Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-03-01 @ 9:01 PM
Study NCT ID:
NCT00538434
Status:
COMPLETED
Last Update Posted:
2016-09-02
First Post:
2007-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of Reslizumab to Treat Eosinophilic Esophagitis in Subjects Aged 5 to 18 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057765', 'term': 'Eosinophilic Esophagitis'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D004941', 'term': 'Esophagitis'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D004802', 'term': 'Eosinophilia'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C515492', 'term': 'reslizumab'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '215-591-3000', 'title': 'Director, Clinical Research', 'organization': 'Teva Branded Pharmaceutical Products, R&D Inc.'}, 'certainAgreement': {'otherDetails': "Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline through Safety Follow-up (Week 16)', 'eventGroups': [{'id': 'EG000', 'title': 'Reslizumab 1 mg/kg', 'description': 'reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles', 'otherNumAtRisk': 55, 'otherNumAffected': 38, 'seriousNumAtRisk': 55, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Reslizumab 2 mg/kg', 'description': 'reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles', 'otherNumAtRisk': 57, 'otherNumAffected': 29, 'seriousNumAtRisk': 57, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Reslizumab 3 mg/kg', 'description': 'reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles', 'otherNumAtRisk': 57, 'otherNumAffected': 39, 'seriousNumAtRisk': 57, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Placebo', 'description': 'saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles', 'otherNumAtRisk': 57, 'otherNumAffected': 40, 'seriousNumAtRisk': 57, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'GASTROENTERITIS VIRAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'OTITIS MEDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'PHARYNGITIS STREPTOCOCCAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'VIRAL INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'PROTEIN URINE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'RED BLOOD CELLS URINE POSITIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'URINARY CASTS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'URINE OXALATE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'WHITE BLOOD CELLS URINE POSITIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 6, 'numAffected': 5}, {'groupId': 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1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'GASTROINTESTINAL INFLAMMATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'ANAPHYLACTIC REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'GASTROENTERITIS VIRAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'RESPIRATORY DISTRESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Percent Change From Baseline to End of Treatment in Peak Esophageal Eosinophil (EE) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Reslizumab 1 mg/kg', 'description': 'reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles'}, {'id': 'OG001', 'title': 'Reslizumab 2 mg/kg', 'description': 'reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles'}, {'id': 'OG002', 'title': 'Reslizumab 3 mg/kg', 'description': 'reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '-37.60', 'spread': '70.86', 'groupId': 'OG000'}, {'value': '-58.27', 'spread': '35.45', 'groupId': 'OG001'}, {'value': '-56.46', 'spread': '34.82', 'groupId': 'OG002'}, {'value': '11.50', 'spread': '91.42', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-52.78', 'ciLowerLimit': '-75.24', 'ciUpperLimit': '-30.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.40', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjustment for stratification factor and for variable at Baseline', 'testedNonInferiority': False}, {'pValue': '< 0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-73.03', 'ciLowerLimit': '-95.28', 'ciUpperLimit': '-50.78', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.29', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjustment for stratification factor and for variable at Baseline', 'testedNonInferiority': False}, {'pValue': '< 0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-64.69', 'ciLowerLimit': '-86.93', 'ciUpperLimit': '-42.45', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.28', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjustment for stratification factor and for variable at Baseline', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, End of Treatment (up to 15 weeks [+/- 4 days])', 'description': 'Participants underwent esophagogastroduodenoscopy (EGD) with biopsy (2 biopsies each at proximal and distal esophageal locations, plus any inflamed or abnormal areas) per standard clinical practice for the determination of esophageal eosinophils.', 'unitOfMeasure': 'percentage change in eosinophils/hpf', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: all randomized participants who received any amount of study drug.'