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Ignite Creation Date: 2025-12-24 @ 4:19 PM

Ignite Modification Date: 2025-12-25 @ 2:16 PM

Study NCT ID: NCT00129766

Status: COMPLETED

Last Update Posted: 2013-08-28

First Post: 2005-08-10

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: Study of MEDI-524 (Motavizumab) for the Prophylaxis of Serious Respiratory Syncytial Virus (RSV) Disease in High-Risk Children

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018357', 'term': 'Respiratory Syncytial Virus Infections'}], 'ancestors': [{'id': 'D018186', 'term': 'Pneumovirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C506968', 'term': 'motavizumab'}, {'id': 'D000069455', 'term': 'Palivizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialenquiries@medimmune.com', 'phone': '301-398-0000', 'title': 'M. Pamela Griffin, Sr. Director, Clinical Development', 'organization': 'MedImmune'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 0 - Day 150', 'eventGroups': [{'id': 'EG000', 'title': 'Palivizumab', 'description': 'Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses', 'otherNumAtRisk': 3298, 'otherNumAffected': 2777, 'seriousNumAtRisk': 3298, 'seriousNumAffected': 506}, {'id': 'EG001', 'title': 'Motavizumab', 'description': 'Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses', 'otherNumAtRisk': 3315, 'otherNumAffected': 2784, 'seriousNumAtRisk': 3315, 'seriousNumAffected': 485}], 'otherEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 75, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 67, 'numAffected': 66}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'DACRYOSTENOSIS CONGENITAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 34, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 37, 'numAffected': 35}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'CONJUNCTIVITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 285, 'numAffected': 251}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 271, 'numAffected': 246}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 73, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 55, 'numAffected': 54}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 262, 'numAffected': 227}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 265, 'numAffected': 234}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 306, 'numAffected': 274}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 295, 'numAffected': 254}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'FLATULENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 135, 'numAffected': 119}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 170, 'numAffected': 126}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'GASTROOESOPHAGEAL REFLUX DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 198, 'numAffected': 190}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 197, 'numAffected': 190}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'TEETHING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 408, 'numAffected': 282}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 417, 'numAffected': 299}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'UMBILICAL HERNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 63, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 77, 'numAffected': 77}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 179, 'numAffected': 164}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 174, 'numAffected': 158}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'INJECTION SITE ERYTHEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 38, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 52, 'numAffected': 41}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'INJECTION SITE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 94, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 81, 'numAffected': 45}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'IRRITABILITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 243, 'numAffected': 164}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 299, 'numAffected': 193}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 729, 'numAffected': 556}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 718, 'numAffected': 543}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'BRONCHIOLITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 263, 'numAffected': 222}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 226, 'numAffected': 193}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 356, 'numAffected': 260}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 328, 'numAffected': 230}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'CANDIDIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 93, 'numAffected': 79}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 65, 'numAffected': 58}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'IMMUNISATION REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 122, 'numAffected': 97}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 138, 'numAffected': 102}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 223, 'numAffected': 207}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 212, 'numAffected': 199}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'GASTROENTERITIS VIRAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 36, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 40, 'numAffected': 40}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'LOWER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 165, 'numAffected': 133}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 159, 'numAffected': 130}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 333, 'numAffected': 262}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 325, 'numAffected': 240}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'ORAL CANDIDIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 120, 'numAffected': 107}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 113, 'numAffected': 101}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'OTITIS MEDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 565, 'numAffected': 418}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 575, 'numAffected': 432}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'OTITIS MEDIA ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 79, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 83, 'numAffected': 65}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'PHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 101, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 81, 'numAffected': 70}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 39, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'RHINITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 593, 'numAffected': 444}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 600, 'numAffected': 440}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 1482, 'numAffected': 981}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 1420, 'numAffected': 956}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'VIRAL INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 112, 'numAffected': 98}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 103, 'numAffected': 86}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'VIRAL UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 64, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 64, 'numAffected': 56}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'BLOOD UREA INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 35, 'numAffected': 35}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'HAEMANGIOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 41, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 34, 'numAffected': 29}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'AGITATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 61, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 51, 'numAffected': 35}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'ASTHMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 45, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 37, 'numAffected': 33}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'BRONCHIAL HYPERREACTIVITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 62, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 48, 'numAffected': 44}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 262, 'numAffected': 216}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 260, 'numAffected': 220}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'NASAL CONGESTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 326, 'numAffected': 265}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 318, 'numAffected': 269}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'RESPIRATORY DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 374, 'numAffected': 275}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 380, 'numAffected': 295}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'RHINORRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 112, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 124, 'numAffected': 99}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'WHEEZING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 85, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 61, 'numAffected': 51}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'DERMATITIS ATOPIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 55, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 48, 'numAffected': 44}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'DERMATITIS DIAPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 233, 'numAffected': 192}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 199, 'numAffected': 177}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'DRY SKIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 26, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 37, 'numAffected': 35}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'ECZEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 100, 'numAffected': 95}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 140, 'numAffected': 132}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 110, 'numAffected': 103}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 147, 'numAffected': 130}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'SEBORRHOEIC DERMATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 53, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 57, 'numAffected': 56}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'seriousEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'ANAEMIA NEONATAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'CYCLIC NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'HAEMOLYTIC ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'HAEMOLYTIC URAEMIC SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'IRON DEFICIENCY ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'ATRIAL THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'BRADYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'CARDIAC ARREST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'CARDIAC FAILURE HIGH OUTPUT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'CARDIO-RESPIRATORY ARREST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'CARDIOGENIC SHOCK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'CYANOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 2, 'numAffected': 2}, 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'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'HAMARTOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'HIP DYSPLASIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'LIMB REDUCTION DEFECT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 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'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'PAPILLOEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'RETINOPATHY OF PREMATURITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'RETINOPATHY PROLIFERATIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 