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A Study to Evaluate MEDI-524 In Children With Hemodynamically Significant Congenital Heart Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00538785
Recruitment Status : Completed
First Posted : October 3, 2007
Results First Posted : February 14, 2012
Last Update Posted : February 16, 2012
Sponsor:
Information provided by:
MedImmune LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Congenital Heart Disease
Interventions Biological: Motavizumab
Biological: Palivizumab
Enrollment 1236
Recruitment Details A total of 1236 subjects were randomized at 162 sites in 16 countries within the northern hemisphere between 21Oct2005 and 14Dec2005 in Season 1 and 02Oct2007 and 31Dec2007 in Season 2; each subject participated in the study for a single RSV season.
Pre-assignment Details Subjects were randomized 1:1 on Study Day 0 to receive either 15 mg/kg motavizumab or 15 mg/kg palivizumab. A permuted-block randomization method was used and a separate randomization schedule was generated for each site and cyanotic CHD strata combination.
Arm/Group Title Motavizumab (MEDI-524) Palivizumab
Hide Arm/Group Description Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection. Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
Period Title: Overall Study
Started 623 [1] 612
Completed 604 595
Not Completed 19 17
Reason Not Completed
Death             9             10
Withdrawal of consent             9             7
Lost to Follow-up             1             0
[1]
A subject was randomized without appropriate consent in France and is not included in the results.
Arm/Group Title Motavizumab (MEDI-524) Palivizumab Total
Hide Arm/Group Description Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection. Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection. Total of all reporting groups
Overall Number of Baseline Participants 623 612 1235
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 623 participants 612 participants 1235 participants
8.47  (6.40) 8.18  (6.51) 8.33  (6.45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 623 participants 612 participants 1235 participants
Female
282
  45.3%
298
  48.7%
580
  47.0%
Male
341
  54.7%
314
  51.3%
655
  53.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 623 participants 612 participants 1235 participants
White/Non-hispanic 540 529 1069
Black 23 20 43
Hispanic 21 23 44
Asian 10 8 18
Other 29 32 61
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 623 participants 612 participants 1235 participants
United States 155 146 301
Spain 31 26 57
Lebanon 62 66 128
Austria 7 7 14
Israel 67 65 132
Russian Federation 32 34 66
United Kingdom 26 31 57
France 13 15 28
Czech Republic 35 39 74
Hungary 27 26 53
Canada 27 22 49
Belgium 28 26 54
Poland 50 49 99
Bulgaria 18 18 36
Germany 35 31 66
Sweden 10 11 21
1.Primary Outcome
Title Number of Subjects Reporting Adverse Events Through Study Day 150
Hide Description Adverse events were summarized by system organ class (SOC) and preferred term (using MedDRA Version 11.1) overall.
Time Frame Days 0-150
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety population included all subjects who received any study drug and had any safety follow-up.
Arm/Group Title Motavizumab (MEDI-524) Palivizumab
Hide Arm/Group Description:
Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
Overall Number of Participants Analyzed 618 612
Measure Type: Number
Unit of Measure: participants
575 566
2.Primary Outcome
Title Number of Subjects Reporting Serious Adverse Events Through Study Day 150
Hide Description Serious adverse events were those that resulted in death; were life-threatening; resulted in subject hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.
Time Frame Days 0-150
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety population included all subjects who received any study drug and had any safety follow-up.
Arm/Group Title Motavizumab (MEDI-524) Palivizumab
Hide Arm/Group Description:
Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
Overall Number of Participants Analyzed 618 612
Measure Type: Number
Unit of Measure: participants
292 304
3.Primary Outcome
Title Number of Subjects Reporting Laboratory Adverse Events
Hide Description [Not Specified]
Time Frame Days 0-150
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Motavizumab (MEDI-524) Palivizumab
Hide Arm/Group Description:
Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
Overall Number of Participants Analyzed 618 612
Measure Type: Number
Unit of Measure: participants
Adrenal insufficiency 3 3
Alanine aminotranferase increased 13 26
Anemia 17 14
Aspartate aminotransferase increased 3 9
Bacteria sputum indentified 1 1
Blood alkaline phosphatase increased 1 0
Blood calcium decreased 0 1
Blood calcium increased 2 0
Blood creatinine increased 0 1
Blood potassium decreased 1 1
Blood potassium increased 1 1
Blood sodium abnormal 0 1
Blood sodium decreased 1 1
Blood thyroid stimulating hormone increased 1 0
Blood urea increased 39 34
Brain natriuretic peptide increased 1 0
C-reactive protein increased 0 5
Clostridium difficiline toxin test positive 1 0
Coagulation test abnormal 1 1
Haematocrit drecreased 0 1
Haemaglobin decreased 0 1
Hepatic enzyme increased 3 3
Hyperbilirubinemia 1 0
Hypertransaminasemia 0 1
Hypothyroidism 3 2
International normalised ratio decreased 0 1
International normalised ratio increased 0 2
Iron deficiency anaemia 1 0
Liver function test abnormal 3 2
Mean cell volume decreased 1 0
Neutropenia 1 0
Occult blood positive 1 0
Oxygen saturation decreased 9 4
Platelet count decreased 0 1
Renal function test abnormal 1 0
Thrombocythemia 1 0
Thrombocytopenia 1 5
Thyroid function test abnormal 0 1
Transaminases increased 0 2
Urine output decreased 1 1
White blood cell count increased 1 0
4.Secondary Outcome
Title The Number of Subjects Hospitalized for RSV Infection.
Hide Description An RSV hospitalization was defined as one of the following: 1) Cardiac/respiratory hospitalization with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory, or 2) New onset of lower respiratory tract symptoms with an objective measure of worsening respiratory status in an already hospitalized subject with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory (nosocomial RSV hospitalization), or 3) Death demonstrated to be caused by RSV (based on virologic evidence and either clinical history or autopsy).
