Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-01-01 @ 1:02 PM
Study NCT ID:
NCT00421304
Status:
COMPLETED
Last Update Posted:
2021-08-27
First Post:
2007-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate a Single Intravenous Dose of Motavizumab for the Treatment of Children Hospitalized With Respiratory Syncytial Virus (RSV) Illness
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C506968', 'term': 'motavizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '+1-877-240-9479', 'title': 'Global Clinical Lead', 'organization': 'AstraZeneca Clinical study Information Center'}, '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 in 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': 'From the start of study drug (Day 0) through Day 90', 'description': 'Adverse events were reported for safety population. Safety population included all the participants who received any dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 30, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 22, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 24, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 14, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Bronchial obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dermatitis diaper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'seriousEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gastroenteritis rotavirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Respiratory syncytial virus bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hypernatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pneumonia respiratory syncytial viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Respiratory Syncytial Virus (RSV) Load in the Upper Respiratory Tract as Measured by Quantitative Real Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) at Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.'}, {'id': 'OG001', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'OG002', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.13', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '8.05', 'spread': '1.22', 'groupId': 'OG001'}, {'value': '8.15', 'spread': '0.86', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.218', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.643', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.677', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 0', 'description': 'The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children less than or equal to (\\<=12) months of age who are hospitalized with lower respiratory tract illness.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples and who tested positive for RSV at Day 0 were analyzed for this outcome.'}, {'type': 'PRIMARY', 'title': 'RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.'}, {'id': 'OG001', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'OG002', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.61', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '7.54', 'spread': '1.26', 'groupId': 'OG001'}, {'value': '7.40', 'spread': '1.26', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.257', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.726', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.551', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \\<=12 months of age who are hospitalized with lower respiratory tract illness.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples and who tested positive for RSV at Day 1 were analyzed for this outcome.'}, {'type': 'PRIMARY', 'title': 'RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.'}, {'id': 'OG001', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'OG002', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.95', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '6.68', 'spread': '1.21', 'groupId': 'OG001'}, {'value': '6.59', 'spread': '1.35', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.591', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.393', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.586', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 2', 'description': 'The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \\<=12 months of age who are hospitalized with lower respiratory tract illness.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples and who tested positive for RSV at Day 2 were analyzed for this outcome.'}, {'type': 'PRIMARY', 'title': 'RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.'}, {'id': 'OG001', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'OG002', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.12', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '6.11', 'spread': '1.26', 'groupId': 'OG001'}, {'value': '5.95', 'spread': '1.46', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.894', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.674', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.636', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 3', 'description': 'The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \\<=12 months of age who are hospitalized with lower respiratory tract illness.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples and who tested positive for RSV at Day 3 were analyzed for this outcome.'}, {'type': 'PRIMARY', 'title': 'RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.'}, {'id': 'OG001', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'OG002', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.00', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '5.76', 'spread': '0.82', 'groupId': 'OG001'}, {'value': '5.41', 'spread': '1.44', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.397', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.238', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.461', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 4', 'description': 'The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \\<=12 months of age who are hospitalized with lower respiratory tract illness.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples, who tested positive for RSV at Day 4 were analyzed for this outcome.'}, {'type': 'PRIMARY', 'title': 'RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.'}, {'id': 'OG001', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'OG002', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.52', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '5.26', 'spread': '1.20', 'groupId': 'OG001'}, {'value': '5.31', 'spread': '1.94', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.322', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.747', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.717', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 5', 'description': 'The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \\<=12 months of age who are hospitalized with lower respiratory tract illness.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples, who tested positive for RSV at Day 5 were analyzed for this outcome.'}, {'type': 'PRIMARY', 'title': 'RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.'}, {'id': 'OG001', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'OG002', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.63', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '5.25', 'spread': '1.58', 'groupId': 'OG001'}, {'value': '5.60', 'spread': '2.08', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.847', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.000', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.000', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 6', 'description': 'The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \\<=12 months of age who are hospitalized with lower respiratory tract illness.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples, who tested positive for RSV at Day 6 were analyzed for this outcome.'}, {'type': 'PRIMARY', 'title': 'RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.'}, {'id': 'OG001', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'OG002', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.86', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '4.73', 'spread': '1.27', 'groupId': 'OG001'}, {'value': '4.52', 'spread': '1.70', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.653', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.283', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.411', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 7', 'description': 'The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \\<=12 months of age who are hospitalized with lower respiratory tract illness.