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'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'MEDICAL DEVICE COMPLICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'POST PROCEDURAL DISCHARGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'SHUNT MALFUNCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'HYPOXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'INTERSTITIAL LUNG DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'LARYNGEAL OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal 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'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'PULMONARY HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'PULMONARY HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'PULMONARY HYPERTENSIVE CRISIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'PULMONARY OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'RESPIRATORY DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'RESPIRATORY DISTRESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'SLEEP APNOEA SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'STATUS ASTHMATICUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'STRIDOR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'TACHYPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'TONSILLAR HYPERTROPHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'VOCAL CORD DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'WHEEZING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'ANGIOEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'PETECHIAE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'URTICARIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'SOCIAL STAY HOSPITALISATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'VICTIM OF CHILD ABUSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'CENTRAL VENOUS CATHETERISATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'COLOSTOMY CLOSURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'EAR TUBE INSERTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'GASTROSTOMY CLOSURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'GASTROSTOMY TUBE INSERTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'ILEOSTOMY CLOSURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'NUTRITIONAL SUPPORT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'VENTRICULO-PERITONEAL SHUNT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3298, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of RSV Hospitalization (Includes Deaths by RSV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3306', 'groupId': 'OG000'}, {'value': '3329', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palivizumab', 'description': 'Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}, {'id': 'OG001', 'title': 'Motavizumab', 'description': 'Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}], 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.740', 'ciLowerLimit': '0.503', 'ciUpperLimit': '1.083', 'estimateComment': 'Relative risk was calculated as (Pn/Ps) where Pn is the proportion of patients with RSV hospitalization in the motavizumab group and Ps is the proportion of patients with RSV hospitalization in the palivizumab group.', 'groupDescription': 'ITT population', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Confidence interval and relative risk adjusted for the stratification factor of presence or absence of CLD of prematurity as specified on the CRF.'}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0 - 150', 'description': 'RSV hospitalization was defined as 1) a respiratory hospitalization with a positive RSV test (primary), 2) a new onset of lower respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test (nosocomial), or 3) death demonstrated to have been caused by RSV (by autopsy or clinical history and virologic evidence).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat (ITT) Population included all patients randomized into the study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Reporting Any Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3298', 'groupId': 'OG000'}, {'value': '3315', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palivizumab', 'description': 'Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}, {'id': 'OG001', 'title': 'Motavizumab', 'description': 'Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}], 'classes': [{'categories': [{'measurements': [{'value': '2837', 'groupId': 'OG000'}, {'value': '2839', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0 - 150', 'description': 'Number of participants reporting one or more AEs', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population included all patients who received any study drug and had any safety follow-up.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Reporting Any Related AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3298', 'groupId': 'OG000'}, {'value': '3315', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palivizumab', 'description': 'Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}, {'id': 'OG001', 'title': 'Motavizumab', 'description': 'Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}], 'classes': [{'categories': [{'measurements': [{'value': '258', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0 - 150', 'description': 'Number of participants reporting one or more AEs considered related to study drug by the investigator', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population included all patients who received any study drug and had any safety follow-up.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Reporting Any Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3298', 'groupId': 'OG000'}, {'value': '3315', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palivizumab', 'description': 'Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}, {'id': 'OG001', 'title': 'Motavizumab', 'description': 'Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}], 'classes': [{'categories': [{'measurements': [{'value': '506', 'groupId': 'OG000'}, {'value': '485', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0 - 150', 'description': 'Number of participants reporting one or more SAEs', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population included all patients who received any study drug and had any safety follow-up.