Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT03580369
Status:
COMPLETED
Last Update Posted:
2023-07-24
First Post:
2018-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080223', 'term': 'Chronic Urticaria'}], 'ancestors': [{'id': 'D014581', 'term': 'Urticaria'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000598891', 'term': 'ligelizumab'}, {'id': 'D000069444', 'term': 'Omalizumab'}], 'ancestors': [{'id': 'D000888', 'term': 'Antibodies, Anti-Idiotypic'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'novartis.email@novartis.com', 'phone': '1 (862) 778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The difference of 4 subjects between RAN (1034) vs FAS (1030) is due to mis-randomization of 4 subjects. These subjects did not receive Ligelizumab and hence rightfully not included in FAS (though included in RAN).'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever is longer.', 'description': 'An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.', 'eventGroups': [{'id': 'EG000', 'title': 'QGE031 72mg', 'description': 'QGE031 72mg', 'otherNumAtRisk': 316, 'deathsNumAtRisk': 316, 'otherNumAffected': 178, 'seriousNumAtRisk': 316, 'deathsNumAffected': 0, 'seriousNumAffected': 22}, {'id': 'EG001', 'title': 'QGE031 120mg', 'description': 'QGE031 120mg', 'otherNumAtRisk': 324, 'deathsNumAtRisk': 324, 'otherNumAffected': 182, 'seriousNumAtRisk': 324, 'deathsNumAffected': 0, 'seriousNumAffected': 32}, {'id': 'EG002', 'title': 'Omalizumab 300mg', 'description': 'Omalizumab 300mg', 'otherNumAtRisk': 319, 'deathsNumAtRisk': 319, 'otherNumAffected': 206, 'seriousNumAtRisk': 319, 'deathsNumAffected': 0, 'seriousNumAffected': 23}, {'id': 'EG003', 'title': 'Placebo Only', 'description': 'Placebo only', 'otherNumAtRisk': 109, 'deathsNumAtRisk': 109, 'otherNumAffected': 38, 'seriousNumAtRisk': 109, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Transitioned to QGE031 120mg', 'description': 'Transitioned to QGE031 120mg', 'otherNumAtRisk': 102, 'deathsNumAtRisk': 102, 'otherNumAffected': 43, 'seriousNumAtRisk': 102, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 38}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'SARS-CoV-2 test negative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'SARS-CoV-2 test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 39}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Chronic spontaneous urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Dermoid cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Abdominal adhesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Diverticulum intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Pancreatitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Sarcoidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Kidney infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Clavicle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Spinal column injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Benign salivary gland neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Chronic lymphocytic leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': "Non-Hodgkin's lymphoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Facial paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Abortion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Cervical dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Paranasal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Chronic spontaneous urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 324, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in UAS7 at Week 12 (Multiple Imputation) of Adult Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ligelizumab 72 mg', 'description': 'Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'OG001', 'title': 'Ligelizumab 120 mg', 'description': 'Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'OG002', 'title': 'Omalizumab 300 mg', 'description': 'Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20; 1 injection of 1.0mL of ligelizumab 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.368', 'spread': '0.668', 'groupId': 'OG000'}, {'value': '-19.330', 'spread': '0.660', 'groupId': 'OG001'}, {'value': '-20.040', 'spread': '0.663', 'groupId': 'OG002'}, {'value': '-11.366', 'spread': '1.129', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.002', 'ciLowerLimit': '-10.576', 'ciUpperLimit': '-5.428', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.313', 'groupDescription': 'Treatment contrast in LS mean (change), Adults', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model with repeated measures (MMRM)'}, {'pValue': '0.7628', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.672', 'ciLowerLimit': '-1.169', 'ciUpperLimit': '2.513', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.939', 'groupDescription': 'Treatment contrast in LS mean (change), Adults', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model with repeated measures (MMRM)'}, {'pValue': '<.