Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-31 @ 4:45 AM
Study NCT ID:
NCT03201003
Status:
COMPLETED
Last Update Posted:
2021-08-03
First Post:
2017-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ARTEMIS Peanut Allergy In Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D021183', 'term': 'Peanut Hypersensitivity'}, {'id': 'C537589', 'term': 'Severe combined immunodeficiency with sensitivity to ionizing radiation'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D000074924', 'term': 'Nut and Peanut Hypersensitivity'}, {'id': 'D005512', 'term': 'Food Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002214', 'term': 'Capsules'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RegulatoryAffairs@aimmune.com', 'phone': '650-409-5164', 'title': 'Director of Regulatory Affairs', 'organization': 'Aimmune Therapeutics, Inc.'}, 'certainAgreement': {'otherDetails': '* Institutions cannot publish until the multi-center sponsor publication is published\n* Or, institutions cannot publish until 18 months after study completion\n* And Sponsor review of any publications is required prior to any institution publications according to contractual agreements', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Approximately 9 months', 'eventGroups': [{'id': 'EG000', 'title': 'AR101', 'description': 'AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed sachets containing 300mg of peanut protein.\n\nThe capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.', 'otherNumAtRisk': 132, 'deathsNumAtRisk': 132, 'otherNumAffected': 130, 'seriousNumAtRisk': 132, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'A placebo matching the AR101 drug product was supplied in 2 presentations. These were capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed sachets matching the peanut protein sachets but without any peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study, while the sachets were used during the Maintenance phase.', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 42, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 42, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Systemic allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 22, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 20, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 41, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 19, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 36, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 15, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 659, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 25, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 157, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 24, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 166, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 53, 'numAffected': 24}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 89, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 22, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 63, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 12, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 40, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 11, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 45, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 8, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Throat tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 31, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 8, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Nasal pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 19, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 99, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 18, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pharyngeal paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 37, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 12, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 7, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 128, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 65, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 37, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 12, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Eye swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 18, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 7, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 21, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Motion sickness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 835, 'numAffected': 88}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 126, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 437, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 31, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Paraesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 961, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 49, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 120, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 17, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Oral pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 236, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lip swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 112, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lip pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 97, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 120, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Tongue pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 133, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 11, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lip oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 20, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 26, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 19, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 44, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lip pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 21, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 300, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 62, 'numAffected': 14}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 156, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 27, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 69, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 38, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 18, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 87, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 25, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 18, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 31, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 25, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 77, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 21, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 51, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 17, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 24, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 21, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'seriousEvents': [{'term': 'Intentional overdose', 'notes': 'Paracetamol and a combination hormone birth control medication. Unrelated to treatment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Bronchitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 1000 mg in the Exit Oral Food Challenge.