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Reporting Any Related SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3298', 'groupId': 'OG000'}, {'value': '3315', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palivizumab', 'description': 'Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}, {'id': 'OG001', 'title': 'Motavizumab', 'description': 'Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0 - 150', 'description': 'Number of participants reporting one or more SAEs considered related to study drug by the investigator', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population included all patients who received any study drug and had any safety follow-up.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Reporting AEs by Highest Severity Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3298', 'groupId': 'OG000'}, {'value': '3315', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palivizumab', 'description': 'Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}, {'id': 'OG001', 'title': 'Motavizumab', 'description': 'Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}], 'classes': [{'title': 'Level 1', 'categories': [{'measurements': [{'value': '1478', 'groupId': 'OG000'}, {'value': '1538', 'groupId': 'OG001'}]}]}, {'title': 'Level 2', 'categories': [{'measurements': [{'value': '1006', 'groupId': 'OG000'}, {'value': '976', 'groupId': 'OG001'}]}]}, {'title': 'Level 3', 'categories': [{'measurements': [{'value': '292', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}]}, {'title': 'Level 4', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0 - 150', 'description': 'Adverse events events were graded by severity; Level 1, 2, 3, or 4', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population included all patients who received any study drug and had any safety follow-up.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Discontinued Study Drug Due to AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3298', 'groupId': 'OG000'}, {'value': '3315', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palivizumab', 'description': 'Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}, {'id': 'OG001', 'title': 'Motavizumab', 'description': 'Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0 - 150', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population included all patients who received any study drug and had any safety follow-up.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Died', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3298', 'groupId': 'OG000'}, {'value': '3315', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palivizumab', 'description': 'Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}, {'id': 'OG001', 'title': 'Motavizumab', 'description': 'Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0 - 150', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population included all patients who received any study drug and had any safety follow-up.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Reporting Changes in Vital Signs From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3298', 'groupId': 'OG000'}, {'value': '3315', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palivizumab', 'description': 'Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}, {'id': 'OG001', 'title': 'Motavizumab', 'description': 'Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}], 'classes': [{'title': 'Fever neonatal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hyperpyrexia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hyperthermia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Hypothermia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Pyrexia', 'categories': [{'measurements': [{'value': '559', 'groupId': 'OG000'}, {'value': '544', 'groupId': 'OG001'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Hypotension', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Arrhythmia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bradycardia', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Tachycardia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0 - 150', 'description': 'Vital signs that were in a higher toxicity grade than observed at baseline were to be recorded as AEs', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population included all patients who received any study drug and had any safety follow-up.'}, {'type': 'SECONDARY', 'title': 'The Incidence of Outpatient Medically-attended Lower Respiratory Illness (LRI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3306', 'groupId': 'OG000'}, {'value': '3329', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palivizumab', 'description': 'Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}, {'id': 'OG001', 'title': 'Motavizumab', 'description': 'Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}], 'classes': [{'categories': [{'measurements': [{'value': '696', 'groupId': 'OG000'}, {'value': '648', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.110', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Test stratified by presence or absence of CLD of prematurity specified on the CRF', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 - 150', 'description': 'LRI was defined as an event of bronchiolitis or pneumonia or the occurance of a lower tract infectious illness as determined by the PI based on medical history, signs, and symptoms.', 'unitOfMeasure': 'Participant', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat (ITT) Population included all patients randomized into the study.'