Evaluate Vaccine Against Chickenpox and a Combined Vaccin... | NCT00226499

ID	Type	Description
104105 (EXT FU Y2)	Other Identifier	GSK
103494 (EXT FU Y1)	Other Identifier	GSK
104106 (EXT FU Y4-Y6-Y8-Y10)	Other Identifier	GSK
2004-002676-41	EudraCT Number

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MMRV Group	Experimental	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).	Biological: Priorix-tetra™
OKAH Group	Experimental	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.	Biological: Priorix™ Biological: Varilrix™
MMR Group	Active Comparator	Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).	Biological: Priorix™

Name	Type	Description	Arm Group Labels	Other Names
Priorix-tetra™	Biological	2 doses administered subcutaneously, one at Day 0 and the other at Day 42 to subjects in MMRV Group	MMRV Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Phase A: Number of Subjects With Confirmed Varicella Case	Confirmed varicella case = A case that met the clinical case definition [an illness with acute onset of diffuse, generalized maculopapulovesicular rash (i.e. spots, papules and/or vesicles) without other apparent cause] at least in the opinion of the investigator and was confirmed by laboratory test [Polymerase Chain Reaction (PCR) (+)] OR a case that met the clinical definition confirmed by the Independent Data Monitoring Committee (IDMC) and was epidemiologically linked [Epi (+)] to a valid index case.	From 42 days post dose 2 until the end of Phase A

Secondary Outcomes

Measure	Description	Time Frame
Phase A: Number of Subjects With Moderate or Severe Confirmed Varicella Case	Confirmed varicella case: A case that met the clinical case definition at least in the opinion of the investigator and was confirmed by laboratory test [PCR (+)] OR a case that met the clinical definition confirmed by the IDMC and was epidemiologically linked [Epi (+)] to a valid index case. Moderately severe disease: 8-15 points; severe disease: ≥ 16 points (scored by IDMC using the modified Vázquez scale).

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol for the whole duration of the study.
Male or female subject between 12 and 22 months of age at the time of the first vaccination.
Subjects free of obvious health problems, as established by medical history and physical examination before entering the study.
Written informed consent obtained from the parents/guardians of the subject after they have been informed on the risks and benefits of the study, in a language they clearly understand and before performance of any study procedure.
Subjects whose parents/guardians have direct access to telephone/mobile phone.
Subjects:
1. with at least one sibling (with negative history of varicella disease/vaccination) at home, or
2. attending day care center, or
3. attending childminders, i.e. someone taking care of several children, or
4. who are in contact for at least once a week with other children without a known positive history of varicella disease/vaccination, while playing in close physical contact for more than 5 minutes.

Exclusion criteria:

Previous vaccination against measles, mumps, rubella and/or varicella.
History of previous measles, mumps, rubella and/or varicella/ herpes zoster diseases.
Known exposure to measles, mumps, rubella and/or varicella/herpes zoster within 30 days prior to the start of the study.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Administration of immunoglobulins and/or any blood products within three months prior to the first vaccine dose or planned administration during the study period.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical.
Family history of congenital or hereditary immunodeficiency.
History of allergic diseases or reactions likely to be exacerbated by any component of the vaccines, including systemic allergy to egg proteins or neomycin.
Major congenital defects or serious chronic illness.
Residence in the same household as newborns (0-4 weeks of age), pregnant women who are varicella-susceptible, persons with a known immunodeficiency or any other persons at high risk for varicella.
History of any neurologic disorders or seizures.
Use of any investigational or non-registered product (drug/vaccine other than the study vaccines) within 14 days prior to vaccination and planned use during the study period.

Additional exclusion criteria for subjects included in the subset:

- Administration of a licensed vaccine within 14 days prior to vaccination and planned use until approximately 42 days after the last study vaccine dose (Day 84) with the exception of oral polio vaccine (OPV).

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Brno		628 00	Czechia
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29224964	Background	Henry O, Brzostek J, Czajka H, Leviniene G, Reshetko O, Gasparini R, Pazdiora P, Plesca D, Desole MG, Kevalas R, Gabutti G, Povey M, Innis B. One or two doses of live varicella virus-containing vaccines: Efficacy, persistence of immune responses, and safety six years after administration in healthy children during their second year of life. Vaccine. 2018 Jan 8;36(3):381-387. doi: 10.1016/j.vaccine.2017.11.081. Epub 2017 Dec 7.
24485548

Label	URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.	View source

ID	Type	URL	Comment
100388	Individual Participant Data Set	View IPD

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
FG001	OKAH Group

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
BG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
BG002	MMR Group	Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
BG003	Total	Total of all reporting groups

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

Phase A: Number of Subjects With Confirmed Varicella Case

Confirmed varicella case = A case that met the clinical case definition [an illness with acute onset of diffuse, generalized maculopapulovesicular rash (i.e. spots, papules and/or vesicles) without other apparent cause] at least in the opinion of the investigator and was confirmed by laboratory test [Polymerase Chain Reaction (PCR) (+)] OR a case that met the clinical definition confirmed by the Independent Data Monitoring Committee (IDMC) and was epidemiologically linked [Epi (+)] to a valid index case.