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples and who tested positive for RSV at Day 7 were analyzed for this outcome.'}, {'type': 'PRIMARY', 'title': 'RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.'}, {'id': 'OG001', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'OG002', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.03', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '3.05', 'spread': '1.33', 'groupId': 'OG001'}, {'value': '2.96', 'spread': '1.08', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.988', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.832', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.748', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 30', 'description': 'The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \\<=12 months of age who are hospitalized with lower respiratory tract illness.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples and who tested positive for RSV at Day 30 were analyzed for this outcome.'}, {'type': 'PRIMARY', 'title': 'RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.'}, {'id': 'OG001', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'OG002', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.66', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '2.55', 'spread': '0.29', 'groupId': 'OG001'}, {'value': '2.50', 'spread': '0.00', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.280', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.108', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.000', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 90', 'description': 'The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \\<=12 months of age who are hospitalized with lower respiratory tract illness.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples and who tested positive for RSV at Day 90 were analyzed for this outcome.'}, {'type': 'PRIMARY', 'title': 'RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.'}, {'id': 'OG001', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'OG002', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.68', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '2.52', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '2.50', 'spread': '0.00', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.742', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.486', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.490', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 180', 'description': 'The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \\<=12 months of age who are hospitalized with lower respiratory tract illness.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples and who tested positive for RSV at Day 180 were analyzed for this outcome.'}, {'type': 'PRIMARY', 'title': 'Motavizumab Concentration in Nasal Wash Aspirates at Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'OG001', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.93', 'spread': '5.72', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 0', 'description': 'Motavizumab concentration in nasal wash aspirates is reported.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population for pharmacokinetics (PK) included all participants who received a full dose of study drug. Participants with adequate motavizumab concentration in nasal wash aspirates at Day 0 were analyzed for the outcome.'}, {'type': 'PRIMARY', 'title': 'Motavizumab Concentration in Nasal Wash Aspirates at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'OG001', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '4673.3', 'spread': '5397.4', 'groupId': 'OG000'}, {'value': '10087', 'spread': '10242', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.050', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Motavizumab concentration in nasal wash aspirates is reported.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population for PK included all participants who received a full dose of study drug. Participants with adequate motavizumab concentration in nasal wash aspirates at Day 1 were analyzed for the outcome.'}, {'type': 'PRIMARY', 'title': 'Motavizumab Concentration in Nasal Wash Aspirates at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'OG001', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2341.2', 'spread': '2928.4', 'groupId': 'OG000'}, {'value': '7436.7', 'spread': '10321', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.008', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 2', 'description': 'Motavizumab concentration in nasal wash aspirates is reported.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population for PK included all participants who received a full dose of study drug. Participants with adequate motavizumab concentration in nasal wash aspirates at Day 2 were analyzed for the outcome.'}, {'type': 'PRIMARY', 'title': 'Motavizumab Concentration in Nasal Wash Aspirates at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'OG001', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '966.37', 'spread': '1016.0', 'groupId': 'OG000'}, {'value': '2464.2', 'spread': '2788.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.012', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 7', 'description': 'Motavizumab concentration in nasal wash aspirates is reported.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population for PK included all participants who received a full dose of study drug. Participants with adequate motavizumab concentration in nasal wash aspirates at Day 7 were analyzed for the outcome.'}, {'type': 'PRIMARY', 'title': 'Motavizumab Concentration in Nasal Wash Aspirates at Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'OG001', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '431.21', 'spread': '597.6', 'groupId': 'OG000'}, {'value': '1934.5', 'spread': '3055.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': "Wilcoxon's rank-sum test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 30', 'description': 'Motavizumab concentration in nasal wash aspirates is reported.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population for PK included all participants who received a full dose of study drug. Participants with adequate motavizumab concentration in nasal wash aspirates at Day 30 were analyzed for the outcome.'}, {'type': 'SECONDARY', 'title': 'Duration of RSV Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.'}, {'id': 'OG001', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'OG002', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.55', 'spread': '2.43', 'groupId': 'OG000'}, {'value': '3.98', 'spread': '3.01', 'groupId': 'OG001'}, {'value': '4.46', 'spread': '4.33', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Randomization Day (Day 0) to Discharge Day (up to Day 30)', 'description': 'Duration of RSV hospitalization is reported.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR.'}, {'type': 'SECONDARY', 'title': 'Respiratory Assessment Change Score (RACS) Derived From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.'