Time Frame Days 0-150
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population is the primary efficacy analysis population and consists of all subjects randomized into the study.
Arm/Group Title Motavizumab (MEDI-524) Palivizumab
Hide Arm/Group Description:
Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
Overall Number of Participants Analyzed 623 612
Measure Type: Number
Unit of Measure: participants
12 16
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Motavizumab (MEDI-524), Palivizumab
Comments Relative risk and confidence interval adjusted for the stratification factor of CHD stratum (cyanotic or other) specified on the CRF
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Guess method
Comments Exact conditional binomial method conditioning on the total number of cases with mid-probability adjustment
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.746
Confidence Interval (2-Sided) 95%
0.344 to 1.586
Estimation Comments [Not Specified]
5.Secondary Outcome
Title The Number of Subjects With RSV Outpatient MA-LRI for Season 2 Only.
Hide Description An RSV outpatient MA-LRI was defined as an outpatient medically-attended event designated by the principal investigator as a lower respiratory illness with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory.
Time Frame Days 0-150
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who were randomized in Season 2
Arm/Group Title Motavizumab (MEDI-524) Palivizumab
Hide Arm/Group Description:
Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
Overall Number of Participants Analyzed 304 310
Measure Type: Number
Unit of Measure: participant
3 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Motavizumab (MEDI-524)
Comments Relative risk and confidence interval adjusted for the stratification factor of CHD stratum (cyanotic or other) specified on the CRF
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Guess method
Comments Exact conditional binomial method conditioning on the total number of cases with mid-probability adjustment
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.495
Confidence Interval (2-Sided) 95%
0.101 to 1.989
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Subjects Who Had Anti-motavizumab Antibodies Detected
Hide Description ECLA-based method
Time Frame Days 0-150
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable for ADA Population; includes all motavizumab-treated subjects who received the correct study drug for their first dose and did not receive commercial palivizumab before receiving any study drug.
Arm/Group Title Motavizumab (MEDI-524)
Hide Arm/Group Description:
Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
Overall Number of Participants Analyzed 605
Measure Type: Number
Unit of Measure: participants
9
7.Secondary Outcome
Title Mean Trough Serum Concentration of Motavizumab at Pre-dose 1
Hide Description Trough serum concentrations (ug/mL) of motavizumab at pre-dose 1
Time Frame Pre-dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.
Arm/Group Title Motavizumab (MEDI-524)
Hide Arm/Group Description:
Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
Overall Number of Participants Analyzed 543
Mean (Standard Deviation)
Unit of Measure: ug/mL
0.0  (0.0)
8.Secondary Outcome
Title Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 1
Hide Description Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 1
Time Frame 30 days post-dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.
Arm/Group Title Motavizumab (MEDI-524)
Hide Arm/Group Description:
Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
Overall Number of Participants Analyzed 521
Mean (Standard Deviation)
Unit of Measure: ug/mL
46.90  (15.20)
9.Secondary Outcome
Title Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 2
Hide Description Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 2
Time Frame 30 days post-dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.
Arm/Group Title Motavizumab (MEDI-524)
Hide Arm/Group Description:
Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
Overall Number of Participants Analyzed 228
Mean (Standard Deviation)
Unit of Measure: ug/mL
60.94  (25.41)
10.Secondary Outcome
Title Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 3
Hide Description Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 3
Time Frame 30 days post-dose 3
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.
Arm/Group Title Motavizumab (MEDI-524)
Hide Arm/Group Description:
Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
Overall Number of Participants Analyzed 203
Mean (Standard Deviation)
Unit of Measure: ug/mL
66.59  (34.51)
11.Secondary Outcome
Title Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 4
Hide Description Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 4
Time Frame 30 days post-dose 4
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.
Arm/Group Title Motavizumab (MEDI-524)
Hide Arm/Group Description:
Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
Overall Number of Participants Analyzed 203
Mean (Standard Deviation)
Unit of Measure: ug/mL
77.87  (32.75)
12.Secondary Outcome
Title Mean Trough Serum Concentrations of Motavizumab in Subjects Who Underwent Cardiac Surgery With Cardiopulmonary Bypass
Hide Description Subjects who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to have a blood sample taken for determination of study drug concentrations prior to receipt of another dose of study drug immediately following surgery.
Time Frame Days 0-150
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable for PK following cardiac surgery with cardiopulomonary bypass; all motivizumab treated subjects who underwent cardiac surgery with cardiopulmonary bypass and who received the correct dose regiment.