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AR101', 'description': 'AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed sachets containing 300mg of peanut protein.\n\nThe capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A placebo matching the AR101 drug product was supplied in 2 presentations. These were capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed sachets matching the peanut protein sachets but without any peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study, while the sachets were used during the Maintenance phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '56.0', 'ciLowerLimit': '44.1', 'ciUpperLimit': '65.2', 'groupDescription': 'Treatment difference at 1000 mg', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Approximately 9 months', 'description': 'The proportion of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild symptoms at the Exit Oral Food Challenge.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 600 mg in the Exit Oral Food Challenge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AR101', 'description': 'AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed sachets containing 300mg of peanut protein.\n\nThe capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A placebo matching the AR101 drug product was supplied in 2 presentations. These were capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed sachets matching the peanut protein sachets but without any peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study, while the sachets were used during the Maintenance phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '58.9', 'ciLowerLimit': '44.2', 'ciUpperLimit': '69.3', 'groupDescription': 'Treatment difference at 600 mg', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Approximately 9 months', 'description': 'The proportion of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild symptoms at the Exit Oral Food Challenge.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 300 mg in the Exit Oral Food Challenge.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AR101', 'description': 'AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed sachets containing 300mg of peanut protein.\n\nThe capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A placebo matching the AR101 drug product was supplied in 2 presentations. These were capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed sachets matching the peanut protein sachets but without any peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study, while the sachets were used during the Maintenance phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '57.2', 'ciLowerLimit': '41.2', 'ciUpperLimit': '69.1', 'groupDescription': 'Treatment difference at 300 mg', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Approximately 9 months', 'description': 'The proportion of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild symptoms at the Exit Oral Food Challenge.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maximum Severity of Symptoms at Any Challenge Dose During the Peanut Exit Oral Food Challenge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AR101', 'description': 'AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed sachets containing 300mg of peanut protein.\n\nThe capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A placebo matching the AR101 drug product was supplied in 2 presentations. These were capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed sachets matching the peanut protein sachets but without any peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study, while the sachets were used during the Maintenance phase.'}], 'classes': [{'categories': [{'title': 'None', 'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'title': 'Severe or higher', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Treatment difference in Maximum Severity', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel statistic (with equally spaced scores) stratified by country'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Approximately 9 months', 'description': 'The maximum severity of symptoms on 4 levels: 0-None, 1-Mild, 2-Moderate, 3-Severe or higher (severe, life threatening, fatal) observed in the DBPCFC at any dose (1000 mg or lower)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AR101', 'description': 'AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed sachets containing 300mg of peanut protein.\n\nThe capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'A placebo matching the AR101 drug product was supplied in 2 presentations. These were capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed sachets matching the peanut protein sachets but without any peanut protein. 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These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed sachets containing 300mg of peanut protein.\n\nThe capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'A placebo matching the AR101 drug product was supplied in 2 presentations. These were capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed sachets matching the peanut protein sachets but without any peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study, while the sachets were used during the Maintenance phase.