}, {'id': 'OG001', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'OG002', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.81', 'spread': '5.05', 'groupId': 'OG000'}, {'value': '-1.36', 'spread': '4.47', 'groupId': 'OG001'}, {'value': '-2.11', 'spread': '4.58', 'groupId': 'OG002'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.14', 'spread': '5.20', 'groupId': 'OG000'}, {'value': '-3.51', 'spread': '4.72', 'groupId': 'OG001'}, {'value': '-3.61', 'spread': '5.02', 'groupId': 'OG002'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.29', 'spread': '5.45', 'groupId': 'OG000'}, {'value': '-5.49', 'spread': '4.53', 'groupId': 'OG001'}, {'value': '-5.41', 'spread': '5.11', 'groupId': 'OG002'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-5.70', 'spread': '5.40', 'groupId': 'OG000'}, {'value': '-6.94', 'spread': '4.89', 'groupId': 'OG001'}, {'value': '-6.18', 'spread': '5.23', 'groupId': 'OG002'}]}]}, {'title': 'Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.00', 'spread': '5.51', 'groupId': 'OG000'}, {'value': '-7.14', 'spread': '4.88', 'groupId': 'OG001'}, {'value': '-7.79', 'spread': '4.01', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Days 1, 2, 3, 7, and 30', 'description': 'The RACS assesses changes in wheezing and retractions as measured by respiratory distress assessment instrument (RDAI) score and changes in respiratory rate. A RDAI score is a measure of the degree of severity of wheezing and retractions, with score range from 0 to 17; higher scores indicate more severe disease. Respiratory rate is summarized by raw scores and standardized change score. A change in respiratory rate of less than or equal to (\\<=) 5% from baseline is counted as a change of 0 units and a change in respiratory rate is assigned 1 point per each 10% change in the respiratory rate. The RACS is calculated as arithmetic sum of RDAI score change and of standardized respiratory rate change (for example, a child showing improvement who had a RDAI of -5 and a respiratory rate change of -2 would have a RACS score of -7). The RACS assessment does not have a minimum and/or maximum scale range. A decrease in RACS represents improvement, whereas an increase signifies deterioration.', 'unitOfMeasure': 'Units on a score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Here, 'Number Analyzed' denotes those participants who were evaluable at the specific time point."}, {'type': 'SECONDARY', 'title': 'Oxygen Saturation Level During RSV Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.'}, {'id': 'OG001', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'OG002', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}], 'classes': [{'title': 'Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '96.8', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '97.5', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '97.1', 'spread': '3.1', 'groupId': 'OG002'}]}]}, {'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '97.3', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '98.1', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '97.2', 'spread': '2.1', 'groupId': 'OG002'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '96.9', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '97.3', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '97.5', 'spread': '2.0', 'groupId': 'OG002'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '97.7', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '97.6', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '97.4', 'spread': '2.3', 'groupId': 'OG002'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '97.6', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '97.8', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '97.6', 'spread': '2.3', 'groupId': 'OG002'}]}]}, {'title': 'Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '97.9', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '98.1', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '98.5', 'spread': '1.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 0, 1, 2, 3, 7, and 30', 'description': 'Oxygen saturation level during RSV hospitalization is reported.', 'unitOfMeasure': 'Percentage of oxygen saturation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Here, 'Number Analyzed' denotes those participants who were evaluable at the specific time point."}, {'type': 'SECONDARY', 'title': 'Heart Rate During RSV Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.'}, {'id': 'OG001', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'OG002', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}], 'classes': [{'title': 'Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '148.6', 'spread': '17.8', 'groupId': 'OG000'}, {'value': '155.6', 'spread': '19.5', 'groupId': 'OG001'}, {'value': '157.6', 'spread': '17.0', 'groupId': 'OG002'}]}]}, {'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '146.0', 'spread': '18.0', 'groupId': 'OG000'}, {'value': '145.9', 'spread': '14.6', 'groupId': 'OG001'}, {'value': '145.9', 'spread': '17.3', 'groupId': 'OG002'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '141.2', 'spread': '11.9', 'groupId': 'OG000'}, {'value': '139.6', 'spread': '15.1', 'groupId': 'OG001'}, {'value': '136.6', 'spread': '17.3', 'groupId': 'OG002'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '138.6', 'spread': '14.8', 'groupId': 'OG000'}, {'value': '140.7', 'spread': '14.8', 'groupId': 'OG001'}, {'value': '143.3', 'spread': '17.4', 'groupId': 'OG002'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '139.6', 'spread': '14.8', 'groupId': 'OG000'}, {'value': '141.4', 'spread': '20.2', 'groupId': 'OG001'}, {'value': '143.5', 'spread': '15.9', 'groupId': 'OG002'}]}]}, {'title': 'Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '139.6', 'spread': '13.4', 'groupId': 'OG000'}, {'value': '140.3', 'spread': '13.8', 'groupId': 'OG001'}, {'value': '137.1', 'spread': '13.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 0, 1, 2, 3, 7, and 30', 'description': 'Heart rate during RSV hospitalization is reported.', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Here, 'Number Analyzed' denotes those participants who were evaluable at the specific time point."}, {'type': 'SECONDARY', 'title': 'Respiratory Rate During RSV Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.'}, {'id': 'OG001', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'OG002', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}], 'classes': [{'title': 'Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '46.86', 'spread': '10.20', 'groupId': 'OG000'}, {'value': '49.28', 'spread': '8.93', 'groupId': 'OG001'}, {'value': '51.78', 'spread': '11.28', 'groupId': 'OG002'}]}]}, {'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '44.35', 'spread': '11.88', 'groupId': 'OG000'}, {'value': '48.67', 'spread': '12.41', 'groupId': 'OG001'}, {'value': '48.00', 'spread': '14.13', 'groupId': 'OG002'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '46.46', 'spread': '9.05', 'groupId': 'OG000'}, {'value': '41.89', 'spread': '10.76', 'groupId': 'OG001'}, {'value': '44.11', 'spread': '11.77', 'groupId': 'OG002'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '43.03', 'spread': '9.28', 'groupId': 'OG000'}, {'value': '40.54', 'spread': '8.54', 'groupId': 'OG001'}, {'value': '43.68', 'spread': '10.81', 'groupId': 'OG002'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '41.76', 'spread': '9.06', 'groupId': 'OG000'}, {'value': '40.14', 'spread': '9.14', 'groupId': 'OG001'}, {'value': '43.64', 'spread': '11.06', 'groupId': 'OG002'}]}]}, {'title': 'Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '38.45', 'spread': '6.73', 'groupId': 'OG000'}, {'value': '41.11', 'spread': '12.81', 'groupId': 'OG001'}, {'value': '38.45', 'spread': '6.53', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 0, 1, 2, 3, 7, and 30', 'description': 'Respiratory rate during RSV hospitalization is reported.', 'unitOfMeasure': 'Breaths per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Here, 'Number Analyzed' denotes those participants who were evaluable at the specific time point."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Supplemental Oxygen Use During RSV Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.'}, {'id': 'OG001', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'OG002', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Randomization Day (Day 0) to Discharge Day (up to Day 30)', 'description': 'Number of participants with supplemental oxygen use during RSV hospitalization is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Participants with hospitalization information available were analyzed for this outcome.'}, {'type': 'SECONDARY', 'title': 'Duration of Supplemental Oxygen Use During RSV Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.'}, {'id': 'OG001', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'OG002', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '2.8', 'groupId': 'OG001'}, {'value': '4.4', 'spread': '4.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Randomization Day (Day 0) to Discharge Day (up to Day 30)', 'description': 'Duration of supplemental oxygen use during RSV hospitalization is reported.