Arm/Group Title Motavizumab (MEDI-524)
Hide Arm/Group Description:
Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
Overall Number of Participants Analyzed 127
Mean (Standard Deviation)
Unit of Measure: ug/mL
48.51  (27.30)
Time Frame Day 0 - Day 150
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Motavizumab (MEDI-524) Palivizumab
Hide Arm/Group Description Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection. Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
All-Cause Mortality
Motavizumab (MEDI-524) Palivizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Motavizumab (MEDI-524) Palivizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   292/618 (47.25%)      304/612 (49.67%)    
Blood and lymphatic system disorders     
ANAEMIA  1  0/618 (0.00%)  0 1/612 (0.16%)  1
THROMBOCYTOPENIA  1  1/618 (0.16%)  1 0/612 (0.00%)  0
Cardiac disorders     
AORTIC VALVE STENOSIS  1  1/618 (0.16%)  1 1/612 (0.16%)  2
ATRIOVENTRICULAR BLOCK  1  0/618 (0.00%)  0 2/612 (0.33%)  2
ATRIOVENTRICULAR BLOCK COMPLETE  1  1/618 (0.16%)  1 1/612 (0.16%)  1
CARDIAC ANEURYSM  1  0/618 (0.00%)  0 1/612 (0.16%)  1
CARDIAC ARREST  1  0/618 (0.00%)  0 3/612 (0.49%)  5
CARDIAC FAILURE  1  5/618 (0.81%)  7 7/612 (1.14%)  8
CARDIAC FAILURE ACUTE  1  1/618 (0.16%)  1 0/612 (0.00%)  0
CARDIAC FAILURE CHRONIC  1  1/618 (0.16%)  2 0/612 (0.00%)  0
CARDIAC FAILURE CONGESTIVE  1  4/618 (0.65%)  4 5/612 (0.82%)  6
CARDIAC PSEUDOANEURYSM  1  0/618 (0.00%)  0 1/612 (0.16%)  1
CARDIAC TAMPONADE  1  0/618 (0.00%)  0 2/612 (0.33%)  2
CARDIO-RESPIRATORY ARREST  1  1/618 (0.16%)  1 3/612 (0.49%)  3
CORONARY ARTERY OCCLUSION  1  0/618 (0.00%)  0 1/612 (0.16%)  2
CYANOSIS  1  9/618 (1.46%)  9 5/612 (0.82%)  7
DRESSLER'S SYNDROME  1  0/618 (0.00%)  0 1/612 (0.16%)  1
LEFT VENTRICULAR DYSFUNCTION  1  1/618 (0.16%)  1 1/612 (0.16%)  1
MITRAL VALVE STENOSIS  1  1/618 (0.16%)  3 0/612 (0.00%)  0
MYOCARDIAL ISCHAEMIA  1  1/618 (0.16%)  1 0/612 (0.00%)  0
PERICARDIAL EFFUSION  1  2/618 (0.32%)  2 2/612 (0.33%)  2
PULMONARY VALVE STENOSIS  1  0/618 (0.00%)  0 1/612 (0.16%)  1
SUPRAVENTRICULAR TACHYCARDIA  1  2/618 (0.32%)  2 1/612 (0.16%)  1
TACHYCARDIA  1  1/618 (0.16%)  1 1/612 (0.16%)  2
VENTRICULAR DYSFUNCTION  1  1/618 (0.16%)  1 0/612 (0.00%)  0
Congenital, familial and genetic disorders     
ANOMALOUS PULMONARY VENOUS CONNECTION  1  2/618 (0.32%)  5 2/612 (0.33%)  2
AORTIC VALVE ATRESIA  1  1/618 (0.16%)  2 0/612 (0.00%)  0
ATRIAL SEPTAL DEFECT  1  5/618 (0.81%)  5 2/612 (0.33%)  3
ATRIOVENTRICULAR SEPTAL DEFECT  1  13/618 (2.10%)  14 22/612 (3.59%)  25
CHARGE SYNDROME  1  1/618 (0.16%)  1 0/612 (0.00%)  0
CLEFT LIP AND PALATE  1  0/618 (0.00%)  0 1/612 (0.16%)  1
CLEFT PALATE  1  1/618 (0.16%)  1 0/612 (0.00%)  0
COARCTATION OF THE AORTA  1  3/618 (0.49%)  4 3/612 (0.49%)  3
CONGENITAL AORTIC DILATATION  1  1/618 (0.16%)  1 0/612 (0.00%)  0
CONGENITAL CORONARY ARTERY MALFORMATION  1  0/618 (0.00%)  0 1/612 (0.16%)  1
CONGENITAL MITRAL VALVE STENOSIS  1  1/618 (0.16%)  1 0/612 (0.00%)  0
CONGENITAL PULMONARY VALVE ATRESIA  1  8/618 (1.29%)  10 14/612 (2.29%)  17
CONGENITAL TRICUSPID VALVE ATRESIA  1  8/618 (1.29%)  11 12/612 (1.96%)  17
DEVELOPMENTAL GLAUCOMA  1  2/618 (0.32%)  2 0/612 (0.00%)  0
DOUBLE OUTLET RIGHT VENTRICLE  1  10/618 (1.62%)  12 7/612 (1.14%)  7
EBSTEIN'S ANOMALY  1  0/618 (0.00%)  0 3/612 (0.49%)  3
FALLOT'S TETRALOGY  1  38/618 (6.15%)  45 49/612 (8.01%)  63
HEART DISEASE CONGENITAL  1  4/618 (0.65%)  4 9/612 (1.47%)  10
HYDROCELE  1  1/618 (0.16%)  1 0/612 (0.00%)  0
HYPOPLASTIC LEFT HEART SYNDROME  1  16/618 (2.59%)  23 18/612 (2.94%)  22
