A Study to Evaluate MEDI-524 In Children With Hemodynamic... | NCT00538785

Status Module

Oversight Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Motavizumab	Experimental	Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a maximum of 5 scheduled doses. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.	Biological: Motavizumab
Pailvizumab	Active Comparator	Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a maximum of 5 scheduled doses. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.	Biological: Palivizumab

Name	Type	Description	Arm Group Labels	Other Names
Motavizumab	Biological	15 mg/kg IM administered at monthly intervals	Motavizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Subjects Reporting Adverse Events Through Study Day 150	Adverse events were summarized by system organ class (SOC) and preferred term (using MedDRA Version 11.1) overall.	Days 0-150
Number of Subjects Reporting Serious Adverse Events Through Study Day 150	Serious adverse events were those that resulted in death; were life-threatening; resulted in subject hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.	Days 0-150
Number of Subjects Reporting Laboratory Adverse Events		Days 0-150

Secondary Outcomes

Measure	Description	Time Frame
The Number of Subjects Hospitalized for RSV Infection.	An RSV hospitalization was defined as one of the following: 1) Cardiac/respiratory hospitalization with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory, or 2) New onset of lower respiratory tract symptoms with an objective measure of worsening respiratory status in an already hospitalized subject with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory (nosocomial RSV hospitalization), or 3) Death demonstrated to be caused by RSV (based on virologic evidence and either clinical history or autopsy).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

24 months of age or younger at randomization (child must have been randomized on or before their 24-month birthday)
Documented, hemodynamically significant CHD
Unoperated or partially corrected CHD
Written informed consent obtained from the patient's parent(s)/legal guardian(s) Note: The following children were not eligible: children with uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus, children with aortic stenosis, pulmonic stenosis, or coarctation of the aorta alone. Children with acyanotic cardiac lesions must have pulmonary hypertension [≥ 40 mmHg measured pressure in the pulmonary artery (PA)] or the need for daily medication to manage CHD.

Exclusion Criteria:

Unstable cardiac or respiratory status, including cardiac defects so severe that survival was not expected or for which cardiac transplantation was planned or anticipated
Hospitalization, unless discharge was anticipated within 21 days
Anticipated cardiac surgery within two weeks of randomization
Requirement for mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure or other mechanical respiratory or cardiac support
Associated non-cardiac anomalies or end organ dysfunction resulting in anticipated survival of less than six months or unstable abnormalities of end organ function
Acute respiratory illness, or other acute infection or illness Note: children with any respiratory symptoms must have had a negative RSV test prior to randomization
Chronic seizure or evolving or unstable neurologic disorder
Known immunodeficiency
Mother with HIV infection (unless the child had been proven to be not infected)
Known allergy to Ig products
Receipt of any polyclonal antibody (for example, Hepatitis B IG, IVIG, VZIG) within 3 months prior to randomization
Receipt of palivizumab (Synagis®) within 3 months prior to randomization
Use of investigational agents within the past three months (other than investigational agents commonly used during cardiac surgery or the immediate post-operative period, e.g., nitric oxide)
Current participation in other investigational protocols of drugs or biological agents
Previous participation in MI-CP124 (Season 1)

Name	Affiliation	Role
Pamela Griffin, 301-398-0000	MedImmune LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Arkansas Pediatric Clinic		Little Rock	Arkansas	72205	United States
Miller Children's Hospital

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Motavizumab (MEDI-524)	Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Motavizumab (MEDI-524)	Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
BG001	Palivizumab	Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

months

Title

Denominators

Categories

Title	Measurements
	BG0008.47± 6.40 BG0018.18± 6.51 BG0028.33± 6.45

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000282 BG001298 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

White/Non-hispanic

Title	Measurements
	BG000540 BG001529 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000155 BG001146 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Subjects Reporting Adverse Events Through Study Day 150

Adverse events were summarized by system organ class (SOC) and preferred term (using MedDRA Version 11.1) overall.

The Safety population included all subjects who received any study drug and had any safety follow-up.