The analysis was performed on the According-to-Protocol (ATP) Cohort for Efficacy (Phase A), which included all evaluable subjects who had efficacy follow-up starting from 42 days post dose 2.

Posted

Count of Participants

Participants

From 42 days post dose 2 until the end of Phase A

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group	Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).

Units	Counts
Participants	OG0002279 OG0012263 OG002743

Title

Denominators

Categories

Title	Measurements
	OG00037 OG001243 OG002201

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	Vaccine Efficacy (VE) was measured by calculating the relative risk of a confirmed varicella case in a vaccine group compared to a confirmed varicella case in the control group.	Regression, Cox		<0.0001		Vaccine Efficacy	94.943			2-Sided	97.5	92.446	96.615					Other	To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).

Secondary

Phase A: Number of Subjects With Moderate or Severe Confirmed Varicella Case

Confirmed varicella case: A case that met the clinical case definition at least in the opinion of the investigator and was confirmed by laboratory test [PCR (+)] OR a case that met the clinical definition confirmed by the IDMC and was epidemiologically linked [Epi (+)] to a valid index case. Moderately severe disease: 8-15 points; severe disease: ≥ 16 points (scored by IDMC using the modified Vázquez scale).

The analysis was performed on the ATP Cohort for Efficacy (Phase A), which included all evaluable subjects who had efficacy follow-up starting from 42 days post dose 2.

Posted

Count of Participants

Participants

From 42 days post dose 2 until the end of Phase A

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group

Secondary

Phase A: Number of Subjects With Probable or Confirmed Varicella Case

Probable or confirmed varicella case = A case that met the clinical case definition (as determined by the IDMC) but was not laboratory confirmed [PCR (-)] AND was not epidemiologically linked [Epi (-)] to another probable or confirmed case.

The analysis was performed on the ATP Cohort for Efficacy (Phase A), which included all evaluable subjects who had efficacy follow-up starting from 42 days post dose 2.

Posted

Count of Participants

Participants

From 42 days post dose 2 until the end of Phase A

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group	Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).

Secondary

Phase A: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations

Anti-VZV antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL).

The analysis was performed on the ATP Cohort for Immunogenicity, which included all evaluable subjects who had pre-vaccination results available for at least one of the vaccine components.

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

At Day 0, Day 42, Day 84, Year 1 and Year 2 time points

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group	Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).

Secondary

Phase A: Number of Subjects With Seroconversion/Seroresponse to VZV

Seronegative (S-) = Subjects with antibody concentration less than (<) 25 mIU/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration greater than or equal to (≥) 25 mIU/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.

The analysis was performed on the ATP Cohort for Immunogenicity, which included all evaluable subjects who had pre-vaccination results available for at least one of the vaccine components.

Posted

Count of Participants

Participants

At Day 0, Day 42, Day 84, Year 1 and Year 2 time points

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group

Secondary

Phase A: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations in a Subset of Subjects

Anti-measles antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL).

The analysis was performed on the ATP Cohort for Immunogenicity, which included all evaluable subjects who had pre-vaccination results available for at least one of the vaccine components.

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

At Day 0, Day 42, Day 84, Year 1 and Year 2 time points

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group	Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).

Secondary

Phase A: Number of Subjects With Seroconversion/Seroresponse to Measles in a Subset of Subjects

Seronegative (S-) = Subjects with antibody concentration < 150 mIU/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration ≥ 150 mIU/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.

The analysis was performed on the ATP Cohort for Immunogenicity, which included all evaluable subjects who had pre-vaccination results available for at least one of the vaccine components.

Posted

Count of Participants

Participants

At Day 0, Day 42, Day 84, Year 1 and Year 2 time points

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group

Secondary

Phase A: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations in a Subset of Subjects

Anti-mumps antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in units per milliliter (U/mL).

The analysis was performed on the ATP Cohort for Immunogenicity, which included all evaluable subjects who had pre-vaccination results available for at least one of the vaccine components.

Posted

Geometric Mean

95% Confidence Interval

U/mL

At Day 0, Day 42, Day 84, Year 1 and Year 2 time points

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group	Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).

Secondary

Phase A: Number of Subjects With Seroconversion/Seroresponse to Mumps in a Subset of Subjects

Seronegative (S-) = Subjects with antibody concentration < 231 U/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration ≥ 231 U/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.

The analysis was performed on the ATP Cohort for Immunogenicity, which included all evaluable subjects who had pre-vaccination results available for at least one of the vaccine components.

Posted

Count of Participants

Participants

At Day 0, Day 42, Day 84, Year 1 and Year 2 time points

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group

Secondary

Phase A: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations in a Subset of Subjects

Anti-rubella antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in International Units per milliliter (IU/mL).

The analysis was performed on the ATP Cohort for Immunogenicity, which included all evaluable subjects who had pre-vaccination results available for at least one of the vaccine components.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

At Day 0, Day 42, Day 84, Year 1 and Year 2 time points

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group	Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).

Secondary

Phase A: Number of Subjects With a Seroconversion/Seroresponse to Rubella in a Subset of Subjects

Seronegative (S-) = Subjects with antibody concentration < 4 IU/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration ≥ 4 IU/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.

The analysis was performed on the ATP Cohort for Immunogenicity, which included all evaluable subjects who had pre-vaccination results available for at least one of the vaccine components.