HYPOPLASTIC RIGHT HEART SYNDROME  1  2/618 (0.32%)  3 2/612 (0.33%)  2
HYPOSPADIAS  1  0/618 (0.00%)  0 1/612 (0.16%)  1
INTERRUPTION OF AORTIC ARCH  1  1/618 (0.16%)  1 0/612 (0.00%)  0
LEFT VENTRICLE OUTFLOW TRACT OBSTRUCTION  1  1/618 (0.16%)  1 0/612 (0.00%)  0
MEDIUM-CHAIN ACETYL-COENZYME A DEHYDROGENASE DEFICIENCY  1  1/618 (0.16%)  1 0/612 (0.00%)  0
MITRAL VALVE ATRESIA  1  0/618 (0.00%)  0 1/612 (0.16%)  2
MULTIPLE CARDIAC DEFECTS  1  0/618 (0.00%)  0 2/612 (0.33%)  2
PATENT DUCTUS ARTERIOSUS  1  4/618 (0.65%)  4 2/612 (0.33%)  2
PHIMOSIS  1  0/618 (0.00%)  0 1/612 (0.16%)  1
PULMONARY ARTERY ATRESIA  1  4/618 (0.65%)  4 1/612 (0.16%)  1
PULMONARY SEQUESTRATION  1  1/618 (0.16%)  1 0/612 (0.00%)  0
PYLORIC STENOSIS  1  0/618 (0.00%)  0 1/612 (0.16%)  1
RIGHT VENTRICLE OUTFLOW TRACT OBSTRUCTION  1  0/618 (0.00%)  0 1/612 (0.16%)  1
SCIMITAR SYNDROME  1  0/618 (0.00%)  0 1/612 (0.16%)  2
SHONE COMPLEX  1  1/618 (0.16%)  1 0/612 (0.00%)  0
TRANSPOSITION OF THE GREAT VESSELS  1  4/618 (0.65%)  4 6/612 (0.98%)  6
TRUNCUS ARTERIOSUS PERSISTENT  1  1/618 (0.16%)  1 0/612 (0.00%)  0
UNIVENTRICULAR HEART  1  9/618 (1.46%)  10 11/612 (1.80%)  12
VENTRICULAR SEPTAL DEFECT  1  29/618 (4.69%)  32 36/612 (5.88%)  38
DEAFNESS BILATERAL  1  1/618 (0.16%)  1 0/612 (0.00%)  0
Endocrine disorders     
ADRENAL INSUFFICIENCY  1  1/618 (0.16%)  1 0/612 (0.00%)  0
HYPOTHYROIDISM  1  1/618 (0.16%)  1 0/612 (0.00%)  0
Eye disorders     
STRABISMUS  1  1/618 (0.16%)  1 0/612 (0.00%)  0
Gastrointestinal disorders     
ABDOMINAL PAIN  1  1/618 (0.16%)  1 0/612 (0.00%)  0
CONSTIPATION  1  1/618 (0.16%)  1 0/612 (0.00%)  0
DIARRHOEA  1  2/618 (0.32%)  2 2/612 (0.33%)  2
ENTERITIS  1  1/618 (0.16%)  1 3/612 (0.49%)  4
ENTEROCOLITIS  1  0/618 (0.00%)  0 2/612 (0.33%)  2
ENTEROCUTANEOUS FISTULA  1  0/618 (0.00%)  0 1/612 (0.16%)  1
GASTRITIS  1  0/618 (0.00%)  0 2/612 (0.33%)  2
GASTROINTESTINAL INFLAMMATION  1  0/618 (0.00%)  0 1/612 (0.16%)  1
GASTROOESOPHAGEAL REFLUX DISEASE  1  4/618 (0.65%)  4 6/612 (0.98%)  8
INGUINAL HERNIA  1  1/618 (0.16%)  1 3/612 (0.49%)  3
INGUINAL HERNIA, OBSTRUCTIVE  1  1/618 (0.16%)  1 0/612 (0.00%)  0
INTESTINAL ISCHAEMIA  1  1/618 (0.16%)  1 0/612 (0.00%)  0
PERITONEAL HAEMORRHAGE  1  1/618 (0.16%)  1 0/612 (0.00%)  0
RECTAL HAEMORRHAGE  1  0/618 (0.00%)  0 1/612 (0.16%)  1
SPIGELIAN HERNIA  1  0/618 (0.00%)  0 1/612 (0.16%)  1
VOLVULUS  1  0/618 (0.00%)  0 1/612 (0.16%)  1
VOMITING  1  1/618 (0.16%)  1 4/612 (0.65%)  5
General disorders     
CATHETER RELATED COMPLICATION  1  0/618 (0.00%)  0 1/612 (0.16%)  1
CYST  1  1/618 (0.16%)  1 0/612 (0.00%)  0
DEATH  1  0/618 (0.00%)  0 1/612 (0.16%)  1
DRUG WITHDRAWAL SYNDROME  1  0/618 (0.00%)  0 1/612 (0.16%)  1
GENERAL PHYSICAL HEALTH DETERIORATION  1  0/618 (0.00%)  0 1/612 (0.16%)  1
IRRITABILITY  1  0/618 (0.00%)  0 1/612 (0.16%)  1
MULTI-ORGAN FAILURE  1  1/618 (0.16%)  1 0/612 (0.00%)  0
PYREXIA  1  5/618 (0.81%)  6 5/612 (0.82%)  7
Hepatobiliary disorders     
HYPERBILIRUBINAEMIA  1  0/618 (0.00%)  0 1/612 (0.16%)  1
Immune system disorders     
DRUG HYPERSENSITIVITY  1  1/618 (0.16%)  1 0/612 (0.00%)  0
Infections and infestations     
ABDOMINAL SEPSIS  1  0/618 (0.00%)  0 1/612 (0.16%)  1
ADENOVIRAL UPPER RESPIRATORY INFECTION  1  0/618 (0.00%)  0 1/612 (0.16%)  1
ADENOVIRUS INFECTION  1  1/618 (0.16%)  1 0/612 (0.00%)  0
BACTERAEMIA  1  0/618 (0.00%)  0 1/612 (0.16%)  1
BACTERIAL PYELONEPHRITIS  1  1/618 (0.16%)  1 2/612 (0.33%)  2
BRONCHIOLITIS  1  15/618 (2.43%)  27 16/612 (2.61%)  17
BRONCHITIS  1  12/618 (1.94%)  16 10/612 (1.63%)  11
