950 at risk
Congenital cystic kidney disease	Congenital, familial and genetic disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Hypertrophic cardiomyopathy	Congenital, familial and genetic disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Pyloric stenosis	Congenital, familial and genetic disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Renal dysplasia	Congenital, familial and genetic disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Sudden hearing loss	Ear and labyrinth disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0014 events4 affected6,950 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0011 events1 affected6,950 at risk
Vestibular disorder	Ear and labyrinth disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0013 events3 affected6,950 at risk
Autoimmune thyroiditis	Endocrine disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Cushingoid	Endocrine disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Goitre	Endocrine disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Hyperparathyroidism primary	Endocrine disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Hypothyroidism	Endocrine disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0013 events3 affected6,950 at risk
Age-related macular degeneration	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Amaurosis fugax	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Cataract	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0007 events7 affected6,950 at risk EG0017 events7 affected6,950 at risk
Choroidal effusion	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Diplopia	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Glaucoma	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Iridocele	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Iritis	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Ocular hypertension	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Ocular vascular disorder	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Optic ischaemic neuropathy	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Retinal degeneration	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Retinal detachment	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0014 events4 affected6,950 at risk
Retinal haemorrhage	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Abdominal adhesions	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0012 events2 affected6,950 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0017 events7 affected6,950 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0012 events2 affected6,950 at risk
Abdominal strangulated hernia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Anal prolapse	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Ascites	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Autoimmune pancreatitis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Barrett's oesophagus	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Colitis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0011 events1 affected6,950 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Constipation	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0012 events2 affected6,950 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Diaphragmatic hernia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Diaphragmatic hernia, obstructive	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0014 events4 affected6,950 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0013 events3 affected6,950 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0012 events2 affected6,950 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events1 affected6,950 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Enteritis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Enterovesical fistula	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Faecal incontinence	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Gastric perforation	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected6,950 at risk EG0016 events6 affected6,950 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0014 events4 affected6,950 at risk
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Gastritis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0016 events6 affected6,950 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Gastrointestinal angiodysplasia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events1 affected6,950 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0015 events4 affected6,950 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0012 events2 affected6,950 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0011 events1 affected6,950 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Ileus	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0006 events6 affected6,950 at risk EG0017 events7 affected6,950 at risk
Incarcerated inguinal hernia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Incarcerated umbilical hernia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0005 events5 affected6,950 at risk EG00110 events10 affected6,950 at risk
Inguinal hernia strangulated	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Intestinal infarction	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0012 events2 affected6,950 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0006 events6 affected6,950 at risk EG0016 events6 affected6,950 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0012 events2 affected6,950 at risk
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0012 events2 affected6,950 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0014 events4 affected6,950 at risk
Mallory-weiss syndrome	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Melaena	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Mesenteric artery embolism	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Mesenteric artery thrombosis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Mesenteritis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Nausea	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Oesophageal haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Oesophageal spasm	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Oesophageal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Pancreatic disorder	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0018 events8 affected6,950 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0005 events5 affected6,950 at risk EG0015 events4 affected6,950 at risk
Peptic ulcer haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Pharyngo-oesophageal diverticulum	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Proctitis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0013 events3 affected6,950 at risk
Rectal perforation	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Rectal polyp	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Rectal prolapse	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Salivary gland calculus	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0014 events4 affected6,950 at risk
Subileus	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Thrombosis mesenteric vessel	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0012 events2 affected6,950 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0012 events2 affected6,950 at risk
Vomiting	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Accidental death	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Administration site erythema	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Administration site pain	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Adverse drug reaction	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Asthenia	General disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Cardiac death	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Chest discomfort	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0014 events3 affected6,950 at risk
