Ignite Creation Date:
2025-12-24 @ 3:18 PM
Ignite Modification Date:
2026-01-23 @ 4:31 AM
Study NCT ID:
NCT01980992
Status:
COMPLETED
Last Update Posted:
2020-08-14
First Post:
2013-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Oral Immunotherapy for Wheat Allergy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D021182', 'term': 'Wheat Hypersensitivity'}, {'id': 'D005512', 'term': 'Food Hypersensitivity'}], 'ancestors': [{'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hugh.sampson@mssm.edu', 'phone': '212-659-9426', 'title': 'Dr. Hugh A. Sampson', 'organization': 'Icahn School of Medicine at Mount Sinai'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 years', 'eventGroups': [{'id': 'EG000', 'title': 'Wheat OIT Before 1 Year', 'description': '2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 23, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Before 1 Year', 'description': '52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 21, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Wheat OIT After 1 Year', 'description': '2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 18, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Placebo Crossover', 'description': '52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 21, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 48, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 27, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 22, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 79, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 57, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 16, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 13, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 49, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 25, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 20, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 484, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 28, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 74, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 146, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 20, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 11, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Gastrontestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 172, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 57, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 14, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 153, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Gastrooescophageal refluz disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 5, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Glossodynia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Lip oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Oral mucosal eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Saliva altered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 85, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 13, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Croup infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Gastrointestinal viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 11, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG002', 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 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[{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 126, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 12, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 31, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 304, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 27, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 200, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Rhimorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 157, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 16, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 14, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 45, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Throat tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 10, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 121, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 311, 'numAffected': 13}, {'groupId': 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'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Flashing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 40, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 26, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}], 'seriousEvents': [{'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Status asthmaticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Anaphylactic Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Percentage of Desensitized Participants as Measured by the Ability to Consume at Least 4443 mg of Wheat Protein During a 7443 mg Wheat Protein Oral Food Challenge (OFC) Performed 1 Year After Initiating Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a week 52 7443mg wheat protein oral food challenge (OFC).'