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Participants who received supplemental oxygen during RSV hospitalization were analyzed for this outcome.'}, {'type': 'SECONDARY', 'title': 'Number of Participants on Mechanical Ventilation During RSV Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.'}, {'id': 'OG001', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'OG002', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Randomization Day (Day 0) to Discharge Day (up to Day 30)', 'description': 'Number of participants on mechanical ventilation during RSV hospitalization is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Participants with hospitalization information available were analyzed for this outcome.'}, {'type': 'SECONDARY', 'title': 'Duration of Mechanical Ventilation During RSV Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.'}, {'id': 'OG001', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'OG002', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.81', 'spread': '0.88', 'groupId': 'OG001'}, {'value': '4.64', 'spread': '2.30', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Randomization Day (Day 0) to Discharge Day (up to Day 30)', 'description': 'Duration of mechanical ventilation during RSV hospitalization is reported.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Participants who received mechanical ventilation during RSV hospitalization were analyzed for this outcome.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Admitted to the Intensive Care Unit (ICU)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.'}, {'id': 'OG001', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'OG002', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Randomization Day (Day 0) to Discharge Day (up to Day 30)', 'description': 'Number of participants admitted to ICU is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Participants with hospitalization information available were analyzed for this outcome.'}, {'type': 'SECONDARY', 'title': 'Duration of ICU Stay During RSV Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.'}, {'id': 'OG001', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'OG002', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'spread': '4.6', 'groupId': 'OG001'}, {'value': '5.0', 'spread': '4.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Randomization Day (Day 0) to Discharge Day (up to Day 30)', 'description': 'Duration of ICU stay during RSV hospitalization is reported.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Participants who were admitted to ICU were analyzed for this outcome.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Medically-attended Wheezing Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.'}, {'id': 'OG001', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'OG002', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}], 'classes': [{'title': '0 event', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': '1 event', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': '2 events', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': '3 events', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': '4 events', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': '5 events', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': '6 events', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '7 events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '8 events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '9 events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization (Day 0) through Day 360 (approximately 12 months)', 'description': 'Wheezing episodes are considered medically-attended wheezing episodes if the medical care provider verifies and documents wheezing in the medical record or, in the case of hospitalization, the medical care provider assigns a discharge diagnosis of asthma, bronchiolitis, wheezing, or reactive airway disease. A new wheezing episode is the one that occurs for more than 2 weeks after the diagnosis of the previous episode and the medical opinion is that the wheezing does not represent a persistence of the previous episode. Medically-attended wheezing episodes were calculated and reported in the range of 0 to 9 events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR.'}, {'type': 'SECONDARY', 'title': 'Serum Concentration of Motavizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'OG001', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '298.73', 'spread': '88.99', 'groupId': 'OG000'}, {'value': '863.05', 'spread': '240.28', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '192.87', 'spread': '57.07', 'groupId': 'OG000'}, {'value': '640.36', 'spread': '95.69', 'groupId': 'OG001'}]}]}, {'title': 'Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.39', 'spread': '9.35', 'groupId': 'OG000'}, {'value': '30.81', 'spread': '23.63', 'groupId': 'OG001'}]}]}, {'title': 'Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.64', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '2.45', 'spread': '3.54', 'groupId': 'OG001'}]}]}, {'title': 'Day 360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 7, 90, 180, and 360', 'description': 'Motavizumab concentration in serum is reported.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population for PK included all participants who received a full dose of study drug. Participants with adequate motavizumab concentration in serum at the specified time points were analyzed for this outcome.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Detectable Anti-motavizumab Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'OG001', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}], 'classes': [{'title': 'Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Day 360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Days 0, 180, and 360', 'description': 'Number of participants with detectable anti-motavizumab antibodies are reported. Detection is defined as an anti-motavizumab antibody titer with a dilution value of 1:30 or greater.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population for anti-drug antibody included all participants who received a full dose of study drug. Participants with adequate anti-motavizumab antibody titer samples at the specified time points were analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Cytokine Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.'}, {'id': 'OG001', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'OG002', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}], 'classes': [{'title': 'Interleukin-1(IL-1) beta: Day 360', 'categories': [{'measurements': [{'value': '-3.005', 'spread': '12.043', 'groupId': 'OG000'}, {'value': '0.48', 'spread': '2.442', 'groupId': 'OG001'}, {'value': '48.943', 'spread': '236.734', 'groupId': 'OG002'}]}]}, {'title': 'IL-1 receptor antagonist (RA): Day 360', 'categories': [{'measurements': [{'value': '-266.925', 'spread': '502.650', 'groupId': 'OG000'}, {'value': '-107.834', 'spread': '201.740', 'groupId': 'OG001'}, {'value': '-171.278', 'spread': '599.988', 'groupId': 'OG002'}]}]}, {'title': 'IL-2: Day 360', 'categories': [{'measurements': [{'value': '-7.881', 'spread': '30.340', 'groupId': 'OG000'}, {'value': '0.446', 'spread': '7.604', 'groupId': 'OG001'}, {'value': '108.245', 'spread': '445.422', 'groupId': 'OG002'}]}]}, {'title': 'IL4: Day 360', 'categories': [{'measurements': [{'value': '-0.717', 'spread': '5.733', 'groupId': 'OG000'}, {'value': '2.187', 'spread': '8.596', 'groupId': 'OG001'}, {'value': '5.394', 'spread': '30.426', 'groupId': 'OG002'}]}]}, {'title': 'Il-5: Day 360', 'categories': [{'measurements': [{'value': '1.045', 'spread': '4.661', 'groupId': 'OG000'}, {'value': '0.763', 'spread': '1.817', 'groupId': 'OG001'}, {'value': '0.774', 'spread': '8.296', 'groupId': 'OG002'}]}]}, {'title': 'IL-6: Day 360', 'categories': [{'measurements': [{'value': '-41.180', 'spread': '72.120', 'groupId': 'OG000'}, {'value': '-24.305', 'spread': '61.462', 'groupId': 'OG001'}, {'value': '118.469', 'spread': '524.680', 'groupId': 'OG002'}]}]}, {'title': 'IL-7: Day 360', 'categories': [{'measurements': [{'value': '-1.328', 'spread': '7.797', 'groupId': 'OG000'}, {'value': '0.691', 'spread': '5.094', 'groupId': 'OG001'}, {'value': '4.305', 'spread': '36.131', 'groupId': 'OG002'}]}]}, {'title': 'IL-8: Day 360', 'categories': [{'measurements': [{'value': '-20.059', 