Chest pain	General disorders	MedDRA 10.0	Systematic Assessment	EG00020 events20 affected6,950 at risk EG00120 events19 affected6,950 at risk
Chills	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Cyst	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Death	General disorders	MedDRA 10.0	Systematic Assessment	EG00017 events17 affected6,950 at risk EG00129 events29 affected6,950 at risk
Device battery issue	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Device deposit issue	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Device dislocation	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0012 events2 affected6,950 at risk
Device leakage	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Device occlusion	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Drowning	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Fatigue	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
General physical health deterioration	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0012 events2 affected6,950 at risk
Generalised oedema	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Ill-defined disorder	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Incarcerated hernia	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Inflammation	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Malaise	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Multi-organ failure	General disorders	MedDRA 10.0	Systematic Assessment	EG0009 events9 affected6,950 at risk EG00112 events12 affected6,950 at risk
Non-cardiac chest pain	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0014 events4 affected6,950 at risk
Oedema peripheral	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Organ failure	General disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0011 events1 affected6,950 at risk
Peripheral swelling	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0012 events2 affected6,950 at risk
Pyrexia	General disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0011 events1 affected6,950 at risk
Sudden cardiac death	General disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0013 events3 affected6,950 at risk
Sudden death	General disorders	MedDRA 10.0	Systematic Assessment	EG00013 events13 affected6,950 at risk EG0014 events4 affected6,950 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Thrombosis in device	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Acute hepatic failure	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0013 events3 affected6,950 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Biliary dilatation	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0005 events5 affected6,950 at risk EG0015 events5 affected6,950 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0008 events7 affected6,950 at risk EG00117 events15 affected6,950 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0007 events7 affected6,950 at risk EG0014 events4 affected6,950 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG00014 events14 affected6,950 at risk EG00114 events14 affected6,950 at risk
Cholestasis	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Chronic hepatic failure	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Cirrhosis alcoholic	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Gallbladder perforation	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0013 events3 affected6,950 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0011 events1 affected6,950 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Hepatitis acute	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Hepatitis alcoholic	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Ischaemic hepatitis	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Allergic granulomatous angiitis	Immune system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Amyloidosis	Immune system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Abdominal abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Abdominal infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Acarodermatitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Alcaligenes infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Anal abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Anal fistula infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Anorectal cellulitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Appendiceal abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Appendicitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0005 events5 affected6,950 at risk EG0015 events5 affected6,950 at risk
Appendicitis perforated	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Arteriosclerotic gangrene	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Arthritis bacterial	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Arthritis infective	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Atypical pneumonia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Bacteraemia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Bacterial sepsis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0012 events2 affected6,950 at risk
Biliary tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Bronchitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0008 events8 affected6,950 at risk EG0018 events7 affected6,950 at risk
Bronchitis bacterial	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Bronchopneumonia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0014 events4 affected6,950 at risk
Candida infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Candida sepsis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Cavernous sinus thrombosis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Cellulitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0008 events8 affected6,950 at risk EG00114 events14 affected6,950 at risk
Cholecystitis infective	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Clostridium bacteraemia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0015 events5 affected6,950 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Colonic abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Cystitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected6,950 at risk EG0010 events0 affected6,950 at risk
Cystitis klebsiella	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Device related infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Diabetic foot infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Diverticulitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0005 events5 affected6,950 at risk EG00111 events11 affected6,950 at risk
Empyema	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0012 events2 affected6,950 at risk
Encephalitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Encephalitis viral	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Endocarditis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0010 events0 affected6,950 at risk
Enterocolitis viral	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Epididymitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Erysipelas	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0004 events3 affected6,950 at risk EG0017 events7 affected6,950 at risk
Escherichia infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Escherichia sepsis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0012 events2 affected6,950 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Gangrene	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Gastroenteritis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0008 events8 affected6,950 at risk EG0018 events8 affected6,950 at risk
Gastroenteritis clostridial	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Gastroenteritis salmonella	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0012 events2 affected6,950 at risk
Graft infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Haematoma infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Helicobacter infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Herpes simplex	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Herpes zoster	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0013 events3 affected6,950 at risk