Posted

Number

participants

Days 0-150

ID	Title	Description
OG000	Motavizumab (MEDI-524)	Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
OG001	Palivizumab	Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.

Units	Counts
Participants	OG000618 OG001612

Title

Denominators

Categories

Title	Measurements
	OG000575 OG001566

Primary

Number of Subjects Reporting Serious Adverse Events Through Study Day 150

Serious adverse events were those that resulted in death; were life-threatening; resulted in subject hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.

The Safety population included all subjects who received any study drug and had any safety follow-up.

Posted

Number

participants

Days 0-150

ID	Title	Description
OG000	Motavizumab (MEDI-524)	Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
OG001	Palivizumab	Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.

Primary

Number of Subjects Reporting Laboratory Adverse Events

Safety population

Posted

Number

participants

Days 0-150

ID	Title	Description
OG000	Motavizumab (MEDI-524)	Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
OG001	Palivizumab	Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.

Units	Counts
Participants

Secondary

The Number of Subjects Hospitalized for RSV Infection.

An RSV hospitalization was defined as one of the following: 1) Cardiac/respiratory hospitalization with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory, or 2) New onset of lower respiratory tract symptoms with an objective measure of worsening respiratory status in an already hospitalized subject with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory (nosocomial RSV hospitalization), or 3) Death demonstrated to be caused by RSV (based on virologic evidence and either clinical history or autopsy).

The ITT population is the primary efficacy analysis population and consists of all subjects randomized into the study.

Posted

Number

participants

Days 0-150

ID	Title	Description
OG000	Motavizumab (MEDI-524)	Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
OG001	Palivizumab	Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.

Secondary

The Number of Subjects With RSV Outpatient MA-LRI for Season 2 Only.

An RSV outpatient MA-LRI was defined as an outpatient medically-attended event designated by the principal investigator as a lower respiratory illness with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory.

All subjects who were randomized in Season 2

Posted

Number

participant

Days 0-150

ID	Title	Description
OG000	Motavizumab (MEDI-524)	Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
OG001	Palivizumab	Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.

Secondary

Number of Subjects Who Had Anti-motavizumab Antibodies Detected

ECLA-based method

Evaluable for ADA Population; includes all motavizumab-treated subjects who received the correct study drug for their first dose and did not receive commercial palivizumab before receiving any study drug.

Posted

Number

participants

Days 0-150

ID	Title	Description
OG000	Motavizumab (MEDI-524)	Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.

Units	Counts
Participants	OG000

Secondary

Mean Trough Serum Concentration of Motavizumab at Pre-dose 1

Trough serum concentrations (ug/mL) of motavizumab at pre-dose 1

Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.

Posted

Mean

Standard Deviation

ug/mL

Pre-dose 1

ID	Title	Description
OG000	Motavizumab (MEDI-524)	Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.

Units	Counts
Participants	OG000

Secondary

Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 1

Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 1

Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.

Posted

Mean

Standard Deviation

ug/mL

30 days post-dose 1

ID	Title	Description
OG000	Motavizumab (MEDI-524)	Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.

Units	Counts
Participants	OG000

Secondary

Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 2

Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 2

Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.

Posted

Mean

Standard Deviation

ug/mL

30 days post-dose 2

ID	Title	Description
OG000	Motavizumab (MEDI-524)	Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.

Units	Counts
Participants	OG000

Secondary

Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 3

Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 3

Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.

Posted

Mean

Standard Deviation

ug/mL

30 days post-dose 3

ID	Title	Description
OG000	Motavizumab (MEDI-524)	Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.

Units	Counts
Participants	OG000

Secondary

Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 4

Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 4

Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.

Posted

Mean

Standard Deviation

ug/mL

30 days post-dose 4

ID	Title	Description
OG000	Motavizumab (MEDI-524)	Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.

Units	Counts
Participants	OG000

Secondary

Mean Trough Serum Concentrations of Motavizumab in Subjects Who Underwent Cardiac Surgery With Cardiopulmonary Bypass

Subjects who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to have a blood sample taken for determination of study drug concentrations prior to receipt of another dose of study drug immediately following surgery.