'spread': '19.790', 'groupId': 'OG000'}, {'value': '-18.323', 'spread': '25.204', 'groupId': 'OG001'}, {'value': '-21.440', 'spread': '20.033', 'groupId': 'OG002'}]}]}, {'title': 'IL-9: Day 360', 'categories': [{'measurements': [{'value': '58.378', 'spread': '308.184', 'groupId': 'OG000'}, {'value': '-45.673', 'spread': '188.920', 'groupId': 'OG001'}, {'value': '-48.034', 'spread': '204.545', 'groupId': 'OG002'}]}]}, {'title': 'IL-10: Day 360', 'categories': [{'measurements': [{'value': '-11.407', 'spread': '21.458', 'groupId': 'OG000'}, {'value': '-6.924', 'spread': '7.927', 'groupId': 'OG001'}, {'value': '3.786', 'spread': '75.604', 'groupId': 'OG002'}]}]}, {'title': 'IL12 P70: Day 360', 'categories': [{'measurements': [{'value': '-10.633', 'spread': '49.320', 'groupId': 'OG000'}, {'value': '2.660', 'spread': '18.759', 'groupId': 'OG001'}, {'value': '48.765', 'spread': '239.216', 'groupId': 'OG002'}]}]}, {'title': 'IL13: Day 360', 'categories': [{'measurements': [{'value': '-0.779', 'spread': '8.086', 'groupId': 'OG000'}, {'value': '1.744', 'spread': '3.244', 'groupId': 'OG001'}, {'value': '9.893', 'spread': '54.188', 'groupId': 'OG002'}]}]}, {'title': 'IL-15: Day 360', 'categories': [{'measurements': [{'value': '-4.999', 'spread': '14.377', 'groupId': 'OG000'}, {'value': '-0.402', 'spread': '1.473', 'groupId': 'OG001'}, {'value': '33.618', 'spread': '139.355', 'groupId': 'OG002'}]}]}, {'title': 'IL-17: Day 360', 'categories': [{'measurements': [{'value': '2.067', 'spread': '16.207', 'groupId': 'OG000'}, {'value': '8.056', 'spread': '24.954', 'groupId': 'OG001'}, {'value': '1.092', 'spread': '22.159', 'groupId': 'OG002'}]}]}, {'title': 'Eotaxin: Day 360', 'categories': [{'measurements': [{'value': '-8.790', 'spread': '138.692', 'groupId': 'OG000'}, {'value': '36.955', 'spread': '118.098', 'groupId': 'OG001'}, {'value': '202.122', 'spread': '728.741', 'groupId': 'OG002'}]}]}, {'title': 'Basic fibroblast growth factor: Day (D) 360', 'categories': [{'measurements': [{'value': '1.886', 'spread': '34.663', 'groupId': 'OG000'}, {'value': '-1.342', 'spread': '6.920', 'groupId': 'OG001'}, {'value': '6.593', 'spread': '34.509', 'groupId': 'OG002'}]}]}, {'title': 'Granulocyte-colony stimulating factor (G-CSF):D360', 'categories': [{'measurements': [{'value': '-98.351', 'spread': '192.339', 'groupId': 'OG000'}, {'value': '-91.782', 'spread': '184.339', 'groupId': 'OG001'}, {'value': '-42.870', 'spread': '108.678', 'groupId': 'OG002'}]}]}, {'title': 'Granulocyte macrophage -CSF: Day 360', 'categories': [{'measurements': [{'value': '-54.862', 'spread': '185.534', 'groupId': 'OG000'}, {'value': '-7.439', 'spread': '26.842', 'groupId': 'OG001'}, {'value': '964.242', 'spread': '4386.145', 'groupId': 'OG002'}]}]}, {'title': 'Interferon (IFN) gamma: Day 360', 'categories': [{'measurements': [{'value': '-65.424', 'spread': '258.871', 'groupId': 'OG000'}, {'value': '9.164', 'spread': '91.580', 'groupId': 'OG001'}, {'value': '464.277', 'spread': '2027.072', 'groupId': 'OG002'}]}]}, {'title': 'IFN alpha: Day 360', 'categories': [{'measurements': [{'value': '-23.980', 'spread': '121.625', 'groupId': 'OG000'}, {'value': '12.281', 'spread': '67.767', 'groupId': 'OG001'}, {'value': '194.351', 'spread': '835.999', 'groupId': 'OG002'}]}]}, {'title': 'IFN gamma induced protein 10 (IP-10): Day 360', 'categories': [{'measurements': [{'value': '-1089.184', 'spread': '1711.708', 'groupId': 'OG000'}, {'value': '-1028.280', 'spread': '1105.987', 'groupId': 'OG001'}, {'value': '-460.829', 'spread': '2216.789', 'groupId': 'OG002'}]}]}, {'title': 'Monocyte chemoattractant protein-1: Day 360', 'categories': [{'measurements': [{'value': '-75.818', 'spread': '96.097', 'groupId': 'OG000'}, {'value': '-52.910', 'spread': '84.827', 'groupId': 'OG001'}, {'value': '17.128', 'spread': '376.408', 'groupId': 'OG002'}]}]}, {'title': 'Macrophage inflammatory protein (MIP)-1 alpha:D360', 'categories': [{'measurements': [{'value': '0.604', 'spread': '7.309', 'groupId': 'OG000'}, {'value': '0.689', 'spread': '2.485', 'groupId': 'OG001'}, {'value': '-31.042', 'spread': '182.639', 'groupId': 'OG002'}]}]}, {'title': 'MIP-1 beta: Day 360', 'categories': [{'measurements': [{'value': '-1.950', 'spread': '105.553', 'groupId': 'OG000'}, {'value': '43.061', 'spread': '121.617', 'groupId': 'OG001'}, {'value': '-1.354', 'spread': '235.052', 'groupId': 'OG002'}]}]}, {'title': 'Platelet-derived growth factor (PDGF)-BB: Day 360', 'categories': [{'measurements': [{'value': '3461.665', 'spread': '5874.913', 'groupId': 'OG000'}, {'value': '4377.256', 'spread': '6050.996', 'groupId': 'OG001'}, {'value': '3631.464', 'spread': '9603.609', 'groupId': 'OG002'}]}]}, {'title': 'Rantes: Day 360', 'categories': [{'measurements': [{'value': '783.389', 'spread': '2664.670', 'groupId': 'OG000'}, {'value': '2946.934', 'spread': '8074.666', 'groupId': 'OG001'}, {'value': '793.431', 'spread': '2672.889', 'groupId': 'OG002'}]}]}, {'title': 'Tumor necrosis factor (TNF) alpha: Day 360', 'categories': [{'measurements': [{'value': '-17.112', 'spread': '62.119', 'groupId': 'OG000'}, {'value': '-2.676', 'spread': '29.385', 'groupId': 'OG001'}, {'value': '403.443', 'spread': '1918.152', 'groupId': 'OG002'}]}]}, {'title': 'Vascular endothelial growth factor (VEGF): Day 360', 'categories': [{'measurements': [{'value': '-17.908', 'spread': '135.254', 'groupId': 'OG000'}, {'value': '-33.293', 'spread': '125.224', 'groupId': 'OG001'}, {'value': '-39.069', 'spread': '87.616', 'groupId': 'OG002'}]}]}, {'title': 'Monokine induced by gamma(MIG): Day 360', 'categories': [{'measurements': [{'value': '1046.002', 'spread': '2735.420', 'groupId': 'OG000'}, {'value': '1086.786', 'spread': '1246.951', 'groupId': 'OG001'}, {'value': '2465.946', 'spread': '7714.076', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0, pre-dose) through Day 360', 'unitOfMeasure': 'Picograms per millilitre (pg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Participants with adequate cytokine levels were analyzed for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.'}, {'id': 'OG001', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'OG002', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}], 'classes': [{'title': 'IL-1 beta: Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2607.852', 'spread': '6378.263', 'groupId': 'OG000'}, {'value': '-2575.906', 'spread': '3423.519', 'groupId': 'OG001'}, {'value': '-1772.376', 'spread': '3150.626', 'groupId': 'OG002'}]}]}, {'title': 'IL-1 RA: Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-91761.764', 'spread': '268797.553', 'groupId': 'OG000'}, {'value': '-97050.821', 'spread': '200487.750', 'groupId': 'OG001'}, {'value': '-69391.250', 'spread': '127840.986', 'groupId': 'OG002'}]}]}, {'title': 'IL-2: Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.849', 'spread': '14.116', 'groupId': 'OG000'}, {'value': '-1.215', 'spread': '10.959', 'groupId': 'OG001'}, {'value': '-0.458', 'spread': '9.316', 'groupId': 'OG002'}]}]}, {'title': 'IL-4: Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.761', 'spread': '3.090', 'groupId': 'OG000'}, {'value': '-1.897', 'spread': '2.939', 'groupId': 'OG001'}, {'value': '-1.435', 'spread': '3.571', 'groupId': 'OG002'}]}]}, {'title': 'IL-5: Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.077', 'spread': '1.865', 'groupId': 'OG000'}, {'value': '-0.351', 'spread': '7.077', 'groupId': 'OG001'}, {'value': '1.732', 'spread': '7.974', 'groupId': 'OG002'}]}]}, {'title': 'IL-6: Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1139.081', 'spread': '1061.467', 'groupId': 'OG000'}, {'value': '-930.388', 'spread': '1730.515', 'groupId': 'OG001'}, {'value': '-551.482', 'spread': '676.661', 'groupId': 'OG002'}]}]}, {'title': 'IL-7: Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.553', 'spread': '26.065', 'groupId': 'OG000'}, {'value': '-20.954', 'spread': '48.390', 'groupId': 'OG001'}, {'value': '-18.219', 'spread': '58.020', 'groupId': 'OG002'}]}]}, {'title': 'IL-8: Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-26762.935', 'spread': '83539.520', 'groupId': 'OG000'}, {'value': '-20794.797', 'spread': '30409.576', 'groupId': 'OG001'}, {'value': '-8610.260', 'spread': '14715.271', 'groupId': 'OG002'}]}]}, {'title': 'IL-9: Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-32.899', 'spread': '40.569', 