Consistency Study of GlaxoSmithKline (GSK) Biologicals' M... | NCT01702428

NCT01702428

ID	Type	Description	Link
2011-004891-12	EudraCT Number

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
INV_MMR_L1 Group	Experimental	Subjects receive 1 dose of GSK's candidate combined measles, mumps and rubella (MMR) investigational vaccine (INV_MMR) Lot 1 (L1) co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects are also given PCV-13 vaccine. The MMR vaccine is administered subcutaneously in the triceps region of the left arm while the VV vaccine is administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Biological: Priorix Biological: Varivax Biological: Havrix Biological: Prevnar 13
INV_MMR_L2 Group	Experimental	Subjects receive 1 dose of GSK's candidate combined measles, mumps and rubella (MMR) investigational vaccine (INV_MMR) Lot 2 (L2) co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects are also given PCV-13 vaccine. The MMR vaccine is administered subcutaneously in the triceps region of the left arm while the VV vaccine is administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Biological: Priorix Biological: Varivax Biological: Havrix Biological: Prevnar 13
INV_MMR_L3 Group	Experimental	Subjects receive 1 dose of GSK's candidate combined measles, mumps and rubella (MMR) investigational vaccine (INV_MMR) Lot 3 (L3) co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects are also given PCV-13 vaccine. The MMR vaccine is administered subcutaneously in the triceps region of the left arm while the VV vaccine is administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Priorix	Biological	Subjects receive 1 dose of MMR vaccine which is administered subcutaneously in the triceps region of the left arm.	INV_MMR_L1 Group INV_MMR_L2 Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value	Seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥200 milli International Unit/Milliliter (mIU/mL) among subjects who were seronegative (antibody concentration <150 mIU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.	At Day 42
Anti-measles Virus Antibody Concentrations	Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.	At Day 42
Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value	Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥10 ELISA Unit/Milliliter (EU/mL) among subjects who were seronegative (antibody concentrations <5 EU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.	At Day 42
Anti-mumps Virus Antibody Concentration	Antibody concentrations were expressed as GMCs in EU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.	At Day 42
Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Subjects With an Anti-Varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off Value in US Sub-cohort of Pooled MMR Groups	Seroresponse was defined as post-vaccination anti-VZV antibody concentration ≥75 mIU/mL among subjects who were seronegative (antibody concentration <25 mIU/mL) before vaccination.	At Day 42

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female child between 12 and 15 months of age at the time of vaccination.
The investigator believes that the parent(s) or Legally Acceptable Representative(s) (LAR(s)) of the child, can, and will comply with the requirements of the protocol.
Written informed consent obtained from the parent(s)/LAR(s) of the child.
Child is in stable health as determined by investigator's clinical examination and assessment of child's medical history.

For US children only:

• Child that previously received a 3-dose series of Prevnar 13 only (i.e., no doses given as Prevnar/Prevenar), with the last dose at least 60 days prior to study entry.

Exclusion Criteria:

Child in care.
Use of any investigational or non-registered product other than the study vaccine(s) during the period starting 30 days before the day of study vaccination (i.e., 30 days prior to Day 0) or planned use during the entire study period.
Concurrently participating in another clinical study, in which the child has been or will be exposed to an investigational or a non-investigational product.
Chronic administration of immunosuppressants, or other immune-modifying drugs during the period starting 180 days prior to the first vaccine dose or any planned administration of immunosuppressive and immune-modifying drugs during the entire study.
- For corticosteroids, this will mean prednisone, ≥0.5 mg/kg/day or equivalent.
- Inhaled and topical steroids are allowed.
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to study vaccination at Visit 1 and ending at Visit 2. Please Note:
- Inactivated influenza (Flu) vaccine and Haemophilus influenzae type b conjugate vaccine (Hib) vaccines may be given at any time, including the day of study vaccination (Flu and Hib vaccines must be administered at a different location than the study vaccine/s).
- Any other age appropriate vaccine may be given starting at Visit 2 and anytime thereafter.
Administration of immunoglobulins and/or any blood products during the period starting 180 days prior to study vaccination at Visit 1 or planned administration from the date of vaccination through the immunogenicity evaluation at Visit 2.
History of measles, mumps, rubella, varicella/zoster and/or hepatitis A disease.
Known exposure to measles, mumps, rubella and/or varicella/zoster during the period starting within 30 days prior to first study vaccination.
Previous vaccination against measles, mumps, rubella, hepatitis A and/or varicella virus.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
A family history of congenital or hereditary immunodeficiency.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including hypersensitivity to neomycin, latex or gelatin.
Blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
Acute disease at the time of enrollment. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection without fever.
Active untreated tuberculosis based on medical history.
Any other condition which, in the opinion of the investigator, prevents the child from participating in the study.