Herpes zoster disseminated	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Herpes zoster meningitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Herpes zoster oticus	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Incision site infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Infected dermal cyst	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Infectious colitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0011 events1 affected6,950 at risk
Influenza	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0011 events1 affected6,950 at risk
Intestinal gangrene	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Kidney infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Klebsiella bacteraemia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Klebsiella sepsis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Labyrinthitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Liver abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0011 events1 affected6,950 at risk
Lobar pneumonia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected6,950 at risk EG0018 events8 affected6,950 at risk
Localised infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Lung abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Lung infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0012 events2 affected6,950 at risk
Medical device site infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Meningitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Nasopharyngitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Necrotising fasciitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Necrotising fasciitis streptococcal	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Neuroborreliosis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Ophthalmic herpes zoster	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Orchitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0013 events3 affected6,950 at risk
Oropharyngeal candidiasis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Osteomyelitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Ovarian abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Pancreatic abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Peritonitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected6,950 at risk EG0014 events4 affected6,950 at risk
Peritonitis bacterial	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Pharyngitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Pneumonia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG00073 events70 affected6,950 at risk EG00186 events81 affected6,950 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0004 events3 affected6,950 at risk EG0010 events0 affected6,950 at risk
Pneumonia influenzal	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0012 events2 affected6,950 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Pneumonia streptococcal	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Pneumonia viral	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Post procedural infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0013 events3 affected6,950 at risk
Postoperative abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0010 events0 affected6,950 at risk
Postoperative wound infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Pseudomembranous colitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Pseudomonas infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Psittacosis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Psoas abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Purulence	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Pyelonephritis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0014 events4 affected6,950 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected6,950 at risk EG0010 events0 affected6,950 at risk
Rectal abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Renal abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Respiratory moniliasis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Respiratory tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0013 events3 affected6,950 at risk
Sepsis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG00027 events26 affected6,950 at risk EG00117 events17 affected6,950 at risk
Septic shock	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG00011 events11 affected6,950 at risk EG00114 events14 affected6,950 at risk
Sinusitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Soft tissue infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Staphylococcal infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected6,950 at risk EG0011 events1 affected6,950 at risk
Staphylococcal osteomyelitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Streptococcal sepsis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Tonsillitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Tooth abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Tuberculosis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0003 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0013 events3 affected6,950 at risk
Urinary tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG00032 events28 affected6,950 at risk EG00127 events24 affected6,950 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Urosepsis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0008 events7 affected6,950 at risk EG0019 events9 affected6,950 at risk
Vestibular neuronitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0013 events3 affected6,950 at risk
Viral infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0012 events2 affected6,950 at risk
Vulvitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Wound infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0012 events2 affected6,950 at risk
Accident	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0015 events5 affected6,950 at risk
Back injury	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Bone fissure	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Carbon monoxide poisoning	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Compression fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected6,950 at risk EG0013 events3 affected6,950 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected6,950 at risk EG0015 events5 affected6,950 at risk
Coronary artery reocclusion	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Deep vein thrombosis postoperative	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Eye penetration	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Face injury	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0014 events4 affected6,950 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0008 events8 affected6,950 at risk EG0015 events5 affected6,950 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0016 events6 affected6,950 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG00010 events10 affected6,950 at risk EG00115 events15 affected6,950 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0012 events2 affected6,950 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Foreign body	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Fractured sacrum	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Gun shot wound	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0011 events1 affected6,950 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0005 events5 affected6,950 at risk EG0014 events4 affected6,950 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0007 events7 affected6,950 at risk EG0012 events2 affected6,950 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0016 events6 affected6,950 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0010 events0 affected6,950 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0012 events2 affected6,950 at risk