}, {'type': 'PRIMARY', 'title': "Mean Change From Baseline in Physician's Esophageal Eosinophil (EE) Global Assessment At The End-of-Treatment Visit (or at Early Withdrawal)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Reslizumab 1 mg/kg', 'description': 'reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles'}, {'id': 'OG001', 'title': 'Reslizumab 2 mg/kg', 'description': 'reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles'}, {'id': 'OG002', 'title': 'Reslizumab 3 mg/kg', 'description': 'reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.85', 'spread': 'NA', 'comment': 'Study documentation from an acquired company does not contain the measure of dispersion.', 'groupId': 'OG000'}, {'value': '-1.02', 'spread': 'NA', 'comment': 'Study documentation from an acquired company does not contain the measure of dispersion.', 'groupId': 'OG001'}, {'value': '-1.12', 'spread': 'NA', 'comment': 'Study documentation from an acquired company does not contain the measure of dispersion.', 'groupId': 'OG002'}, {'value': '-1.14', 'spread': 'NA', 'comment': 'Study documentation from an acquired company does not contain the measure of dispersion.', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0313', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5793', 'groupIds': ['OG001', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4905', 'groupIds': ['OG002', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1, pre-treatment), End of Treatment (Week 15, 3 weeks [± 4 days] after the last dose of study drug, or at early withdrawal)', 'description': "The investigator completed the Physician's EE Global Assessment based upon the participant's reporting of symptoms, weight, dietary status, and overall well-being. The assessment rated severity on a five-point scale (0=none to 4=very severe), taking into account physical findings, vital signs, the Subject's Predominant EE Symptom Assessment, the subject's diary data, and dietary questions. The Subject's Predominant EE Symptom was the EE symptom (vomiting/regurgitation, abdominal/chest pain, or dysphagia) that had the greatest negative impact on the subject based on patient diary data as of the baseline visit.\n\nThe full range for change from baseline values is -4 (very severe at baseline, none at end of study) to 4 (none at baseline, severe at end of study). Negative change from baseline scores in the Physician's EE Global Assessment indicate improvement in EE status.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: all randomized participants who received any amount of study drug with both a baseline and an End of Treatment assessment.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to End of Treatment in EE Predominant Symptom Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Reslizumab 1 mg/kg', 'description': 'reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles'}, {'id': 'OG001', 'title': 'Reslizumab 2 mg/kg', 'description': 'reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles'}, {'id': 'OG002', 'title': 'Reslizumab 3 mg/kg', 'description': 'reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.94', 'spread': 'NA', 'comment': 'Study documentation from an acquired company does not contain the measure of dispersion.', 'groupId': 'OG000'}, {'value': '-1.20', 'spread': 'NA', 'comment': 'Study documentation from an acquired company does not contain the measure of dispersion.', 'groupId': 'OG001'}, {'value': '-1.28', 'spread': 'NA', 'comment': 'Study documentation from an acquired company does not contain the measure of dispersion.', 'groupId': 'OG002'}, {'value': '-1.44', 'spread': 'NA', 'comment': 'Study documentation from an acquired company does not contain the measure of dispersion.', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0062', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0943', 'groupIds': ['OG001', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2955', 'groupIds': ['OG002', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1, pre-treatment), End of Treatment (Week 15, 3 weeks [± 4 days] after the last dose of study drug, or at early withdrawal)', 'description': "Participants rated the severity of each EE symptom (vomiting/regurgitation, abdominal/chest pain, and dysphagia) based on the previous week's daily diary as none (=0), mild, moderate, severe, or very severe (=4). The predominant symptom was selected at the baseline visit and remained the same throughout the trial. The predominant symptom was defined as the EE symptom that had the greatest negative impact on the participant. The full range for change from baseline values is -4 (very severe at baseline, none at end of study) to 4 (none at baseline, severe at end of study). Negative change from baseline scores in the Patient's EE Predominant Symptom Assessment indicate improvement in the selected symptom.