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.964', 'ciLowerLimit': '-10.522', 'ciUpperLimit': '-5.047', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.305', 'groupDescription': 'Treatment contrast in LS mean (change), Adults', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model with repeated measures (MMRM)'}, {'pValue': '0.7768', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.710', 'ciLowerLimit': '-1.118', 'ciUpperLimit': '2.538', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.933', 'groupDescription': 'Treatment contrast in LS mean (change), Adults', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model with repeated measures (MMRM)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'The Urticaria Activity Score (UAS) is sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is sum of the HSS7 and the ISS7 scores. Possible range of weekly UAS7 score is 0 to 42. Complete UAS7 response is UAS7 = 0.\n\nHives Severity Score (HSS) scale is 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. Possible range of the weekly score is therefore 0 to 21. Hives Severity Score scale: 0 - None 1 - Mild (1-6 hives/12 hours) 2 - Moderate (7-12 hives/12 hours) 3 - Severe (\\>12 hives/12 hours).\n\nItch Severity Score (ISS) scale is 0 to 3. Score (ISS7) is derived by adding up average daily scores of 7 days preceding visit. Possible range of weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate).\n\nNegative change from baseline indicates improvement', 'unitOfMeasure': 'Score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized Adult subjects who received at least one dose of study drug. Subjects were analyzed according to the treatment to which they were assigned at randomization. FAS was used for all efficacy variables, unless otherwise stated.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in UAS7 at Week 12 (Observed Data) of Adolescent Subjects (FAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ligelizumab 72 mg', 'description': 'Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'OG001', 'title': 'Ligelizumab 120 mg', 'description': 'Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'OG002', 'title': 'Omalizumab 300 mg', 'description': 'Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20; 1 injection of 1.0mL of ligelizumab 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48'}], 'classes': [{'categories': [{'measurements': [{'value': '-17.39', 'spread': '13.070', 'groupId': 'OG000'}, {'value': '-14.64', 'spread': '14.662', 'groupId': 'OG001'}, {'value': '-13.84', 'spread': '15.343', 'groupId': 'OG002'}, {'value': '-12.75', 'spread': '18.738', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'The Urticaria Activity Score (UAS) is sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is sum of the HSS7 and the ISS7 scores. Possible range of weekly UAS7 score is 0 to 42. Complete UAS7 response is UAS7 = 0.\n\nHives Severity Score (HSS) scale is 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. Possible range of the weekly score is therefore 0 to 21. Hives Severity Score scale: 0 - None 1 - Mild (1-6 hives/12 hours) 2 - Moderate (7-12 hives/12 hours) 3 - Severe (\\>12 hives/12 hours).\n\nItch Severity Score (ISS) scale is 0 to 3. Score (ISS7) is derived by adding up average daily scores of 7 days preceding visit. Possible range of weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate).\n\nNegative change from baseline indicates improvement', 'unitOfMeasure': 'Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized adolescent subjects who received at least one dose of study drug. Subjects were analyzed according to the treatment to which they were assigned at randomization. FAS was used for all efficacy variables, unless otherwise stated.'}, {'type': 'SECONDARY', 'title': 'Number and Proportion of Subjects With UAS7=0 Response at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '315', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '318', 'groupId': 'OG002'}, {'value': '108', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ligelizumab 72 mg', 'description': 'Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'OG001', 'title': 'Ligelizumab 120 mg', 'description': 'Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'OG002', 'title': 'Omalizumab 300 mg', 'description': 'Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20; 1 injection of 1.0mL of ligelizumab 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48'}], 'classes': [{'title': 'Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Adolescents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.680', 'ciLowerLimit': '2.667', 'ciUpperLimit': '12.095', 'groupDescription': 'Adults', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '95% confidence interval for the odds ratio', 'nonInferiorityComment': 'Wald chi-square test based on logistic regression'}, {'pValue': '0.8430', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.840', 'ciLowerLimit': '0.598', 'ciUpperLimit': '1.180', 'groupDescription': 'Adults', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '95% confidence interval for the odds ratio', 'nonInferiorityComment': 'Wald chi-square test based on logistic regression'}, {'pValue': '<.