Kidney contusion	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0013 events2 affected6,950 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Limb crushing injury	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0012 events2 affected6,950 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0012 events2 affected6,950 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0012 events2 affected6,950 at risk
Muscle rupture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0011 events1 affected6,950 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0014 events4 affected6,950 at risk
Pneumothorax traumatic	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0012 events2 affected6,950 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0013 events3 affected6,950 at risk
Post procedural pulmonary embolism	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Postoperative wound complication	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Procedural intestinal perforation	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Pubis fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0013 events3 affected6,950 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0005 events5 affected6,950 at risk EG0015 events5 affected6,950 at risk
Respiratory fume inhalation disorder	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0006 events6 affected6,950 at risk EG0017 events7 affected6,950 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Skin wound	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0010 events0 affected6,950 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0006 events6 affected6,950 at risk EG0011 events1 affected6,950 at risk
Spinal cord injury	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Spinal cord injury cervical	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Splenic rupture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG00010 events9 affected6,950 at risk EG0016 events6 affected6,950 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Synovial rupture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected6,950 at risk EG0014 events4 affected6,950 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0013 events3 affected6,950 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected6,950 at risk EG0012 events2 affected6,950 at risk
Traumatic fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected6,950 at risk EG0014 events4 affected6,950 at risk
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Wound evisceration	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Wound haemorrhage	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Blood glucose fluctuation	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Blood pressure increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
C-reactive protein increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Haemoglobin decreased	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Heart rate decreased	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Liver function test abnormal	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Weight increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0012 events2 affected6,950 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0008 events8 affected6,950 at risk EG0018 events8 affected6,950 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0013 events3 affected6,950 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Gout	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0012 events2 affected6,950 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0006 events6 affected6,950 at risk EG0014 events4 affected6,950 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0007 events7 affected6,950 at risk EG0012 events2 affected6,950 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0015 events5 affected6,950 at risk
Hypophagia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0012 events2 affected6,950 at risk
Marasmus	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0005 events5 affected6,950 at risk EG0016 events6 affected6,950 at risk
Uraemic acidosis	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Acquired claw toe	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Arthrofibrosis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0015 events5 affected6,950 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Chondrocalcinosis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Chondropathy	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0011 events1 affected6,950 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0005 events5 affected6,950 at risk EG0014 events4 affected6,950 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Meniscal degeneration	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Mixed connective tissue disease	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0011 events1 affected6,950 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG00026 events26 affected6,950 at risk EG00117 events17 affected6,950 at risk
Osteochondritis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0005 events5 affected6,950 at risk EG0014 events4 affected6,950 at risk
Polymyositis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Pseudarthrosis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0011 events1 affected6,950 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0012 events2 affected6,950 at risk
Sjogren's syndrome	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0006 events6 affected6,950 at risk EG0016 events6 affected6,950 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0015 events5 affected6,950 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Spondyloarthropathy	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Still's disease adult onset	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Trigger finger	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Acral lentiginous melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Acute monocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0013 events3 affected6,950 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0011 events1 affected6,950 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected6,950 at risk EG0014 events4 affected6,950 at risk
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Adrenal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Adrenal gland cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Anaplastic astrocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Anaplastic thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
B precursor type acute leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0012 events2 affected6,950 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0005 events5 affected6,950 at risk EG0013 events3 affected6,950 at risk
Benign neoplasm of thyroid gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Benign ovarian tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Bile duct cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0006 events6 affected6,950 at risk EG00113 events13 affected6,950 at risk
Bladder cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0011 events1 affected6,950 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0014 events4 affected6,950 at risk
Bladder papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0012 events2 affected6,950 at risk
Bladder transitional cell carcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Bone cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Brain neoplasm benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0005 events5 affected6,950 at risk EG0014 events4 affected6,950 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Carcinoid tumour pulmonary	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Central nervous system neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0013 events3 affected6,950 at risk
Cholesteatoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0009 events9 affected6,950 at risk EG0016 events6 affected6,950 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0013 events3 affected6,950 at risk