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: all randomized participants who received any amount of study drug with both a baseline and an End of Treatment assessment.'}, {'type': 'SECONDARY', 'title': 'Mean Percent Change From Baseline to End of Treatment in the Child Health Questionnaire (CHQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Reslizumab 1 mg/kg', 'description': 'reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles'}, {'id': 'OG001', 'title': 'Reslizumab 2 mg/kg', 'description': 'reslizumab 2 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles'}, {'id': 'OG002', 'title': 'Reslizumab 3 mg/kg', 'description': 'reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles'}], 'classes': [{'title': 'Physical Summary Score; n=49, 52, 53, 57', 'categories': [{'measurements': [{'value': '11.2', 'spread': 'NA', 'comment': 'Study documentation from an acquired company does not contain the measure of dispersion.', 'groupId': 'OG000'}, {'value': '18.6', 'spread': 'NA', 'comment': 'Study documentation from an acquired company does not contain the measure of dispersion.', 'groupId': 'OG001'}, {'value': '18.5', 'spread': 'NA', 'comment': 'Study documentation from an acquired company does not contain the measure of dispersion.', 'groupId': 'OG002'}, {'value': '11.8', 'spread': 'NA', 'comment': 'Study documentation from an acquired company does not contain the measure of dispersion.', 'groupId': 'OG003'}]}]}, {'title': 'Psychosocial Summary Score; n=51, 52, 53, 55', 'categories': [{'measurements': [{'value': '5.0', 'spread': 'NA', 'comment': 'Study documentation from an acquired company does not contain the measure of dispersion.', 'groupId': 'OG000'}, {'value': '12.2', 'spread': 'NA', 'comment': 'Study documentation from an acquired company does not contain the measure of dispersion.', 'groupId': 'OG001'}, {'value': '14.1', 'spread': 'NA', 'comment': 'Study documentation from an acquired company does not contain the measure of dispersion.', 'groupId': 'OG002'}, {'value': '10.1', 'spread': 'NA', 'comment': 'Study documentation from an acquired company does not contain the measure of dispersion.', 'groupId': 'OG003'}]}]}, {'title': 'Global Health Summary Score; n=50, 54, 54, 55', 'categories': [{'measurements': [{'value': '10.2', 'spread': 'NA', 'comment': 'Study documentation from an acquired company does not contain the measure of dispersion.', 'groupId': 'OG000'}, {'value': '15.5', 'spread': 'NA', 'comment': 'Study documentation from an acquired company does not contain the measure of dispersion.', 'groupId': 'OG001'}, {'value': '10.3', 'spread': 'NA', 'comment': 'Study documentation from an acquired company does not contain the measure of dispersion.', 'groupId': 'OG002'}, {'value': '9.7', 'spread': 'NA', 'comment': 'Study documentation from an acquired company does not contain the measure of dispersion.', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.4644', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.75', 'ciLowerLimit': '-17.53', 'ciUpperLimit': '8.03', 'pValueComment': 'Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.48', 'estimateComment': 'Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.', 'groupDescription': 'Physical Summary Score', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8196', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.47', 'ciLowerLimit': '-14.17', 'ciUpperLimit': '11.23', 'pValueComment': 'Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.44', 'estimateComment': 'Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.', 'groupDescription': 'Physical Summary Score', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8306', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.36', 'ciLowerLimit': '-11.19', 'ciUpperLimit': '13.91', 'pValueComment': 'Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.36', 'estimateComment': 'Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.', 'groupDescription': 'Physical Summary Score', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1459', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.38', 'ciLowerLimit': '-15.01', 'ciUpperLimit': '2.24', 'pValueComment': 'Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.37', 'estimateComment': 'Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.', 'groupDescription': 'Psychosocial Summary Score', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4375', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.41', 'ciLowerLimit': '-12.05', 'ciUpperLimit': '5.23', 'pValueComment': 'Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.38', 'estimateComment': 'Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.', 'groupDescription': 'Psychosocial Summary Score', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.9217', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.43', 'ciLowerLimit': '-9.00', 'ciUpperLimit': '8.15', 