Vaccine Efficacy Against Rotavirus Diarrhea; Vaccine Give... | NCT00241644

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rotarix 3-Dose Group	Experimental	Subjects received 3 doses of Rotarix™ vaccine given concomitantly with routine EPI vaccines.	Biological: Rotarix™
Rotarix 2-Dose Group	Experimental	Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ vaccine given concomitantly with routine EPI vaccines.	Biological: Rotarix™ Biological: Placebo
Placebo Group	Placebo Comparator	Subjects received 3 doses of placebo given concomitantly with routine EPI vaccines.	Biological: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Rotarix™	Biological	Two or Three doses, oral administration	Rotarix 2-Dose Group Rotarix 3-Dose Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain	Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.	From 2 weeks after the last vaccine or placebo dose up to 1 year of age

Secondary Outcomes

Measure	Description	Time Frame
Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain, Classified by Rotavirus Type	Number of subjects presenting with three or more looser than normal stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system. Rotavirus types were G1 wild type (WT) and non-G1.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
A male or female child between, and including, 5 and 10 weeks of age at the time of the first study vaccination.
Written informed consent obtained from the parent or guardian of the subject who is of legal age
Healthy subjects as established by medical history and clinical examination before entering into the study.
In South Africa, birth weight > 2000 grams or if weight unknown, gestation period > 36 weeks.

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
Planned administration of a vaccine not foreseen by the study protocol within 14 days before each dose of study vaccine(s) and ending 14 days after.
Chronic administration (defined as more than 14 days) of immunosuppressants since birth.
History of use of experimental rotavirus vaccine.
Previous routine vaccination except Bacille Calmette-Guérin (BCG), hepatitis B virus (HBV) and oral poliovirus (OPV) vaccination at birth
Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract, intussusception or other medical condition determined to be serious by the investigator.
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
Acute disease at the time of enrolment.
Gastroenteritis within 7 days preceding the first study vaccine administration
Previous confirmed occurrence of rotavirus gastroenteritis (RV GE).
A family history of congenital or hereditary immunodeficiency.
Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
History of any neurologic disorders or seizures.
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Bangwe, Blantyre		3	Malawi
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation
	Background	Cunliffe N et al. Efficacy of human rotavirus vaccine RIX4414 in Africa during the first year of life. Abstract presented at the 27th Annual Meeting of the European Society for Paediatric Infectious Disease (ESPID), Brussels, Belgium, 9-13 June 2009.
22520135	Background	Cunliffe NA, Witte D, Ngwira BM, Todd S, Bostock NJ, Turner AM, Chimpeni P, Victor JC, Steele AD, Bouckenooghe A, Neuzil KM. Efficacy of human rotavirus vaccine against severe gastroenteritis in Malawian children in the first two years of life: a randomized, double-blind, placebo controlled trial. Vaccine. 2012 Apr 27;30 Suppl 1(0 1):A36-43. doi: 10.1016/j.vaccine.2011.09.120.
	Background	Cunliffe NA et al. Efficacy of Human Rotavirus Vaccine RIX4414 in Malawian Infants in the first two years of life. Abstract presented at the 6th African Rotavirus Symposium, Johannesburg, South Africa, 2-3 August 2010.

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

ID	Type	URL	Comment
102248	Individual Participant Data Set	View IPD

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Rotarix 2-dose Group	Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
FG001	Rotarix 3-dose Group	Subjects received 3 doses of Rotarix™ (rotavirus vaccine).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Rotarix 2-dose Group	Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
BG001	Rotarix 3-dose Group	Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
BG002	Placebo Group	Subjects received 3 doses of placebo.
BG003	Rotarix Pooled Group	Subjects received 2 or 3 doses of Rotarix™ (rotavirus vaccine).
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

Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain

Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.

Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy

Posted

Number

subjects

From 2 weeks after the last vaccine or placebo dose up to 1 year of age

ID	Title	Description
OG000	Rotarix 2-dose Group	Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
OG001	Rotarix 3-dose Group	Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
OG002	Rotarix Pooled Group	For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
OG003	Placebo Group	Subjects received 3 doses of placebo.