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Diffuse large b-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Diffuse large b-cell lymphoma stage iv	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Fallopian tube cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Follicular thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Gallbladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0006 events6 affected6,950 at risk EG0013 events3 affected6,950 at risk
Gastrointestinal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Gastrointestinal tract adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Glioblastoma multiforme	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0016 events6 affected6,950 at risk
Hepatic cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Hepatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0004 events2 affected6,950 at risk EG0011 events1 affected6,950 at risk
Hypergammaglobulinaemia benign monoclonal	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Intestinal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0012 events2 affected6,950 at risk
Invasive lobular breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Invasive papillary breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Large cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Large intestine benign neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0016 events6 affected6,950 at risk
Lung adenocarcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0012 events2 affected6,950 at risk
Lung adenocarcinoma stage iii	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0006 events6 affected6,950 at risk EG0014 events4 affected6,950 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0013 events3 affected6,950 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG00023 events22 affected6,950 at risk EG00113 events13 affected6,950 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0003 events2 affected6,950 at risk EG0013 events3 affected6,950 at risk
Malignant fibrous histiocytoma of bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Malignant lymphoma unclassifiable high grade	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Malignant mast cell neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0014 events4 affected6,950 at risk
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Malignant neoplasm of ampulla of vater	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Malignant palate neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Mesothelioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Metastases to adrenals	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0014 events4 affected6,950 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected6,950 at risk EG0012 events2 affected6,950 at risk
Metastases to gastrointestinal tract	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0005 events5 affected6,950 at risk EG0015 events5 affected6,950 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0011 events1 affected6,950 at risk
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Metastases to peritoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0010 events0 affected6,950 at risk
Metastases to stomach	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Metastatic carcinoma of the bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0011 events1 affected6,950 at risk
Metastatic gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0012 events2 affected6,950 at risk
Metastatic malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0012 events2 affected6,950 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0012 events2 affected6,950 at risk
Metastatic renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Metastatic squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0013 events3 affected6,950 at risk
Neoplasm prostate	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Non-hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0013 events3 affected6,950 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Non-small cell lung cancer stage iv	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Oesophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Oesophageal adenocarcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Oesophageal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0011 events1 affected6,950 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0006 events6 affected6,950 at risk EG0011 events1 affected6,950 at risk
Oesophageal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected6,950 at risk EG0010 events0 affected6,950 at risk
Ovarian cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Ovarian epithelial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Ovarian germ cell teratoma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0007 events7 affected6,950 at risk EG00110 events10 affected6,950 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0012 events2 affected6,950 at risk
Pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0010 events0 affected6,950 at risk
Pancreatic neuroendocrine tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Paraganglion neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Parathyroid tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Pituitary tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG00019 events19 affected6,950 at risk EG00118 events18 affected6,950 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0012 events2 affected6,950 at risk
Prostate cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0010 events0 affected6,950 at risk
Prostate cancer stage iv	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected6,950 at risk EG0011 events1 affected6,950 at risk
Rectal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0012 events2 affected6,950 at risk
Rectal cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0012 events2 affected6,950 at risk
Renal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0014 events4 affected6,950 at risk
Renal cell carcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Renal oncocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Salivary gland cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Small intestine adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0013 events3 affected6,950 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Squamous cell carcinoma of the oral cavity	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Sweat gland tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
T-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Throat cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Tongue neoplasm malignant stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Transitional cell carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Urethral neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Vulval cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Amnesia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Amyotrophic lateral sclerosis	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Ataxia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Balance disorder	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Basal ganglia haemorrhage	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Basilar artery thrombosis	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Brain injury	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Brain stem infarction	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Brain stem syndrome	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Carotid artery occlusion	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Carotid sinus syndrome	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Central nervous system lesion	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Cerebellar haemorrhage	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Cerebellar ischaemia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Cerebral artery embolism	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Cerebral artery thrombosis	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Cerebral atrophy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0006 events6 affected6,950 at risk EG0017 events7 affected6,950 at risk