'pValueComment': 'Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.35', 'estimateComment': 'Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.', 'groupDescription': 'Psychosocial Summary Score', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8412', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.57', 'ciLowerLimit': '-16.98', 'ciUpperLimit': '13.85', 'pValueComment': 'Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.82', 'estimateComment': 'Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.', 'groupDescription': 'Global Health Score', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4794', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.54', 'ciLowerLimit': '-20.94', 'ciUpperLimit': '9.87', 'pValueComment': 'Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.81', 'estimateComment': 'Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.', 'groupDescription': 'Global Health Score', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8906', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.06', 'ciLowerLimit': '-16.16', 'ciUpperLimit': '14.06', 'pValueComment': 'Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.66', 'estimateComment': 'Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.', 'groupDescription': 'Global Health Score', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, End of Treatment (up to 15 weeks +/- 4 days)', 'description': 'CHQ is a quality-of-life (QoL), observer-rated (the parent in this study) instrument designed to assess the general health and well-being of pediatric subjects aged 5 to 18 years. The instrument comprises 50 items that cover 14 unique physical and psychological concepts. Each item was scored separately following different scales and timeframes for response. Proprietary scoring algorithms are used. This outcome reports the two CHQ Summary Scores (Physical Summary Score and the Psychosocial Summary Scores) which are indexed to a 0 (poorest quality of life) to 100 (best quality of life) scores. The two summary scores are subsequently combined (via proprietary algorithm) to create the Global Health Summary Score (also on a 0-100 scale). Percent change from baseline values range from 100% (poorest QoL at baseline, best QoL at end of treatment) to -100% (best QoL at baseline, poorest QoL at end of treatment). Higher percent change from baseline values indicate improved QoL.', 'unitOfMeasure': 'percentage change in score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: all randomized participants who received any amount of study drug with both a baseline and an End of Treatment assessment; n=number of participants with a response in the given category.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Reslizumab 1 mg/kg', 'description': 'reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles'}, {'id': 'FG001', 'title': 'Reslizumab 2 mg/kg', 'description': 'reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles'}, {'id': 'FG002', 'title': 'Reslizumab 3 mg/kg', 'description': 'reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '57'}, {'groupId': 'FG003', 'numSubjects': '57'}]}, {'type': 'Intent-to-treat (ITT) Population', 'achievements': [{'comment': '1 participant was randomized but not treated', 'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '57'}, {'groupId': 'FG003', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed all scheduled study visits', 'groupId': 'FG000', 'numSubjects': '47'}, {'comment': 'Completed all scheduled study visits', 'groupId': 'FG001', 'numSubjects': '46'}, {'comment': 'Completed all scheduled study visits', 'groupId': 'FG002', 'numSubjects': '50'}, {'comment': 'Completed all scheduled study visits', 'groupId': 'FG003', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}, {'value': '226', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Reslizumab 1 mg/kg', 'description': 'reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles'}, {'id': 'BG001', 'title': 'Reslizumab 2 mg/kg', 'description': 'reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles'}, {'id': 'BG002', 'title': 'Reslizumab 3 mg/kg', 'description': 'reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '12.3', 'spread': '3.83', 'groupId': 'BG000'}, {'value': '11.8', 'spread': '3.82', 'groupId': 'BG001'}, {'value': '11.5', 'spread': '4.04', 'groupId': 'BG002'}, {'value': '11.9', 'spread': '4.17', 'groupId': 'BG003'}, {'value': '11.9', 'spread': '3.95', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '5 to < 12 years', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '99', 'groupId': 'BG004'}]}]}, {'title': '12 to < 19 years', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '127', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '54', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}, {'value': '172', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'ITT population: all randomized participants who received any amount