BRONCHITIS VIRAL  1  0/618 (0.00%)  0 1/612 (0.16%)  1
BRONCHOPNEUMONIA  1  4/618 (0.65%)  4 6/612 (0.98%)  6
CELLULITIS  1  0/618 (0.00%)  0 2/612 (0.33%)  2
CLOSTRIDIUM DIFFICILE COLITIS  1  1/618 (0.16%)  1 1/612 (0.16%)  1
CROUP INFECTIOUS  1  2/618 (0.32%)  2 1/612 (0.16%)  1
EAR INFECTION  1  2/618 (0.32%)  2 0/612 (0.00%)  0
ENDOCARDITIS  1  2/618 (0.32%)  2 0/612 (0.00%)  0
ENDOCARDITIS BACTERIAL  1  1/618 (0.16%)  1 0/612 (0.00%)  0
ENTEROBACTER BACTERAEMIA  1  1/618 (0.16%)  1 0/612 (0.00%)  0
ESCHERICHIA URINARY TRACT INFECTION  1  1/618 (0.16%)  1 3/612 (0.49%)  3
GASTROENTERITIS  1  17/618 (2.75%)  17 18/612 (2.94%)  19
GASTROENTERITIS NOROVIRUS  1  0/618 (0.00%)  0 1/612 (0.16%)  1
GASTROENTERITIS ROTAVIRUS  1  7/618 (1.13%)  7 14/612 (2.29%)  14
GASTROENTERITIS VIRAL  1  5/618 (0.81%)  5 6/612 (0.98%)  6
KLEBSIELLA SEPSIS  1  1/618 (0.16%)  1 1/612 (0.16%)  1
LARYNGITIS  1  1/618 (0.16%)  1 2/612 (0.33%)  2
LOBAR PNEUMONIA  1  3/618 (0.49%)  3 1/612 (0.16%)  2
LOWER RESPIRATORY TRACT INFECTION  1  4/618 (0.65%)  4 4/612 (0.65%)  4
LOWER RESPIRATORY TRACT INFECTION VIRAL  1  0/618 (0.00%)  0 1/612 (0.16%)  1
LUNG INFECTION  1  0/618 (0.00%)  0 1/612 (0.16%)  1
LUNG INFECTION PSEUDOMONAL  1  0/618 (0.00%)  0 1/612 (0.16%)  1
LYMPHANGITIS  1  0/618 (0.00%)  0 1/612 (0.16%)  1
MEDIASTINITIS  1  1/618 (0.16%)  1 2/612 (0.33%)  2
MENINGITIS MENINGOCOCCAL  1  1/618 (0.16%)  1 0/612 (0.00%)  0
METAPNEUMOVIRUS INFECTION  1  1/618 (0.16%)  1 0/612 (0.00%)  0
NASOPHARYNGITIS  1  2/618 (0.32%)  3 1/612 (0.16%)  1
OTITIS MEDIA  1  5/618 (0.81%)  5 1/612 (0.16%)  1
OTITIS MEDIA ACUTE  1  2/618 (0.32%)  2 1/612 (0.16%)  1
OTITIS MEDIA VIRAL  1  0/618 (0.00%)  0 1/612 (0.16%)  1
PARAINFLUENZAE VIRUS INFECTION  1  0/618 (0.00%)  0 3/612 (0.49%)  3
PHARYNGITIS  1  2/618 (0.32%)  2 1/612 (0.16%)  1
PNEUMONIA  1  20/618 (3.24%)  27 23/612 (3.76%)  24
PNEUMONIA ADENOVIRAL  1  0/618 (0.00%)  0 1/612 (0.16%)  1
PNEUMONIA INFLUENZAL  1  0/618 (0.00%)  0 1/612 (0.16%)  1
PSEUDOMONAL SEPSIS  1  1/618 (0.16%)  1 0/612 (0.00%)  0
PYELONEPHRITIS  1  0/618 (0.00%)  0 1/612 (0.16%)  1
RESPIRATORY SYNCYTIAL VIRUS BRONCHIOLITIS  1  6/618 (0.97%)  6 9/612 (1.47%)  9
RESPIRATORY SYNCYTIAL VIRUS INFECTION  1  2/618 (0.32%)  2 4/612 (0.65%)  4
RESPIRATORY TRACT INFECTION  1  2/618 (0.32%)  2 4/612 (0.65%)  4
RESPIRATORY TRACT INFECTION VIRAL  1  2/618 (0.32%)  2 1/612 (0.16%)  1
RHINITIS  1  1/618 (0.16%)  1 0/612 (0.00%)  0
ROTAVIRUS INFECTION  1  1/618 (0.16%)  1 1/612 (0.16%)  1
SEPSIS  1  1/618 (0.16%)  1 1/612 (0.16%)  1
SINUSITIS  1  1/618 (0.16%)  1 0/612 (0.00%)  0
STAPHYLOCOCCAL INFECTION  1  1/618 (0.16%)  1 0/612 (0.00%)  0
STAPHYLOCOCCAL MEDIASTINITIS  1  1/618 (0.16%)  1 0/612 (0.00%)  0
STREPTOCOCCAL BACTERAEMIA  1  0/618 (0.00%)  0 1/612 (0.16%)  1
SUBCUTANEOUS ABSCESS  1  0/618 (0.00%)  0 1/612 (0.16%)  1
TONSILLITIS  1  1/618 (0.16%)  1 0/612 (0.00%)  0
TRACHEITIS  1  2/618 (0.32%)  2 0/612 (0.00%)  0
UPPER RESPIRATORY TRACT INFECTION  1  11/618 (1.78%)  12 11/612 (1.80%)  12
URINARY TRACT INFECTION  1  6/618 (0.97%)  6 2/612 (0.33%)  2
URINARY TRACT INFECTION BACTERIAL  1  1/618 (0.16%)  1 0/612 (0.00%)  0
URINARY TRACT INFECTION PSEUDOMONAL  1  1/618 (0.16%)  1 1/612 (0.16%)  1
VARICELLA  1  1/618 (0.16%)  1 0/612 (0.00%)  0
VIRAL INFECTION  1  1/618 (0.16%)  1 1/612 (0.16%)  1
VIRAL SINUSITIS  1  1/618 (0.16%)  2 0/612 (0.00%)  0
VIRAL UPPER RESPIRATORY TRACT INFECTION  1  3/618 (0.49%)  3 0/612 (0.00%)  0
WOUND INFECTION  1  1/618 (0.16%)  1 0/612 (0.00%)  0
WOUND INFECTION STAPHYLOCOCCAL  1  0/618 (0.00%)  0 1/612 (0.16%)  1