Evaluable for PK following cardiac surgery with cardiopulomonary bypass; all motivizumab treated subjects who underwent cardiac surgery with cardiopulmonary bypass and who received the correct dose regiment.

Posted

Mean

Standard Deviation

ug/mL

Days 0-150

ID	Title	Description
OG000	Motavizumab (MEDI-524)	Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Motavizumab (MEDI-524)	Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.			292	618	553	618
EG001	Palivizumab	Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.			304	612	540	612

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
AORTIC VALVE STENOSIS	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0012 events1 affected612 at risk
ATRIOVENTRICULAR BLOCK	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0012 events2 affected612 at risk
ATRIOVENTRICULAR BLOCK COMPLETE	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0011 events1 affected612 at risk
CARDIAC ANEURYSM	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
CARDIAC ARREST	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0015 events3 affected612 at risk
CARDIAC FAILURE	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0007 events5 affected618 at risk EG0018 events7 affected612 at risk
CARDIAC FAILURE ACUTE	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
CARDIAC FAILURE CHRONIC	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events1 affected618 at risk EG0010 events0 affected612 at risk
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0004 events4 affected618 at risk EG0016 events5 affected612 at risk
CARDIAC PSEUDOANEURYSM	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
CARDIAC TAMPONADE	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0012 events2 affected612 at risk
CARDIO-RESPIRATORY ARREST	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0013 events3 affected612 at risk
CORONARY ARTERY OCCLUSION	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0012 events1 affected612 at risk
CYANOSIS	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0009 events9 affected618 at risk EG0017 events5 affected612 at risk
DRESSLER'S SYNDROME	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
LEFT VENTRICULAR DYSFUNCTION	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0011 events1 affected612 at risk
MITRAL VALVE STENOSIS	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0003 events1 affected618 at risk EG0010 events0 affected612 at risk
MYOCARDIAL ISCHAEMIA	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
PERICARDIAL EFFUSION	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected618 at risk EG0012 events2 affected612 at risk
PULMONARY VALVE STENOSIS	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
SUPRAVENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected618 at risk EG0011 events1 affected612 at risk
TACHYCARDIA	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0012 events1 affected612 at risk
VENTRICULAR DYSFUNCTION	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
ANOMALOUS PULMONARY VENOUS CONNECTION	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG0005 events2 affected618 at risk EG0012 events2 affected612 at risk
AORTIC VALVE ATRESIA	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events1 affected618 at risk EG0010 events0 affected612 at risk
ATRIAL SEPTAL DEFECT	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG0005 events5 affected618 at risk EG0013 events2 affected612 at risk
ATRIOVENTRICULAR SEPTAL DEFECT	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG00014 events13 affected618 at risk EG00125 events22 affected612 at risk
CHARGE SYNDROME	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
CLEFT LIP AND PALATE	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
CLEFT PALATE	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
COARCTATION OF THE AORTA	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG0004 events3 affected618 at risk EG0013 events3 affected612 at risk
CONGENITAL AORTIC DILATATION	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
CONGENITAL CORONARY ARTERY MALFORMATION	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
CONGENITAL MITRAL VALVE STENOSIS	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
CONGENITAL PULMONARY VALVE ATRESIA	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG00010 events8 affected618 at risk EG00117 events14 affected612 at risk
CONGENITAL TRICUSPID VALVE ATRESIA	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG00011 events8 affected618 at risk EG00117 events12 affected612 at risk
DEVELOPMENTAL GLAUCOMA	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected618 at risk EG0010 events0 affected612 at risk
DOUBLE OUTLET RIGHT VENTRICLE	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG00012 events10 affected618 at risk EG0017 events7 affected612 at risk
EBSTEIN'S ANOMALY	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0013 events3 affected612 at risk
FALLOT'S TETRALOGY	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG00045 events38 affected618 at risk EG00163 events49 affected612 at risk
HEART DISEASE CONGENITAL	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG0004 events4 affected618 at risk EG00110 events9 affected612 at risk
HYDROCELE	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
HYPOPLASTIC LEFT HEART SYNDROME	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG00023 events16 affected618 at risk EG00122 events18 affected612 at risk
HYPOPLASTIC RIGHT HEART SYNDROME	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG0003 events2 affected618 at risk EG0012 events2 affected612 at risk