}, {'id': 'OG001', 'title': 'Wheat OIT', 'description': '2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 Year', 'description': 'Determine in wheat allergic children, whether relative to placebo, daily oral administration of Vital Wheat Gluten escalated to a maximum of 2035 mg/day of Vital Wheat Gluten increases desensitization as measured by consuming without dose limiting symptoms 4443 mg of wheat protein on a 7443 mg wheat protein OFC performed 1 year after initiating treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants were included.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Who Successfully Consume a Wheat Protein Oral Food Challenge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Then High Dose Group', 'description': '52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).'}, {'id': 'OG001', 'title': 'Wheat OIT', 'description': '2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 to 10 weeks after passing the 2 Year OFC', 'description': 'The number of subjects who successfully consume a 7443 mg wheat protein oral food challenge (OFC) 8-10 weeks after therapy discontinuation and after passing the 7443 mg wheat protein OFC at the 2 year time point.This OFC will only be administered to subjects in the initial active treatment group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This is not applicable for the Placebo Crossover subjects as they did not complete at 2 Year Tolerance OFC per the protocol.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Who Achieve the Targeted Maintenance Dose of Wheat OIT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Then High Dose Group', 'description': '52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).'}, {'id': 'OG001', 'title': 'Wheat OIT', 'description': '2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '44 Weeks', 'description': 'The number of subjects who achieve the targeted maintenance dose of wheat OIT during the desensitization phase of the study. For Wheat OIT group, reached target dose of 2035 mg wheat powder/1445 mg wheat protein. For placebo group, reached target dose of 2035 mg placebo powder.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects That Achieve Desensitization in the Placebo Cross Over Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Then High Dose Group', 'description': '52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 Years', 'description': 'The number of subjects that achieve desensitization in the placebo cross over group after 1 year of dosing. Able to consume at least 4443 mg wheat protein on the Week 52 Crossover OFC (4443 mg wheat protein is the amount that was used for the primary endpoint).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Two Placebo subjects did not crossover. This outcome measure is only for the Placebo crossover group.'}, {'type': 'SECONDARY', 'title': 'Incidence of All Serious Adverse Events During the Study.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Wheat OIT Before 1 Year', 'description': 'During the first year of 2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.'}, {'id': 'OG001', 'title': 'Placebo Before 1 Year', 'description': 'During the first year of 52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).'}, {'id': 'OG002', 'title': 'Wheat OIT After 1 Year', 'description': '2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.'}, {'id': 'OG003', 'title': 'Placebo Crossover', 'description': '52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year and 2 Years', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was available for 22 participants in the Wheat OIT group and 21 participants for the Placebo Crossover group at the end of the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Then High Dose Group', 'description': '52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).'}, {'id': 'FG001', 'title': 'Wheat OIT', 'description': '2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.'}], 'periods': [{'title': '52 Weeks Blinded Study Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Dosing Symptoms', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': '52 Weeks Open Label Active Wheat OIT', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Dosing Symptoms', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Enrollment began November 2013 and was completed in November 2014'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Then High Dose Group', 'description': '52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).'}, {'id': 'BG001', 'title': 'Wheat OIT', 'description': '2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'groupId': 'BG000', 'lowerLimit': '4.2', 'upperLimit': '22.3'}, {'value': '8.6', 'groupId': 'BG001', 'lowerLimit': '4.6', 'upperLimit': '18.4'}, {'value': '8.7', 'groupId': 'BG002', 'lowerLimit': '4.2', 'upperLimit': '22.