Units	Counts
Participants	OG0001496 OG0011478 OG0022974 OG003

Title

Denominators

Categories

Title	Measurements
	OG00030 OG00126 OG00256 OG003

Secondary

Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain, Classified by Rotavirus Type

Number of subjects presenting with three or more looser than normal stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.

Rotavirus types were G1 wild type (WT) and non-G1.

Analysis was performed on the ATP cohort for efficacy

Posted

Number

subjects

From 2 weeks after the last vaccine or placebo dose up to 1 year of age

ID	Title	Description
OG000	Rotarix 2-dose Group	Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
OG001	Rotarix 3-dose Group	Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
OG002	Rotarix Pooled Group	For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
OG003	Placebo Group

Secondary

Number of Subjects Reporting Any Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain

Analysis was performed on the ATP cohort for efficacy

Posted

Number

subjects

From 2 weeks after the last vaccine or placebo dose up to 1 year of age

ID	Title	Description
OG000	Rotarix 2-dose Group	Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
OG001	Rotarix 3-dose Group	Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
OG002	Rotarix Pooled Group	For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
OG003	Placebo Group	Subjects received 3 doses of placebo.

Secondary

Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain

Posted

Number

subjects

From the first vaccine or placebo dose up to 1 year of age

ID	Title	Description
OG000	Rotarix 2-dose Group	Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
OG001	Rotarix 3-dose Group	Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
OG002	Rotarix Pooled Group	For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
OG003	Placebo Group	Subjects received 3 doses of placebo.

Secondary

In South Africa, Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain

Analysis was performed on the ATP cohort for efficacy, only for the subset of subjects in South Africa who were fully vaccinated before the beginning of the rotavirus season.

For this analysis, data from Rotarix 2-dose Group and Rotarix 3-dose Group were pooled into one group (Rotarix pooled Group).

Posted

Number

subjects

From 2 weeks after the third dose of vaccine or placebo up to 1 year of age

ID	Title	Description
OG000	Rotarix 2-dose Group	Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
OG001	Rotarix 3-dose Group	Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
OG002	Rotarix Pooled Group	For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.

Secondary

Number of Subjects Reporting Severe Gastroenteritis of Any Cause

Number of subjects with gastroenteritis (three or more looser than normal stools or watery stools within a day) that scored ≥ 11 on the 20-point Vesikari scoring system.

Analysis was performed on the ATP cohort for efficacy.

Posted

Number

subjects

From 2 weeks after the last vaccine or placebo dose up to 1 year of age

ID	Title	Description
OG000	Rotarix 2-dose Group	Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
OG001	Rotarix 3-dose Group	Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
OG002	Rotarix Pooled Group	For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
OG003	Placebo Group	Subjects received 3 doses of placebo.

Secondary

Number of Subjects Hospitalized and/or With Supervised Re-hydration Therapy Due to Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain

RV GE caused by the circulating wild-type rotavirus strain: three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample collected as soon as possible after the symptoms begin.

Analysis was performed on the ATP cohort for efficacy

Posted

Number

subjects

From 2 weeks after the last vaccine or placebo dose up to 1 year of age

ID	Title	Description
OG000	Rotarix 2-dose Group	Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
OG001	Rotarix 3-dose Group	Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
OG002	Rotarix Pooled Group	For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
OG003

Secondary

For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strains

The analysis was performed on the According-To-Protocol (ATP) cohort for efficacy of the combined efficacy follow-up periods.

Posted

Number

subjects

During the period from 2 weeks after the last dose of vaccine or placebo until study end

ID	Title	Description
OG000	Rotarix 2-dose Group	Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
OG001	Rotarix 3-dose Group	Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
OG002	Rotarix Pooled Group	For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.

Secondary

For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strains

The analysis was performed on the According-To-Protocol (ATP) cohort for efficacy of the second efficacy period.

Posted

Number

subjects

During the period from 1 year of age to study end

ID	Title	Description
OG000	Rotarix 2-dose Group	Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
OG001	Rotarix 3-dose Group	Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
OG002	Rotarix Pooled Group	For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
OG003

Secondary

For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects Hospitalized and/or With Supervised Re-hydration Therapy Due to Rotavirus Gastroenteritis (RV GE) Episode Caused by the Circulating Wild-type RV Strains

The analysis was performed on the ATP cohort for efficacy of the combined efficacy follow-up periods.