'groupId': 'OG000'}, {'value': '-48.923', 'spread': '57.492', 'groupId': 'OG001'}, {'value': '-45.623', 'spread': '85.438', 'groupId': 'OG002'}]}]}, {'title': 'Il-10: Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-55.412', 'spread': '65.437', 'groupId': 'OG000'}, {'value': '-65.522', 'spread': '107.589', 'groupId': 'OG001'}, {'value': '-37.755', 'spread': '60.765', 'groupId': 'OG002'}]}]}, {'title': 'IL-12 P70: Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-52.927', 'spread': '60.597', 'groupId': 'OG000'}, {'value': '-54.300', 'spread': '55.463', 'groupId': 'OG001'}, {'value': '-40.912', 'spread': '64.739', 'groupId': 'OG002'}]}]}, {'title': 'IL-13: Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-54.573', 'spread': '151.800', 'groupId': 'OG000'}, {'value': '-59.583', 'spread': '116.696', 'groupId': 'OG001'}, {'value': '-43.758', 'spread': '93.016', 'groupId': 'OG002'}]}]}, {'title': 'IL-15: Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.018', 'spread': '17.009', 'groupId': 'OG000'}, {'value': '-7.107', 'spread': '14.202', 'groupId': 'OG001'}, {'value': '-5.039', 'spread': '15.169', 'groupId': 'OG002'}]}]}, {'title': 'IL-17: Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-22.557', 'spread': '27.252', 'groupId': 'OG000'}, {'value': '-31.352', 'spread': '25.301', 'groupId': 'OG001'}, {'value': '-25.215', 'spread': '36.297', 'groupId': 'OG002'}]}]}, {'title': 'Eotaxin: Day180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-16.905', 'spread': '140.534', 'groupId': 'OG000'}, {'value': '-42.034', 'spread': '90.948', 'groupId': 'OG001'}, {'value': '-23.358', 'spread': '78.999', 'groupId': 'OG002'}]}]}, {'title': 'Basic FGF: Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-82.364', 'spread': '125.246', 'groupId': 'OG000'}, {'value': '-149.153', 'spread': '267.861', 'groupId': 'OG001'}, {'value': '-117.656', 'spread': '183.542', 'groupId': 'OG002'}]}]}, {'title': 'G-CSF:Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3547.084', 'spread': '7428.810', 'groupId': 'OG000'}, {'value': '-3732.054', 'spread': '9873.369', 'groupId': 'OG001'}, {'value': '-112.012', 'spread': '9701.760', 'groupId': 'OG002'}]}]}, {'title': 'GM-CSF: Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-86.359', 'spread': '139.214', 'groupId': 'OG000'}, {'value': '-79.592', 'spread': '119.261', 'groupId': 'OG001'}, {'value': '-79.668', 'spread': '157.497', 'groupId': 'OG002'}]}]}, {'title': 'IFN gamma: Day180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-5754.670', 'spread': '27853.042', 'groupId': 'OG000'}, {'value': '-3026.337', 'spread': '13551.380', 'groupId': 'OG001'}, {'value': '-2755.333', 'spread': '15534.906', 'groupId': 'OG002'}]}]}, {'title': 'IFN alpha: Day180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-59.346', 'spread': '413.227', 'groupId': 'OG000'}, {'value': '-95.529', 'spread': '442.959', 'groupId': 'OG001'}, {'value': '-15.090', 'spread': '240.549', 'groupId': 'OG002'}]}]}, {'title': 'IP-10: Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2907.151', 'spread': '14396.032', 'groupId': 'OG000'}, {'value': '-21562.675', 'spread': '94358.228', 'groupId': 'OG001'}, {'value': '-15729.066', 'spread': '93210.658', 'groupId': 'OG002'}]}]}, {'title': 'MCP-1: Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-510.596', 'spread': '821.385', 'groupId': 'OG000'}, {'value': '-336.373', 'spread': '230.303', 'groupId': 'OG001'}, {'value': '-317.251', 'spread': '532.157', 'groupId': 'OG002'}]}]}, {'title': 'MIP-1 alpha: Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-81.063', 'spread': '106.178', 'groupId': 'OG000'}, {'value': '-79.610', 'spread': '100.858', 'groupId': 'OG001'}, {'value': '-54.416', 'spread': '96.391', 'groupId': 'OG002'}]}]}, {'title': 'MIP-1 beta: Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-924.715', 'spread': '913.488', 'groupId': 'OG000'}, {'value': '-921.287', 'spread': '770.658', 'groupId': 'OG001'}, {'value': '-824.330', 'spread': '1063.855', 'groupId': 'OG002'}]}]}, {'title': 'PDGF-BB: Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-95.616', 'spread': '197.836', 'groupId': 'OG000'}, {'value': '-90.821', 'spread': '192.864', 'groupId': 'OG001'}, {'value': '-55.547', 'spread': '127.111', 'groupId': 'OG002'}]}]}, {'title': 'Rantes: Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-244.749', 'spread': '971.092', 'groupId': 'OG000'}, {'value': '-789.419', 'spread': '3136.828', 'groupId': 'OG001'}, {'value': '-194.783', 'spread': '493.671', 'groupId': 'OG002'}]}]}, {'title': 'TNF alpha: Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1489.621', 'spread': '3190.856', 'groupId': 'OG000'}, {'value': '-1038.889', 'spread': '1660.820', 'groupId': 'OG001'}, {'value': '-610.185', 'spread': '1129.565', 'groupId': 'OG002'}]}]}, {'title': 'VEGF: Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1167.204', 'spread': '1698.618', 'groupId': 'OG000'}, {'value': '-1118.459', 'spread': '1365.524', 'groupId': 'OG001'}, {'value': '-700.258', 'spread': '1154.582', 'groupId': 'OG002'}]}]}, {'title': 'MIG: Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-42371.446', 'spread': '124818.988', 'groupId': 'OG000'}, {'value': '-6693.146', 'spread': '25633.807', 'groupId': 'OG001'}, {'value': '-25881.359', 'spread': '110834.744', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0, pre-dose) through Day 180', 'description': 'Change from baseline in upper respiratory tract (nasal wash) cytokine levels are reported.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Participants with adequate nasal wash cytokine levels at specified time points were analysed for this outcome.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.'}, {'id': 'OG001', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'OG002', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}], 'classes': [{'title': 'Any TEAEs', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}, {'title': 'Any TESAEs', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the start of study drug (Day 0) through Day 90', 'description': 'An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all the participants who received any dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.'}, {'id': 'OG001', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'OG002', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}], 'classes': [{'title': 'Hypoalbuminaemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blood urea increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Liver function test abnormal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Anaemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Thrombocythaemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Platelet count increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypokalaemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hypercalcaemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hyperkalaemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypernatraemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hyperphosphatasaemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the start of study drug (Day 0) through Day 30', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all the participants who received any dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.'}, {'id': 'FG001', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'FG002', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Mistakenly randomized, chose not to participate in study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Did not attend Day 360 visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '118', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.'}, {'id': 'BG001', 'title': 'Motavizumab 30 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.'}, {'id': 'BG002', 'title': 'Motavizumab 100 mg/kg', 'description': 'Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '3.72', 'spread': '2.90', 'groupId': 'BG000'}, {'value': '3.07', 'spread': '2.62', 'groupId': 'BG001'}, {'value': '3.47', 'spread': '2.98', 'groupId': 'BG002'}, {'value': '3.42', 'spread': '2.83', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '96', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Intent to treat population (ITT) included all participants who were randomized in the study.