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Wheat IgE', 'classes': [{'categories': [{'measurements': [{'value': '86.8', 'groupId': 'BG000', 'lowerLimit': '63.7', 'upperLimit': '101.0'}, {'value': '94.1', 'groupId': 'BG001', 'lowerLimit': '45.0', 'upperLimit': '101.0'}, {'value': '88.4', 'groupId': 'BG002', 'lowerLimit': '51.9', 'upperLimit': '101.0'}]}]}], 'paramType': 'MEDIAN', 'description': 'Amount of serum wheat-specific immunoglobulin E (IgE). Individuals with a wheat IgE of \\<0.35 kUA/L are considered not to be sensitized to wheat. The limits of detection for the wheat IgE assay were 0.1 to 100 kUA/L. Values below the limit of detection were set to 0.05 kUA/L and those above the limit of detection were set to 101 kUA/L.', 'unitOfMeasure': 'kUA/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Wheat IgG4', 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'groupId': 'BG000', 'lowerLimit': '2.5', 'upperLimit': '8.6'}, {'value': '2.9', 'groupId': 'BG001', 'lowerLimit': '1.7', 'upperLimit': '10.2'}, {'value': '4.2', 'groupId': 'BG002', 'lowerLimit': '2.1', 'upperLimit': '9.9'}]}]}], 'paramType': 'MEDIAN', 'description': 'Amount of immunoglobulin G4 (IgG4). The limits of detection for the wheat IgG4 assay were 0.1 to 30 mgA/L. Values below the limit of detection were set to 0.05 mgA/L and those above the limit of detection were set to 31 mgA/L for wheat IgG4.', 'unitOfMeasure': 'mgA/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Wheat Skin Prick Test', 'classes': [{'categories': [{'measurements': [{'value': '6.8', 'spread': '2.8', 'groupId': 'BG000'}, {'value': '5.3', 'spread': '3.4', 'groupId': 'BG001'}, {'value': '6.1', 'spread': '3.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'This score is calculated by subtracting the size of the saline wheal (in mm) from the size of the wheat wheal (in mm) observed for a skin prick test. Individuals with a wheat skin prick test score of \\< 3 mm are considered to have a negative result.', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Wheat OFC Dose at First Symptom', 'classes': [{'categories': [{'measurements': [{'value': '13.0', 'groupId': 'BG000', 'lowerLimit': '3.0', 'upperLimit': '43.0'}, {'value': '43.0', 'groupId': 'BG001', 'lowerLimit': '13.0', 'upperLimit': '443.0'}, {'value': '13.0', 'groupId': 'BG002', 'lowerLimit': '3.0', 'upperLimit': '143.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg protein', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Wheat OFC Successfully Consumed Dose', 'classes': [{'categories': [{'measurements': [{'value': '43.0', 'groupId': 'BG000', 'lowerLimit': '3.0', 'upperLimit': '143.0'}, {'value': '43.0', 'groupId': 'BG001', 'lowerLimit': '13.0', 'upperLimit': '143.0'}, {'value': '43.0', 'groupId': 'BG002', 'lowerLimit': '3.0', 'upperLimit': '143.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg protein', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Maximum Initial Escalation Day Dose', 'classes': [{'categories': [{'measurements': [{'value': '12.0', 'groupId': 'BG000', 'lowerLimit': '3.0', 'upperLimit': '12.0'}, {'value': '12.0', 'groupId': 'BG001', 'lowerLimit': '6.0', 'upperLimit': '12.0'}, {'value': '12.0', 'groupId': 'BG002', 'lowerLimit': '3.0', 'upperLimit': '12.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg powder', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-12', 'studyFirstSubmitDate': '2013-11-05', 'resultsFirstSubmitDate': '2017-02-13', 'studyFirstSubmitQcDate': '2013-11-05', 'lastUpdatePostDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-13', 'studyFirstPostDateStruct': {'date': '2013-11-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Percentage of Desensitized Participants as Measured by the Ability to Consume at Least 4443 mg of Wheat Protein During a 7443 mg Wheat Protein Oral Food Challenge (OFC) Performed 1 Year After Initiating Treatment.', 'timeFrame': '1 Year', 'description': 'Determine in wheat allergic children, whether relative to placebo, daily oral administration of Vital Wheat Gluten escalated to a maximum of 2035 mg/day of Vital Wheat Gluten increases desensitization as measured by consuming without dose limiting symptoms 4443 mg of wheat protein on a 7443 mg wheat protein OFC performed 1 year after initiating treatment.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects Who Successfully Consume a Wheat Protein Oral Food Challenge', 'timeFrame': '8 to 10 weeks after passing the 2 Year OFC', 'description': 'The number of subjects who successfully consume a 7443 mg wheat protein oral food challenge (OFC) 8-10 weeks after therapy discontinuation and after passing the 7443 mg wheat protein OFC at the 2 year time point.This OFC will only be administered to subjects in the initial active treatment group.'}, {'measure': 'Number of Subjects Who Achieve the Targeted Maintenance Dose of Wheat OIT', 'timeFrame': '44 Weeks', 'description': 'The number of subjects who achieve the targeted maintenance dose of wheat OIT during the desensitization phase of the study. For Wheat OIT group, reached target dose of 2035 mg wheat powder/1445 mg wheat protein. For placebo group, reached target dose of 2035 mg placebo powder.'}, {'measure': 'Number of Subjects That Achieve Desensitization in the Placebo Cross Over Group', 'timeFrame': '2 Years', 'description': 'The number of subjects that achieve desensitization in the placebo cross over group after 1 year of dosing. Able to consume at least 4443 mg wheat protein on the Week 52 Crossover OFC (4443 mg wheat protein is the amount that was used for the primary endpoint).'