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.734', 'ciLowerLimit': '2.694', 'ciUpperLimit': '12.207', 'groupDescription': 'Adults', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '95% confidence interval for the odds ratio', 'nonInferiorityComment': 'Wald chi-square test based on logistic regression'}, {'pValue': '0.8312', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.848', 'ciLowerLimit': '0.605', 'ciUpperLimit': '1.188', 'groupDescription': 'Adults', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '95% confidence interval for the odds ratio', 'nonInferiorityComment': 'Wald chi-square test based on logistic regression'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'The Urticaria Activity Score (UAS) is the sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42. Complete UAS7 response is defined as UAS7 = 0.\n\nNo Statistical analysis was planned for adolescent group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: Adults + Adolescents (observed data) = Total'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in ISS7 at Week 12 (Multiple Imputation) of Adult Subjects (FAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ligelizumab 72 mg', 'description': 'Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'OG001', 'title': 'Ligelizumab 120 mg', 'description': 'Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'OG002', 'title': 'Omalizumab 300 mg', 'description': 'Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20; 1 injection of 1.0mL of ligelizumab 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.502', 'spread': '0.305', 'groupId': 'OG000'}, {'value': '-8.532', 'spread': '0.301', 'groupId': 'OG001'}, {'value': '-8.921', 'spread': '0.302', 'groupId': 'OG002'}, {'value': '-5.402', 'spread': '0.514', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.100', 'ciLowerLimit': '-4.271', 'ciUpperLimit': '-1.929', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.597', 'groupDescription': 'Adults', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model with repeated measures (MMRM)'}, {'pValue': '0.8366', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.419', 'ciLowerLimit': '-0.419', 'ciUpperLimit': '1.258', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.428', 'groupDescription': 'Adults', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model with repeated measures (MMRM)'}, {'pValue': '<.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.130', 'ciLowerLimit': '-4.295', 'ciUpperLimit': '-1.966', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.594', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model with repeated measures (MMRM)', 'nonInferiorityComment': 'Adults'}, {'pValue': '0.8201', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.389', 'ciLowerLimit': '-0.444', 'ciUpperLimit': '1.222', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.425', 'groupDescription': 'Adults', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model with repeated measures (MMRM)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Improvement of severity of itch assessed as absolute change from baseline in ISS7 score at Week 12\n\nItch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate)\n\nNegative change from baseline indicates improvement.', 'unitOfMeasure': 'score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: Adults'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in ISS7 at Week 12 (Observed Data) of Adolescent Subjects, (FAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ligelizumab 72 mg', 'description': 'Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'OG001', 'title': 'Ligelizumab 120 mg', 'description': 'Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'OG002', 'title': 'Omalizumab 300 mg', 'description': 'Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20; 1 injection of 1.0mL of ligelizumab 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.40', 'spread': '6.779', 'groupId': 'OG000'}, {'value': '-6.82', 'spread': '7.404', 'groupId': 'OG001'}, {'value': '-5.10', 'spread': '7.153', 'groupId': 'OG002'}, {'value': '-7.00', 'spread': '9.899', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Improvement of severity of itch assessed as absolute change from baseline in ISS7 score at Week 12\n\nItch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate)\n\nNegative change from baseline indicates improvement.. No Statistical Analysis was planned for adolescent population.', 'unitOfMeasure': 'score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: Adolescents'}, {'type': 'SECONDARY', 'title': 'Number and Proportion of Participants With DLQI Score of 0 - 1 at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '315', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}, {'value': '318', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ligelizumab 72 mg', 'description': 'Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'OG001', 'title': 'Ligelizumab 120 mg', 'description': 'Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'OG002', 'title': 'Omalizumab 300 mg', 'description': 'Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20; 1 injection of 1.0mL of ligelizumab 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48'}], 'classes': [{'title': 'Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}]}, {'title': 'Adolescents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.747', 'ciLowerLimit': '1.621', 'ciUpperLimit': '4.656', 'groupDescription': 'Adults', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '95% confidence interval for the odds ratio', 'nonInferiorityComment': 'Wald chi-square test based on logistic regression'}, {'pValue': '0.8586', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.836', 'ciLowerLimit': '0.603', 'ciUpperLimit': '1.159', 'groupDescription': 'Adults', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '95% confidence interval for the odds ratio', 'nonInferiorityComment': 'Wald chi-square test based on logistic regression'}, {'pValue': '<.