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'dispFirstSubmitDate': '2012-06-27', 'completionDateStruct': {'date': '2009-09-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-02', 'studyFirstSubmitDate': '2007-01-09', 'dispFirstSubmitQcDate': '2012-06-27', 'resultsFirstSubmitDate': '2021-08-02', 'studyFirstSubmitQcDate': '2007-01-09', 'dispFirstPostDateStruct': {'date': '2012-07-02', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-02', 'studyFirstPostDateStruct': {'date': '2007-01-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-09-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory Syncytial Virus (RSV) Load in the Upper Respiratory Tract as Measured by Quantitative Real Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) at Day 0', 'timeFrame': 'Day 0', 'description': 'The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children less than or equal to (\\<=12) months of age who are hospitalized with lower respiratory tract illness.'}, {'measure': 'RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 1', 'timeFrame': 'Day 1', 'description': 'The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \\<=12 months of age who are hospitalized with lower respiratory tract illness.'}, {'measure': 'RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 2', 'timeFrame': 'Day 2', 'description': 'The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \\<=12 months of age who are hospitalized with lower respiratory tract illness.'}, {'measure': 'RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 3', 'timeFrame': 'Day 3', 'description': 'The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \\<=12 months of age who are hospitalized with lower respiratory tract illness.'}, {'measure': 'RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 4', 'timeFrame': 'Day 4', 'description': 'The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \\<=12 months of age who are hospitalized with lower respiratory tract illness.'}, {'measure': 'RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 5', 'timeFrame': 'Day 5', 'description': 'The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \\<=12 months of age who are hospitalized with lower respiratory tract illness.'}, {'measure': 'RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 6', 'timeFrame': 'Day 6', 'description': 'The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \\<=12 months of age who are hospitalized with lower respiratory tract illness.'}, {'measure': 'RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 7', 'timeFrame': 'Day 7', 'description': 'The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \\<=12 months of age who are hospitalized with lower respiratory tract illness.'}, {'measure': 'RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 30', 'timeFrame': 'Day 30', 'description': 'The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \\<=12 months of age who are hospitalized with lower respiratory tract illness.'}, {'measure': 'RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 90', 'timeFrame': 'Day 90', 'description': 'The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \\<=12 months of age who are hospitalized with lower respiratory tract illness.'}, {'measure': 'RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 180', 'timeFrame': 'Day 180', 'description': 'The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \\<=12 months of age who are hospitalized with lower respiratory tract illness.'}, {'measure': 'Motavizumab Concentration in Nasal Wash Aspirates at Day 0', 'timeFrame': 'Day 0', 'description': 'Motavizumab concentration in nasal wash aspirates is reported.'}, {'measure': 'Motavizumab Concentration in Nasal Wash Aspirates at Day 1', 'timeFrame': 'Day 1', 'description': 'Motavizumab concentration in nasal wash aspirates is reported.'}, {'measure': 'Motavizumab Concentration in Nasal Wash Aspirates at Day 2', 'timeFrame': 'Day 2', 'description': 'Motavizumab concentration in nasal wash aspirates is reported.'}, {'measure': 'Motavizumab Concentration in Nasal Wash Aspirates at Day 7', 'timeFrame': 'Day 7', 'description': 'Motavizumab concentration in nasal wash aspirates is reported.'}, {'measure': 'Motavizumab Concentration in Nasal Wash Aspirates at Day 30', 'timeFrame': 'Day 30', 'description': 'Motavizumab concentration in nasal wash aspirates is reported.'}], 'secondaryOutcomes': [{'measure': 'Duration of RSV Hospitalization', 'timeFrame': 'From Randomization Day (Day 0) to Discharge Day (up to Day 30)', 'description': 'Duration of RSV hospitalization is reported.'}, {'measure': 'Respiratory Assessment Change Score (RACS) Derived From Baseline', 'timeFrame': 'Baseline (Day 0), Days 1, 2, 3, 7, and 30', 'description': 'The RACS assesses changes in wheezing and retractions as measured by respiratory distress assessment instrument (RDAI) score and changes in respiratory rate. A RDAI score is a measure of the degree of severity of wheezing and retractions, with score range from 0 to 17; higher scores indicate more severe disease. Respiratory rate is summarized by raw scores and standardized change score. A change in respiratory rate of less than or equal to (\\<=) 5% from baseline is counted as a change of 0 units and a change in respiratory rate is assigned 1 point per each 10% change in the respiratory rate. The RACS is calculated as arithmetic sum of RDAI score change and of standardized respiratory rate change (for example, a child showing improvement who had a RDAI of -5 and a respiratory rate change of -2 would have a RACS score of -7). The RACS assessment does not have a minimum and/or maximum scale range. A decrease in RACS represents improvement, whereas an increase signifies deterioration.'}, {'measure': 'Oxygen Saturation Level During RSV Hospitalization', 'timeFrame': 'Days 0, 1, 2, 3, 7, and 30', 'description': 'Oxygen saturation level during RSV hospitalization is reported.'}, {'measure': 'Heart Rate During RSV Hospitalization', 'timeFrame': 'Days 0, 1, 2, 3, 7, and 30', 'description': 'Heart rate during RSV hospitalization is reported.'}, {'measure': 'Respiratory Rate During RSV Hospitalization', 'timeFrame': 'Days 0, 1, 2, 3, 7, and 30', 'description': 'Respiratory rate during RSV hospitalization is reported.'}, {'measure': 'Number of Participants With Supplemental Oxygen Use During RSV Hospitalization', 'timeFrame': 'From Randomization Day (Day 0) to Discharge Day (up to Day 30)', 'description': 'Number of participants with supplemental oxygen use during RSV hospitalization is reported.'}, {'measure': 'Duration of Supplemental Oxygen Use During RSV Hospitalization', 'timeFrame': 'From Randomization Day (Day 0) to Discharge Day (up to Day 30)', 'description': 'Duration of supplemental oxygen use during RSV hospitalization is reported.'}, {'measure': 'Number of Participants on Mechanical Ventilation During RSV Hospitalization', 'timeFrame': 'From Randomization Day (Day 0) to Discharge Day (up to Day 30)', 'description': 'Number of participants on mechanical ventilation during RSV hospitalization is reported.'}, {'measure': 'Duration of Mechanical Ventilation During RSV Hospitalization', 'timeFrame': 'From Randomization Day (Day 0) to Discharge Day (up to Day 30)', 'description': 'Duration of mechanical ventilation during RSV hospitalization is reported.'}, {'measure': 'Number of Participants Admitted to the Intensive Care Unit (ICU)', 'timeFrame': 'From Randomization Day (Day 0) to Discharge Day (up to Day 30)', 'description': 'Number of participants admitted to ICU is reported.'}, {'measure': 'Duration of ICU Stay During RSV Hospitalization', 'timeFrame': 'From Randomization Day (Day 0) to Discharge Day (up to Day 30)', 'description': 'Duration of ICU stay during RSV hospitalization is reported.'}, {'measure': 'Number of Participants With Medically-attended Wheezing Episodes', 'timeFrame': 'From randomization (Day 0) through Day 360 (approximately 12 months)', 'description': 'Wheezing episodes are considered medically-attended wheezing episodes if the medical care provider verifies and documents wheezing in the medical record or, in the case of hospitalization, the medical care provider assigns a discharge diagnosis of asthma, bronchiolitis, wheezing, or reactive airway disease. A new wheezing episode is the one that occurs for more than 2 weeks after the diagnosis of the previous episode and the medical opinion is that the wheezing does not represent a persistence of the previous episode. Medically-attended wheezing episodes were calculated and reported in the range of 0 to 9 events.'