Cerebral infarction	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG00016 events16 affected6,950 at risk EG00117 events17 affected6,950 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0013 events3 affected6,950 at risk
Cerebrospinal fluid leakage	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG00034 events34 affected6,950 at risk EG00133 events31 affected6,950 at risk
Cerebrovascular disorder	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0011 events1 affected6,950 at risk
Cervical myelopathy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Cognitive disorder	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Coma	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Dementia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected6,950 at risk EG0012 events2 affected6,950 at risk
Dementia alzheimer's type	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Dementia with lewy bodies	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Diabetic coma	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Dizziness	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0015 events5 affected6,950 at risk
Drop attacks	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Dural arteriovenous fistula	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Dyspraxia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Epilepsy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0014 events4 affected6,950 at risk
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Guillain-barre syndrome	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0012 events2 affected6,950 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0012 events2 affected6,950 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0014 events4 affected6,950 at risk
Headache	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Hemiplegia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Hydrocephalus	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Hypertonia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Intraventricular haemorrhage	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0007 events7 affected6,950 at risk EG0016 events6 affected6,950 at risk
Lacunar infarction	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0012 events2 affected6,950 at risk
Loss of consciousness	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Memory impairment	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Miller fisher syndrome	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Mixed dementia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Myasthenia gravis	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Myoclonus	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Nerve compression	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Neuralgia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Paralysis	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Parkinson's disease	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Parkinsonism	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Partial seizures	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Polyneuropathy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Post herpetic neuralgia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Presyncope	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0012 events2 affected6,950 at risk
Progressive supranuclear palsy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Radiculopathy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Restless legs syndrome	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Sciatica	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected6,950 at risk EG0014 events4 affected6,950 at risk
Seizure	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Senile dementia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Somnolence	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Spondylitic myelopathy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Status epilepticus	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0005 events5 affected6,950 at risk EG0017 events7 affected6,950 at risk
Syncope	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG00011 events11 affected6,950 at risk EG00122 events20 affected6,950 at risk
Thalamic infarction	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Thalamus haemorrhage	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Thrombotic cerebral infarction	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Transient global amnesia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG00022 events20 affected6,950 at risk EG00115 events14 affected6,950 at risk
Trigeminal neuralgia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Vascular dementia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Viiith nerve lesion	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Viith nerve paralysis	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0012 events2 affected6,950 at risk
Abnormal behaviour	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Acute psychosis	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Affective disorder	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Anxiety disorder	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Breathing-related sleep disorder	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Completed suicide	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Confusional state	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Delirium	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0013 events3 affected6,950 at risk
Depressed mood	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Depression	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected6,950 at risk EG0013 events3 affected6,950 at risk
Disorientation	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Hallucination	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Major depression	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Mental disorder	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Mental disorder due to a general medical condition	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Mental status changes	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Panic attack	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Panic disorder	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Psychotic disorder	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Schizoaffective disorder bipolar type	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Schizophrenia	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Somatoform disorder	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG00019 events18 affected6,950 at risk EG00120 events19 affected6,950 at risk
Acute prerenal failure	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Bladder neck obstruction	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Bladder perforation	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Bladder prolapse	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected6,950 at risk EG00112 events11 affected6,950 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Cystitis interstitial	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Dysuria	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Glomerulonephritis	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Haematuria	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0012 events2 affected6,950 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Nephroangiosclerosis	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0006 events6 affected6,950 at risk EG0012 events2 affected6,950 at risk