}, {'type': 'SECONDARY', 'title': 'The Incidence of RSV-specific Medically-attended Outpatient Lower Respiratory Illnesses (LRIs) Between Treatment Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1183', 'groupId': 'OG000'}, {'value': '1227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palivizumab', 'description': 'Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}, {'id': 'OG001', 'title': 'Motavizumab', 'description': 'Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'No adjustment for multiple comparisons.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The CMH test was stratified by presence or absence of CLD of prematurity as specified on the CRF', 'testedNonInferiority': True, 'nonInferiorityComment': 'A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.'}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0 - 150', 'description': 'The RSV-specific LRI was defined as an outpatient medically-attended LRI associated with a positive RSV test and was not inclusive of events that required hospitalization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects were from a pre-specified subsets of sites participating in the nasal secretion sample collection for this endpoint.'}, {'type': 'SECONDARY', 'title': 'The Incidence of Medically-attended Otitis Media (OM) Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3306', 'groupId': 'OG000'}, {'value': '3329', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palivizumab', 'description': 'Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}, {'id': 'OG001', 'title': 'Motavizumab', 'description': 'Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}], 'classes': [{'title': 'Overall incidence', 'categories': [{'measurements': [{'value': '461', 'groupId': 'OG000'}, {'value': '484', 'groupId': 'OG001'}]}]}, {'title': '0 infections', 'categories': [{'measurements': [{'value': '2845', 'groupId': 'OG000'}, {'value': '2845', 'groupId': 'OG001'}]}]}, {'title': '1 infection', 'categories': [{'measurements': [{'value': '329', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}]}, {'title': '2 infections', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}, {'title': '3 or more infections', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.476', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'P-value is for overall incidence', 'statisticalMethod': 'Van Eleteren test', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Test stratified by presence or absence of CLD of prematurity specified on the CRF', 'testedNonInferiority': True, 'nonInferiorityComment': 'A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.'}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0 - 150', 'description': 'Otitis media (OM) was to be recorded as the diagnosis if the following terms were used by the medical care provider: acute OM, acute tympanic membrane (TM) perforation, bulging TM, red TM with fever, OM with effusion, or middle ear effusion. A new episode was defined as a physician-diagnosed OM in either ear after a normal middle ear exam of the ear in question or an episode of acute OM greater than or equal to 21 days after resolution of the previous episode. A diagnosis of persistent middle ear effusion was not to be recorded as a new OM event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat (ITT) Population included all patients randomized into the study.'}, {'type': 'SECONDARY', 'title': 'The Frequency of Prescribed Antibiotics for Medically-attended LRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3306', 'groupId': 'OG000'}, {'value': '3329', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palivizumab', 'description': 'Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}, {'id': 'OG001', 'title': 'Motavizumab', 'description': 'Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}], 'classes': [{'categories': [{'measurements': [{'value': '0.32', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.30', 'spread': '0.02', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.493', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Test stratified by presence or absence of CLD of prematurity specified on the CRF', 'statisticalMethod': 'Van Eleteren test', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.'}], 'paramType': 'MEAN', 'timeFrame': 'Days 0 - 150', 'description': 'The average number of presciptions per event per subject was summarized for each treatment group.', 'unitOfMeasure': 'Number of prescriptions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat (ITT) Population included all patients randomized into the study.'}, {'type': 'SECONDARY', 'title': 'The Frequency of Prescribed Antibiotics for Medically-attended OM Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3306', 'groupId': 'OG000'}, {'value': '3329', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palivizumab', 'description': 'Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}, {'id': 'OG001', 'title': 'Motavizumab', 'description': 'Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}], 'classes': [{'categories': [{'measurements': [{'value': '1.08', 'spread': '0.003', 'groupId': 'OG000'}, {'value': '1.10', 'spread': '0.003', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.652', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Test stratified by presence or absence of CLD of prematurity specified on the CRF', 'statisticalMethod': 'Van Eleteren test', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.'}], 'paramType': 'MEAN', 'timeFrame': 'Days 0 - 150', 'description': 'The average number of presciptions per event per subject was summarized for each treatment group.', 'unitOfMeasure': 'number of prescriptions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat (ITT) Population included all patients randomized into the study.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With Anti-motavizumab Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3217', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Motavizumab', 'description': 'Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}], 'classes': [{'title': 'Pre-dose 1', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': '30 Days Post-Dose 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '30 Days Post-Dose 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '30 Days Post-Dose 3', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': '30 Days Post-Dose 4', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'At any time post baseline', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 - 120', 'description': 'Detection of anti-motavizumab antibodies was defined as a titer with a dilution value equal to or greater than 1:10.