For US children only:

Child that previously received a vaccination with heptavalent Prevnar/Prevenar (prior vaccination should be with 3 doses of Prevnar 13 only).
Child that previously received a fourth dose of any pneumococcal conjugate vaccine.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Dothan	Alabama	36305	United States
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
30849175	Background	Klein NP, Abu-Elyazeed R, Povey M, Macias Parra M, Diez-Domingo J, Ahonen A, Korhonen T, Tinoco JC, Weiner L, Marshall GS, Silas PE, Sarpong KO, Ramsey KP, Fling JA, Speicher D, Campos M, Munjal I, Peltier C, Vesikari T, Baccarini C, Caplanusi A, Gillard P, Carryn S, Henry O. Immunogenicity and Safety of a Measles-Mumps-Rubella Vaccine Administered as a First Dose to Children Aged 12 to 15 Months: A Phase III, Randomized, Noninferiority, Lot-to-Lot Consistency Study. J Pediatric Infect Dis Soc. 2020 Apr 30;9(2):194-201. doi: 10.1093/jpids/piz010.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	INV_MMR_L1 Group	Subjects received 1 dose of GSK's candidate combined measles, mumps and rubella (MMR) investigational vaccine (INV_MMR) Lot 1 (L1) co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	INV_MMR_L1 Group	Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
BG001	INV_MMR_L2 Group	Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
BG002	INV_MMR_L3 Group	Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
BG003	COM_MMR Group	Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.
BG004	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

Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value

Seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥200 milli International Unit/Milliliter (mIU/mL) among subjects who were seronegative (antibody concentration <150 mIU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.

According to protocol (ATP) cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule

Posted

Number

95% Confidence Interval

Percentage of subjects

At Day 42

ID	Title	Description
OG000	INV_MMR _L1 Group	Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
OG001	INV_MMR _L2 Group	Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
OG002	INV_MMR _L3 Group	Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

Units	Counts
Participants	OG0001083 OG0011069 OG0021096

Title

Denominators

Categories

Anti-measles ≥ 150 mIU/mL

Title	Measurements
	OG00098.2(97.3 to 98.9) OG00198.9(98.0 to 99.4) OG00298.1(97.1 to 98.8)

Anti-measles ≥ 200 mIU/mL

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 OG001	Difference between groups (INV_MMR_L1 Group minus INV_MMR_L2 Group) in percentage of subjects with anti-measles antibody concentration ≥200 mIU/mL.					Difference in seroresponse rate	-0.54			2-Sided	95	-1.69	0.58			Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.		Non-Inferiority or Equivalence (legacy)	For each pair-wise comparison, the 2-sided 95% confidence interval (CI) on the lot difference in seroresponse rates should be within the [-5%;5%] margin for antibodies to measles virus.

Primary

Anti-measles Virus Antibody Concentrations

Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.

ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

At Day 42

ID	Title	Description
OG000	INV_MMR _L1 Group	Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
OG001	INV_MMR _L2 Group	Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

Primary

Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value

Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥10 ELISA Unit/Milliliter (EU/mL) among subjects who were seronegative (antibody concentrations <5 EU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.

Posted

Number

95% Confidence Interval

Percentage of subjects

At Day 42

ID	Title	Description
OG000	INV_MMR_L1 Group	Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
OG001	INV_MMR_L2 Group	Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

Primary

Anti-mumps Virus Antibody Concentration

Antibody concentrations were expressed as GMCs in EU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.