HYPOSPADIAS	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
INTERRUPTION OF AORTIC ARCH	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
LEFT VENTRICLE OUTFLOW TRACT OBSTRUCTION	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
MEDIUM-CHAIN ACETYL-COENZYME A DEHYDROGENASE DEFICIENCY	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
MITRAL VALVE ATRESIA	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0012 events1 affected612 at risk
MULTIPLE CARDIAC DEFECTS	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0012 events2 affected612 at risk
PATENT DUCTUS ARTERIOSUS	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG0004 events4 affected618 at risk EG0012 events2 affected612 at risk
PHIMOSIS	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
PULMONARY ARTERY ATRESIA	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG0004 events4 affected618 at risk EG0011 events1 affected612 at risk
PULMONARY SEQUESTRATION	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
PYLORIC STENOSIS	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
RIGHT VENTRICLE OUTFLOW TRACT OBSTRUCTION	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
SCIMITAR SYNDROME	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0012 events1 affected612 at risk
SHONE COMPLEX	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
TRANSPOSITION OF THE GREAT VESSELS	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG0004 events4 affected618 at risk EG0016 events6 affected612 at risk
TRUNCUS ARTERIOSUS PERSISTENT	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
UNIVENTRICULAR HEART	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG00010 events9 affected618 at risk EG00112 events11 affected612 at risk
VENTRICULAR SEPTAL DEFECT	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG00032 events29 affected618 at risk EG00138 events36 affected612 at risk
DEAFNESS BILATERAL	Congenital, familial and genetic disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
ADRENAL INSUFFICIENCY	Endocrine disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
HYPOTHYROIDISM	Endocrine disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
STRABISMUS	Eye disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected618 at risk EG0012 events2 affected612 at risk
ENTERITIS	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0014 events3 affected612 at risk
ENTEROCOLITIS	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0012 events2 affected612 at risk
ENTEROCUTANEOUS FISTULA	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
GASTRITIS	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0012 events2 affected612 at risk
GASTROINTESTINAL INFLAMMATION	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0004 events4 affected618 at risk EG0018 events6 affected612 at risk
INGUINAL HERNIA	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0013 events3 affected612 at risk
INGUINAL HERNIA, OBSTRUCTIVE	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
INTESTINAL ISCHAEMIA	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
PERITONEAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
RECTAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
SPIGELIAN HERNIA	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
VOLVULUS	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
VOMITING	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0015 events4 affected612 at risk
CATHETER RELATED COMPLICATION	General disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
CYST	General disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
DEATH	General disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
DRUG WITHDRAWAL SYNDROME	General disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
IRRITABILITY	General disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
MULTI-ORGAN FAILURE	General disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
PYREXIA	General disorders	MedDRA (11.1)	Systematic Assessment	EG0006 events5 affected618 at risk EG0017 events5 affected612 at risk
HYPERBILIRUBINAEMIA	Hepatobiliary disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
DRUG HYPERSENSITIVITY	Immune system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
ABDOMINAL SEPSIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
ADENOVIRAL UPPER RESPIRATORY INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
ADENOVIRUS INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
BACTERAEMIA	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
BACTERIAL PYELONEPHRITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0012 events2 affected612 at risk
BRONCHIOLITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00027 events15 affected618 at risk EG00117 events16 affected612 at risk
BRONCHITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00016 events12 affected618 at risk EG00111 events10 affected612 at risk
BRONCHITIS VIRAL	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
BRONCHOPNEUMONIA	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0004 events4 affected618 at risk EG0016 events6 affected612 at risk
CELLULITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0012 events2 affected612 at risk
CLOSTRIDIUM DIFFICILE COLITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0011 events1 affected612 at risk
CROUP INFECTIOUS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected618 at risk EG0011 events1 affected612 at risk
EAR INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected618 at risk EG0010 events0 affected612 at risk
ENDOCARDITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected618 at risk EG0010 events0 affected612 at risk