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'N varied at different timepoints: at pre-dose 1 N=3193; at 30 days post-dose 1 N=998; at 30 days post-dose 2 N=1049; at 30 days post-dose 3 N=1049; at 30 days post-dose 4, N=3013; at any time post baseline, N=3217'}, {'type': 'SECONDARY', 'title': 'The Serum Concentrations of Motavizumab at Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3147', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Motavizumab', 'description': 'Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01193', 'spread': '0.2072', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0', 'description': 'Mean serum concentrations of motavizumab at Day 0', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug.'}, {'type': 'SECONDARY', 'title': 'The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '974', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Motavizumab', 'description': 'Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}], 'classes': [{'categories': [{'measurements': [{'value': '45.95', 'spread': '15.17', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days post Dose 1', 'description': 'Mean serum concentrations of motavizumab at 30 days post Dose 1', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 1 measurements'}, {'type': 'SECONDARY', 'title': 'The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '915', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Motavizumab', 'description': 'Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}], 'classes': [{'categories': [{'measurements': [{'value': '64.59', 'spread': '25.60', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days post Dose 2', 'description': 'Mean serum concentrations of motavizumab at 30 days post Dose 2', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 2 measurements'}, {'type': 'SECONDARY', 'title': 'The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '918', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Motavizumab', 'description': 'Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}], 'classes': [{'categories': [{'measurements': [{'value': '80.24', 'spread': '31.22', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days post Dose 3', 'description': 'Mean serum concentrations of motavizumab at 30 days post Dose 3', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 3 measurements'}, {'type': 'SECONDARY', 'title': 'The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2669', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Motavizumab', 'description': 'Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}], 'classes': [{'categories': [{'measurements': [{'value': '88.52', 'spread': '35.43', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days post Dose 4', 'description': 'Mean serum concentrations of motavizumab at 30 days post Dose 4', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 4 measurements'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Palivizumab', 'description': 'Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}, {'id': 'FG001', 'title': 'Motavizumab', 'description': 'Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3306'}, {'groupId': 'FG001', 'numSubjects': '3329'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3246'}, {'groupId': 'FG001', 'numSubjects': '3270'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '59'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Withdrawal of consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '21'}]}]}], 'recruitmentDetails': 'A total of 6,635 children were randomized in a 1:1 ratio at 347 centers in 24 countries within the Northern and Southern hemispheres between 01/Nov/2004 and 09/Dec/2005; each child participated in the study for a single RSV season.', 'preAssignmentDetails': 'Randomization was blocked by study site and stratified according to presence/absence of CLD of prematurity requiring medical intervention/management.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3306', 'groupId': 'BG000'}, {'value': '3329', 'groupId': 'BG001'}, {'value': '6635', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Palivizumab', 'description': 'Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}, {'id': 'BG001', 'title': 'Motavizumab', 'description': 'Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '3.98', 'spread': '3.78', 'groupId': 'BG000'}, {'value': '3.99', 'spread': '3.75', 'groupId': 'BG001'}, {'value': '3.99', 'spread': '3.76', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1495', 'groupId': 'BG000'}, {'value': '1513', 'groupId': 'BG001'}, {'value': '3008', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1811', 'groupId': 'BG000'}, {'value': '1816', 'groupId': 'BG001'}, {'value': '3627', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1130', 'groupId': 'BG000'}, {'value': '1167', 'groupId': 'BG001'}, {'value': '2297', 'groupId': 'BG002'}]}]}, {'title': 'Greece', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '191', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '372', 'groupId': 'BG002'}]}]}, {'title': 'Turkey', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '301', 'groupId': 'BG000'}, {'value': '305', 'groupId': 'BG001'}, {'value': '606', 'groupId': 'BG002'}]}]}, {'title': 'Chile', 'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '198', 'groupId': 'BG000'}, {'value': '192', 'groupId': 'BG001'}, {'value': '390', 'groupId': 'BG002'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '171', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '348', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '134', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '266', 'groupId': 'BG002'}]}]}, {'title': 