Posted

Count of Participants

Participants

At Day 0, Day 42, Day 84, Year 1 and Year 2 time points

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group

Secondary

Phase A: Number of Subjects With Confirmed Cases of Herpes Zoster

The number of subjects with confirmed cases of herpes zoster is reported.

The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.

Posted

Count of Participants

Participants

From Day 0 until the end of Phase A (Year 2)

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group	Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).

Secondary

Phase A: Number of Subjects Reporting Fever

All fever = Occurrence of any fever (measured rectally) regardless of its intensity grade or relationship to vaccination. Related = fever (measured rectally) assessed by the investigator to be causally related to the study vaccination. Medical Advice = seek for medical advice.

The analysis was performed on a subset of the Total Vaccinated Cohort. The subset of subjects was identified as 200 subjects from each country. Depending on the country, this subset was stipulated to be either the first 200 subjects enrolled irrespective of the study center or 200 subjects enrolled at selected centers.

Posted

Count of Participants

Participants

Within 43 days (Day 0-42) post-vaccination period following each dose

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group

Secondary

Phase A: Number of Subjects Reporting Fever

All fever = Occurrence of any fever (measured rectally) regardless of its intensity grade or relationship to vaccination. Related fever = fever (measured rectally) assessed by the investigator to be causally related to the study vaccination. Medical Advice = seek for medical advice.

Posted

Count of Participants

Participants

Within 15 days (Day 0-14) post-vaccination period following each dose

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group

Secondary

Phase A: Number of Subjects Reporting Solicited Local Symptoms

Solicited local symptoms assessed were pain, redness and swelling. Any solicited local symptom = Occurrence of any local symptom regardless of their intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling = greater than (>) 20 mm.

Posted

Count of Participants

Participants

4 days post-vaccination period following each dose

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group

Secondary

Phase A: Number of Subjects Reporting Meningism

Any = Occurrence of meningism regardless of its intensity grade. Grade 3 meningism = Prevented normal, everyday activities. Related = Assessed by the investigator to be causally related to the study vaccination.

Posted

Count of Participants

Participants

Within 43 days (Day 0-42) post-vaccination period following each dose

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group	Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).

Secondary

Phase A: Number of Subjects Reporting Parotitis

Any = Occurrence of parotitis regardless of its intensity grade. Grade 3 parotitis = Swelling with accompanying general symptoms. Related = Assessed by the investigator to be causally related to the study.

Posted

Count of Participants

Participants

Within 43 days (Day 0-42) post-vaccination period following each dose

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group	Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).

Secondary

Phase A: Number of Subjects Reporting Rash

Any = Occurrence of rash regardless of its intensity grade. Grade 3 rash = 101-500 lesions. Grade 4 rash = > 500 lesions. Related rash = Assessed by the investigator to be causally related to the study vaccination.

Posted

Count of Participants

Participants

Within 43 days (Day 0-42) post-vaccination period following each dose

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group	Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).

Secondary

Phase A: Number of Subjects With Suspected Sign of Meningism Including Febrile Convulsions

Any = Occurrence of meningism including febrile convulsions regardless of intensity grade.

Posted

Count of Participants

Participants

Within 43 days (Day 0-42) post-vaccination period following each dose

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group	Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).

Secondary

Phase A: Number of Subjects Reporting Unsolicited Adverse Events (AEs)

Unsolicited AE assessed included any AE 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 = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.

Posted

Count of Participants

Participants

Within 43 days (Day 0-42) post-vaccination period following each dose

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group

Secondary

Phase A: Number of Subjects Reporting Serious Adverse Events (SAEs)

SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalisation or prolongation of hospitalisation or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Posted

Count of Participants

Participants

From Day 0 until the end of Phase A (Year 2)

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group	Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).

Secondary

Phase A: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness

Parameters assessed: 1. Number of hours lost from work by parents/guardians as a result of taking care of their child due to varicella. 2. Number of hours the child lost attendance in: day care/childminder, school, or in any extra-curricular activities (e.g. sports or recreation or any type of organised leisure activities) due to varicella. 3. Number of hours spent by a nurse, a babysitter or any type of existing paid caregiver to look after the child (if applicable).

The analysis was performed on the ATP Cohort for Efficacy (Phase A), which included all evaluable subjects who had efficacy follow-up starting from 42 days post dose 2.

Posted

Mean

Standard Deviation

Hours

During Phase A (from Day 0 up to Year 2)

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group

Secondary

Phase B: Number of Subjects With Confirmed Varicella Case

Confirmed varicella case = A case that met the clinical case definition at least in the opinion of the investigator and was confirmed by laboratory test [PCR (+)] OR a case that met the clinical definition confirmed by the IDMC and was epidemiologically linked [Epi (+)] to a valid index case.

The analysis was performed on the ATP Cohort for Efficacy (Phase B), which included all evaluable subjects who had efficacy follow-up from the period when Phase A was completed.

Posted

Count of Participants

Participants

From the beginning of Phase B (Year 2) up to study end (Year 10)

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group	Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).

Secondary

Phase B: Number of Subjects With Moderate or Severe Confirmed Varicella Case

The analysis was performed on the ATP Cohort for Efficacy (Phase B), which included all evaluable subjects who had efficacy follow-up from the period when Phase A was completed.