}, {'measure': 'Serum Concentration of Motavizumab', 'timeFrame': 'Days 1, 7, 90, 180, and 360', 'description': 'Motavizumab concentration in serum is reported.'}, {'measure': 'Number of Participants With Detectable Anti-motavizumab Antibodies', 'timeFrame': 'Days 0, 180, and 360', 'description': 'Number of participants with detectable anti-motavizumab antibodies are reported. Detection is defined as an anti-motavizumab antibody titer with a dilution value of 1:30 or greater.'}, {'measure': 'Change From Baseline in Serum Cytokine Levels', 'timeFrame': 'Baseline (Day 0, pre-dose) through Day 360'}, {'measure': 'Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels', 'timeFrame': 'Baseline (Day 0, pre-dose) through Day 180', 'description': 'Change from baseline in upper respiratory tract (nasal wash) cytokine levels are reported.'}, {'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'From the start of study drug (Day 0) through Day 90', 'description': 'An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.'}, {'measure': 'Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs', 'timeFrame': 'From the start of study drug (Day 0) through Day 30'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Respiratory Syncytial Virus illness', 'RSV'], 'conditions': ['RSV Illness in ≤12 Months of Participants']}, 'referencesModule': {'references': [{'pmid': '24356256', 'type': 'DERIVED', 'citation': 'Ramilo O, Lagos R, Saez-Llorens X, Suzich J, Wang CK, Jensen KM, Harris BS, Losonsky GA, Griffin MP; Motavizumab Study Group. Motavizumab treatment of infants hospitalized with respiratory syncytial virus infection does not decrease viral load or severity of illness. Pediatr Infect Dis J. 2014 Jul;33(7):703-9. doi: 10.1097/INF.0000000000000240.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to describe the effect of a single dose of medication compared to placebo in the upper respiratory tract in previously healthy children less than or equal to 12 months of age who are hospitalized with lower respiratory tract illness.', 'detailedDescription': 'The primary objective of this study is to describe the effect of a single 30 mg/kg or 100 mg/kg intravenous (IV) dose of Motavizumab compared to placebo on study drug levels and viral load as measured by cultivatable virus and real-time reverse transcriptase-polymerase chain reaction (RT-PCR) in the upper respiratory tract in previously healthy children ≤12 months of age who are hospitalized with lower respiratory tract illness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'minimumAge': '0 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nChildren must meet all of the following criteria:\n\n* Previously healthy\n* Age less or equal to 12 months at the time of randomization\n* Gestational age more or equal to 36 weeks\n* Hospitalized for lower respiratory tract illness (i.e., RSV bronchiolitis and/or pneumonia)\n* Documented positive RSV test within 48 hours prior to randomization\n* Randomization within 12 hours of the decision to hospitalize a child for RSV illness\n* Written informed consent obtained from the participant's parent(s)/legal guardian\n\nExclusion Criteria:\n\nChildren must have none of the following:\n\n* Prior receipt of or receiving ribavirin or other anti-viral treatment for the current episode of RSV infection prior to randomization\n* Any use of systemic or inhaled steroids within the past 30 days prior to randomization\n* Intubation for ventilatory support at randomization\n* Any medically significant underlying ongoing chronic illness or organ system dysfunction, or other known acute illness except for RSV infection\n* Known renal impairment, hepatic dysfunction, hematologic abnormalities, seizure or other neurologic disorder or immunodeficiency\n* Requirement for supplemental oxygen at any time prior to the current RSV infection (brief use of oxygen in the immediate postnatal period to treat a transient condition is allowed)\n* Mechanical ventilation at any time prior to the onset of the current RSV infection\n* Congenital heart disease \\[children with medically or surgically closed patent ductus arteriosis (PDA), small atrial septal defect (ASD) or small ventricular septal defect (VSD) will be allowed\\]\n* Previous reaction to IVIG, blood products, or other foreign proteins\n* Prior use of intravenous immunoglobulin (IVIG), palivizumab (SynagisÒ), or other immunoglobulin products within the past 2 months\n* Currently receiving other investigational agents or have received any other investigational agents within the 3 months prior to randomization\n* Prior or current participation in any investigational study with a therapeutic agent or vaccine for RSV"}, 'identificationModule': {'nctId': 'NCT00421304', 'briefTitle': 'A Study to Evaluate a Single Intravenous Dose of Motavizumab for the Treatment of Children Hospitalized With Respiratory Syncytial Virus (RSV) Illness', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedImmune LLC'}, 'officialTitle': 'A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate a Single Intravenous Dose of Motavizumab (MEDI-524), a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), for the Treatment of Children Hospitalized With RSV Illness', 'orgStudyIdInfo': {'id': 'MI-CP141'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Motavizumab 30 mg/kg', 'description': 'Participants will receive a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.', 'interventionNames': ['Biological: Motavizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Motavizumab 100 mg/kg', 'description': 'Participants will receive a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.', 'interventionNames': ['Biological: Motavizumab']}], 'interventions': [{'name': 'Motavizumab', 'type': 'BIOLOGICAL', 'otherNames': ['MEDI-524'], 'description': 'A single IV dose of motavizumab 30 mg/kg or 100 mg/kg will be administered on Day 0 of the study.', 'armGroupLabels': ['Motavizumab 100 mg/kg', 'Motavizumab 30 mg/kg']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'A single IV dose of placebo matched to motavizumab will be administered on Day 0 of the study.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '96826', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60453', 'city': 'Oak Lawn', 'state': 'Illinois', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.71087, 'lon': -87.75811}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '39216-4505', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '11201', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '14222', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '11501', 'city': 'Mineola', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}, {'zip': '11040', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '73104-5066', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '4029', 'city': 'Herston', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'city': 'Independencia', 'country': 'Chile', 'facility': 'Research Site', 'geoPoint': {'lat': -33.41167, 'lon': -70.66647}}, {'zip': '8360160', 'city': 'Santiago', 'country': 'Chile', 'facility': 'Research Site', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '8380418', 'city': 'Santiago', 'country': 'Chile', 'facility': 'Research Site', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'Research Site', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '2025', 'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Research Site', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'city': 'Hamilton', 'country': 'New Zealand', 'facility': 'Research Site', 'geoPoint': {'lat': -37.78333, 'lon': 175.28333}}, {'zip': '5301', 'city': 'Palmerston North', 'country': 'New Zealand', 'facility': 'Research Site', 'geoPoint': {'lat': -40.35636, 'lon': 175.61113}}, {'city': 'Panama City', 'country': 'Panama', 'facility': 'Research Site', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}], 'overallOfficials': [{'name': 'M. Pamela Griffin, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MedImmune LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MedImmune LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}