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Children (4-11 years)', 'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}]}, {'title': 'Adolescents (12-17 years)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '15', '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': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', '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': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Sweden', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Ireland', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-28', 'size': 1246259, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-07-13T09:17', 'hasProtocol': True}, {'date': '2018-12-04', 'size': 1210417, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-07-13T09:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 175}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'dispFirstSubmitDate': '2019-08-16', 'completionDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-13', 'studyFirstSubmitDate': '2017-06-22', 'dispFirstSubmitQcDate': '2019-08-16', 'resultsFirstSubmitDate': '2021-07-13', 'studyFirstSubmitQcDate': '2017-06-26', 'dispFirstPostDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-13', 'studyFirstPostDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 1000 mg in the Exit Oral Food Challenge.', 'timeFrame': 'Approximately 9 months', 'description': 'The proportion of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild symptoms at the Exit Oral Food Challenge.'}], 'secondaryOutcomes': [{'measure': 'Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 600 mg in the Exit Oral Food Challenge', 'timeFrame': 'Approximately 9 months', 'description': 'The proportion of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild symptoms at the Exit Oral Food Challenge.'}, {'measure': 'Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 300 mg in the Exit Oral Food Challenge.', 'timeFrame': 'Approximately 9 months', 'description': 'The proportion of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild symptoms at the Exit Oral Food Challenge.'}, {'measure': 'Maximum Severity of Symptoms at Any Challenge Dose During the Peanut Exit Oral Food Challenge', 'timeFrame': 'Approximately 9 months', 'description': 'The maximum severity of symptoms on 4 levels: 0-None, 1-Mild, 2-Moderate, 3-Severe or higher (severe, life threatening, fatal) observed in the DBPCFC at any dose (1000 mg or lower)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AR101', 'Characterized Peanut Allergen', 'CPNA (Characterized Peanut Allergen)', 'OIT (oral immunotherapy)', 'Peanut Allergy', 'Peanut-Allergic Children', 'Desensitization', 'ARTEMIS', 'Allergy'], 'conditions': ['Peanut Allergy']}, 'referencesModule': {'references': [{'pmid': '36915184', 'type': 'DERIVED', 'citation': 'Blumchen K, Kleinheinz A, Klimek L, Beyer K, Anagnostou A, Vogelberg C, Butovas S, Ryan R, Norval D, Zeitler S, Du Toit G. Post hoc analysis examining symptom severity reduction and symptom absence during food challenges in individuals who underwent oral immunotherapy for peanut allergy: results from three trials. Allergy Asthma Clin Immunol. 2023 Mar 13;19(1):21. doi: 10.1186/s13223-023-00757-8.'}, {'pmid': '34389504', 'type': 'DERIVED', 'citation': 'Nilsson C, Scurlock AM, Dellon ES, Brostoff JM, Pham T, Ryan R, Brown KR, Adelman DC, Aceves SS. Onset of eosinophilic esophagitis during a clinical trial program of oral immunotherapy for peanut allergy. J Allergy Clin Immunol Pract. 2021 Dec;9(12):4496-4501. doi: 10.1016/j.jaip.2021.07.048. Epub 2021 Aug 11. No abstract available.'}, {'pmid': '34320250', 'type': 'DERIVED', 'citation': 'Fernandez-Rivas M, Vereda A, Vickery BP, Sharma V, Nilsson C, Muraro A, Hourihane JO, DunnGalvin A, du Toit G, Blumchen K, Beyer K, Smith A, Ryan R, Adelman DC, Jones SM. Open-label follow-on study evaluating the efficacy, safety, and quality of life with extended daily oral immunotherapy in children with peanut allergy. Allergy. 2022 Mar;77(3):991-1003. doi: 10.1111/all.15027. Epub 2021 Sep 24.'}, {'pmid': '32702315', 'type': 'DERIVED', 'citation': "O'B Hourihane J, Beyer K, Abbas A, Fernandez-Rivas M, Turner PJ, Blumchen K, Nilsson C, Ibanez MD, Deschildre A, Muraro A, Sharma V, Erlewyn-Lajeunesse M, Zubeldia JM, De Blay F, Sauvage CD, Byrne A, Chapman J, Boralevi F, DunnGalvin A, O'Neill C, Norval D, Vereda A, Skeel B, Adelman DC, du Toit G. Efficacy and safety of oral immunotherapy with AR101 in European children with a peanut allergy (ARTEMIS): a multicentre, double-blind, randomised, placebo-controlled phase 3 trial. Lancet Child Adolesc Health. 2020 Oct;4(10):728-739. doi: 10.1016/S2352-4642(20)30234-0. Epub 2020 Jul 20."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the efficacy and safety of AR101 through oral immunotherapy (OIT) in peanut-allergic children.', 'detailedDescription': 'This is a European, multicenter, double-blind, randomized, placebo-controlled 2-arm study of the efficacy and safety of AR101 in peanut-allergic children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Age 4 to 17 years, inclusive\n* Clinical history of allergy to peanuts\n* Serum SPT ≥ 3 mm greater than control and/or psIgE ≥ 0.35 kUa/L\n* Dose limiting symptoms after consuming a single dose of peanut protein ≤ 300 mg\n* Written informed consent from the subject's parent/guardian\n* Written assent from the subject as appropriate (per local regulatory requirements)\n* Use of effective birth control by sexually active female subjects of childbearing potential\n\nKey Exclusion Criteria:\n\n* History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension\n* History of severe asthma (NHLBI criteria steps 5 or 6), or mild to moderate asthma (2007 NHLBI criteria steps 1-4) that is uncontrolled or difficult to control\n* History of severe or life threatening episode of anaphylaxis or anaphylactic shock within 60 days of screening\n* History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD), symptoms of dysphagia or recurrent gastrointestinal symptoms of undiagnosed etiology\n* History of a mast cell disorder, including mastocytosis, urticaria pigmentosa, chronic idiopathic or chronic physical urticaria beyond simple dermatographism (e.g., cold urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema\n* Any other condition that, in the opinion of the Investigator, precludes participation for reasons of safety"}, 'identificationModule': {'nctId': 'NCT03201003', 'acronym': 'ARTEMIS', 'briefTitle': 'ARTEMIS Peanut Allergy In Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aimmune Therapeutics, Inc.'}, 'officialTitle': 'AR101 Trial in Europe Measuring Oral Immunotherapy Success in Peanut Allergic Children (ARTEMIS)', 'orgStudyIdInfo': {'id': 'ARC010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'AR101', 'description': 'AR101 powder provided in capsules \\& sachets', 'interventionNames': ['Biological: AR101 powder provided in capsules & sachets']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo powder provided in capsules \\& sachets', 'interventionNames': ['Other: Placebo powder provided in capsules & sachets']}], 'interventions': [{'name': 'AR101 powder provided in capsules & sachets', 'type': 'BIOLOGICAL', 'description': 'Study product formulated to 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