Posted

Count of Participants

Participants

From the beginning of Phase B (Year 2) up to study end (Year 10)

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group

Secondary

Phase B: Number of Subjects With Probable or Confirmed Varicella Case

Probable or confirmed varicella = A case that met the clinical case definition (as determined by the IDMC) but was not laboratory confirmed [PCR (-)] AND was not epidemiologically linked [Epi (-)] to another probable or confirmed case.

The analysis was performed on the ATP Cohort for Efficacy (Phase B), which included all evaluable subjects who had efficacy follow-up from the period when Phase A was completed.

Posted

Count of Participants

Participants

From the beginning of Phase B (Year 2) up to study end (Year 10)

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group	Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).

Secondary

Phase B: Characteristics of Varicella Cases

Varicella cases were characterized by type, number and character of lesions, duration of rash, incidence of fever, systemic signs, the assessment by investigator, complications, treatment, outcome and intensity of severity.

The analysis was performed on the ATP Cohort for Efficacy (Phase B), which included all evaluable subjects who had efficacy follow-up from the period when Phase A was completed.

Posted

Count of Participants

Participants

From the beginning of Phase B (Year 2) up to study end (Year 10)

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group	Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).

Secondary

Phase B: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations

Anti-VZV antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL).

The analysis was performed on the Adapted persistence cohort (Adapted ATP cohort for each specific time point).

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

At Year 4, Year 6, Year 8 and Year 10 time points

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group	Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).

Secondary

Phase B: Number of Subjects With Anti-VZV Antibody Concentrations Above the Cut-off Value

The anti-VZV antibody concentration cut-off value assessed was greater than or equal to (≥) 25 mIU/mL, in the sera of subjects seronegative before vaccination.

The analysis was performed on the Adapted persistence cohort (Adapted ATP cohort for each specific time point).

Posted

Count of Participants

Participants

At Year 4, Year 6, Year 8 and Year 10 time points

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group	Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).

Secondary

Phase B: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations

Anti-measles antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL).

The analysis was performed on the Adapted persistence cohort, subset for MMR testing (Adapted ATP cohort for each specific time point).

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

At Year 4, Year 6, Year 8 and Year 10 time points

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group	Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).

Secondary

Phase B: Number of Subjects With Anti-measles Antibody Concentrations Above the Cut-off Value

The anti-measles antibody concentration cut-off value assessed was ≥ 150 mIU/mL, in the sera of subjects seronegative before vaccination.

The analysis was performed on the Adapted persistence cohort, subset for MMR testing (Adapted ATP cohort for each specific time point).

Posted

Count of Participants

Participants

At Year 4, Year 6, Year 8 and Year 10 time points

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group	Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).

Secondary

Phase B: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations

Anti-mumps antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in units per milliliter (U/mL).

The analysis was performed on the Adapted persistence cohort, subset for MMR testing (Adapted ATP cohort for each specific time point).

Posted

Geometric Mean

95% Confidence Interval

U/mL

At Year 4, Year 6, Year 8 and Year 10 time points

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group	Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).

Secondary

Phase B: Number of Subjects With Anti-mumps Antibody Concentrations Above the Cut-off Value

The anti-mumps antibody concentration cut-off value assessed was ≥ 231 U/mL, in the sera of subjects seronegative before vaccination.

The analysis was performed on the Adapted persistence cohort, subset for MMR testing (Adapted ATP cohort for each specific time point).

Posted

Count of Participants

Participants

At Year 4, Year 6, Year 8 and Year 10 time points

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group	Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).

Secondary

Phase B: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations

Anti-rubella antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in international units per milliliter (IU/mL).

The analysis was performed on the Adapted persistence cohort, subset for MMR testing (Adapted ATP cohort for each specific time point).

Posted

Geometric Mean

95% Confidence Interval

IU/mL

At Year 4, Year 6, Year 8 and Year 10 time points

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group	Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).

Secondary

Phase B: Number of Subjects With Anti-rubella Antibody Concentrations Above the Cut-off Value

The anti-rubella antibody concentration cut-off value assessed was ≥ 4 IU/mL, in the sera of subjects seronegative before vaccination.

The analysis was performed on the Adapted persistence cohort, subset for MMR testing (Adapted ATP cohort for each specific time point).

Posted

Count of Participants

Participants

At Year 4, Year 6, Year 8 and Year 10 time points

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group	Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).

Secondary

Phase B: Characteristics of Zoster Cases

Zoster cases were characterized by number and character of lesions, duration of rash, incidence of fever, systemic signs, the assessment by investigator, complications, treatment, outcome and intensity of severity.

The analysis was performed on the ATP Cohort for Efficacy (Phase A), which included all evaluable subjects who had efficacy follow-up starting from 42 days post dose 2 and from the period when Phase A was completed.

Posted

Count of Participants

Participants

From 6 weeks after Dose 2 until study end (Year 10)

ID	Title	Description
OG000	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG001	MMR Group	Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).

Units	Counts
Participants

Secondary

Phase B: Number of Subjects Reporting Serious Adverse Events (SAEs)

The analysis was performed on the Total enrolled cohort in Phase B, which included all subjects from the Total Vaccinated cohort in Phase A who returned for at least one visit in Phase B

Posted

Count of Participants

Participants

From the beginning of Phase B (Year 2) up to study end (Year 10)

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group	Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).