Posted

Geometric Mean

95% Confidence Interval

EU/mL

At Day 42

ID	Title	Description
OG000	INV_MMR_L1 Group	Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
OG001	INV_MMR_L2 Group	Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

Primary

Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value

Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥10 International Unit/Milliliter (IU/mL) among subjects who were seronegative (antibody concentrations <4 IU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.

Posted

Number

95% Confidence Interval

Percentage of subjects

At Day 42

ID	Title	Description
OG000	INV_MMR_L1 Group	Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
OG001	INV_MMR_L2 Group	Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

Primary

Anti-rubella Virus Antibody Concentration

Antibody concentrations were expressed as GMCs in IU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

At Day 42

ID	Title	Description
OG000	INV_MMR_L1 Group	Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
OG001	INV_MMR_L2 Group	Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

Primary

Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups

Seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥200 mIU/mL among subjects who were seronegative (antibody concentration <150 mIU/mL) before vaccination. Criteria to demonstrate an acceptable immune response for INV_MMR in terms of seroresponse rates to measles virus at Day 42: The LL of 2-sided 95% CI for the seroresponse rate for the pooled INV_MMR lots is ≥90% for antibodies to measles virus.

Posted

Number

95% Confidence Interval

Percentage of subjects

At Day 42

ID	Title	Description
OG000	INV_MMR Group	This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.
OG001	COM_MMR Group	Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.

Primary

Anti-measles Virus Antibody Concentrations in Pooled MMR Groups

Antibody concentrations were expressed as GMCs in mIU/mL.

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

At Day 42

ID	Title	Description
OG000	INV_MMR Group	This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.
OG001	COM_MMR Group	Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.

Primary

Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups

Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥10 EU/mL among subjects who were seronegative (antibody concentrations <5 EU/mL) before vaccination.

Posted

Number

95% Confidence Interval

Percentage of subjects

At Day 42

ID	Title	Description
OG000	INV_MMR Group	This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.
OG001	COM_MMR Group	Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.

Primary

Anti-mumps Virus Antibody Concentration in Pooled MMR Groups

Antibody concentrations were expressed as GMCs in EU/mL.

Posted

Geometric Mean

95% Confidence Interval

EU/mL

At Day 42

ID	Title	Description
OG000	INV_MMR Group	This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.
OG001	COM_MMR Group	Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.

Primary

Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups

Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥10 IU/mL among subjects who were seronegative (antibody concentrations <4 IU/mL) before vaccination. Criteria to demonstrate an acceptable immune response for INV_MMR in terms of seroresponse rates to rubella virus at Day 42: The LL of 2-sided 95% CI for the seroresponse rate for the pooled INV_MMR lots is ≥90% for antibodies to rubella virus.

Posted

Number

95% Confidence Interval

Percentage of subjects

At Day 42

ID	Title	Description
OG000	INV_MMR Group	This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.
OG001	COM_MMR Group	Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.

Primary

Anti-rubella Virus Antibody Concentration in Pooled MMR Groups

Antibody concentrations were expressed as GMCs in IU/mL.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

At Day 42

ID	Title	Description
OG000	INV_MMR Group	This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.
OG001	COM_MMR Group	Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.

Secondary

Percentage of Subjects With an Anti-Varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off Value in US Sub-cohort of Pooled MMR Groups

Seroresponse was defined as post-vaccination anti-VZV antibody concentration ≥75 mIU/mL among subjects who were seronegative (antibody concentration <25 mIU/mL) before vaccination.

ATP cohort for immunogenicity included subjects from US sub-cohort who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule

Posted

Number

95% Confidence Interval

Percentage of subjects

At Day 42

ID	Title	Description
OG000	INV_MMR Group	This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.
OG001	COM_MMR Group	Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.

Secondary

Anti-VZV Virus Antibody Concentration in US Sub-cohort of Pooled MMR Groups

Antibody concentrations were expressed as GMCs in mIU/mL.

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

At Day 42

ID	Title	Description
OG000	INV_MMR Group	This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.
OG001	COM_MMR Group	Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.