Posted

Number

subjects

During the period from 2 weeks after the last dose of vaccine or placebo until study end

ID	Title	Description
OG000	Rotarix 2-dose Group	Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
OG001	Rotarix 3-dose Group	Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
OG002	Rotarix Pooled Group	For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.

Secondary

The analysis was performed on the ATP cohort for efficacy of the second efficacy period.

Posted

Number

subjects

During the period from 1 year of age to study end

ID	Title	Description
OG000	Rotarix 2-dose Group	Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
OG001	Rotarix 3-dose Group	Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
OG002	Rotarix Pooled Group	For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.

Secondary

For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strains, Classified by Rotavirus Type

Rotavirus types were G1 wild type (WT) and non-G1.

The analysis was performed on the ATP cohort for efficacy of the combined efficacy follow-up periods.

Posted

Number

subjects

During the period from 2 weeks after the last dose of vaccine or placebo until study end

ID	Title	Description
OG000	Rotarix 2-dose Group	Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
OG001	Rotarix 3-dose Group	Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
OG002	Rotarix Pooled Group	For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.

Secondary

Rotavirus types were G1 wild type (WT) and non-G1.

The analysis was performed on the ATP cohort for efficacy of the second efficacy period.

Posted

Number

subjects

During the period from 1 year of age to study end

ID	Title	Description
OG000	Rotarix 2-dose Group	Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
OG001	Rotarix 3-dose Group	Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
OG002	Rotarix Pooled Group	For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.

Secondary

Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs) Leading to Drop Out

An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

Posted

Number

subjects

From the first dose of vaccine or placebo up to end of the study

ID	Title	Description
OG000	Rotarix 2-dose Group	Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
OG001	Rotarix 3-dose Group	Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
OG002	Rotarix Pooled Group	For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
OG003

Secondary

Number of Subjects Reporting Serious Adverse Events (SAEs)

Posted

Number

subjects

From the first dose of vaccine or placebo up to end of the study

ID	Title	Description
OG000	Rotarix 2-dose Group	Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
OG001	Rotarix 3-dose Group	Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
OG002	Rotarix Pooled Group	For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
OG003	Placebo Group	Subjects received 3 doses of placebo.

Secondary

Geometric Mean Concentration of Anti-rotavirus Immunoglobulin A (IgA) Antibodies in Initially Seronegative Subjects

An initially seronegative subject is a subject whose IgA antibody concentration was below the assay cut-off value of 20 Units per milliliter (U/mL) before administration of the first vaccine dose.

Analysis was performed on the ATP cohort for immunogenicity, only for initially seronegative subjects.

Posted

Geometric Mean

95% Confidence Interval

Units per milliliter (U/mL)

One month after the last vaccine dose

ID	Title	Description
OG000	Rotarix 2-dose Group	Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
OG001	Rotarix 3-dose Group	Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
OG002	Rotarix Pooled Group	For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
OG003	Placebo Group

Secondary

Number of Seroconverted Subjects

Seroconverted subjects are defined as subjects with appearance of anti-rotavirus IgA antibody concentration ≥ 20 U/mL in subjects initially (i.e. prior to the first dose of vaccine or placebo) seronegative for rotavirus.

Analysis was performed on the ATP cohort for immunogenicity, only for inititally seronegative subjects.

Posted

Number

subjects

One month after the last vaccine or placebo dose

ID	Title	Description
OG000	Rotarix 2-dose Group	Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
OG001	Rotarix 3-dose Group	Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
OG002	Rotarix Pooled Group	For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
OG003	Placebo Group	Subjects received 3 doses of placebo.

Secondary

Geometric Mean Concentration of Anti-rotavirus Immunoglobulin A (IgA) Antibodies

Geometric mean concentrations are given as Units per milliliter (U/mL).

Analysis was performed on the ATP cohort for immunogenicity.

Posted

Geometric Mean

95% Confidence Interval

U/mL

One month after the last vaccine or placebo dose

ID	Title	Description
OG000	Rotarix 2-dose Group	Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
OG001	Rotarix 3-dose Group	Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
OG002	Rotarix Pooled Group	For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
OG003	Placebo Group	Subjects received 3 doses of placebo.