Secondary

Phase B: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness

The analysis was performed on the ATP Cohort for Efficacy (Phase B), which included all evaluable subjects who had efficacy follow-up from the period when Phase A was completed.

Posted

Mean

Standard Deviation

Hours

During Phase B

ID	Title	Description
OG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
OG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
OG002	MMR Group

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	MMRV Group	Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).	1	2,489	649	2,489	666	2,489
EG001	OKAH Group	Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.	1	2,487	681	2,487	641	2,487
EG002	MMR Group	Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).	0	827	208	827	204	827

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal lymphadenopathy	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0007 events6 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0020 events0 affected827 at risk
Haemorrhagic diathesis	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Immune thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0020 events0 affected827 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0008 events7 affected2,489 at risk EG0019 events9 affected2,487 at risk EG0021 events1 affected827 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Arrhythmia	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Cyanosis	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Long qt syndrome	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Palpitations	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Tachycardia	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Anomaly of external ear congenital	Congenital, familial and genetic disorders	MedDRA 12.1	Systematic Assessment	EG0002 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Atrial septal defect	Congenital, familial and genetic disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Choledochal cyst	Congenital, familial and genetic disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Congenital cystic kidney disease	Congenital, familial and genetic disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Congenital inguinal hernia	Congenital, familial and genetic disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Congenital oral malformation	Congenital, familial and genetic disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Cryptorchism	Congenital, familial and genetic disorders	MedDRA 12.1	Systematic Assessment	EG0003 events3 affected2,489 at risk EG0013 events3 affected2,487 at risk EG0020 events0 affected827 at risk
Cystic fibrosis	Congenital, familial and genetic disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Double ureter	Congenital, familial and genetic disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Duane's syndrome	Congenital, familial and genetic disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Hereditary pancreatitis	Congenital, familial and genetic disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0015 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Hernia congenital	Congenital, familial and genetic disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA 12.1	Systematic Assessment	EG0009 events8 affected2,489 at risk EG0015 events5 affected2,487 at risk EG0020 events0 affected827 at risk
Neurofibromatosis	Congenital, familial and genetic disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Phimosis	Congenital, familial and genetic disorders	MedDRA 12.1	Systematic Assessment	EG00012 events12 affected2,489 at risk EG0015 events5 affected2,487 at risk EG0022 events2 affected827 at risk
Primary ciliary dyskinesia	Congenital, familial and genetic disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Thalassaemia beta	Congenital, familial and genetic disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Ear deformity acquired	Ear and labyrinth disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
External ear disorder	Ear and labyrinth disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Inner ear disorder	Ear and labyrinth disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Otorrhoea	Ear and labyrinth disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0021 events1 affected827 at risk
Endocrine disorder	Endocrine disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Thyroiditis	Endocrine disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Astigmatism	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Chalazion	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0020 events0 affected827 at risk
Eye haemorrhage	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Eyelid oedema	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Inflammation of lacrimal passage	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Papilloedema	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Strabismus	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0020 events0 affected827 at risk
Visual impairment	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0007 events7 affected2,489 at risk EG00114 events14 affected2,487 at risk EG0025 events5 affected827 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Anal stenosis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Aphthous ulcer	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0003 events3 affected2,489 at risk EG0013 events3 affected2,487 at risk EG0020 events0 affected827 at risk
Coeliac disease	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0021 events1 affected827 at risk
Constipation	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0013 events3 affected2,487 at risk EG0020 events0 affected827 at risk
Dental caries	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0014 events4 affected2,487 at risk EG0021 events1 affected827 at risk
Diarrhoea haemorrhagic	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Duodenitis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0004 events4 affected2,489 at risk EG0016 events6 affected2,487 at risk EG0020 events0 affected827 at risk
Enteritis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0006 events6 affected2,489 at risk EG0017 events7 affected2,487 at risk EG0022 events2 affected827 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0004 events4 affected2,489 at risk EG0014 events4 affected2,487 at risk EG0020 events0 affected827 at risk
Functional gastrointestinal disorder	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Gastritis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG00034 events31 affected2,489 at risk EG00125 events22 affected2,487 at risk EG0029 events9 affected827 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Gastroduodenitis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0003 events3 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0021 events1 affected827 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0021 events1 affected827 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG00013 events13 affected2,489 at risk EG00116 events16 affected2,487 at risk EG0026 events5 affected827 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Intussusception	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Lip disorder	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0020 events0 affected827 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Teething	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Tooth loss	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0006 events6 affected2,489 at risk EG0015 events5 affected2,487 at risk EG0021 events1 affected827 at risk
Vomiting	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0005 events5 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0021 events1 affected827 at risk
Accidental death	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Chest pain	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Crying	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Cyst	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Granuloma	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Hyperpyrexia	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Hyperthermia malignant	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Ill-defined disorder	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Influenza like illness	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Pain	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Polyp	General disorders	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Pyrexia	General disorders	MedDRA 12.1	Systematic Assessment	EG0003 events2 affected2,489 at risk EG0012 events1 affected2,487 at risk EG0021 events1 affected827 at risk
Soft tissue inflammation	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Gallbladder disorder	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Liver disorder	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Allergic oedema	Immune system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Allergy to arthropod sting	Immune system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Anaphylactoid reaction	Immune system disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Atopy	Immune system disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0020 events0 affected827 at risk
Hypersensitivity	Immune system disorders	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0021 events1 affected827 at risk