Secondary

Percentage of Subjects With an Anti-HAV Antibody Concentration Equal to or Above the Cut-off Value in US Sub-cohort of Pooled MMR Groups

Percentage of subjects with an Anti-HAV antibody concentration equal to or above 15 mIU/mL were reported.

Posted

Number

95% Confidence Interval

Percentage of subjects

At Day 42

ID	Title	Description
OG000	INV_MMR Group	This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.
OG001	COM_MMR Group	Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.

Secondary

Anti-HAV Antibody Concentrations in US Sub-cohort of Pooled MMR Groups

Antibody concentrations were expressed as GMCs in mIU/mL.

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

At Day 42

ID	Title	Description
OG000	INV_MMR Group	This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.
OG001	COM_MMR Group	Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.

Secondary

Anti-S.Pneumoniae Antibody Concentration in US Sub-cohort of Pooled MMR Groups

Antibody concentrations were expressed as GMCs in microgram/Milliliter (µg/mL).

Posted

Geometric Mean

95% Confidence Interval

µg/mL

At Day 42

ID	Title	Description
OG000	INV_MMR Group	This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.
OG001	COM_MMR Group	Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.

Secondary

Number of Subjects With Any Solicited Local Adverse Events (AEs)

Assessed solicited local AEs were pain, redness and swelling. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.

Total Vaccinated cohort (TVC) included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented

Posted

Count of Participants

Participants

During the 4-days (Days 0-3) post-vaccination period

ID	Title	Description
OG000	INV_MMR_L1 Group	Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
OG001	INV_MMR_L2 Group	Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

Secondary

Number of Subjects With Any Solicited General AEs

Assessed solicited general AEs were drowsiness, irritability and loss of appetite. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.

TVC included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented

Posted

Count of Participants

Participants

During the 15-days (Days 0-14) post-vaccination period

ID	Title	Description
OG000	INV_MMR_L1 Group	Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
OG001	INV_MMR_L2 Group	Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

Secondary

Number of Subjects Reporting Any Fever

Any fever = Fever ≥ 38°C.

TVC included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented

Posted

Count of Participants

Participants

During the 43-days (Days 0-42) post-vaccination period

ID	Title	Description
OG000	INV_MMR_L1 Group	Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
OG001	INV_MMR_L2 Group	Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
OG002	INV_MMR_L3 Group

Secondary

Number of Subjects Reporting Any Rash

Assessed were any localized or generalized rash, rash with fever, varicella-like rash, measles/rubella-like rash. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.

TVC included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented

Posted

Count of Participants

Participants

During the 43-days (Days 0-42) post-vaccination period

ID	Title	Description
OG000	INV_MMR_L1 Group	Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
OG001	INV_MMR_L2 Group	Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

Secondary

Number of Subjects Reporting Any MMR Specific Solicited AEs

Assessed MMR specific solicited AEs were any suspected signs of meningism including febrile convulsions and parotid/salivary gland swelling. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.

TVC included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented

Posted

Count of Participants

Participants

During the 43-days (Days 0-42) post-vaccination period

ID	Title	Description
OG000	INV_MMR_L1 Group	Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
OG001	INV_MMR_L2 Group	Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

Secondary

Number of Subjects Reporting Any Unsolicited AEs

Unsolicited adverse event (AE) was defined as any adverse event reported in addition to those solicited during the clinical study and also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.

TVC included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented

Posted

Count of Participants

Participants

During the 43-days (Days 0-42) post-vaccination period

ID	Title	Description
OG000	INV_MMR_L1 Group	Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
OG001	INV_MMR_L2 Group	Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

Secondary

Number of Subjects Reporting AEs of Specific Interest

AEs of specific interest included new onset chronic disease (NOCD) (e.g., autoimmune disorders, asthma, type I diabetes, vasculitis, celiac disease, conditions associated with sub-acute or chronic thrombocytopenia and allergies) and AEs prompting emergency room (ER) visits.