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.261', 'ciLowerLimit': '1.929', 'ciUpperLimit': '5.513', 'groupDescription': 'Adults', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '95% confidence interval for the odds ratio', 'nonInferiorityComment': 'Wald chi-square test based on logistic regression'}, {'pValue': '0.5190', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.992', 'ciLowerLimit': '0.717', 'ciUpperLimit': '1.373', 'groupDescription': 'Adults', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '95% confidence interval for the odds ratio', 'nonInferiorityComment': 'Wald chi-square test based on logistic regression'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 12', 'description': 'Assessed as percentage of subjects achieving DLQI = 0-1, meaning, no impact on subjects quality of life at Week 12\n\nThe Dermatology life Quality Index (DLQI) score range is 0 to 30, with 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).\n\nNo statistical anaylsis was planned for adolescent group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: Adults + Adolescents (observed) = Total'}, {'type': 'SECONDARY', 'title': 'Cumulative Number of Weeks of AAS7=0 up to Week 12 (Multiple Imputation) of Adult Subjects (FAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ligelizumab 72 mg', 'description': 'Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'OG001', 'title': 'Ligelizumab 120 mg', 'description': 'Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'OG002', 'title': 'Omalizumab 300 mg', 'description': 'Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20; 1 injection of 1.0mL of ligelizumab 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48'}], 'classes': [{'categories': [{'measurements': [{'value': '8.568', 'spread': '0.235', 'groupId': 'OG000'}, {'value': '8.912', 'spread': '0.239', 'groupId': 'OG001'}, {'value': '8.790', 'spread': '0.239', 'groupId': 'OG002'}, {'value': '6.475', 'spread': '0.327', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.323', 'ciLowerLimit': '1.183', 'ciUpperLimit': '1.480', 'groupDescription': 'Adults', 'statisticalMethod': 'Negative binomial regression model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '95% confidence interval for the relative risk ratio'}, {'pValue': '0.7469', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.975', 'ciLowerLimit': '0.904', 'ciUpperLimit': '1.051', 'groupDescription': 'Adults', 'statisticalMethod': 'Negative binomial regression model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '95% confidence interval for the relative risk ratio'}, {'pValue': '<.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.376', 'ciLowerLimit': '1.230', 'ciUpperLimit': '1.540', 'groupDescription': 'Adults', 'statisticalMethod': 'Negative binomial regression model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '95% confidence interval for the relative risk ratio'}, {'pValue': '0.3586', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.014', 'ciLowerLimit': '0.941', 'ciUpperLimit': '1.092', 'groupDescription': 'Adults', 'statisticalMethod': 'Negative binomial regression model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '95% confidence interval for the relative risk ratio'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Cumulative number of weeks that subjects achieve AAS7 = 0 responses between baseline and Week 12\n\nAngioedema Activity Score (AAS7) is a measure of the frequency and intensity of angioedema episodes. The total possible range of scores over 7 days is 0-15 (mean day sum score) where higher scores indicate increased angioedema activity.', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: Adults'}, {'type': 'SECONDARY', 'title': 'Cumulative Number of Weeks of AAS7=0 up to Week 12 (Observed Data) of Adolescent Subjects (FAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ligelizumab 72 mg', 'description': 'Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'OG001', 'title': 'Ligelizumab 120 mg', 'description': 'Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'OG002', 'title': 'Omalizumab 300 mg', 'description': 'Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20; 1 injection of 1.0mL of ligelizumab 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48'}], 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'spread': '4.94', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '5.44', 'groupId': 'OG001'}, {'value': '9.0', 'spread': '3.50', 'groupId': 'OG002'}, {'value': '11.0', 'spread': '0.00', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Cumulative number of weeks that subjects achieve AAS7 = 0 responses between baseline and Week 12\n\nAngioedema Activity Score (AAS7) is a measure of the frequency and intensity of angioedema episodes. The total possible range of scores over 7 days is 0-15 (mean day sum score) where higher scores indicate increased angioedema activity.