'Argentina', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '211', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}, {'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '196', 'groupId': 'BG002'}]}]}, {'title': 'Iceland', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '253', 'groupId': 'BG002'}]}]}, {'title': 'New Zealand', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6635}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-21', 'studyFirstSubmitDate': '2005-08-10', 'resultsFirstSubmitDate': '2013-06-21', 'studyFirstSubmitQcDate': '2005-08-10', 'lastUpdatePostDateStruct': {'date': '2013-08-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-06-21', 'studyFirstPostDateStruct': {'date': '2005-08-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of RSV Hospitalization (Includes Deaths by RSV)', 'timeFrame': 'Days 0 - 150', 'description': 'RSV hospitalization was defined as 1) a respiratory hospitalization with a positive RSV test (primary), 2) a new onset of lower respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test (nosocomial), or 3) death demonstrated to have been caused by RSV (by autopsy or clinical history and virologic evidence).'}, {'measure': 'Number of Participants Reporting Any Adverse Events (AEs)', 'timeFrame': 'Days 0 - 150', 'description': 'Number of participants reporting one or more AEs'}, {'measure': 'Number of Participants Reporting Any Related AEs', 'timeFrame': 'Days 0 - 150', 'description': 'Number of participants reporting one or more AEs considered related to study drug by the investigator'}, {'measure': 'Number of Participants Reporting Any Serious Adverse Events (SAEs)', 'timeFrame': 'Days 0 - 150', 'description': 'Number of participants reporting one or more SAEs'}, {'measure': 'Number of Participants Reporting Any Related SAEs', 'timeFrame': 'Days 0 - 150', 'description': 'Number of participants reporting one or more SAEs considered related to study drug by the investigator'}, {'measure': 'Number of Participants Reporting AEs by Highest Severity Grade', 'timeFrame': 'Days 0 - 150', 'description': 'Adverse events events were graded by severity; Level 1, 2, 3, or 4'}, {'measure': 'Number of Participants Who Discontinued Study Drug Due to AEs', 'timeFrame': 'Days 0 - 150'}, {'measure': 'Number of Participants Who Died', 'timeFrame': 'Days 0 - 150'}, {'measure': 'Number of Participants Reporting Changes in Vital Signs From Baseline', 'timeFrame': 'Days 0 - 150', 'description': 'Vital signs that were in a higher toxicity grade than observed at baseline were to be recorded as AEs'}], 'secondaryOutcomes': [{'measure': 'The Incidence of Outpatient Medically-attended Lower Respiratory Illness (LRI)', 'timeFrame': 'Day 0 - 150', 'description': 'LRI was defined as an event of bronchiolitis or pneumonia or the occurance of a lower tract infectious illness as determined by the PI based on medical history, signs, and symptoms.'}, {'measure': 'The Incidence of RSV-specific Medically-attended Outpatient Lower Respiratory Illnesses (LRIs) Between Treatment Groups', 'timeFrame': 'Days 0 - 150', 'description': 'The RSV-specific LRI was defined as an outpatient medically-attended LRI associated with a positive RSV test and was not inclusive of events that required hospitalization.'}, {'measure': 'The Incidence of Medically-attended Otitis Media (OM) Infections', 'timeFrame': 'Days 0 - 150', 'description': 'Otitis media (OM) was to be recorded as the diagnosis if the following terms were used by the medical care provider: acute OM, acute tympanic membrane (TM) perforation, bulging TM, red TM with fever, OM with effusion, or middle ear effusion. A new episode was defined as a physician-diagnosed OM in either ear after a normal middle ear exam of the ear in question or an episode of acute OM greater than or equal to 21 days after resolution of the previous episode. A diagnosis of persistent middle ear effusion was not to be recorded as a new OM event.'}, {'measure': 'The Frequency of Prescribed Antibiotics for Medically-attended LRI', 'timeFrame': 'Days 0 - 150', 'description': 'The average number of presciptions per event per subject was summarized for each treatment group.'}, {'measure': 'The Frequency of Prescribed Antibiotics for Medically-attended OM Infections', 'timeFrame': 'Days 0 - 150', 'description': 'The average number of presciptions per event per subject was summarized for each treatment group.'}, {'measure': 'The Number of Participants With Anti-motavizumab Antibodies', 'timeFrame': 'Day 0 - 120', 'description': 'Detection of anti-motavizumab antibodies was defined as a titer with a dilution value equal to or greater than 1:10.'}, {'measure': 'The Serum Concentrations of Motavizumab at Day 0', 'timeFrame': 'Day 0', 'description': 'Mean serum concentrations of motavizumab at Day 0'}, {'measure': 'The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 1', 'timeFrame': '30 days post Dose 1', 'description': 'Mean serum concentrations of motavizumab at 30 days post Dose 1'}, {'measure': 'The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 2', 'timeFrame': '30 days post Dose 2', 'description': 'Mean serum concentrations of motavizumab at 30 days post Dose 2'}, {'measure': 'The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 3', 'timeFrame': '30 days post Dose 3', 'description': 'Mean serum concentrations of motavizumab at 30 days post Dose 3'}, {'measure': 'The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 4', 'timeFrame': '30 days post Dose 4', 'description': 'Mean serum concentrations of motavizumab at 30 days post Dose 4'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Respiratory Syncytial Virus (RSV)', 'motavizumab', 'palivizumab', 'Synagis'], 'conditions': ['Respiratory Syncytial Virus Infections']}, 'referencesModule': {'references': [{'pmid': '20008423', 'type': 'RESULT', 'citation': 'Carbonell-Estrany X, Simoes EA, Dagan R, Hall CB, Harris B, Hultquist M, Connor EM, Losonsky GA; Motavizumab Study Group. Motavizumab for prophylaxis of respiratory syncytial virus in high-risk children: a noninferiority trial. Pediatrics. 2010 Jan;125(1):e35-51. doi: 10.1542/peds.2008-1036. Epub 2009 Dec 14.