TVC included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented

Posted

Count of Participants

Participants

From Day 0 through the end of study (Day 180)

ID	Title	Description
OG000	INV_MMR_L1 Group	Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
OG001	INV_MMR_L2 Group	Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

Secondary

Number of Subjects Reporting Any Serious Adverse Events (SAEs)

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

TVC included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented

Posted

Count of Participants

Participants

From Day 0 through the end of study (Day 180)

ID	Title	Description
OG000	INV_MMR_L1 Group	Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
OG001	INV_MMR_L2 Group	Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	INV_MMR_L1 Group	Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	1,239	21	1,239	1,089	1,239
EG001	INV_MMR_L2 Group	Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	1,232	28	1,232	1,053	1,232
EG002	INV_MMR_L3 Group	Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	1,243	28	1,243	1,090	1,243
EG003	INV_MMR Group	This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.	3,714	77	3,714	3,232	3,714
EG004	COM_MMR Group	Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.	1,289	25	1,289	1,138	1,289

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Leukocytosis	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG0031 events1 affected3,714 at risk EG0042 events2 affected1,289 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Pyrexia	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Milk allergy	Immune system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Abscess	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Bronchiolitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0012 events2 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Bronchitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0003 events3 affected1,239 at risk EG0012 events2 affected1,232 at risk EG0023 events3 affected1,243 at risk EG003
Cellulitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0022 events2 affected1,243 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Croup infectious	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Escherichia urinary tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0022 events2 affected1,243 at risk EG003
Gastroenteritis adenovirus	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Gastroenteritis rotavirus	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Herpangina	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Laryngitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Mycoplasma infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Neutropenic infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Otitis media	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0024 events4 affected1,243 at risk EG003
Otitis media acute	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Pneumococcal sepsis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Pneumonia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0023 events3 affected1,243 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Pneumonia respiratory syncytial viral	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Pneumonia viral	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0012 events2 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Respiratory syncytial virus bronchiolitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Respiratory tract infection viral	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Rotavirus infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Tonsillitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Viral infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0022 events2 affected1,243 at risk EG003
Viral pharyngitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Burns second degree	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0012 events2 affected1,232 at risk EG0023 events3 affected1,243 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Epilepsy	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Febrile convulsion	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Seizure	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0022 events2 affected1,243 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected1,239 at risk EG0012 events2 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0013 events3 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Finger amputation	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal discomfort	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG0031 events1 affected3,714 at risk EG0041 events1 affected1,289 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Abscess limb	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Accidental exposure to product	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Acquired phimosis	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Acute sinusitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Adenovirus infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Aggression	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Allergy to arthropod bite	Immune system disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0012 events2 affected1,232 at risk EG0024 events4 affected1,243 at risk EG003
Anal fissure	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Animal bite	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0022 events2 affected1,243 at risk EG003
Aphthous ulcer	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0007 events7 affected1,239 at risk EG0017 events7 affected1,232 at risk EG0025 events5 affected1,243 at risk EG003
Arthropod sting	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0023 events2 affected1,243 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0022 events2 affected1,243 at risk EG003
Balanoposthitis	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0022 events2 affected1,243 at risk EG003
Beta haemolytic streptococcal infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Bilateral breast buds	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Bite	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Blister	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0022 events1 affected1,243 at risk EG003
Body tinea	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0022 events2 affected1,243 at risk EG003
Bronchiolitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected1,239 at risk EG0017 events7 affected1,232 at risk EG0027 events7 affected1,243 at risk EG003
Bronchitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG00010 events10 affected1,239 at risk EG00113 events12 affected1,232 at risk EG00211 events10 affected1,243 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0013 events3 affected1,232 at risk EG0023 events3 affected1,243 at risk EG003
Bullous impetigo	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Candida infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0013 events2 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Candida nappy rash	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Cardiac murmur	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Catarrh	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Cellulitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0023 events3 affected1,243 at risk EG003