Immunodeficiency	Immune system disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Abscess neck	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Acute sinusitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0014 events4 affected2,487 at risk EG0022 events2 affected827 at risk
Adenoiditis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Adenovirus infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Anal abscess	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Appendicitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG00014 events14 affected2,489 at risk EG00112 events12 affected2,487 at risk EG0025 events5 affected827 at risk
Ascariasis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Bacterial diarrhoea	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Bacterial infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0021 events1 affected827 at risk
Bacteriuria	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Body tinea	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Borrelia infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0021 events1 affected827 at risk
Bronchiolitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0022 events2 affected827 at risk
Bronchitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG00055 events47 affected2,489 at risk EG00165 events51 affected2,487 at risk EG00215 events15 affected827 at risk
Bronchitis haemophilus	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Campylobacter gastroenteritis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0021 events1 affected827 at risk
Campylobacter infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0020 events0 affected827 at risk
Cellulitis orbital	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Chronic tonsillitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0003 events3 affected2,489 at risk EG0019 events9 affected2,487 at risk EG0022 events2 affected827 at risk
Conjunctivitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0021 events1 affected827 at risk
Croup infectious	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Cystitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0003 events3 affected2,489 at risk EG0013 events3 affected2,487 at risk EG0021 events1 affected827 at risk
Diarrhoea infectious	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Ear infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0004 events4 affected2,489 at risk EG0013 events3 affected2,487 at risk EG0020 events0 affected827 at risk
Eczema impetiginous	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Encephalitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Enteritis infectious	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0005 events5 affected2,489 at risk EG0015 events5 affected2,487 at risk EG0026 events6 affected827 at risk
Enterobiasis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Enterocolitis infectious	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Enterovirus infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Epididymitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Epstein-barr virus infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Erythema infectiosum	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0021 events1 affected827 at risk
Exanthema subitum	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Eye infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Febrile infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Gastritis viral	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Gastroenteritis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG00074 events67 affected2,489 at risk EG00179 events71 affected2,487 at risk EG00228 events26 affected827 at risk
Gastroenteritis adenovirus	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Gastroenteritis bacterial	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Gastroenteritis rotavirus	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG00027 events27 affected2,489 at risk EG00142 events42 affected2,487 at risk EG00213 events13 affected827 at risk
Gastroenteritis salmonella	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0019 events9 affected2,487 at risk EG0020 events0 affected827 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0014 events4 affected2,487 at risk EG0021 events1 affected827 at risk
Gastrointestinal bacterial overgrowth	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Gastrointestinal viral infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0021 events1 affected827 at risk
H1n1 influenza	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0020 events0 affected827 at risk
Helicobacter gastritis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Hepatitis a	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Herpangina	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0003 events3 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0022 events2 affected827 at risk
Herpes simplex	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Herpes zoster	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Infectious mononucleosis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0005 events5 affected2,489 at risk EG0017 events7 affected2,487 at risk EG0020 events0 affected827 at risk
Influenza	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0021 events1 affected827 at risk
Laryngitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG00051 events39 affected2,489 at risk EG00156 events45 affected2,487 at risk EG0028 events8 affected827 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Mastoiditis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Meningitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0013 events3 affected2,487 at risk EG0020 events0 affected827 at risk
Meningitis aseptic	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Meningitis borrelia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Meningococcal sepsis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Molluscum contagiosum	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0013 events3 affected2,487 at risk EG0020 events0 affected827 at risk
Nasal abscess	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Nasopharyngitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG00017 events17 affected2,489 at risk EG0016 events6 affected2,487 at risk EG0023 events3 affected827 at risk
Neuroborreliosis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Oral herpes	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0014 events3 affected2,487 at risk EG0022 events2 affected827 at risk
Orchitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Oropharyngitis fungal	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Otitis media	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG00019 events17 affected2,489 at risk EG0017 events7 affected2,487 at risk EG0023 events3 affected827 at risk
Otitis media acute	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0005 events5 affected2,489 at risk EG0017 events7 affected2,487 at risk EG0020 events0 affected827 at risk
Otitis media chronic	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0021 events1 affected827 at risk
Overgrowth bacterial	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Parotitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Parvovirus b19 infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Periodontitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Peritonitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Peritonsillar abscess	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0015 events4 affected2,487 at risk EG0020 events0 affected827 at risk
Pharyngitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG00021 events20 affected2,489 at risk EG00113 events13 affected2,487 at risk EG0022 events2 affected827 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0006 events6 affected2,489 at risk EG00110 events10 affected2,487 at risk EG0023 events3 affected827 at risk
Pilonidal cyst	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Pneumonia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG00080 events70 affected2,489 at risk EG00166 events63 affected2,487 at risk EG00231 events30 affected827 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Pneumonia viral	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Pseudocroup	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0020 events0 affected827 at risk
Pyelonephritis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0004 events3 affected2,489 at risk EG0014 events4 affected2,487 at risk EG0023 events3 affected827 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0004 events4 affected2,489 at risk EG0017 events7 affected2,487 at risk EG0021 events1 affected827 at risk
Pyoderma	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Respiratory tract infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0004 events4 affected2,489 at risk EG0013 events3 affected2,487 at risk EG0022 events2 affected827 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Rhinitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0014 events3 affected2,487 at risk EG0020 events0 affected827 at risk
Rotavirus infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Salmonellosis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0006 events6 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0021 events1 affected827 at risk