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study was to compare the safety and efficacy of motavizumab to palivizumab when administered monthly by intramuscular (IM) injection for the reduction of the incidence of RSV hospitalization among children at high risk for serious RSV disease. A secondary objective was to compare the incidence of medically-attended lower respiratory infections (LRIs) between treatment groups.', 'detailedDescription': 'A randomized, double-blind, palivizumab-controlled, multi-center, multi-national trial conducted during 2 Northern Hemisphere RSV seasons with an intervening season in the Southern Hemisphere. Each child only participated during a single RSV season. Approximately 6,600 children at risk for serious RSV disease were to be randomized in a 1:1 ratio to receive either 15 mg/kg of palivizumab or motavizumab by IM injection every 30 days for a total of 5 doses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 24 months of age or younger at randomization (child must be randomized on or before his/her 24-month birthday) with a diagnosis of chronic lung disease (CLD) of prematurity requiring medical intervention/management (i.e., supplemental oxygen, bronchodilators, or diuretics) within 6 months before randomization\n\nOR:\n\n* 35 weeks gestational age or less at birth and 6 months of age or younger at randomization (children were to be randomized on or before his/her 6-month birthday)\n\nExclusion Criteria:\n\n* Hospitalization at the time of randomization (unless discharge was anticipated within 10 days)\n* Mechanical ventilation or other mechanical support (including continuous positive airways pressure \\[CPAP\\])\n* Life expectancy \\< 6 months\n* Active RSV infection (a child with signs/symptoms of respiratory infection must have had negative RSV testing)\n* Known renal impairment\n* Known hepatic dysfunction\n* Chronic seizure or evolving or unstable neurologic disorder\n* Congenital heart disease \\[CHD\\] (children with uncomplicated CHD \\[e.g., patent ductus arterious (PDA), small septal defect\\] and children with complicated CHD that were currently anatomically and hemodynamically normal could be enrolled)\n* Known immunodeficiency\n* Mother with HIV infection (unless the child has been proven to be not infected)\n* Known allergy to Ig products\n* Receipt of palivizumab, RSV-IGIV, or other RSV-specific monoclonal antibody, or any other polyclonal antibody (for example, hepatitis B IG, IVIG, VZIG) within 3 months prior to randomization\n* Anticipated use of palivizumab or IVIG during the study (blood transfusions permitted)\n* Previous receipt of RSV vaccines\n* Participation in other investigational drug product studies'}, 'identificationModule': {'nctId': 'NCT00129766', 'briefTitle': 'Study of MEDI-524 (Motavizumab) for the Prophylaxis of Serious Respiratory Syncytial Virus (RSV) Disease in High-Risk Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedImmune LLC'}, 'officialTitle': 'A Pivotal Phase 3 Study of MEDI-524 (Numax; Motavizumab), an Enhanced Potency Humanized RSV Monoclonal Antibody, for the Prophylaxis of Serious RSV Disease in High-Risk Children', 'orgStudyIdInfo': {'id': 'MI-CP110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'palivizumab', 'description': '15 mg/kg administered intramuscularly for 5 monthly doses', 'interventionNames': ['Biological: palivizumab']}, {'type': 'EXPERIMENTAL', 'label': 'motavizumab (MEDI-524)', 'description': '15 mg/kg of motavizumab was administered intramuscularly for 5 monthly doses', 'interventionNames': ['Biological: motavizumab (MEDI-524)']}], 'interventions': [{'name': 'motavizumab (MEDI-524)', 'type': 'BIOLOGICAL', 'otherNames': ['MEDI-524'], 'description': 'Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses', 'armGroupLabels': ['motavizumab (MEDI-524)']}, {'name': 'palivizumab', 'type': 'BIOLOGICAL', 'otherNames': ['Synagis'], 'description': 'Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses', 'armGroupLabels': ['palivizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University Of Alabama At Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35233', 'city': 'Pike Road', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Neonatal Medicine OC', 'geoPoint': {'lat': 32.28431, 'lon': -86.10302}}, {'zip': '85008', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Maricopa Medical Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72015', 'city': 'Benton', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Central Arkansas Pediatric Clinic, PA', 'geoPoint': {'lat': 34.56454, 'lon': -92.58683}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': "The Children's Clinic Of Jonesboro, P.A.", 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Hospital Research Institute", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Pediatric Clinic', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Little Rock Children's Clinic, PA", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': "Miller Children's Hospital", 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital of Oakland", 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '94611', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Health Care Plan', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital of Orange County", 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital San Diego", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'California Pacific Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '95728', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Santa Clara Valley Medical Center', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital", 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': "Connecticut Children's Medical Center", 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '06920', 'city': 'Stamford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pediatric Pulmonology, LLC', 'geoPoint': {'lat': 41.05343, 'lon': -73.53873}}, {'zip': '19803', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'A. 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