Cephalhaematoma	Pregnancy, puerperium and perinatal conditions	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Cerumen impaction	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Chapped lips	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Chemical poisoning	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Cold agglutinins positive	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG00026 events26 affected1,239 at risk EG00121 events21 affected1,232 at risk EG00241 events39 affected1,243 at risk EG003
Conjunctivitis allergic	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Conjunctivitis bacterial	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0005 events5 affected1,239 at risk EG0012 events2 affected1,232 at risk EG0029 events9 affected1,243 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0004 events4 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Corneal abrasion	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG00036 events33 affected1,239 at risk EG00142 events42 affected1,232 at risk EG00238 events38 affected1,243 at risk EG003
Coxsackie viral infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Croup infectious	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0004 events4 affected1,239 at risk EG00111 events11 affected1,232 at risk EG0028 events8 affected1,243 at risk EG003
Crying	General disorders	MedDRA 20.1	Systematic Assessment	EG0004 events4 affected1,239 at risk EG0017 events5 affected1,232 at risk EG0022 events2 affected1,243 at risk EG003
Cyst	General disorders	MedDRA 20.1	Systematic Assessment	EG0002 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Dacryostenosis acquired	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Deafness	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG000548 events547 affected1,239 at risk EG001538 events537 affected1,232 at risk EG002528 events526 affected1,243 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Depressed mood	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0012 events2 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected1,239 at risk EG0013 events3 affected1,232 at risk EG0024 events4 affected1,243 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0012 events2 affected1,232 at risk EG0022 events2 affected1,243 at risk EG003
Dermatitis diaper	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0004 events3 affected1,239 at risk EG0014 events4 affected1,232 at risk EG0024 events3 affected1,243 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG00071 events64 affected1,239 at risk EG00163 events58 affected1,232 at risk EG00255 events49 affected1,243 at risk EG003
Diet noncompliance	Social circumstances	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Discomfort	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Drooling	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0022 events2 affected1,243 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0022 events2 affected1,243 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Ear canal injury	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Ear infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0009 events9 affected1,239 at risk EG00114 events14 affected1,232 at risk EG0024 events4 affected1,243 at risk EG003
Ear injury	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0003 events3 affected1,239 at risk EG0013 events3 affected1,232 at risk EG0024 events4 affected1,243 at risk EG003
Ear swelling	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0012 events2 affected1,232 at risk EG0022 events2 affected1,243 at risk EG003
Eczema nummular	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Elbow deformity	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Enterovirus infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0012 events2 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected1,239 at risk EG0014 events4 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Epstein-barr virus infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Eustachian tube dysfunction	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Exaggerated startle response	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Exanthema subitum	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Excessive cerumen production	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Eye contusion	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Eye discharge	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0012 events2 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Eye infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0013 events3 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Eye inflammation	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Eye irritation	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Eye swelling	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Eyelid oedema	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0002 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Face injury	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Faeces soft	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0012 events2 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Febrile convulsion	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0004 events4 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0025 events5 affected1,243 at risk EG003
Feeling hot	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected1,239 at risk EG0012 events2 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Folliculitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0013 events3 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Food allergy	Immune system disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected1,239 at risk EG0012 events2 affected1,232 at risk EG0026 events5 affected1,243 at risk EG003
Foreign body in gastrointestinal tract	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0022 events2 affected1,243 at risk EG003
Fungal infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG00028 events27 affected1,239 at risk EG00121 events21 affected1,232 at risk EG00238 events35 affected1,243 at risk EG003
Gastroenteritis norovirus	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Gastroenteritis rotavirus	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0003 events3 affected1,239 at risk EG0016 events6 affected1,232 at risk EG0026 events6 affected1,243 at risk EG003
Gastrointestinal infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0013 events3 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Genital labial adhesions	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Gingival hypertrophy	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Gingival injury	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Gingival pain	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Gingival swelling	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0012 events2 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Gingivitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Gross motor delay	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Haematoma	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Hand fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Hand-foot-and-mouth disease	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected1,239 at risk EG0013 events3 affected1,232 at risk EG0029 events9 affected1,243 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0005 events5 affected1,239 at risk EG0016 events6 affected1,232 at risk EG0026 events6 affected1,243 at risk EG003