of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 227}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'dispFirstSubmitDate': '2013-08-16', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-21', 'studyFirstSubmitDate': '2007-10-01', 'dispFirstSubmitQcDate': '2013-08-16', 'resultsFirstSubmitDate': '2016-03-23', 'studyFirstSubmitQcDate': '2007-10-01', 'dispFirstPostDateStruct': {'date': '2013-08-26', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-09-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-07-21', 'studyFirstPostDateStruct': {'date': '2007-10-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Percent Change From Baseline to End of Treatment in Peak Esophageal Eosinophil (EE) Levels', 'timeFrame': 'Baseline, End of Treatment (up to 15 weeks [+/- 4 days])', 'description': 'Participants underwent esophagogastroduodenoscopy (EGD) with biopsy (2 biopsies each at proximal and distal esophageal locations, plus any inflamed or abnormal areas) per standard clinical practice for the determination of esophageal eosinophils.'}, {'measure': "Mean Change From Baseline in Physician's Esophageal Eosinophil (EE) Global Assessment At The End-of-Treatment Visit (or at Early Withdrawal)", 'timeFrame': 'Baseline (Day 1, pre-treatment), End of Treatment (Week 15, 3 weeks [± 4 days] after the last dose of study drug, or at early withdrawal)', 'description': "The investigator completed the Physician's EE Global Assessment based upon the participant's reporting of symptoms, weight, dietary status, and overall well-being. The assessment rated severity on a five-point scale (0=none to 4=very severe), taking into account physical findings, vital signs, the Subject's Predominant EE Symptom Assessment, the subject's diary data, and dietary questions. The Subject's Predominant EE Symptom was the EE symptom (vomiting/regurgitation, abdominal/chest pain, or dysphagia) that had the greatest negative impact on the subject based on patient diary data as of the baseline visit.\n\nThe full range for change from baseline values is -4 (very severe at baseline, none at end of study) to 4 (none at baseline, severe at end of study). Negative change from baseline scores in the Physician's EE Global Assessment indicate improvement in EE status."}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline to End of Treatment in EE Predominant Symptom Assessment', 'timeFrame': 'Baseline (Day 1, pre-treatment), End of Treatment (Week 15, 3 weeks [± 4 days] after the last dose of study drug, or at early withdrawal)', 'description': "Participants rated the severity of each EE symptom (vomiting/regurgitation, abdominal/chest pain, and dysphagia) based on the previous week's daily diary as none (=0), mild, moderate, severe, or very severe (=4). The predominant symptom was selected at the baseline visit and remained the same throughout the trial. The predominant symptom was defined as the EE symptom that had the greatest negative impact on the participant. The full range for change from baseline values is -4 (very severe at baseline, none at end of study) to 4 (none at baseline, severe at end of study). Negative change from baseline scores in the Patient's EE Predominant Symptom Assessment indicate improvement in the selected symptom."}, {'measure': 'Mean Percent Change From Baseline to End of Treatment in the Child Health Questionnaire (CHQ)', 'timeFrame': 'Baseline, End of Treatment (up to 15 weeks +/- 4 days)', 'description': 'CHQ is a quality-of-life (QoL), observer-rated (the parent in this study) instrument designed to assess the general health and well-being of pediatric subjects aged 5 to 18 years. The instrument comprises 50 items that cover 14 unique physical and psychological concepts. Each item was scored separately following different scales and timeframes for response. Proprietary scoring algorithms are used. This outcome reports the two CHQ Summary Scores (Physical Summary Score and the Psychosocial Summary Scores) which are indexed to a 0 (poorest quality of life) to 100 (best quality of life) scores. The two summary scores are subsequently combined (via proprietary algorithm) to create the Global Health Summary Score (also on a 0-100 scale). Percent change from baseline values range from 100% (poorest QoL at baseline, best QoL at end of treatment) to -100% (best QoL at baseline, poorest QoL at end of treatment). Higher percent change from baseline values indicate improved QoL.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Eosinophilic Esophagitis', 'GERD', 'EE', 'Reslizumab', 'IL-5', 'Interleukin-5', 'Cinquil'], 'conditions': ['Eosinophilic Esophagitis']}, 'referencesModule': {'references': [{'pmid': '22206777', 'type': 'RESULT', 'citation': "Spergel JM, Rothenberg ME, Collins MH, Furuta GT, Markowitz JE, Fuchs G 3rd, O'Gorman MA, Abonia JP, Young J, Henkel T, Wilkins HJ, Liacouras CA. Reslizumab in children and adolescents with eosinophilic esophagitis: results of a double-blind, randomized, placebo-controlled trial. J Allergy Clin Immunol. 