Nephropathy toxic	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Neurogenic bladder	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Prerenal failure	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Renal cyst	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0011 events1 affected6,950 at risk
Renal disorder	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Renal failure	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG00011 events11 affected6,950 at risk EG00112 events11 affected6,950 at risk
Renal hypertension	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Renal mass	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0014 events4 affected6,950 at risk
Urethral haemorrhage	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Urethral meatus stenosis	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0012 events2 affected6,950 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Urinary retention	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0013 events3 affected6,950 at risk
Urinary tract disorder	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Atrophic vulvovaginitis	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0009 events9 affected6,950 at risk EG0017 events7 affected6,950 at risk
Breast dysplasia	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Prostatic obstruction	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0012 events2 affected6,950 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Rectocele	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0014 events4 affected6,950 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Vaginal prolapse	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Vaginal ulceration	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0013 events3 affected6,950 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0015 events4 affected6,950 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0014 events4 affected6,950 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG00026 events21 affected6,950 at risk EG00118 events18 affected6,950 at risk
Diaphragmatic disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0014 events4 affected6,950 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0013 events3 affected6,950 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0010 events0 affected6,950 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Hyperventilation	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0006 events5 affected6,950 at risk EG0018 events8 affected6,950 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG00010 events10 affected6,950 at risk EG0013 events3 affected6,950 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Pulmonary cavitation	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG00015 events15 affected6,950 at risk EG00121 events21 affected6,950 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0013 events3 affected6,950 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0014 events4 affected6,950 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected6,950 at risk EG0010 events0 affected6,950 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0012 events2 affected6,950 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG00015 events15 affected6,950 at risk EG00115 events15 affected6,950 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0012 events2 affected6,950 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Dermatomyositis	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0015 events5 affected6,950 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0011 events1 affected6,950 at risk
Lichen planus	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Hospitalisation	Surgical and medical procedures	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Rectal polypectomy	Surgical and medical procedures	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Aneurysm	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Aneurysm ruptured	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Aortic aneurysm	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0006 events6 affected6,950 at risk EG0012 events2 affected6,950 at risk
Aortic aneurysm rupture	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected6,950 at risk EG0014 events4 affected6,950 at risk
Aortic arteriosclerosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Aortic dissection	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0012 events2 affected6,950 at risk
Aortic occlusion	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Aortic rupture	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Aortic stenosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0018 events8 affected6,950 at risk
Arteriosclerosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0017 events5 affected6,950 at risk
Arteriovenous fistula	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Blood pressure inadequately controlled	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Circulatory collapse	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0005 events5 affected6,950 at risk EG0013 events3 affected6,950 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0006 events6 affected6,950 at risk EG00110 events9 affected6,950 at risk
Embolism	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Femoral artery aneurysm	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Femoral artery occlusion	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Haematoma	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0016 events6 affected6,950 at risk
Haemorrhage	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0013 events3 affected6,950 at risk
Hypertension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG00022 events22 affected6,950 at risk EG00127 events25 affected6,950 at risk
Hypertensive crisis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0008 events7 affected6,950 at risk EG0016 events6 affected6,950 at risk
Hypertensive emergency	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Hypotension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0006 events6 affected6,950 at risk EG0015 events5 affected6,950 at risk
Inferior vena caval occlusion	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Intermittent claudication	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0012 events2 affected6,950 at risk
Internal haemorrhage	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0010 events0 affected6,950 at risk
Labile hypertension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Microscopic polyangiitis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Necrosis ischaemic	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected6,950 at risk EG0014 events4 affected6,950 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0006 events6 affected6,950 at risk EG0016 events6 affected6,950 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Temporal arteritis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 at risk
Thromboangiitis obliterans	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Thrombophlebitis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Thrombosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0012 events2 affected6,950 at risk
Varicose vein	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected6,950 at risk EG0011 events1 affected6,950 at risk
Vasculitis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Venous thrombosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0010 events0 affected6,950 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected6,950 at risk EG0011 events1 affected6,950 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	Zoster-022 GSK1437173A Group	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
BG001	Zoster-022 Placebo Group	Subjects receiving 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	Zoster-022 GSK1437173A Group	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	426	6,950	1,153	6,950	3,067	6,950
EG001	Zoster-022 Placebo Group	Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	459	6,950	1,214	6,950	610	6,950