Scarlet fever	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Sepsis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Sinusitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0007 events7 affected2,489 at risk EG0015 events4 affected2,487 at risk EG0025 events5 affected827 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0020 events0 affected827 at risk
Tonsillitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG00023 events23 affected2,489 at risk EG00119 events18 affected2,487 at risk EG0029 events7 affected827 at risk
Tonsillitis bacterial	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0004 events4 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Tonsillitis streptococcal	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Toxocariasis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Tracheitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0009 events9 affected2,489 at risk EG0015 events4 affected2,487 at risk EG0024 events3 affected827 at risk
Tracheobronchitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0013 events3 affected2,487 at risk EG0021 events1 affected827 at risk
Tuberculosis of intrathoracic lymph nodes	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0008 events8 affected2,489 at risk EG0019 events9 affected2,487 at risk EG0023 events3 affected827 at risk
Urinary tract infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0006 events6 affected2,489 at risk EG0013 events3 affected2,487 at risk EG0021 events1 affected827 at risk
Varicella	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0013 events3 affected2,487 at risk EG0020 events0 affected827 at risk
Viral diarrhoea	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Viral infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0004 events4 affected2,489 at risk EG00111 events11 affected2,487 at risk EG0024 events4 affected827 at risk
Viral myositis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Viral pharyngitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Viral tonsillitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0006 events5 affected2,489 at risk EG00110 events9 affected2,487 at risk EG0025 events5 affected827 at risk
Vulvitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Abdominal injury	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Accident	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Accidental exposure to product	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0004 events4 affected2,489 at risk EG00110 events10 affected2,487 at risk EG0021 events1 affected827 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Arthropod sting	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0021 events1 affected827 at risk
Bite	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Burn oral cavity	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Burns second degree	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0020 events0 affected827 at risk
Carbon monoxide poisoning	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0020 events0 affected827 at risk
Chemical injury	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0003 events3 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Chemical poisoning	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Child maltreatment syndrome	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG00024 events23 affected2,489 at risk EG00126 events26 affected2,487 at risk EG0028 events7 affected827 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG00015 events15 affected2,489 at risk EG00113 events13 affected2,487 at risk EG0022 events2 affected827 at risk
Dislocation of vertebra	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0020 events0 affected827 at risk
Exposure to toxic agent	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Eye contusion	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Eye injury	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0013 events3 affected2,487 at risk EG0021 events1 affected827 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0020 events0 affected827 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0006 events6 affected2,489 at risk EG0019 events9 affected2,487 at risk EG0020 events0 affected827 at risk
Foreign body	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0003 events3 affected2,489 at risk EG0013 events2 affected2,487 at risk EG0022 events2 affected827 at risk
Foreign body aspiration	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Fracture displacement	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0013 events3 affected2,487 at risk EG0020 events0 affected827 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0008 events8 affected2,489 at risk EG0019 events9 affected2,487 at risk EG0020 events0 affected827 at risk
Heat stroke	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0005 events5 affected2,489 at risk EG0019 events9 affected2,487 at risk EG0020 events0 affected827 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Kidney contusion	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0004 events4 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Liver contusion	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Nasal injury	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Near drowning	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Neck injury	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Open fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0020 events0 affected827 at risk
Pancreatic injury	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Penile contusion	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Poisoning	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0021 events1 affected827 at risk
Poisoning deliberate	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0004 events4 affected2,489 at risk EG0016 events6 affected2,487 at risk EG0021 events1 affected827 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Skin wound	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Struck by lightning	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0006 events6 affected2,489 at risk EG0019 events9 affected2,487 at risk EG0021 events1 affected827 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Tongue injury	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Tooth injury	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0022 events2 affected827 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0013 events3 affected2,487 at risk EG0021 events1 affected827 at risk
Venomous sting	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0004 events4 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0020 events0 affected827 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Medical observation	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG00010 events9 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0006 events2 affected2,489 at risk EG0013 events3 affected2,487 at risk EG0022 events1 affected827 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0015 events1 affected2,487 at risk EG0024 events1 affected827 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0020 events0 affected827 at risk
Ketoacidosis	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Lactose intolerance	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0020 events0 affected827 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0020 events0 affected827 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0013 events3 affected2,487 at risk EG0021 events1 affected827 at risk
Weight gain poor	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0003 events3 affected2,489 at risk EG0013 events3 affected2,487 at risk EG0022 events2 affected827 at risk
Arthritis reactive	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Bone disorder	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Fistula	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Growth retardation	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Juvenile idiopathic arthritis	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0020 events0 affected827 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Periostitis	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0020 events0 affected827 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Rickets	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Sacroiliitis	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Scoliosis	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Torticollis	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0020 events0 affected827 at risk
Trigger finger	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Acute leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Acute lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0021 events1 affected827 at risk