Secondary

Number of Seropositive Subjects

Seropositive subjects are defined as subjects with anti-rotavirus IgA antibody concentration ≥ 20 U/mL.

Analysis was performed on the ATP cohort for immunogenicity.

Posted

Number

subjects

One month after the last vaccine or placebo dose

ID	Title	Description
OG000	Rotarix 2-dose Group	Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
OG001	Rotarix 3-dose Group	Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
OG002	Rotarix Pooled Group	For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
OG003	Placebo Group	Subjects received 3 doses of placebo.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (At Risk)
EG000	Rotarix 2-dose Group	Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).	222	1,647	1,647
EG001	Rotarix 3-dose Group	Subjects received 3 doses of Rotarix™ (rotavirus vaccine).	199	1,651	1,651
EG002	Rotarix Pooled Group	For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.	421	3,298	3,298
EG003	Placebo Group	Subjects received 3 doses of placebo.	246	1,641	1,641

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Gastroenteritis	Infections and infestations		Non-systematic Assessment	EG00094 affected1,647 at risk EG00167 affected1,651 at risk EG002161 affected3,298 at risk EG003104 affected1,641 at risk
Pneumonia	Infections and infestations		Non-systematic Assessment	EG00055 affected1,647 at risk EG00154 affected1,651 at risk EG002109 affected3,298 at risk EG003
Bronchopneumonia	Infections and infestations		Non-systematic Assessment	EG00029 affected1,647 at risk EG00125 affected1,651 at risk EG00254 affected3,298 at risk EG003
Sepsis	Infections and infestations		Non-systematic Assessment	EG00033 affected1,647 at risk EG00128 affected1,651 at risk EG00261 affected3,298 at risk EG003
Bronchiolitis	Infections and infestations		Non-systematic Assessment	EG00021 affected1,647 at risk EG00117 affected1,651 at risk EG00238 affected3,298 at risk EG003
Malaria	Infections and infestations		Non-systematic Assessment	EG00019 affected1,647 at risk EG00125 affected1,651 at risk EG00244 affected3,298 at risk EG003
Upper respiratory tract infection	Infections and infestations		Non-systematic Assessment	EG0007 affected1,647 at risk EG0017 affected1,651 at risk EG00214 affected3,298 at risk EG003
Meningitis	Infections and infestations		Non-systematic Assessment	EG0007 affected1,647 at risk EG0014 affected1,651 at risk EG00211 affected3,298 at risk EG003
Pneumocystis jiroveci pneumonia	Infections and infestations		Non-systematic Assessment	EG0004 affected1,647 at risk EG0014 affected1,651 at risk EG0028 affected3,298 at risk EG003
Febrile convulsion	Nervous system disorders		Non-systematic Assessment	EG0004 affected1,647 at risk EG0017 affected1,651 at risk EG00211 affected3,298 at risk EG003
Anemia	Blood and lymphatic system disorders		Non-systematic Assessment	EG0002 affected1,647 at risk EG0016 affected1,651 at risk EG0028 affected3,298 at risk EG003
Pulmonary tuberculosis	Infections and infestations		Non-systematic Assessment	EG0003 affected1,647 at risk EG0013 affected1,651 at risk EG0026 affected3,298 at risk EG003
Dehydration	Metabolism and nutrition disorders		Non-systematic Assessment	EG0003 affected1,647 at risk EG0013 affected1,651 at risk EG0026 affected3,298 at risk EG003
Kwashiorkor	Metabolism and nutrition disorders		Non-systematic Assessment	EG0003 affected1,647 at risk EG0014 affected1,651 at risk EG0027 affected3,298 at risk EG003
Gastrointestinal disorder	Gastrointestinal disorders		Non-systematic Assessment	EG0004 affected1,647 at risk EG0012 affected1,651 at risk EG0026 affected3,298 at risk EG003
Malnutrition	Metabolism and nutrition disorders		Non-systematic Assessment	EG0005 affected1,647 at risk EG0010 affected1,651 at risk EG0025 affected3,298 at risk EG003
Death	General disorders		Non-systematic Assessment	EG0002 affected1,647 at risk EG0012 affected1,651 at risk EG0024 affected3,298 at risk EG003
Lower respiratory tract infection	Infections and infestations		Non-systematic Assessment	EG0000 affected1,647 at risk EG0012 affected1,651 at risk EG0022 affected3,298 at risk EG003
Oral candidiasis	Infections and infestations		Non-systematic Assessment	EG0002 affected1,647 at risk EG0011 affected1,651 at risk EG0023 affected3,298 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment	EG0003 affected1,647 at risk EG0012 affected1,651 at risk EG0025 affected3,298 at risk EG003
Bronchitis	Infections and infestations		Non-systematic Assessment	EG0002 affected1,647 at risk EG0010 affected1,651 at risk EG0022 affected3,298 at risk EG003
Pneumonia viral	Infections and infestations		Non-systematic Assessment	EG0003 affected1,647 at risk EG0010 affected1,651 at risk EG0023 affected3,298 at risk EG003
Pyrexia	General disorders		Non-systematic Assessment	EG0001 affected1,647 at risk EG0013 affected1,651 at risk EG0024 affected3,298 at risk EG003
Sudden infant death syndrome	General disorders		Non-systematic Assessment	EG0000 affected1,647 at risk EG0012 affected1,651 at risk EG0022 affected3,298 at risk EG003
Croup infectious	Infections and infestations		Non-systematic Assessment	EG0001 affected1,647 at risk EG0011 affected1,651 at risk EG0022 affected3,298 at risk EG003
Marasmus	Metabolism and nutrition disorders		Non-systematic Assessment	EG0003 affected1,647 at risk EG0015 affected1,651 at risk EG0028 affected3,298 at risk EG003
Otitis media	Infections and infestations		Non-systematic Assessment	EG0002 affected1,647 at risk EG0011 affected1,651 at risk EG0023 affected3,298 at risk EG003
Arthritis bacterial	Infections and infestations		Non-systematic Assessment	EG0001 affected1,647 at risk EG0011 affected1,651 at risk EG0022 affected3,298 at risk EG003
Encephalitis	Nervous system disorders		Non-systematic Assessment	EG0001 affected1,647 at risk EG0010 affected1,651 at risk EG0021 affected3,298 at risk EG003
Heart disease congenital	Congenital, familial and genetic disorders		Non-systematic Assessment	EG0001 affected1,647 at risk EG0011 affected1,651 at risk EG0022 affected3,298 at risk EG003
Ileus paralytic	Gastrointestinal disorders		Non-systematic Assessment	EG0002 affected1,647 at risk EG0010 affected1,651 at risk EG0022 affected3,298 at risk EG003
Meningitis pneumococcal	Infections and infestations		Non-systematic Assessment	EG0000 affected1,647 at risk EG0012 affected1,651 at risk EG0022 affected3,298 at risk EG003
Otitis media acute	Infections and infestations		Non-systematic Assessment	EG0001 affected1,647 at risk EG0011 affected1,651 at risk EG0022 affected3,298 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment	EG0003 affected1,647 at risk EG0010 affected1,651 at risk EG0023 affected3,298 at risk EG003
Status epilepticus	Nervous system disorders		Non-systematic Assessment	EG0001 affected1,647 at risk EG0011 affected1,651 at risk EG0022 affected3,298 at risk EG003
Subcutaneous abscess	Infections and infestations		Non-systematic Assessment	EG0001 affected1,647 at risk EG0010 affected1,651 at risk EG0021 affected3,298 at risk EG003
Tonsillitis	Infections and infestations		Non-systematic Assessment	EG0002 affected1,647 at risk EG0010 affected1,651 at risk EG0022 affected3,298 at risk EG003
Urinary tract infection	Infections and infestations		Non-systematic Assessment	EG0000 affected1,647 at risk EG0012 affected1,651 at risk EG0022 affected3,298 at risk EG003
Acquired immunodeficiency syndrome	Infections and infestations		Non-systematic Assessment	EG0000 affected1,647 at risk EG0011 affected1,651 at risk EG0021 affected3,298 at risk EG003
Convulsion	Nervous system disorders		Non-systematic Assessment	EG0001 affected1,647 at risk EG0012 affected1,651 at risk EG0023 affected3,298 at risk EG003
Fontanelle bulging	Nervous system disorders		Non-systematic Assessment	EG0000 affected1,647 at risk EG0011 affected1,651 at risk EG0021 affected3,298 at risk EG003
Inguinal hernia	Gastrointestinal disorders		Non-systematic Assessment	EG0001 affected1,647 at risk EG0010 affected1,651 at risk EG0021 affected3,298 at risk EG003
Lymphadenitis	Blood and lymphatic system disorders		Non-systematic Assessment	EG0001 affected1,647 at risk EG0010 affected1,651 at risk EG0021 affected3,298 at risk EG003
Metabolic acidosis	Metabolism and nutrition disorders		Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Respiratory tract infection	Infections and infestations		Non-systematic Assessment	EG0001 affected1,647 at risk EG0010 affected1,651 at risk EG0021 affected3,298 at risk EG003
Staphylococcal skin infection	Infections and infestations		Non-systematic Assessment	EG0001 affected1,647 at risk EG0011 affected1,651 at risk EG0022 affected3,298 at risk EG003
Thermal burn	Injury, poisoning and procedural complications		Non-systematic Assessment	EG0002 affected1,647 at risk EG0014 affected1,651 at risk EG0026 affected3,298 at risk EG003
Abscess	Infections and infestations		Non-systematic Assessment	EG0000 affected1,647 at risk EG0011 affected1,651 at risk EG0021 affected3,298 at risk EG003
Abscess neck	Infections and infestations		Non-systematic Assessment	EG0001 affected1,647 at risk EG0010 affected1,651 at risk EG0021 affected3,298 at risk EG003
Adenoidectomy	Surgical and medical procedures		Non-systematic Assessment	EG0001 affected1,647 at risk EG0010 affected1,651 at risk EG0021 affected3,298 at risk EG003
Asphyxia	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment	EG0000 affected1,647 at risk EG0012 affected1,651 at risk EG0022 affected3,298 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment	EG0000 affected1,647 at risk EG0011 affected1,651 at risk EG0021 affected3,298 at risk EG003
Blindness	Eye disorders		Non-systematic Assessment	EG0001 affected1,647 at risk EG0010 affected1,651 at risk EG0021 affected3,298 at risk EG003
Brachial plexus injury	Injury, poisoning and procedural complications		Non-systematic Assessment	EG0001 affected1,647 at risk EG0010 affected1,651 at risk EG0021 affected3,298 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment	EG0000 affected1,647 at risk EG0011 affected1,651 at risk EG0021 affected3,298 at risk EG003
Cardiac failure congestive	Cardiac disorders		Non-systematic Assessment	EG0000 affected1,647 at risk EG0011 affected1,651 at risk EG0021 affected3,298 at risk EG003
Cerebral malaria	Infections and infestations		Non-systematic Assessment	EG0001 affected1,647 at risk EG0010 affected1,651 at risk EG0021 affected3,298 at risk EG003
Cyst	General disorders		Non-systematic Assessment	EG0000 affected1,647 at risk EG0011 affected1,651 at risk EG0021 affected3,298 at risk EG003
Eczema infected	Infections and infestations		Non-systematic Assessment	EG0001 affected1,647 at risk EG0010 affected1,651 at risk EG0021 affected3,298 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment	EG0001 affected1,647 at risk EG0010 affected1,651 at risk EG0021 affected3,298 at risk EG003
Febrile infection	Infections and infestations		Non-systematic Assessment	EG0000 affected1,647 at risk EG0011 affected1,651 at risk EG0021 affected3,298 at risk EG003
Fractured skull depressed	Injury, poisoning and procedural complications		Non-systematic Assessment	EG0001 affected1,647 at risk EG0010 affected1,651 at risk EG0021 affected3,298 at risk EG003
Head injury	Injury, poisoning and procedural complications		Non-systematic Assessment	EG0002 affected1,647 at risk EG0010 affected1,651 at risk EG0022 affected3,298 at risk EG003
Herpes simplex	Infections and infestations		Non-systematic Assessment	EG0001 affected1,647 at risk EG0010 affected1,651 at risk EG0021 affected3,298 at risk EG003
Hydrocephalus	Nervous system disorders		Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Hypernatraemia	Metabolism and nutrition disorders		Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders		Non-systematic Assessment	EG0000 affected1,647 at risk EG0011 affected1,651 at risk EG0021 affected3,298 at risk EG003
Hyponatraemic syndrome	Metabolism and nutrition disorders		Non-systematic Assessment	EG0000 affected1,647 at risk EG0011 affected1,651 at risk EG0021 affected3,298 at risk EG003
Hypovolaemic shock	Cardiac disorders		Non-systematic Assessment	EG0000 affected1,647 at risk EG0011 affected1,651 at risk EG0021 affected3,298 at risk EG003
Ileus	Gastrointestinal disorders		Non-systematic Assessment	EG0001 affected1,647 at risk EG0010 affected1,651 at risk EG0021 affected3,298 at risk EG003
Intussusception	Gastrointestinal disorders		Non-systematic Assessment	EG0000 affected1,647 at risk EG0011 affected1,651 at risk EG0021 affected3,298 at risk EG003
Klebsiella bacteremia	Infections and infestations		Non-systematic Assessment	EG0000 affected1,647 at risk EG0011 affected1,651 at risk EG0021 affected3,298 at risk EG003
Meningitis bacterial	Infections and infestations		Non-systematic Assessment	EG0000 affected1,647 at risk EG0011 affected1,651 at risk EG0021 affected3,298 at risk EG003
Neuroblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)		Non-systematic Assessment	EG0001 affected1,647 at risk EG0010 affected1,651 at risk EG0021 affected3,298 at risk EG003
Nosocomial infection	Infections and infestations		Non-systematic Assessment	EG0001 affected1,647 at risk EG0010 affected1,651 at risk EG0021 affected3,298 at risk EG003
Pancytopenia	Blood and lymphatic system disorders		Non-systematic Assessment	EG0000 affected1,647 at risk EG0011 affected1,651 at risk EG0021 affected3,298 at risk EG003
Parotid abscess	Infections and infestations		Non-systematic Assessment	EG0001 affected1,647 at risk EG0010 affected1,651 at risk EG0021 affected3,298 at risk EG003
Pharyngotonsillitis	Infections and infestations		Non-systematic Assessment	EG0001 affected1,647 at risk EG0010 affected1,651 at risk EG0021 affected3,298 at risk EG003
Pneumonia bacterial	Infections and infestations		Non-systematic Assessment	EG0000 affected1,647 at risk EG0012 affected1,651 at risk EG0022 affected3,298 at risk EG003
Postoperative wound infection	Infections and infestations		Non-systematic Assessment	EG0000 affected1,647 at risk EG0011 affected1,651 at risk EG0021 affected3,298 at risk EG003
Renal failure	Renal and urinary disorders		Non-systematic Assessment	EG0000 affected1,647 at risk EG0011 affected1,651 at risk EG0021 affected3,298 at risk EG003
Respiratory arrest	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment	EG0000 affected1,647 at risk EG0011 affected1,651 at risk EG0021 affected3,298 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment	EG0000 affected1,647 at risk EG0011 affected1,651 at risk EG0021 affected3,298 at risk EG003
Respiratory tract infection viral	Infections and infestations		Non-systematic Assessment	EG0001 affected1,647 at risk EG0010 affected1,651 at risk EG0021 affected3,298 at risk EG003
Sepsis neonatal	Infections and infestations		Non-systematic Assessment	EG0000 affected1,647 at risk EG0011 affected1,651 at risk EG0021 affected3,298 at risk EG003
Septic shock	Infections and infestations		Non-systematic Assessment	EG0000 affected1,647 at risk EG0011 affected1,651 at risk EG0021 affected3,298 at risk EG003
Tachycardia	Cardiac disorders		Non-systematic Assessment	EG0001 affected1,647 at risk EG0010 affected1,651 at risk EG0021 affected3,298 at risk EG003
Tuberculosis	Infections and infestations		Non-systematic Assessment	EG0001 affected1,647 at risk EG0011 affected1,651 at risk EG0022 affected3,298 at risk EG003
Varicella	Infections and infestations		Non-systematic Assessment	EG0001 affected1,647 at risk EG0010 affected1,651 at risk EG0021 affected3,298 at risk EG003
Viral tonsillitis	Infections and infestations		Non-systematic Assessment	EG0001 affected1,647 at risk EG0010 affected1,651 at risk EG0021 affected3,298 at risk EG003
Viral upper respiratory tract infection	Infections and infestations		Non-systematic Assessment	EG0001 affected1,647 at risk EG0010 affected1,651 at risk EG0021 affected3,298 at risk EG003
Abdominal distension	Gastrointestinal disorders		Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Cachexia	Metabolism and nutrition disorders		Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Cellulitis	Infections and infestations		Non-systematic Assessment	EG0000 affected1,647 at risk EG0011 affected1,651 at risk EG0021 affected3,298 at risk EG003
Disseminated tuberculosis	Infections and infestations		Non-systematic Assessment	EG0000 affected1,647 at risk EG0011 affected1,651 at risk EG0021 affected3,298 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Eczema	Skin and subcutaneous tissue disorders		Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Electrolyte imbalance	Metabolism and nutrition disorders		Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Empyema	Infections and infestations		Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Escherichia urinary tract infection	Infections and infestations		Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Femur fracture	Injury, poisoning and procedural complications		Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Grunting	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Haemorrhagic disorder	Blood and lymphatic system disorders		Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Hypoglycaemic seizure	Metabolism and nutrition disorders		Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Immunosuppression	Immune system disorders		Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Infection	Infections and infestations		Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Injury	Injury, poisoning and procedural complications		Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Intestinal obstruction	Gastrointestinal disorders		Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Irritability	General disorders		Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Meningitis tuberculous	Infections and infestations		Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Patent ductus arteriosus	Congenital, familial and genetic disorders		Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Perianal abscess	Infections and infestations		Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Pneumonitis chemical	Injury, poisoning and procedural complications		Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Soft tissue injury	Injury, poisoning and procedural complications		Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Sudden death	General disorders		Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Therapeutic agent toxicity	Injury, poisoning and procedural complications		Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders		Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Vomiting	Gastrointestinal disorders		Non-systematic Assessment	EG0003 affected1,647 at risk EG0010 affected1,651 at risk EG0023 affected3,298 at risk EG003
Adenoidal hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected1,647 at risk EG0011 affected1,651 at risk EG0021 affected3,298 at risk EG003
Chemical poisoning	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected1,647 at risk EG0010 affected1,651 at risk EG0021 affected3,298 at risk EG003
Food poisoning	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected1,647 at risk EG0011 affected1,651 at risk EG0021 affected3,298 at risk EG003
Genital rash	Reproductive system and breast disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected1,647 at risk EG0010 affected1,651 at risk EG0021 affected3,298 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected1,647 at risk EG0011 affected1,651 at risk EG0021 affected3,298 at risk EG003
Keratitis herpetic	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected1,647 at risk EG0010 affected1,651 at risk EG0021 affected3,298 at risk EG003
Phimosis	Congenital, familial and genetic disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected1,647 at risk EG0011 affected1,651 at risk EG0021 affected3,298 at risk EG003
Respiratory syncytial virus bronchiolitis	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected1,647 at risk EG0010 affected1,651 at risk EG0021 affected3,298 at risk EG003
Salmonella sepsis	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected1,647 at risk EG0011 affected1,651 at risk EG0021 affected3,298 at risk EG003
skin infection	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected1,647 at risk EG0011 affected1,651 at risk EG0021 affected3,298 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected1,647 at risk EG0011 affected1,651 at risk EG0021 affected3,298 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected1,647 at risk EG0010 affected1,651 at risk EG0021 affected3,298 at risk EG003
Conjunctivitis	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Abscess limb	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Drug toxicity	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Foreign body aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Influenza	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003
Strabismus	Eye disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected1,647 at risk EG0010 affected1,651 at risk EG0020 affected3,298 at risk EG003

ID	Term
D012088	Reoviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D007239	Infections