ENDOCARDITIS BACTERIAL	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
ENTEROBACTER BACTERAEMIA	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
ESCHERICHIA URINARY TRACT INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0013 events3 affected612 at risk
GASTROENTERITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00017 events17 affected618 at risk EG00119 events18 affected612 at risk
GASTROENTERITIS NOROVIRUS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
GASTROENTERITIS ROTAVIRUS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0007 events7 affected618 at risk EG00114 events14 affected612 at risk
GASTROENTERITIS VIRAL	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0005 events5 affected618 at risk EG0016 events6 affected612 at risk
KLEBSIELLA SEPSIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0011 events1 affected612 at risk
LARYNGITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0012 events2 affected612 at risk
LOBAR PNEUMONIA	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0003 events3 affected618 at risk EG0012 events1 affected612 at risk
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0004 events4 affected618 at risk EG0014 events4 affected612 at risk
LOWER RESPIRATORY TRACT INFECTION VIRAL	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
LUNG INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
LUNG INFECTION PSEUDOMONAL	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
LYMPHANGITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
MEDIASTINITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0012 events2 affected612 at risk
MENINGITIS MENINGOCOCCAL	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
METAPNEUMOVIRUS INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
NASOPHARYNGITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0003 events2 affected618 at risk EG0011 events1 affected612 at risk
OTITIS MEDIA	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0005 events5 affected618 at risk EG0011 events1 affected612 at risk
OTITIS MEDIA ACUTE	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected618 at risk EG0011 events1 affected612 at risk
OTITIS MEDIA VIRAL	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
PARAINFLUENZAE VIRUS INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0013 events3 affected612 at risk
PHARYNGITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected618 at risk EG0011 events1 affected612 at risk
PNEUMONIA	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00027 events20 affected618 at risk EG00124 events23 affected612 at risk
PNEUMONIA ADENOVIRAL	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
PNEUMONIA INFLUENZAL	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
PSEUDOMONAL SEPSIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
PYELONEPHRITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
RESPIRATORY SYNCYTIAL VIRUS BRONCHIOLITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0006 events6 affected618 at risk EG0019 events9 affected612 at risk
RESPIRATORY SYNCYTIAL VIRUS INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected618 at risk EG0014 events4 affected612 at risk
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected618 at risk EG0014 events4 affected612 at risk
RESPIRATORY TRACT INFECTION VIRAL	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected618 at risk EG0011 events1 affected612 at risk
RHINITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
ROTAVIRUS INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0011 events1 affected612 at risk
SEPSIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0011 events1 affected612 at risk
SINUSITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
STAPHYLOCOCCAL INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
STAPHYLOCOCCAL MEDIASTINITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
STREPTOCOCCAL BACTERAEMIA	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
SUBCUTANEOUS ABSCESS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
TONSILLITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
TRACHEITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected618 at risk EG0010 events0 affected612 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00012 events11 affected618 at risk EG00112 events11 affected612 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0006 events6 affected618 at risk EG0012 events2 affected612 at risk
URINARY TRACT INFECTION BACTERIAL	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
URINARY TRACT INFECTION PSEUDOMONAL	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0011 events1 affected612 at risk
VARICELLA	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
VIRAL INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0011 events1 affected612 at risk
VIRAL SINUSITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0002 events1 affected618 at risk EG0010 events0 affected612 at risk
VIRAL UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0003 events3 affected618 at risk EG0010 events0 affected612 at risk
WOUND INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
WOUND INFECTION STAPHYLOCOCCAL	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
ACCIDENTAL OVERDOSE	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
AORTIC INJURY	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
CONTUSION	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
FEMUR FRACTURE	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
HEAD INJURY	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0012 events2 affected612 at risk