Injury, poisoning and procedural complications     
ACCIDENTAL OVERDOSE  1  0/618 (0.00%)  0 1/612 (0.16%)  1
AORTIC INJURY  1  1/618 (0.16%)  1 0/612 (0.00%)  0
CONTUSION  1  0/618 (0.00%)  0 1/612 (0.16%)  1
FEMUR FRACTURE  1  0/618 (0.00%)  0 1/612 (0.16%)  1
HEAD INJURY  1  0/618 (0.00%)  0 2/612 (0.33%)  2
MEDICAL DEVICE COMPLICATION  1  0/618 (0.00%)  0 1/612 (0.16%)  2
MULTIPLE FRACTURES  1  1/618 (0.16%)  1 0/612 (0.00%)  0
POST PROCEDURAL HAEMORRHAGE  1  2/618 (0.32%)  2 0/612 (0.00%)  0
POSTPERICARDIOTOMY SYNDROME  1  1/618 (0.16%)  1 0/612 (0.00%)  0
SEROMA  1  0/618 (0.00%)  0 1/612 (0.16%)  1
SHUNT MALFUNCTION  1  1/618 (0.16%)  1 0/612 (0.00%)  0
SHUNT OCCLUSION  1  1/618 (0.16%)  1 1/612 (0.16%)  1
SHUNT STENOSIS  1  0/618 (0.00%)  0 1/612 (0.16%)  1
SUBDURAL HAEMATOMA  1  1/618 (0.16%)  1 0/612 (0.00%)  0
UPPER LIMB FRACTURE  1  1/618 (0.16%)  1 1/612 (0.16%)  1
VASCULAR PSEUDOANEURYSM  1  2/618 (0.32%)  2 0/612 (0.00%)  0
Investigations     
ALANINE AMINOTRANSFERASE INCREASED  1  0/618 (0.00%)  0 1/612 (0.16%)  1
C-REACTIVE PROTEIN INCREASED  1  0/618 (0.00%)  0 1/612 (0.16%)  1
CENTRAL VENOUS PRESSURE INCREASED  1  1/618 (0.16%)  1 0/612 (0.00%)  0
COAGULATION TEST ABNORMAL  1  0/618 (0.00%)  0 1/612 (0.16%)  1
HEPATIC ENZYME INCREASED  1  0/618 (0.00%)  0 2/612 (0.33%)  2
LIVER FUNCTION TEST ABNORMAL  1  0/618 (0.00%)  0 1/612 (0.16%)  1
MEDICAL OBSERVATION  1  2/618 (0.32%)  2 1/612 (0.16%)  2
SLEEP STUDY  1  1/618 (0.16%)  1 0/612 (0.00%)  0
Metabolism and nutrition disorders     
DEHYDRATION  1  3/618 (0.49%)  3 1/612 (0.16%)  1
DIET REFUSAL  1  0/618 (0.00%)  0 2/612 (0.33%)  2
FAILURE TO THRIVE  1  3/618 (0.49%)  3 5/612 (0.82%)  5
FEEDING DISORDER  1  1/618 (0.16%)  1 0/612 (0.00%)  0
FEEDING DISORDER OF INFANCY OR EARLY CHILDHOOD  1  1/618 (0.16%)  1 3/612 (0.49%)  3
FOOD INTOLERANCE  1  0/618 (0.00%)  0 2/612 (0.33%)  2
HYPOPHAGIA  1  1/618 (0.16%)  1 2/612 (0.33%)  2
METABOLIC ACIDOSIS  1  1/618 (0.16%)  1 0/612 (0.00%)  0
WEIGHT GAIN POOR  1  3/618 (0.49%)  3 2/612 (0.33%)  2
Musculoskeletal and connective tissue disorders     
SOFT TISSUE NECROSIS  1  0/618 (0.00%)  0 1/612 (0.16%)  1
Nervous system disorders     
ANOXIC ENCEPHALOPATHY  1  0/618 (0.00%)  0 1/612 (0.16%)  1
CEREBRAL INFARCTION  1  0/618 (0.00%)  0 1/612 (0.16%)  1
CEREBROVASCULAR ACCIDENT  1  1/618 (0.16%)  1 0/612 (0.00%)  0
CONVULSION  1  2/618 (0.32%)  2 1/612 (0.16%)  1
FEBRILE CONVULSION  1  1/618 (0.16%)  1 1/612 (0.16%)  1
MYOCLONUS  1  0/618 (0.00%)  0 1/612 (0.16%)  1
PHRENIC NERVE PARALYSIS  1  0/618 (0.00%)  0 1/612 (0.16%)  1
TONIC CLONIC MOVEMENTS  1  0/618 (0.00%)  0 1/612 (0.16%)  1
Renal and urinary disorders     
NEPHROLITHIASIS  1  1/618 (0.16%)  1 0/612 (0.00%)  0
PYELOCALIECTASIS  1  0/618 (0.00%)  0 1/612 (0.16%)  1
RENAL FAILURE ACUTE  1  1/618 (0.16%)  1 0/612 (0.00%)  0
RENAL TUBULAR NECROSIS  1  1/618 (0.16%)  1 0/612 (0.00%)  0
Reproductive system and breast disorders     
EPIDIDYMITIS  1  1/618 (0.16%)  1 0/612 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
ACUTE PULMONARY OEDEMA  1  0/618 (0.00%)  0 1/612 (0.16%)  1
ADENOIDAL HYPERTROPHY  1  0/618 (0.00%)  0 1/612 (0.16%)  1
APNOEA  1  1/618 (0.16%)  1 3/612 (0.49%)  3
APNOEIC ATTACK  1  1/618 (0.16%)  1 0/612 (0.00%)  0
ASPIRATION  1  1/618 (0.16%)  1 2/612 (0.33%)  2
ATELECTASIS  1  1/618 (0.16%)  1 2/612 (0.33%)  3
BRONCHIAL HYPERREACTIVITY  1  0/618 (0.00%)  0 1/612 (0.16%)  1
BRONCHOPULMONARY DYSPLASIA  1  1/618 (0.16%)  1 0/612 (0.00%)  0
BRONCHOSPASM  1  0/618 (0.00%)  0 2/612 (0.33%)  2
CHOKING  1  1/618 (0.16%)  1 1/612 (0.16%)  1
