Viewing Study NCT00310466

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Ignite Creation Date: 2025-12-24 @ 4:42 PM
Ignite Modification Date: 2026-01-04 @ 4:56 PM
Study NCT ID: NCT00310466
Status: COMPLETED
Last Update Posted: 2013-05-14
First Post: 2006-04-02
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Efficacy and Safety Trial of SLITone(TM) Birch in Subjects With Hayfever
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D063729', 'term': 'Sublingual Immunotherapy'}], 'ancestors': [{'id': 'D003888', 'term': 'Desensitization, Immunologic'}, {'id': 'D007165', 'term': 'Immunosuppression Therapy'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+4545747576', 'title': 'Kim Simonsen, Senior Director', 'organization': 'ALK-Abelló A/S'}, 'certainAgreement': {'otherDetails': 'ALK must receive copies of any intended communication in advance of publication (at least 15 working days for an abstract or oral presentation and 45 working days for a journal submission). ALK will review the communications for accuracy (thus avoiding potential discrepancies with submissions to health authorities), verify that confidential information is not being inadvertently divulged and provide any relevant supplementary information.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Clinical improvement following SLIT is thought to be due to immunological mechanisms that develop over time. Even though clear immunological changes were observed in this trial it appears that the treatment was too short to reach full clinical effect'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'SLITone Birch', 'description': 'Birch pollen extract for sublingual administration', 'otherNumAtRisk': 113, 'otherNumAffected': 81, 'seriousNumAtRisk': 113, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Corresponding placebo for sublingual administration', 'otherNumAtRisk': 113, 'otherNumAffected': 87, 'seriousNumAtRisk': 113, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arrhytmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ear pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abnormal sensation in eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Glossodynia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoaesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intestinal polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oedema mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oral discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oral pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 45, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 31, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Application site anaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Application site eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Application site papules', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Mucous membrane disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oedema mucosal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sensation of foreign body', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Biliary colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Allergy to arthropod sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bladder infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Herpes soster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Infected naevus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Laryngitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 17, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rhinitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinobronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tinea pedis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tinea versicolour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tonsilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vaginitis', 'stats': 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113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tonsillectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Daily Rhinoconjunctivitis Symptom Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SLITone Birch', 'description': 'Birch pollen extract for sublingual administration'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Corresponding placebo for sublingual administration'}], 'classes': [{'categories': [{'measurements': [{'value': '4.07', 'spread': '2.59', 'groupId': 'OG000'}, {'value': '4.14', 'spread': '2.56', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.87', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Birch pollen season 2006', 'description': 'A total of 6 rhinoconjunctivitis symptoms are recorded (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, watery eyes). Each symptoms is scored on a scale from 0-3 (no symptoms-severe symptoms). I.e. the total daily score can be 0-18.', 'unitOfMeasure': 'Units on a scale (0-18)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Global Improvement of Rhinoconjunctivitis Symptoms Assessed by the Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SLITone Birch', 'description': 'Birch pollen extract for sublingual administration'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Corresponding placebo for sublingual administration'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Birch pollen season 2006', 'description': 'The number of participants who reported improved overall symptoms compared to the previous birch pollen season (each patient was asked to compare his/her symptoms in the 2006 birch pollen season with the symptoms in the 2005 birch pollen season).