MEDICAL DEVICE COMPLICATION	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0012 events1 affected612 at risk
MULTIPLE FRACTURES	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
POST PROCEDURAL HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected618 at risk EG0010 events0 affected612 at risk
POSTPERICARDIOTOMY SYNDROME	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
SEROMA	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
SHUNT MALFUNCTION	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
SHUNT OCCLUSION	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0011 events1 affected612 at risk
SHUNT STENOSIS	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
SUBDURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
UPPER LIMB FRACTURE	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0011 events1 affected612 at risk
VASCULAR PSEUDOANEURYSM	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected618 at risk EG0010 events0 affected612 at risk
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
C-REACTIVE PROTEIN INCREASED	Investigations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
CENTRAL VENOUS PRESSURE INCREASED	Investigations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
COAGULATION TEST ABNORMAL	Investigations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
HEPATIC ENZYME INCREASED	Investigations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0012 events2 affected612 at risk
LIVER FUNCTION TEST ABNORMAL	Investigations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
MEDICAL OBSERVATION	Investigations	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected618 at risk EG0012 events1 affected612 at risk
SLEEP STUDY	Investigations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0003 events3 affected618 at risk EG0011 events1 affected612 at risk
DIET REFUSAL	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0012 events2 affected612 at risk
FAILURE TO THRIVE	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0003 events3 affected618 at risk EG0015 events5 affected612 at risk
FEEDING DISORDER	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
FEEDING DISORDER OF INFANCY OR EARLY CHILDHOOD	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0013 events3 affected612 at risk
FOOD INTOLERANCE	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0012 events2 affected612 at risk
HYPOPHAGIA	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0012 events2 affected612 at risk
METABOLIC ACIDOSIS	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
WEIGHT GAIN POOR	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0003 events3 affected618 at risk EG0012 events2 affected612 at risk
SOFT TISSUE NECROSIS	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
ANOXIC ENCEPHALOPATHY	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
CEREBRAL INFARCTION	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
CONVULSION	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected618 at risk EG0011 events1 affected612 at risk
FEBRILE CONVULSION	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0011 events1 affected612 at risk
MYOCLONUS	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
PHRENIC NERVE PARALYSIS	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
TONIC CLONIC MOVEMENTS	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
NEPHROLITHIASIS	Renal and urinary disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
PYELOCALIECTASIS	Renal and urinary disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
RENAL FAILURE ACUTE	Renal and urinary disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
RENAL TUBULAR NECROSIS	Renal and urinary disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
EPIDIDYMITIS	Reproductive system and breast disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
ACUTE PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
ADENOIDAL HYPERTROPHY	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
APNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0013 events3 affected612 at risk
APNOEIC ATTACK	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
ASPIRATION	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0012 events2 affected612 at risk
ATELECTASIS	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0013 events2 affected612 at risk
BRONCHIAL HYPERREACTIVITY	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
BRONCHOPULMONARY DYSPLASIA	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
BRONCHOSPASM	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0012 events2 affected612 at risk
CHOKING	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0011 events1 affected612 at risk
CHYLOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0012 events2 affected612 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
DIAPHRAGM MUSCLE WEAKNESS	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
DIAPHRAGMATIC HERNIA	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
DIAPHRAGMATIC PARALYSIS	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected618 at risk EG0012 events2 affected612 at risk
HYPOXIA	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0011 events1 affected612 at risk
LARYNGEAL GRANULOMA	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
LUNG CONSOLIDATION	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
LUNG INFILTRATION	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0012 events2 affected612 at risk
PNEUMONIA ASPIRATION	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected618 at risk EG0013 events3 affected612 at risk
PNEUMONITIS	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
PNEUMOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
PULMONARY ARTERY STENOSIS	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0016 events5 affected612 at risk
PULMONARY CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
PULMONARY HYPERTENSION	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0004 events3 affected618 at risk EG0012 events2 affected612 at risk
PULMONARY HYPERTENSIVE CRISIS	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0012 events1 affected612 at risk
PULMONARY VEIN OCCLUSION	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
PULMONARY VEIN STENOSIS	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
RESPIRATORY ARREST	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected618 at risk EG0011 events1 affected612 at risk
RESPIRATORY DISTRESS	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0004 events4 affected618 at risk EG0016 events4 affected612 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected618 at risk EG0015 events4 affected612 at risk
STRIDOR	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
TACHYPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
TRACHEOMALACIA	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0012 events2 affected612 at risk
WHEEZING	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
DERMATITIS ALLERGIC	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
RASH MACULO-PAPULAR	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
URTICARIA	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected618 at risk EG0010 events0 affected612 at risk
SOCIAL STAY HOSPITALISATION	Social circumstances	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected618 at risk EG0010 events0 affected612 at risk
IMMUNISATION	Surgical and medical procedures	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
URETHRAL MEATOTOMY	Surgical and medical procedures	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
AORTIC STENOSIS	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected618 at risk EG0010 events0 affected612 at risk
ARTERIAL THROMBOSIS LIMB	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0003 events3 affected618 at risk EG0011 events1 affected612 at risk
FEMORAL ARTERY OCCLUSION	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0010 events0 affected612 at risk
HYPOTENSION	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
HYPOVOLAEMIC SHOCK	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk
THROMBOSIS	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected618 at risk EG0011 events1 affected612 at risk
VASOSPASM	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected618 at risk EG0011 events1 affected612 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA (11.1)	Systematic Assessment	EG00015 events14 affected618 at risk EG00122 events16 affected612 at risk
CARDIAC FAILURE	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG00010 events9 affected618 at risk EG00110 events10 affected612 at risk
CYANOSIS	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG00042 events25 affected618 at risk EG00132 events25 affected612 at risk
CONJUNCTIVITIS	Eye disorders	MedDRA (11.1)	Systematic Assessment	EG00042 events39 affected618 at risk EG00132 events27 affected612 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG00047 events44 affected618 at risk EG00135 events31 affected612 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG00080 events69 affected618 at risk EG00170 events64 affected612 at risk
FLATULENCE	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0005 events5 affected618 at risk EG0017 events6 affected612 at risk
ENTERITIS	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0008 events7 affected618 at risk EG0014 events4 affected612 at risk
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG00019 events19 affected618 at risk EG00123 events23 affected612 at risk
TEETHING	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG00054 events44 affected618 at risk EG00156 events36 affected612 at risk
VOMITING	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG00070 events59 affected618 at risk EG00160 events49 affected612 at risk
IRRITABILITY	General disorders	MedDRA (11.1)	Systematic Assessment	EG00033 events22 affected618 at risk EG00148 events37 affected612 at risk
PYREXIA	General disorders	MedDRA (11.1)	Systematic Assessment	EG000285 events180 affected618 at risk EG001286 events177 affected612 at risk
IMMUNISATION REACTION	Immune system disorders	MedDRA (11.1)	Systematic Assessment	EG0008 events6 affected618 at risk EG00111 events8 affected612 at risk
BRONCHIOLITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00018 events16 affected618 at risk EG00111 events10 affected612 at risk
BRONCHITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00048 events40 affected618 at risk EG00157 events41 affected612 at risk
CANDIDIASIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0006 events6 affected618 at risk EG0017 events5 affected612 at risk
CROUP INFECTIOUS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected618 at risk EG0019 events9 affected612 at risk
EAR INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00011 events9 affected618 at risk EG0019 events7 affected612 at risk
EXANTHEMA SUBITUM	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0006 events6 affected618 at risk EG0017 events7 affected612 at risk
GASTROENTERITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00062 events56 affected618 at risk EG00153 events48 affected612 at risk
GASTROENTERITIS VIRAL	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0009 events9 affected618 at risk EG0015 events5 affected612 at risk