Acute lymphocytic leukaemia recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Astrocytoma, low grade	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Benign bone neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Laryngeal papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Medulloblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Nephroblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Neuroblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Osteochondroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Ovarian germ cell teratoma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Rhabdomyosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Teratoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Autism	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Benign rolandic epilepsy	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Brain injury	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Cluster headache	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Coordination abnormal	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Dizziness	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Dysgraphia	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Dyslexia	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Epilepsy	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0005 events4 affected2,489 at risk EG0016 events5 affected2,487 at risk EG0022 events1 affected827 at risk
Facial paralysis	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Facial paresis	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0012 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Febrile convulsion	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG00023 events21 affected2,489 at risk EG00123 events20 affected2,487 at risk EG0024 events4 affected827 at risk
Headache	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0014 events4 affected2,487 at risk EG0021 events1 affected827 at risk
Intellectual disability	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Language disorder	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Loss of consciousness	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Migraine	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0020 events0 affected827 at risk
Nervous system disorder	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Paraparesis	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Peripheral nerve palsy	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Polyneuropathy	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Postictal state	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Seizure	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0016 events5 affected2,487 at risk EG0021 events1 affected827 at risk
Speech disorder	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Speech disorder developmental	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Syncope	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0014 events4 affected2,487 at risk EG0021 events1 affected827 at risk
Abnormal behaviour	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Adjustment disorder	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0020 events0 affected827 at risk
Adjustment disorder with mixed anxiety and depressed mood	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Affective disorder	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Agitation	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Attention deficit/hyperactivity disorder	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0003 events3 affected2,489 at risk EG0015 events3 affected2,487 at risk EG0020 events0 affected827 at risk
Breath holding	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0003 events3 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Depression	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Enuresis	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0021 events1 affected827 at risk
Learning disorder	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Mental disorder	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Neurosis	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Nightmare	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Psychomotor retardation	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Reading disorder	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Tic	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Dysuria	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Glomerulonephritis	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Glomerulonephritis acute	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Glomerulonephritis chronic	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Haematuria	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Micturition disorder	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Nephritis	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0021 events1 affected827 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Proteinuria	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0002 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Renal haematoma	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Urinary retention	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0022 events2 affected827 at risk
Vesicoureteric reflux	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Acquired phimosis	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Balanoposthitis	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Penile adhesion	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0003 events3 affected2,489 at risk EG0014 events4 affected2,487 at risk EG0021 events1 affected827 at risk
Penis disorder	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0003 events3 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Testicular appendage torsion	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Testicular atrophy	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Testicular disorder	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Testicular retraction	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0020 events0 affected827 at risk
Adenoidal hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG000116 events111 affected2,489 at risk EG001129 events123 affected2,487 at risk EG00239 events39 affected827 at risk
Asphyxia	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG00013 events11 affected2,489 at risk EG0018 events8 affected2,487 at risk EG0025 events5 affected827 at risk
Asthmatic crisis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Hyperventilation	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Laryngeal obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0013 events2 affected2,487 at risk EG0020 events0 affected827 at risk
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Laryngospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0020 events0 affected827 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Status asthmaticus	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0012 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Tonsillar hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0007 events7 affected2,489 at risk EG0016 events6 affected2,487 at risk EG0023 events3 affected827 at risk
Vocal cord thickening	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0021 events1 affected827 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0006 events6 affected2,489 at risk EG0014 events4 affected2,487 at risk EG0023 events3 affected827 at risk
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0003 events2 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0020 events0 affected827 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0002 events2 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Erythema nodosum	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk
Henoch-schonlein purpura	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Prurigo	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0021 events1 affected827 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Rash vesicular	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Skin burning sensation	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Toxic skin eruption	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0004 events4 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0021 events1 affected827 at risk
Circumcision	Surgical and medical procedures	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Circulatory collapse	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0011 events1 affected2,487 at risk EG0020 events0 affected827 at risk
Kawasaki's disease	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected2,489 at risk EG0012 events2 affected2,487 at risk EG0020 events0 affected827 at risk
Vasculitis	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected2,489 at risk EG0010 events0 affected2,487 at risk EG0020 events0 affected827 at risk

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

ID	Term
D017778	Vaccines, Combined
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures
D008458	Measles Vaccine
D014765	Viral Vaccines
D009108	Mumps Vaccine
D012411	Rubella Vaccine

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Injection site erythema	General disorders	MedDRA 12.1	Systematic Assessment	EG000325 events244 affected2,489 at risk EG001260 events183 affected2,487 at risk EG00260 events43 affected827 at risk
Pyrexia	General disorders	MedDRA 12.1	Systematic Assessment	EG000849 events604 affected2,489 at risk EG001790 events574 affected2,487 at risk EG002253 events188 affected827 at risk
Injection site pain	General disorders	MedDRA 12.1	Systematic Assessment	EG000165 events124 affected2,489 at risk EG001146 events111 affected2,487 at risk EG00237 events31 affected827 at risk

ID	Term
C577557	Priorix-Tetra vaccine
D022542	Measles-Mumps-Rubella Vaccine