\n\nNo Statistical Analysis was planned.', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: Adolescents'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ligelizumab 72 mg - Adults', 'description': 'Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'FG001', 'title': 'Ligelizumab 72 mg - Adolescents', 'description': 'Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'FG002', 'title': 'Ligelizumab 120 mg - Adults', 'description': 'Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'FG003', 'title': 'Ligelizumab 120 mg - Adolescents', 'description': 'Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'FG004', 'title': 'Omalizumab 300 mg - Adults', 'description': 'Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w'}, {'id': 'FG005', 'title': 'Omalizumab 300 mg - Adolescents', 'description': 'Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w'}, {'id': 'FG006', 'title': 'Placebo - Ligelizumab 120mg - Adults', 'description': 'This is when patients switched to Ligelizumab: 2 injections of 1.0 mL of ligelizumab placebo q4w from Week 0 to Week 20; 1.0 mL of ligelizumab 120 mg + 1.0 mL of ligelizumab placebo q4w from Week 24 through Week 48'}, {'id': 'FG007', 'title': 'Placebo - Ligelizumab 120mg - Adolesecents', 'description': '2 injections of 1.0 mL of ligelizumab placebo q4w from Week 0 to Week 20; 1.0 mL of ligelizumab 120 mg + 1.0 mL of ligelizumab placebo q4w from Week 24 through Week 48'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '307'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '312'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '309'}, {'groupId': 'FG005', 'numSubjects': '13'}, {'groupId': 'FG006', 'numSubjects': '106'}, {'groupId': 'FG007', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '263'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '258'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '267'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '91'}, {'groupId': 'FG007', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '54'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '42'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '15'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'No treatment due to mis-randomization', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Reason unknown', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Technical problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '1,072 participants enrolled at 164 sites in 28 countries', 'preAssignmentDetails': 'There were 1,034 adult subjects and 38 adolescent subjects'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'BG000'}, {'value': '324', 'groupId': 'BG001'}, {'value': '322', 'groupId': 'BG002'}, {'value': '109', 'groupId': 'BG003'}, {'value': '1072', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Ligelizumab 120 mg', 'description': 'Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'BG001', 'title': 'Ligelizumab 72 mg', 'description': 'Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w'}, {'id': 'BG002', 'title': 'Omalizumab 300 mg', 'description': 'Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20; 1 injection of 1.0mL of ligelizumab 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'BG000'}, {'value': '324', 'groupId': 'BG001'}, {'value': '322', 'groupId': 'BG002'}, {'value': '109', 'groupId': 'BG003'}, {'value': '1072', 'groupId': 'BG004'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '288', 'groupId': 'BG000'}, {'value': '297', 'groupId': 'BG001'}, {'value': '291', 'groupId': 'BG002'}, {'value': '95', 'groupId': 'BG003'}, {'value': '971', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Adults (971+63=1,034) + Adolescents (38) = Total (1,072)', 'unitOfMeasure': 'Participants', 'populationDescription': 'Randomized Set'}, {'title': 'Age, Continuous', 'classes': [{'title': 'Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}, {'value': '1034', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '42.3', 'spread': '13.48', 'groupId': 'BG000'}, {'value': '43.3', 'spread': '13.12', 'groupId': 'BG001'}, {'value': '42.2', 'spread': '13.19', 'groupId': 'BG002'}, {'value': '43.2', 'spread': '14.06', 'groupId': 'BG003'}, {'value': '42.7', 'spread': '13.34', 'groupId': 'BG004'}]}]}, {'title': 'Adolescents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '14.6', 'spread': '2.01', 'groupId': 'BG000'}, {'value': '15.1', 'spread': '1.62', 'groupId': 'BG001'}, {'value': '14.7', 'spread': '1.65', 'groupId': 'BG002'}, {'value': '15.3', 'spread': '2.08', 'groupId': 'BG003'}, {'value': '14.8', 'spread': '1.72', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.