CHYLOTHORAX  1  0/618 (0.00%)  0 2/612 (0.33%)  2
COUGH  1  1/618 (0.16%)  1 0/612 (0.00%)  0
DIAPHRAGM MUSCLE WEAKNESS  1  1/618 (0.16%)  1 0/612 (0.00%)  0
DIAPHRAGMATIC HERNIA  1  1/618 (0.16%)  1 0/612 (0.00%)  0
DIAPHRAGMATIC PARALYSIS  1  1/618 (0.16%)  1 0/612 (0.00%)  0
DYSPNOEA  1  2/618 (0.32%)  2 2/612 (0.33%)  2
HYPOXIA  1  1/618 (0.16%)  1 1/612 (0.16%)  1
LARYNGEAL GRANULOMA  1  0/618 (0.00%)  0 1/612 (0.16%)  1
LUNG CONSOLIDATION  1  0/618 (0.00%)  0 1/612 (0.16%)  1
LUNG INFILTRATION  1  0/618 (0.00%)  0 1/612 (0.16%)  1
PLEURAL EFFUSION  1  1/618 (0.16%)  1 2/612 (0.33%)  2
PNEUMONIA ASPIRATION  1  2/618 (0.32%)  2 3/612 (0.49%)  3
PNEUMONITIS  1  1/618 (0.16%)  1 0/612 (0.00%)  0
PNEUMOTHORAX  1  0/618 (0.00%)  0 1/612 (0.16%)  1
PULMONARY ARTERY STENOSIS  1  0/618 (0.00%)  0 5/612 (0.82%)  6
PULMONARY CONGESTION  1  0/618 (0.00%)  0 1/612 (0.16%)  1
PULMONARY HYPERTENSION  1  3/618 (0.49%)  4 2/612 (0.33%)  2
PULMONARY HYPERTENSIVE CRISIS  1  1/618 (0.16%)  1 0/612 (0.00%)  0
PULMONARY OEDEMA  1  1/618 (0.16%)  1 1/612 (0.16%)  2
PULMONARY VEIN OCCLUSION  1  0/618 (0.00%)  0 1/612 (0.16%)  1
PULMONARY VEIN STENOSIS  1  1/618 (0.16%)  1 0/612 (0.00%)  0
RESPIRATORY ARREST  1  2/618 (0.32%)  2 1/612 (0.16%)  1
RESPIRATORY DISTRESS  1  4/618 (0.65%)  4 4/612 (0.65%)  6
RESPIRATORY FAILURE  1  2/618 (0.32%)  2 4/612 (0.65%)  5
STRIDOR  1  1/618 (0.16%)  1 0/612 (0.00%)  0
TACHYPNOEA  1  0/618 (0.00%)  0 1/612 (0.16%)  1
TRACHEOMALACIA  1  0/618 (0.00%)  0 2/612 (0.33%)  2
WHEEZING  1  0/618 (0.00%)  0 1/612 (0.16%)  1
Skin and subcutaneous tissue disorders     
DERMATITIS ALLERGIC  1  0/618 (0.00%)  0 1/612 (0.16%)  1
RASH MACULO-PAPULAR  1  0/618 (0.00%)  0 1/612 (0.16%)  1
URTICARIA  1  2/618 (0.32%)  2 0/612 (0.00%)  0
Social circumstances     
SOCIAL STAY HOSPITALISATION  1  2/618 (0.32%)  2 0/612 (0.00%)  0
Surgical and medical procedures     
IMMUNISATION  1  1/618 (0.16%)  1 0/612 (0.00%)  0
URETHRAL MEATOTOMY  1  0/618 (0.00%)  0 1/612 (0.16%)  1
Vascular disorders     
AORTIC STENOSIS  1  2/618 (0.32%)  2 0/612 (0.00%)  0
ARTERIAL THROMBOSIS LIMB  1  3/618 (0.49%)  3 1/612 (0.16%)  1
FEMORAL ARTERY OCCLUSION  1  1/618 (0.16%)  1 0/612 (0.00%)  0
HYPOTENSION  1  0/618 (0.00%)  0 1/612 (0.16%)  1
HYPOVOLAEMIC SHOCK  1  0/618 (0.00%)  0 1/612 (0.16%)  1
THROMBOSIS  1  1/618 (0.16%)  1 1/612 (0.16%)  1
VASOSPASM  1  0/618 (0.00%)  0 1/612 (0.16%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Motavizumab (MEDI-524) Palivizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   553/618 (89.48%)      540/612 (88.24%)    
Blood and lymphatic system disorders     
ANAEMIA  1  14/618 (2.27%)  15 16/612 (2.61%)  22
Cardiac disorders     
CARDIAC FAILURE  1  9/618 (1.46%)  10 10/612 (1.63%)  10
CYANOSIS  1  25/618 (4.05%)  42 25/612 (4.08%)  32
Eye disorders     
CONJUNCTIVITIS  1  39/618 (6.31%)  42 27/612 (4.41%)  32
Gastrointestinal disorders     
CONSTIPATION  1  44/618 (7.12%)  47 31/612 (5.07%)  35
DIARRHOEA  1  69/618 (11.17%)  80 64/612 (10.46%)  70
FLATULENCE  1  5/618 (0.81%)  5 6/612 (0.98%)  7
ENTERITIS  1  7/618 (1.13%)  8 4/612 (0.65%)  4
GASTROOESOPHAGEAL REFLUX DISEASE  1  19/618 (3.07%)  19 23/612 (3.76%)  23
TEETHING  1  44/618 (7.12%)  54 36/612 (5.88%)  56
VOMITING  1  59/618 (9.55%)  70 49/612 (8.01%)  60
General disorders     
IRRITABILITY  1  22/618 (3.56%)  33 37/612 (6.05%)  48
PYREXIA  1  180/618 (29.13%)  285 177/612 (28.92%)  286
Immune system disorders     
IMMUNISATION REACTION  1  6/618 (0.97%)  8 8/612 (1.31%)  11
Infections and infestations     