Headache	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0004 events4 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Heat stroke	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Herpangina	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Herpes simplex	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Hordeolum	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Hypermetropia	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Immunisation reaction	Immune system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Impetigo	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0004 events4 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Infected bite	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Influenza	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected1,239 at risk EG0015 events5 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Influenza like illness	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Injection site abscess	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Injection site bruising	General disorders	MedDRA 20.1	Systematic Assessment	EG0004 events4 affected1,239 at risk EG0015 events5 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Injection site erosion	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Injection site erythema	General disorders	MedDRA 20.1	Systematic Assessment	EG000331 events321 affected1,239 at risk EG001303 events294 affected1,232 at risk EG002334 events328 affected1,243 at risk EG003
Injection site haematoma	General disorders	MedDRA 20.1	Systematic Assessment	EG0006 events5 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0023 events3 affected1,243 at risk EG003
Injection site haemorrhage	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Injection site induration	General disorders	MedDRA 20.1	Systematic Assessment	EG0003 events3 affected1,239 at risk EG0013 events3 affected1,232 at risk EG0022 events2 affected1,243 at risk EG003
Injection site mass	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0012 events2 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Injection site nodule	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Injection site pain	General disorders	MedDRA 20.1	Systematic Assessment	EG000336 events335 affected1,239 at risk EG001317 events316 affected1,232 at risk EG002277 events275 affected1,243 at risk EG003
Injection site papule	General disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected1,239 at risk EG0012 events2 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Injection site swelling	General disorders	MedDRA 20.1	Systematic Assessment	EG000128 events127 affected1,239 at risk EG001107 events106 affected1,232 at risk EG002115 events113 affected1,243 at risk EG003
Injection site vesicles	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Irritability	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG000775 events765 affected1,239 at risk EG001741 events730 affected1,232 at risk EG002775 events768 affected1,243 at risk EG003
Keratosis pilaris	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Knee deformity	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0005 events5 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0022 events2 affected1,243 at risk EG003
Lacrimation increased	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Lactose intolerance	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Laryngitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0019 events7 affected1,232 at risk EG0022 events2 affected1,243 at risk EG003
Lethargy	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Lice infestation	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Lid sulcus deepened	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0003 events3 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Lip injury	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Lip swelling	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Localised infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0005 events5 affected1,239 at risk EG0015 events5 affected1,232 at risk EG0022 events2 affected1,243 at risk EG003
Macule	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Middle insomnia	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Miliaria	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Milk allergy	Immune system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Molluscum contagiosum	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Nail avulsion	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG00010 events10 affected1,239 at risk EG00112 events11 affected1,232 at risk EG0025 events5 affected1,243 at risk EG003
Nasal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG00083 events74 affected1,239 at risk EG00182 events75 affected1,232 at risk EG00282 events74 affected1,243 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Nystagmus	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Oedema peripheral	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected1,239 at risk EG0012 events2 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Oral contusion	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Oral herpes	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Oral infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Oral mucosal eruption	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Otic examination normal	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Otitis externa	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Otitis media	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG00086 events80 affected1,239 at risk EG00179 events75 affected1,232 at risk EG00267 events62 affected1,243 at risk EG003
Otitis media acute	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG00010 events8 affected1,239 at risk EG0017 events7 affected1,232 at risk EG00214 events13 affected1,243 at risk EG003
Otitis media chronic	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Otorrhoea	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0012 events2 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Pallor	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Papule	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Paronychia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Periorbital cellulitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG00020 events20 affected1,239 at risk EG00130 events30 affected1,232 at risk EG00214 events14 affected1,243 at risk EG003
Pharyngitis streptococcal	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0013 events3 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Pharyngotonsillitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Pneumonia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0025 events5 affected1,243 at risk EG003
Polydipsia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Polyuria	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Poor quality sleep	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0005 events4 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Post-traumatic headache	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Post-tussive vomiting	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Prurigo	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Pyrexia	General disorders	MedDRA 20.1	Systematic Assessment	EG000406 events405 affected1,239 at risk EG001423 events422 affected1,232 at risk EG002419 events419 affected1,243 at risk EG003