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SLITone Birch', 'description': 'Birch pollen extract for sublingual administration'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Corresponding placebo for sublingual administration'}], 'classes': [{'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Birch pollen season 2006', 'description': 'An adverse event was defined as: Any untoward medical occurence in a patient or clinical trial subject administered a trial product and which does not necessarily have a causal relationship with this treatment (International Conference of Harmonisation (ICH) Harmonised Tripartite Guideline E2A, Step 5).', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Daily Rhinoconjunctivitis Rescue Medication Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SLITone Birch', 'description': 'Birch pollen extract for sublingual administration'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Corresponding placebo for sublingual administration'}], 'classes': [{'categories': [{'measurements': [{'value': '2.76', 'spread': '3.30', 'groupId': 'OG000'}, {'value': '2.54', 'spread': '2.99', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.55', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Birch pollen season 2006', 'description': 'Rescue medication (desloratadine tablets, budesonide nasal spray, prednisone tablets) used for treatment of rhinoconjunctivitis symptoms not controlled by the study medication, were recorded. The total daily score was 0-30 (No medication-Maximum use of medication).', 'unitOfMeasure': 'Units on a scale (0-30)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SLITone Birch', 'description': 'Birch pollen extract for sublingual administration'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Corresponding placebo for sublingual administration'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '113'}, {'groupId': 'FG001', 'numSubjects': '113'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '101'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}], 'recruitmentDetails': 'First patient first visit: 13 June 2005'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '226', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SLITone Birch', 'description': 'Birch pollen extract for sublingual administration'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Corresponding placebo for sublingual administration'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0.0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '226.0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0.0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.3', 'spread': '10.9', 'groupId': 'BG000'}, {'value': '39.5', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '39.4', 'spread': '11.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '140.0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '86.0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '226.0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 226}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-29', 'studyFirstSubmitDate': '2006-04-02', 'resultsFirstSubmitDate': '2009-03-12', 'studyFirstSubmitQcDate': '2006-04-02', 'lastUpdatePostDateStruct': {'date': '2013-05-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-06-19', 'studyFirstPostDateStruct': {'date': '2006-04-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Daily Rhinoconjunctivitis Symptom Score', 'timeFrame': 'Birch pollen season 2006', 'description': 'A total of 6 rhinoconjunctivitis symptoms are recorded (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, watery eyes). Each symptoms is scored on a scale from 0-3 (no symptoms-severe symptoms). I.e. the total daily score can be 0-18.'}, {'measure': 'Daily Rhinoconjunctivitis Rescue Medication Score', 'timeFrame': 'Birch pollen season 2006', 'description': 'Rescue medication (desloratadine tablets, budesonide nasal spray, prednisone tablets) used for treatment of rhinoconjunctivitis symptoms not controlled by the study medication, were recorded. The total daily score was 0-30 (No medication-Maximum use of medication).'}], 'secondaryOutcomes': [{'measure': 'Global Improvement of Rhinoconjunctivitis Symptoms Assessed by the Subjects', 'timeFrame': 'Birch pollen season 2006', 'description': 'The number of participants who reported improved overall symptoms compared to the previous birch pollen season (each patient was asked to compare his/her symptoms in the 2006 birch pollen season with the symptoms in the 2005 birch pollen season).'}, {'measure': 'Adverse Events', 'timeFrame': 'Birch pollen season 2006', 'description': 'An adverse event was defined as: Any untoward medical occurence in a patient or clinical trial subject administered a trial product and which does not necessarily have a causal relationship with this treatment (International Conference of Harmonisation (ICH) Harmonised Tripartite Guideline E2A, Step 5).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Allergy']}, 'descriptionModule': {'briefSummary': 'The trial is performed to assess the efficacy and safety of SLIT One birch for treatment of birch pollen induced allergy', 'detailedDescription': 'Daily rhinoconjunctivits symptom and medication scores from patient diaries, adverse events'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A history of birch pollen allergy\n* Positive skin prick test to birch\n* Positive conjunctival test to birch\n* Positive specific Immunoglobulin E (IgE) to birch\n\nExclusion Criteria:\n\n* Forced expiratory volume in 1 second (FEV1)\\<70% of predicted value\n* History of seasonal allergy interfering with study\n* History of symptomatic perennial allergy\n* History of emergency visit or admission for asthma in the previous 12 month'}, 'identificationModule': {'nctId': 'NCT00310466', 'briefTitle': 'Efficacy and Safety Trial of SLITone(TM) Birch in Subjects With Hayfever', 'organization': {'class': 'INDUSTRY', 'fullName': 'ALK-Abelló A/S'}, 'officialTitle': 'A Multicentre, Randomised, Double-blind, Placebo-controlled Parallel Group Clinical Trial to Investigate the Efficacy and Safety of Specific Sublingual Immunotherapy With SLITone Birch in Patients With Seasonal Birch Pollen Induced Rhinoconjunctivitis', 'orgStudyIdInfo': {'id': 'SHX0712'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sublingual immunotherapy', 'description': 'sublingual immunotherapy with drops applied once daily by single dose containers (200 STU per dose)', 'interventionNames': ['Biological: Sublingual immunotherapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo sublingual drops', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'Sublingual immunotherapy', 'type': 'BIOLOGICAL', 'otherNames': ['SLITone(TM) Birch'], 'description': 'once daily intake of sublingual drops', 'armGroupLabels': ['Sublingual immunotherapy']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'once daily intake of sublingual drops', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-10117', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Charité Klinik für Dermatologie, Venerologie und Allergologie', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Hendrik Wolf, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ALK-SCHERAX Arzneimittel GmbH'}, {'name': 'Margitta Worm, MD, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ALK-Abelló A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}