INFLUENZA	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0006 events6 affected618 at risk EG0013 events3 affected612 at risk
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00012 events9 affected618 at risk EG00113 events9 affected612 at risk
NASOPHARYNGITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00083 events67 affected618 at risk EG00179 events57 affected612 at risk
ORAL CANDIDIASIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00010 events10 affected618 at risk EG00111 events7 affected612 at risk
OTITIS MEDIA	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00097 events73 affected618 at risk EG00195 events70 affected612 at risk
OTITIS MEDIA ACUTE	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00030 events26 affected618 at risk EG00125 events19 affected612 at risk
PHARYNGITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00037 events31 affected618 at risk EG00128 events24 affected612 at risk
PNEUMONIA	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00012 events11 affected618 at risk EG00114 events13 affected612 at risk
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00012 events11 affected618 at risk EG0015 events4 affected612 at risk
RHINITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG000115 events91 affected618 at risk EG00199 events77 affected612 at risk
SINUSITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00011 events10 affected618 at risk EG0018 events7 affected612 at risk
TONSILLITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00021 events18 affected618 at risk EG0018 events8 affected612 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG000235 events160 affected618 at risk EG001254 events164 affected612 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00013 events12 affected618 at risk EG0019 events9 affected612 at risk
VARICELLA	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00011 events11 affected618 at risk EG0015 events5 affected612 at risk
VIRAL INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00047 events38 affected618 at risk EG00133 events30 affected612 at risk
VIRAL UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00013 events12 affected618 at risk EG00116 events15 affected612 at risk
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA (11.1)	Systematic Assessment	EG00013 events13 affected618 at risk EG00125 events25 affected612 at risk
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	MedDRA (11.1)	Systematic Assessment	EG0003 events3 affected618 at risk EG0019 events9 affected612 at risk
BLOOD UREA INCREASED	Investigations	MedDRA (11.1)	Systematic Assessment	EG00039 events39 affected618 at risk EG00135 events34 affected612 at risk
OXYGEN SATURATION DECREASED	Investigations	MedDRA (11.1)	Systematic Assessment	EG00010 events9 affected618 at risk EG0015 events4 affected612 at risk
WEIGHT DECREASED	Investigations	MedDRA (11.1)	Systematic Assessment	EG0007 events7 affected618 at risk EG0016 events6 affected612 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0005 events4 affected618 at risk EG0016 events6 affected612 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0006 events6 affected618 at risk EG0016 events5 affected612 at risk
RESTLESSNESS	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG0007 events6 affected618 at risk EG0013 events3 affected612 at risk
ATELECTASIS	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0003 events3 affected618 at risk EG0017 events7 affected612 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG000120 events92 affected618 at risk EG00195 events71 affected612 at risk
NASAL CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG00031 events26 affected618 at risk EG00145 events33 affected612 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0009 events9 affected618 at risk EG0017 events6 affected612 at risk
PNEUMOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected618 at risk EG0017 events7 affected612 at risk
RESPIRATORY DISORDER	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG00027 events23 affected618 at risk EG00135 events28 affected612 at risk
RHINORRHOEA	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG00064 events49 affected618 at risk EG00170 events45 affected612 at risk
WHEEZING	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG00010 events10 affected618 at risk EG00112 events10 affected612 at risk
DERMATITIS	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0007 events7 affected618 at risk EG0013 events3 affected612 at risk
DERMATITIS ATOPIC	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0007 events6 affected618 at risk EG0013 events3 affected612 at risk
DERMATITIS CONTACT	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0005 events5 affected618 at risk EG0017 events7 affected612 at risk
DERMATITIS DIAPER	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG00038 events32 affected618 at risk EG00138 events31 affected612 at risk
DRY SKIN	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0006 events6 affected618 at risk EG0012 events2 affected612 at risk
ECZEMA	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG00013 events11 affected618 at risk EG0019 events9 affected612 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG00027 events27 affected618 at risk EG00125 events21 affected612 at risk
RASH MACULO-PAPULAR	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG00010 events9 affected618 at risk EG0016 events6 affected612 at risk

ID	Term
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D006331	Heart Diseases
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins