5-Year Safety Study of Pimecrolimus Cream 1% in Infants 3... | NCT00120523

Label	Type	Description	Intervention Names
1	Experimental	Pimecrolimus	Drug: Pimecrolimus
2	Active Comparator	Topical corticosteroids	Drug: Topical corticosteroids

Name	Type	Description	Arm Group Labels	Other Names
Pimecrolimus	Drug	Pimecrolimus cream 1 %	1	Elidel

Measure	Description	Time Frame
Safety Assessed by Adverse Events	crude incidence of adverse events of primary interest and most frequent adverse events (greater than or equal to 5% crude incidence in either treatment group) in the treatment period	throughout the 5-year study
Growth Velocity (Height)		throughout the 5-year study
Growth Velocity (Weight)		throughout the 5-year study
Potential Effect on the Developing Immune System	number (%) of patients with positive antibody titers to tetanus, hepatitis B, and measles vaccines at baseline, weeks 26 (6 months), 52 (1 year), 104 (2 years), 156 (3 years), 208 (4 years) and 260 (5 years) Varicella antibody titers were measured at the above time points in US patients only.	throughout the 5-year study

Measure	Description	Time Frame
Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate	IGA = Investigator's global Assessment. CI = Confidence interval for treatment success using binomial distribution: lower CI<0 is set to 0, upper CI>100 is set to 100. Treatment success (n): IGA score of 0 or 1 (clear or almost clear). Outcome gives percentage of patients with treatment success.

Facility	Status	City	State	ZIP	Country	Contacts
Phoenix Children's Hospital		Phoenix	Arizona	85016	United States
Cholla Pediatrics

PubMed Identifier	Type	Citation	Retractions
25802354	Derived	Sigurgeirsson B, Boznanski A, Todd G, Vertruyen A, Schuttelaar ML, Zhu X, Schauer U, Qaqundah P, Poulin Y, Kristjansson S, von Berg A, Nieto A, Boguniewicz M, Paller AS, Dakovic R, Ring J, Luger T. Safety and efficacy of pimecrolimus in atopic dermatitis: a 5-year randomized trial. Pediatrics. 2015 Apr;135(4):597-606. doi: 10.1542/peds.2014-1990. Epub 2015 Mar 23.

ID	Title	Description
FG000	Pimecrolimus	1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
FG001	Topical Corticosteroids

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

Safety Assessed by Adverse Events

crude incidence of adverse events of primary interest and most frequent adverse events (greater than or equal to 5% crude incidence in either treatment group) in the treatment period

complete safety/ITT population of experimental and control

Posted

Number

percentage of participants

throughout the 5-year study

ID	Title	Description
OG000	Pimecrolimus	Pimecrolimus 1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
OG001	Topical Corticosteroids	Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g. Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently.

Units	Counts
Participants	OG0001205 OG0011213

Title

Denominators

Categories

Acute tonsillitis

Title	Measurements
	OG0008.6 OG0017.8

Allergy to arthropod bite

Title	Measurements
	OG000

Primary

Growth Velocity (Height)

Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.Patient who do not have a baseline value are excluded from the analysis.

Posted

Mean

Standard Deviation

throughout the 5-year study

ID	Title	Description
OG000	Pimecrolimus	Pimecrolimus 1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
OG001	Topical Corticosteroids	Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g. Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently.

Units	Counts
Participants	OG000

Primary

Growth Velocity (Weight)

Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.Patient who do not have a baseline value are excluded from the analysis.

Posted

Mean

Standard Deviation

throughout the 5-year study

ID	Title	Description
OG000	Pimecrolimus	Pimecrolimus 1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
OG001	Topical Corticosteroids	Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g. Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently.

Units	Counts
Participants	OG000

Secondary

Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate

IGA = Investigator's global Assessment. CI = Confidence interval for treatment success using binomial distribution: lower CI<0 is set to 0, upper CI>100 is set to 100.

Treatment success (n): IGA score of 0 or 1 (clear or almost clear). Outcome gives percentage of patients with treatment success.

Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.

Posted

Number

95% Confidence Interval

percentage of participants

throughout the 5-year study

ID	Title	Description
OG000	Pimecrolimus	1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
OG001	Topical Corticosteroids	Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g. Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently.

Secondary

Body Surface Area Involved With Atopic Dermatitis

TBSA = Total body surface area; percent BSA affected = (BSA affected/TBSA) x 100.

Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.

Posted

Mean

Standard Deviation

percentage of TBSA affected

throughout the 5-year study

ID	Title	Description
OG000	Pimecrolimus	1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
OG001	Topical Corticosteroids	Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g. Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently.

Units	Counts
Participants

Secondary

Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD)

PIQoL-AD questionnaire (28 questions) was only done in countries where validated questionnaire was available: Germany, Hungary, Netherlands, Spain, UK and US.

For the purposes of data presentation, a "Not True" response was coded a value of zero and a "True" a value of one. The total score (i.e., sum of individual questions) was calculated; lower the score, better the QoL. Minimum score = 0; maximum score = 28. If the patient has answered ≤14 questions at a time point, then the patient's total score at the time point was set to missing.

Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication. Patients who do not have baseline value are excluded from the analysis.

Posted

Mean

Standard Deviation

units on a scale

throughout the 5-year study

ID	Title	Description
OG000	Pimecrolimus	Pimecrolimus 1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
OG001	Topical Corticosteroids	Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g. Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently.

Secondary

Vital Signs and Physical Examinations: Blood Pressure (BP)

Significant findings are included in the relevant medical history/current medical conditions (prior to study start) or in the AE documentation (after study start.

Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.Patients who do not have baseline value are excluded from analysis.

Posted

Mean

Standard Deviation

mmHg

throughout the 5-year study

ID	Title	Description
OG000	Pimecrolimus	1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
OG001	Topical Corticosteroids	Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g. Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently.

Units	Counts
Participants

Primary

Potential Effect on the Developing Immune System

number (%) of patients with positive antibody titers to tetanus, hepatitis B, and measles vaccines at baseline, weeks 26 (6 months), 52 (1 year), 104 (2 years), 156 (3 years), 208 (4 years) and 260 (5 years) Varicella antibody titers were measured at the above time points in US patients only.

Immune system function data analyses were performed on the immunology set (774 patients). Varicella titers were assessed for USA patients only (n= 104, n=108).

Posted

Number

% of patients with positive ab titer

throughout the 5-year study

ID	Title	Description
OG000	Pimecrolimus	Pimecrolimus 1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
OG001	Topical Corticosteroids	Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g. Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently.

Units

Secondary

Vital Signs and Physical Examinations: Pulse

Significant findings are included in the relevant medical history/current medical conditions (prior to study start) or in the AE documentation (after study start.

Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.Patients who do not have baseline value are excluded from analysis.

Posted

Mean

Standard Deviation

bpm

throughout the 5-year study

ID	Title	Description
OG000	Pimecrolimus	1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
OG001	Topical Corticosteroids	Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g. Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0006 affected1,205 at risk EG0012 affected1,213 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected1,205 at risk EG0010 affected1,213 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected1,205 at risk EG0010 affected1,213 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0011 affected1,213 at risk
Acute chest syndrome	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Lymphoid tissue hyperplasia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Arrhytmia	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Phimosis	Congenital, familial and genetic disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0013 affected1,213 at risk
Cryptorchism	Congenital, familial and genetic disorders	MedDRA 13.1	Systematic Assessment	EG0003 affected1,205 at risk EG0010 affected1,213 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0011 affected1,213 at risk
Ankyloglossia congenital	Congenital, familial and genetic disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Atrioventricular septal defect	Congenital, familial and genetic disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Hereditary fructose intolerance	Congenital, familial and genetic disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Sickle cell anaemia	Congenital, familial and genetic disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Eustachian tube dysfunction	Ear and labyrinth disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Middle ear effusion	Ear and labyrinth disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Amblyopia	Eye disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Strabismus	Eye disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Vomiting	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG00017 affected1,205 at risk EG0015 affected1,213 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG00015 affected1,205 at risk EG0014 affected1,213 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0013 affected1,213 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0011 affected1,213 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0011 affected1,213 at risk
Aphthous stomatitis	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0012 affected1,213 at risk
Enteritis	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected1,205 at risk EG0010 affected1,213 at risk
Intussusception	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0012 affected1,213 at risk
Nausea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0011 affected1,213 at risk
Peritonitis	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0011 affected1,213 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected1,205 at risk EG0010 affected1,213 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Constipation	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Disbacteriosis	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Perianal erythema	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Reflux oesophagitis	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Pyrexia	General disorders	MedDRA 13.1	Systematic Assessment	EG00010 affected1,205 at risk EG0013 affected1,213 at risk
Malaise	General disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected1,205 at risk EG0010 affected1,213 at risk
Asthenia	General disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Drowning	General disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Fatigue	General disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Gait disturbance	General disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Hernia	General disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Hyperplasia	General disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Influenza like illness	General disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Local swelling	General disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Vaccination site hypersensitivity	General disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Food allergy	Immune system disorders	MedDRA 13.1	Systematic Assessment	EG0003 affected1,205 at risk EG0012 affected1,213 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 13.1	Systematic Assessment	EG0003 affected1,205 at risk EG0011 affected1,213 at risk
Milk allergy	Immune system disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0013 affected1,213 at risk
Anaphylactic shock	Immune system disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Antiphospholipid syndrome	Immune system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Pneumonia	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG00022 affected1,205 at risk EG00128 affected1,213 at risk
Gastroenteritis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG00020 affected1,205 at risk EG00124 affected1,213 at risk
Bronchitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG00023 affected1,205 at risk EG00116 affected1,213 at risk
Bronchopneumonia	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0009 affected1,205 at risk EG00118 affected1,213 at risk
Bronchiolitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0007 affected1,205 at risk EG00112 affected1,213 at risk
Gastroenteritis rotavirus	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG00012 affected1,205 at risk EG0016 affected1,213 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0009 affected1,205 at risk EG0019 affected1,213 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0009 affected1,205 at risk EG0016 affected1,213 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0003 affected1,205 at risk EG0018 affected1,213 at risk
Otitis media	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0005 affected1,205 at risk EG0015 affected1,213 at risk
Pharyngitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0005 affected1,205 at risk EG0013 affected1,213 at risk
Croup infections	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0003 affected1,205 at risk EG0014 affected1,213 at risk
Tonsillitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0004 affected1,205 at risk EG0013 affected1,213 at risk
Urinary tract infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0002 affected1,205 at risk EG0015 affected1,213 at risk
Cellulitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0004 affected1,205 at risk EG0012 affected1,213 at risk
Sinusitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0004 affected1,205 at risk EG0012 affected1,213 at risk
Viral infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0004 affected1,205 at risk EG0012 affected1,213 at risk
Lobar pneumonia	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0002 affected1,205 at risk EG0013 affected1,213 at risk
Acute tonsillitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0004 affected1,205 at risk EG0010 affected1,213 at risk
Laryngitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0003 affected1,205 at risk EG0011 affected1,213 at risk
Otitis media acute	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0002 affected1,205 at risk EG0012 affected1,213 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0013 affected1,213 at risk
Abscess limb	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0002 affected1,205 at risk EG0011 affected1,213 at risk
Eczema infected	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0003 affected1,205 at risk EG0010 affected1,213 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0002 affected1,205 at risk EG0011 affected1,213 at risk
Gastroenteritis salmonella	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0002 affected1,205 at risk EG0011 affected1,213 at risk
Oral herpes	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0013 affected1,213 at risk
Pneumonia mycoplasmal	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0013 affected1,213 at risk
Respiratory tract infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0002 affected1,205 at risk EG0011 affected1,213 at risk
Viral diarrhoea	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0012 affected1,213 at risk
Appendicitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0002 affected1,205 at risk EG0010 affected1,213 at risk
Arthritis bacterial	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0002 affected1,205 at risk EG0010 affected1,213 at risk
Epstein-Barr virus infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0011 affected1,213 at risk
Exanthema subitum	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0012 affected1,213 at risk
Gastroenteritis bacterial	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0011 affected1,213 at risk
Herpangina	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0012 affected1,213 at risk
Impetigo	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0002 affected1,205 at risk EG0010 affected1,213 at risk
Infected bites	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0011 affected1,213 at risk
Influenza	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0002 affected1,205 at risk EG0010 affected1,213 at risk
Lung infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0011 affected1,213 at risk
Mastoiditis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0011 affected1,213 at risk
Periorbital cellulitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0011 affected1,213 at risk
Pneumonia respiratory syncytial viral	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0012 affected1,213 at risk
Pneumonia viral	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0011 affected1,213 at risk
Respiratory syncytial virus bronchiolitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0002 affected1,205 at risk EG0010 affected1,213 at risk
Rotavirus infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0011 affected1,213 at risk
Subcutaneous abcess	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0002 affected1,205 at risk EG0010 affected1,213 at risk
Tonsillitis streptococcal	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0012 affected1,213 at risk
Varicella	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0011 affected1,213 at risk
Abscess	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Abscess jaw	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Acarodermatitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Adenoiditis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Adenovirus infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Alpha haemolytic streptococcal infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Application site infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Bacterial diarrhoea	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Bacterial infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Bacterial pyelonephritis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Bacterial rhinitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Bronchitis bacterial	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Bronchitis viral	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Cellulitis orbital	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Chronic tonsillitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Cystitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Dysentery	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Enteritis infectious	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Escherichia infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Eye infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Febrile infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Gastroenteritis adenovirus	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Gastroenteritis astroviral	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Gastrointestinal viral infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Groin abscess	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Haemophilus infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Hepatitis A	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Hepatitis infectious	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Herpes simplex	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Infectious mononucleosis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Kaposi's varicelliform eruption	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Laryngotracheitis obstructive	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Lower respiratory tract infection viral	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Lymph node abscess	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Measles	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Meningococcal bacteraemia	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Molluscum contagiosum	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Muscle abscess	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Naspoharyngitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Orchitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Osteomyelitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Perineal abscess	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Pertussis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Pneumonia adenoviral	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Pneumonia chlamydial	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Pneumonia influenzal	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Pneumonia primary atypical	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Pneumonia streptococcal	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Rhinitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Salmonellosis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Sepsis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Septic shock	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Skin bacterial infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Skin infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Staphylococcal abscess	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Staphylococcal skin infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Tracheitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Typhoid fever	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Upper respiratory tract infection bacterial	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Viraemia	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Viral skin infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Viral tonsillitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Viral tracheitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0004 affected1,205 at risk EG0010 affected1,213 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0002 affected1,205 at risk EG0010 affected1,213 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0012 affected1,213 at risk
Accidential drug intake by child	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Conjunctival abrasion	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Drug toxicity	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Fracture displacement	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Near drowning	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Tooth fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Rotavirus test positive	Investigations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
White blood cell count decreased	Investigations	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG00018 affected1,205 at risk EG0019 affected1,213 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected1,205 at risk EG0013 affected1,213 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0011 affected1,213 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Food intolerance	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Acute lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Benign neoplasm of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Ependymoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Febrile convulsion	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0006 affected1,205 at risk EG0013 affected1,213 at risk
Autism	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0012 affected1,213 at risk
Convulsion	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0011 affected1,213 at risk
Epilepsy	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0011 affected1,213 at risk
Acute disseminated encephalomyelitis	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Ataxia	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Hydrocephalus	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Hyperkinesia	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Intracranial pressure increased	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Nervous system disorder	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Neurological symptom	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Post-traumatic headache	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Somnolence	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Speech disorder developmental	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Tongue biting	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Abnormal behaviour	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Autism spectrum disorder	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Glomerulonephritis acute	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Balanoposthitis	Reproductive system and breast disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Penile adhesion	Reproductive system and breast disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG00025 affected1,205 at risk EG00119 affected1,213 at risk
Adenoidal hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0009 affected1,205 at risk EG0016 affected1,213 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0006 affected1,205 at risk EG0019 affected1,213 at risk
Tonsillar hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0005 affected1,205 at risk EG0016 affected1,213 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0017 affected1,213 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0003 affected1,205 at risk EG0012 affected1,213 at risk
Sleep apnoe syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0003 affected1,205 at risk EG0011 affected1,213 at risk
Tonsillar disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0003 affected1,205 at risk EG0011 affected1,213 at risk
Bronchial obstuction	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0012 affected1,213 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected1,205 at risk EG0011 affected1,213 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected1,205 at risk EG0010 affected1,213 at risk
Allergic cough	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Asthmatic crisis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Laryngeal stenosis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Mouth breathing	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Snoring	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected1,205 at risk EG0012 affected1,213 at risk
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0011 affected1,213 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Eczema nummular	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected1,205 at risk EG0011 affected1,213 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected1,205 at risk EG0010 affected1,213 at risk
Kawasaki's disease	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0003 affected1,205 at risk EG0011 affected1,213 at risk

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D017443	Skin Diseases, Eczematous
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

ID	Term
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

ID	Title	Description
BG000	Pimecrolimus	1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
BG001	Topical Corticosteroids	Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g. Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Pimecrolimus	1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver			247	1,205	1,162	1,205
EG001	Topical Corticosteroids	Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g. Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently.			210	1,213	1,160	1,213

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG000711 affected1,205 at risk EG001715 affected1,213 at risk
Pyrexia	General disorders	MedDRA 13.1	Systematic Assessment	EG000589 affected1,205 at risk EG001605 affected1,213 at risk
Bronchitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG000438 affected1,205 at risk EG001410 affected1,213 at risk
Otitis media	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG000418 affected1,205 at risk EG001385 affected1,213 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG000384 affected1,205 at risk EG001381 affected1,213 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG000386 affected1,205 at risk EG001378 affected1,213 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG000360 affected1,205 at risk EG001369 affected1,213 at risk
Gastroenteritis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG000340 affected1,205 at risk EG001329 affected1,213 at risk
Varicella	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG000306 affected1,205 at risk EG001284 affected1,213 at risk
Vomiting	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG000271 affected1,205 at risk EG001258 affected1,213 at risk
Pharyngitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG000215 affected1,205 at risk EG001231 affected1,213 at risk
Tonsillitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG000204 affected1,205 at risk EG001200 affected1,213 at risk
Influenza like illness	General disorders	MedDRA 13.1	Systematic Assessment	EG000201 affected1,205 at risk EG001201 affected1,213 at risk
Conjunctivitis	Eye disorders	MedDRA 13.1	Systematic Assessment	EG000199 affected1,205 at risk EG001197 affected1,213 at risk
Teething	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG000179 affected1,205 at risk EG001181 affected1,213 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG000182 affected1,205 at risk EG001177 affected1,213 at risk
Rhinitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG000168 affected1,205 at risk EG001163 affected1,213 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG000159 affected1,205 at risk EG001154 affected1,213 at risk
Otitis media acute	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG000150 affected1,205 at risk EG001141 affected1,213 at risk
Dermatitis diaper	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG000151 affected1,205 at risk EG001137 affected1,213 at risk
Impetigo	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG000143 affected1,205 at risk EG001126 affected1,213 at risk
Pneumonia	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG000133 affected1,205 at risk EG001131 affected1,213 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG000126 affected1,205 at risk EG001126 affected1,213 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG000114 affected1,205 at risk EG001129 affected1,213 at risk
Molluscum contagiosum	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG000109 affected1,205 at risk EG00199 affected1,213 at risk
Acute tonsillitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG000104 affected1,205 at risk EG00195 affected1,213 at risk
Arthropode bite	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG00086 affected1,205 at risk EG001107 affected1,213 at risk
Sinusitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG00091 affected1,205 at risk EG00198 affected1,213 at risk
Constipation	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG00083 affected1,205 at risk EG00181 affected1,213 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG00082 affected1,205 at risk EG00182 affected1,213 at risk
Food allergy	Immune system disorders	MedDRA 13.1	Systematic Assessment	EG00089 affected1,205 at risk EG00173 affected1,213 at risk
Influenza	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG00083 affected1,205 at risk EG00169 affected1,213 at risk
Immunisation reaction	Immune system disorders	MedDRA 13.1	Systematic Assessment	EG00078 affected1,205 at risk EG00167 affected1,213 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG00063 affected1,205 at risk EG00181 affected1,213 at risk
Eczema infected	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG00089 affected1,205 at risk EG00155 affected1,213 at risk
Conjunctivitis allergic	Eye disorders	MedDRA 13.1	Systematic Assessment	EG00060 affected1,205 at risk EG00176 affected1,213 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG00073 affected1,205 at risk EG00163 affected1,213 at risk
Bronchiolitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG00065 affected1,205 at risk EG00169 affected1,213 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG00068 affected1,205 at risk EG00164 affected1,213 at risk
Allergy to arthropod bite	Immune system disorders	MedDRA 13.1	Systematic Assessment	EG00071 affected1,205 at risk EG00159 affected1,213 at risk
Heat rash	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG00066 affected1,205 at risk EG00158 affected1,213 at risk
Laryngitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG00065 affected1,205 at risk EG00159 affected1,213 at risk
Oral candidiasis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG00056 affected1,205 at risk EG00159 affected1,213 at risk
Urinary tract infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG00052 affected1,205 at risk EG00163 affected1,213 at risk