2012 Feb;129(2):456-63, 463.e1-3. doi: 10.1016/j.jaci.2011.11.044. Epub 2011 Dec 28."}]}, 'descriptionModule': {'briefSummary': 'This trial will study three doses of reslizumab versus placebo in children with eosinophilic esophagitis (EE). The objectives of the trial will be to study the effectiveness of reslizumab in improving the clinical signs and symptoms and reducing esophageal eosinophils as well as assessing the safety profile compared to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* written informed consent obtained\n* male or female patients aged 5 to 18 years at time of screening\n* of non-childbearing potential, of childbearing potential and willing to use specific barrier methods outlined in the protocol\n* confirmed active EE (at Screening or within six weeks prior to Baseline Visit) as defined by esophageal mucosal eosinophils greater than or equal to 24 per high power field (hpf; 400X magnification)\n* within the week prior to dosing, patient has one of the following symptoms of moderate (or worse) severity: vomiting, regurgitation (acid taste or feeling material movement upward), abdominal, chest pain/heartburn (burning or pain behind the sternum), or difficulty swallowing\n* been on a therapeutic dose of proton pump inhibitors (PPIs; with or without histamine H2 receptor antagonists)for at least four weeks without resolution of symptoms, or by negative pH probe (with or without having failed a course of PPIs)\n\nExclusion Criteria:\n\n* another disorder that causes esophageal eosinophilia (e.g., hypereosinophilic syndrome \\[HES\\],Churg Strauss vasculitis, eosinophilic gastroenteritis \\[EG\\], or a parasitic infection)\n* history of abnormal gastric or duodenal biopsy or documented gastrointestinal \\[GI\\] disorders (e.g., celiac disease, Crohn's disease or Helicobacter pylori infection)\n* history of the following GI surgeries: fundoplication, gastric surgery or surgery for intestinal atresia\n* use of systemic immunosuppressive or immunomodulating agents (anti-immunoglobulin E \\[IgE\\] monoclinal antibody \\[mAb\\], methotrexate, cyclosporin, interferon alpha \\[α\\], or anti tumor necrosis factor \\[TNF\\] mAb) within six months prior to study entry\n* received attenuated live attenuated vaccines (e.g., measles, mumps, rubella \\[MMR\\], bacillus Calmette-Guerin \\[BCG\\], varicella, FluMist or polio) within three months prior to study entry\n* use of swallowed inhaled corticosteroids for the treatment of EE within one month prior to study entry. Note: Inhaled and nasal corticosteroids for the treatment of asthma and allergies, respectively, are permitted provided that the dose remains the same during the study\n* a stricture on endoscopy that prevents passage of the endoscope\n* participation in any investigational drug or device study within 30 days prior to study entry\n* female subjects who are pregnant or nursing\n* concurrent infection or disease that may preclude assessment of EE\n* concurrent immunodeficiency (human immunodeficiency \\[HIV\\], or acquired immunodeficiency syndrome \\[AIDS\\] or congenital immunodeficiency)"}, 'identificationModule': {'nctId': 'NCT00538434', 'briefTitle': 'Efficacy and Safety Study of Reslizumab to Treat Eosinophilic Esophagitis in Subjects Aged 5 to 18 Years', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'An Efficacy and Safety Study of Reslizumab (CTx55700) in the Treatment of Eosinophilic Esophagitis in Subjects Aged 5 to 18 Years', 'orgStudyIdInfo': {'id': 'Res-05-0002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reslizumab 1 mg/kg', 'description': 'reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles', 'interventionNames': ['Biological: Reslizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Reslizumab 2 mg/kg', 'description': 'reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles', 'interventionNames': ['Biological: Reslizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Reslizumab 3 mg/kg', 'description': 'reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles', 'interventionNames': ['Biological: Reslizumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles', 'interventionNames': ['Other: Saline']}], 'interventions': [{'name': 'Reslizumab', 'type': 'BIOLOGICAL', 'otherNames': ['CTx55700', 'Cinquil™', 'CEP-38072'], 'armGroupLabels': ['Reslizumab 1 mg/kg', 'Reslizumab 2 mg/kg', 'Reslizumab 3 mg/kg']}, {'name': 'Saline', 'type': 'OTHER', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': "The Children's Hospital of Alabama", 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona Dept. of Pediatrics', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Hospital/University of Arkansas for Medical Sciences", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '94545', 'city': 'Hayward', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Hospital- Pediatric 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