}, {'measure': 'Incidence of All Serious Adverse Events During the Study.', 'timeFrame': '1 year and 2 Years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Food Allergy', 'Wheat Allergy', 'Oral Immunotherapy'], 'conditions': ['Wheat Allergy']}, 'descriptionModule': {'briefSummary': 'This study is being done to learn about the medical effects, the safety, and the immunologic effects of Wheat Oral Immunotherapy (OIT) treatment. The goal of the study is to find out whether subjects can develop the ability to eat wheat (the food allergen) regularly without allergic symptoms after stopping the study treatment.', 'detailedDescription': 'Food allergy affects 6-8 percent of children in the United States. Wheat is one of the eight most common foods inducing allergic reactions in the US. Current treatment for food allergy is complete avoidance of the food and to carry antihistamines and self-injectable epinephrine if an accidental reaction occurs. However, accidental exposure to allergens in processed foods may be difficult to avoid. Currently, several therapeutic strategies are being investigated to prevent and treat food allergies. Since immunotherapy injections for food allergy are associated with a high rate of allergic reactions, alternate approaches to treatment are needed. Oral (by mouth) immunotherapy (OIT) is one approach that has been tried in some studies in the treatment of food allergies. The intent of the study is to examine the clinical effects and safety of wheat OIT. This study will last 2 years. All eligible subjects will receive a wheat oral food challenge (OFC). Those who react to 1923mg or less of vital wheat gluten will be randomized to Wheat OIT or a placebo. All eligible and enrolled subjects will have a 1-year and 2-year OFC. Placebo subjects will crossover to Wheat OIT at the 1-year time point. At selected visits, blood and urine collection, physical examination, prick skin tests, and atopic dermatitis and asthma evaluations will occur.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 4-30 years either sex, any race, any ethnicity\n* Positive Prick Skin Test to wheat greater than 3mm compared to control and/or a wheat specific IgE \\>= 0.35 kUA/L\n* Positive baseline challenge to wheat (\\<= 1923 mg of vital wheat gluten)\n* Written informed consent from subject and/or parent/guardian\n* Written assent from all subjects as appropriate\n* All females of child bearing age must be using appropriate birth control\n\nExclusion Criteria:\n\n* History of anaphylaxis to wheat resulting in hypotension, neurological compromise or mechanical ventilation\n* Known allergy to corn\n* Known celiac disease\n* Chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy (e.g., heart disease, diabetes)\n* Active eosinophilic gastrointestinal disease in the past two years\n* Participation in any interventional study for the treatment of food allergy in the past 6 months\n* Subject is on "build-up phase" of immunotherapy (i.e., has not reached maintenance dosing). Subjects tolerating maintenance allergen immunotherapy can be enrolled.\n* Severe asthma, uncontrolled mild or moderate asthma. More information on this criterion can be found in the protocol.\n* A burst of oral, IM or IV steroids of more than 2 days for an indication other than asthma in the past 1 month\n* Inability to discontinue antihistamines for initial day escalation, skin testing or OFC\n* Use of omalizumab or other non-traditional forms of allergen immunotherapy or immunomodulator therapy (not including corticosteroids) or biologic therapy within the past year\n* Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers\n* Use of investigational drug within 90 days or plan to use investigational drug during the study period\n* Pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT01980992', 'acronym': 'Wheat OIT', 'briefTitle': 'Oral Immunotherapy for Wheat Allergy', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Oral Immunotherapy for Wheat Allergy', 'orgStudyIdInfo': {'id': 'GCO 11-0197'}, 'secondaryIdInfos': [{'id': 'FAI001', 'type': 'OTHER', 'domain': 'Jaffe Food Allergy Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Wheat OIT', 'description': 'Active treatment participants receive Vital Wheat Gluten, and have up to four oral food challenges as directed by the protocol.', 'interventionNames': ['Drug: Wheat OIT']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo for Vital Wheat Gluten followed by crossover to open-label active therapy (Vital Wheat Gluten), and up to three oral food challenges as directed by the protocol.', 'interventionNames': ['Drug: Wheat OIT']}], 'interventions': [{'name': 'Wheat OIT', 'type': 'DRUG', 'otherNames': ['Vital Wheat Gluten'], 'description': 'Vital Wheat Gluten dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses.', 'armGroupLabels': ['Placebo', 'Wheat OIT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann & Robert H. Lurie Children's Hospital of Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '100029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Hugh A Sampson, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}, {'name': 'Hugh A Sampson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hugh A Sampson, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dean for Translational Biomedical Sciences, Director, Jaffe Food Allergy Institute', 'investigatorFullName': 'Hugh A Sampson, MD', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}