Radial head dislocation	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Ranula	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG000352 events352 affected1,239 at risk EG001331 events331 affected1,232 at risk EG002360 events360 affected1,243 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Regurgitation	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0024 events4 affected1,243 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Respiratory syncytial virus bronchiolitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Respiratory syncytial virus infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0008 events8 affected1,239 at risk EG00112 events11 affected1,232 at risk EG00211 events9 affected1,243 at risk EG003
Respiratory tract infection viral	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0003 events3 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Restlessness	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Rhinitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG00050 events46 affected1,239 at risk EG00155 events49 affected1,232 at risk EG00242 events38 affected1,243 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0003 events3 affected1,239 at risk EG0012 events2 affected1,232 at risk EG0023 events3 affected1,243 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG00023 events22 affected1,239 at risk EG00126 events23 affected1,232 at risk EG00221 events20 affected1,243 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Roseola	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0012 events2 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Salivary gland enlargement	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Salivary gland pain	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Salivary hypersecretion	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Salmonellosis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Scarlet fever	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Scratch	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected1,239 at risk EG0012 events2 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Seborrhoea	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Secretion discharge	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0022 events1 affected1,243 at risk EG003
Sinusitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG00010 events9 affected1,239 at risk EG0013 events3 affected1,232 at risk EG0024 events4 affected1,243 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0012 events2 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Skin bacterial infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Skin candida	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Skin mass	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Skin warm	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Sleep disorder	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0003 events3 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Sleep terror	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Solar dermatitis	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Somnolence	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG000534 events534 affected1,239 at risk EG001535 events535 affected1,232 at risk EG002533 events533 affected1,243 at risk EG003
Speech disorder developmental	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0014 events4 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Strabismus	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Streptococcal infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0012 events2 affected1,232 at risk EG0023 events3 affected1,243 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Superficial injury of eye	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Swelling	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Tearfulness	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0012 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Teething	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG000114 events91 affected1,239 at risk EG001106 events92 affected1,232 at risk EG00292 events77 affected1,243 at risk EG003
Terminal insomnia	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0013 events3 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Tongue injury	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Tonsillar hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Tonsillitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG00022 events21 affected1,239 at risk EG00110 events9 affected1,232 at risk EG00211 events9 affected1,243 at risk EG003
Tooth abscess	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0006 events4 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Tremor	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Upper respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG000117 events106 affected1,239 at risk EG001132 events124 affected1,232 at risk EG002132 events122 affected1,243 at risk EG003
Urinary tract disorder	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 events1 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0004 events2 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Vaginal mucosal blistering	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Vessel puncture site haematoma	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0011 events1 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Viral diarrhoea	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003
Viral infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG00015 events15 affected1,239 at risk EG00122 events21 affected1,232 at risk EG00226 events23 affected1,243 at risk EG003
Viral pharyngitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected1,239 at risk EG0012 events2 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Viral rash	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Viral tonsillitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0003 events3 affected1,239 at risk EG0013 events3 affected1,232 at risk EG0024 events4 affected1,243 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG00039 events38 affected1,239 at risk EG00138 events35 affected1,232 at risk EG00238 events34 affected1,243 at risk EG003
Weight decreased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected1,239 at risk EG0010 events0 affected1,232 at risk EG0020 events0 affected1,243 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0003 events2 affected1,239 at risk EG0016 events6 affected1,232 at risk EG0026 events6 affected1,243 at risk EG003
Wound	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected1,239 at risk EG0013 events3 affected1,232 at risk EG0021 events1 affected1,243 at risk EG003

ID	Term
D018355	Rubivirus Infections
D014036	Togaviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D007239	Infections
D018185	Morbillivirus Infections
D018184	Paramyxoviridae Infections
D018701	Mononegavirales Infections
D019351	Rubulavirus Infections
D010309	Parotitis
D010305	Parotid Diseases
D012466	Salivary Gland Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

ID	Term
D022542	Measles-Mumps-Rubella Vaccine
D012411	Rubella Vaccine
D019433	Chickenpox Vaccine
D022362	Hepatitis A Vaccines
C538862	13-valent pneumococcal vaccine

ID	Term
D017778	Vaccines, Combined
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures
D008458	Measles Vaccine
D014765	Viral Vaccines
D009108	Mumps Vaccine
D022283	Herpesvirus Vaccines
D014761	Viral Hepatitis Vaccines