BRONCHIOLITIS  1  16/618 (2.59%)  18 10/612 (1.63%)  11
BRONCHITIS  1  40/618 (6.47%)  48 41/612 (6.70%)  57
CANDIDIASIS  1  6/618 (0.97%)  6 5/612 (0.82%)  7
CROUP INFECTIOUS  1  2/618 (0.32%)  2 9/612 (1.47%)  9
EAR INFECTION  1  9/618 (1.46%)  11 7/612 (1.14%)  9
EXANTHEMA SUBITUM  1  6/618 (0.97%)  6 7/612 (1.14%)  7
GASTROENTERITIS  1  56/618 (9.06%)  62 48/612 (7.84%)  53
GASTROENTERITIS VIRAL  1  9/618 (1.46%)  9 5/612 (0.82%)  5
INFLUENZA  1  6/618 (0.97%)  6 3/612 (0.49%)  3
LOWER RESPIRATORY TRACT INFECTION  1  9/618 (1.46%)  12 9/612 (1.47%)  13
NASOPHARYNGITIS  1  67/618 (10.84%)  83 57/612 (9.31%)  79
ORAL CANDIDIASIS  1  10/618 (1.62%)  10 7/612 (1.14%)  11
OTITIS MEDIA  1  73/618 (11.81%)  97 70/612 (11.44%)  95
OTITIS MEDIA ACUTE  1  26/618 (4.21%)  30 19/612 (3.10%)  25
PHARYNGITIS  1  31/618 (5.02%)  37 24/612 (3.92%)  28
PNEUMONIA  1  11/618 (1.78%)  12 13/612 (2.12%)  14
RESPIRATORY TRACT INFECTION  1  11/618 (1.78%)  12 4/612 (0.65%)  5
RHINITIS  1  91/618 (14.72%)  115 77/612 (12.58%)  99
SINUSITIS  1  10/618 (1.62%)  11 7/612 (1.14%)  8
TONSILLITIS  1  18/618 (2.91%)  21 8/612 (1.31%)  8
UPPER RESPIRATORY TRACT INFECTION  1  160/618 (25.89%)  235 164/612 (26.80%)  254
URINARY TRACT INFECTION  1  12/618 (1.94%)  13 9/612 (1.47%)  9
VARICELLA  1  11/618 (1.78%)  11 5/612 (0.82%)  5
VIRAL INFECTION  1  38/618 (6.15%)  47 30/612 (4.90%)  33
VIRAL UPPER RESPIRATORY TRACT INFECTION  1  12/618 (1.94%)  13 15/612 (2.45%)  16
Investigations     
ALANINE AMINOTRANSFERASE INCREASED  1  13/618 (2.10%)  13 25/612 (4.08%)  25
ASPARTATE AMINOTRANSFERASE INCREASED  1  3/618 (0.49%)  3 9/612 (1.47%)  9
BLOOD UREA INCREASED  1  39/618 (6.31%)  39 34/612 (5.56%)  35
OXYGEN SATURATION DECREASED  1  9/618 (1.46%)  10 4/612 (0.65%)  5
WEIGHT DECREASED  1  7/618 (1.13%)  7 6/612 (0.98%)  6
Metabolism and nutrition disorders     
DECREASED APPETITE  1  4/618 (0.65%)  5 6/612 (0.98%)  6
HYPOKALAEMIA  1  6/618 (0.97%)  6 5/612 (0.82%)  6
Psychiatric disorders     
RESTLESSNESS  1  6/618 (0.97%)  7 3/612 (0.49%)  3
Respiratory, thoracic and mediastinal disorders     
ATELECTASIS  1  3/618 (0.49%)  3 7/612 (1.14%)  7
COUGH  1  92/618 (14.89%)  120 71/612 (11.60%)  95
NASAL CONGESTION  1  26/618 (4.21%)  31 33/612 (5.39%)  45
PLEURAL EFFUSION  1  9/618 (1.46%)  9 6/612 (0.98%)  7
PNEUMOTHORAX  1  2/618 (0.32%)  2 7/612 (1.14%)  7
RESPIRATORY DISORDER  1  23/618 (3.72%)  27 28/612 (4.58%)  35
RHINORRHOEA  1  49/618 (7.93%)  64 45/612 (7.35%)  70
WHEEZING  1  10/618 (1.62%)  10 10/612 (1.63%)  12
Skin and subcutaneous tissue disorders     
DERMATITIS  1  7/618 (1.13%)  7 3/612 (0.49%)  3
DERMATITIS ATOPIC  1  6/618 (0.97%)  7 3/612 (0.49%)  3
DERMATITIS CONTACT  1  5/618 (0.81%)  5 7/612 (1.14%)  7
DERMATITIS DIAPER  1  32/618 (5.18%)  38 31/612 (5.07%)  38
DRY SKIN  1  6/618 (0.97%)  6 2/612 (0.33%)  2
ECZEMA  1  11/618 (1.78%)  13 9/612 (1.47%)  9
RASH  1  27/618 (4.37%)  27 21/612 (3.43%)  25
RASH MACULO-PAPULAR  1  9/618 (1.46%)  10 6/612 (0.98%)  6
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
Results Point of Contact
Name/Title: Pamela Griffin, Senior Director, Clinical Development
Organization: MedImmune, LLC
Phone: 301 398 0000
Responsible Party: Pamela Griffin, Senior Director, Clinical Development, MedImmune, LLC
ClinicalTrials.gov Identifier: NCT00538785     History of Changes
Obsolete Identifiers: NCT00240890
Other Study ID Numbers: MI-CP124-S2
First Submitted: October 1, 2007
First Posted: October 3, 2007
Results First Submitted: January 11, 2012
Results First Posted: February 14, 2012
Last Update Posted: February 16, 2012