\n\nAdults (1,034) + Adolescents (38) = Total (1,072)'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Adult', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}, {'value': '1034', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '217', 'groupId': 'BG000'}, {'value': '226', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}, {'value': '737', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '297', 'groupId': 'BG004'}]}]}, {'title': 'Adolescent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Adults (1,034) + Adolescents (38) = Total (1,072)', 'unitOfMeasure': 'Participants', 'populationDescription': 'Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to. Adults (1,034) + Adolescents (38) = Total (1,072)'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Adult White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}, {'value': '1034', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '226', 'groupId': 'BG000'}, {'value': '220', 'groupId': 'BG001'}, {'value': '221', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}, {'value': '747', 'groupId': 'BG004'}]}]}, {'title': 'Adolescent White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}]}]}, {'title': 'Adult Black or African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}, {'value': '1034', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}]}, {'title': 'Adolescent Black or African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Adult Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}, {'value': '1034', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '218', 'groupId': 'BG004'}]}]}, {'title': 'Adolescent Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}, {'title': 'Adult Native Hawaiian or Other Pacific Islander', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}, {'value': '1034', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Adolescent Native Hawaiian or Pacific Islander', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'Adult Native American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}, {'value': '1034', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}]}]}, {'title': 'Adolescents Native American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}, {'title': 'Adult Multi-racial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}, {'value': '1034', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}]}, {'title': 'Adolescent Multi-racial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'Adult Race Not Reported', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}, {'value': '1034', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': 'Adolescent Race Not Reported', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants', 'populationDescription': 'Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to. Adults (1,034) + Adolescents (38) = Total (1,072)'}], 'populationDescription': 'Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.\n\nAdults (1,034) + Adolescents (38) = Total (1,072)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-07', 'size': 2243702, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-11-30T15:18', 'hasProtocol': True}, {'date': '2022-07-01', 'size': 1097829, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-11-30T15:20', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Patients, investigator staff and personnel performing the study assessments remained blinded to the identity of the treatment from the time of randomization until final database lock. The study drug was prepared by an independent unblinded pharmacist (or authorized delegate) and administered by an independent unblinded study drug administrator. Neither the unblinded pharmacist nor the unblinded study drug administrator was involved in any assessments.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This was a Phase III multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There was a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1072}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'dispFirstSubmitDate': '2021-06-30', 'completionDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-20', 'studyFirstSubmitDate': '2018-06-26', 'dispFirstSubmitQcDate': '2021-06-30', 'resultsFirstSubmitDate': '2022-11-30', 'studyFirstSubmitQcDate': '2018-06-26', 'dispFirstPostDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-12-12', 'studyFirstPostDateStruct': {'date': '2018-07-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in UAS7 at Week 12 (Multiple Imputation) of Adult Subjects', 'timeFrame': 'Baseline, Week 12', 'description': 'The Urticaria Activity Score (UAS) is sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is sum of the HSS7 and the ISS7 scores. Possible range of weekly UAS7 score is 0 to 42. Complete UAS7 response is UAS7 = 0.\n\nHives Severity Score (HSS) scale is 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. Possible range of the weekly score is therefore 0 to 21. Hives Severity Score scale: 0 - None 1 - Mild (1-6 hives/12 hours) 2 - Moderate (7-12 hives/12 hours) 3 - Severe (\\>12 hives/12 hours).\n\nItch Severity Score (ISS) scale is 0 to 3. Score (ISS7) is derived by adding up average daily scores of 7 days preceding visit. Possible range of weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate).\n\nNegative change from baseline indicates improvement'}, {'measure': 'Mean Change From Baseline in UAS7 at Week 12 (Observed Data) of Adolescent Subjects (FAS)', 'timeFrame': 'Baseline, Week 12', 'description': 'The Urticaria Activity Score (UAS) is sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is sum of the HSS7 and the ISS7 scores. Possible range of weekly UAS7 score is 0 to 42. Complete UAS7 response is UAS7 = 0.\n\nHives Severity Score (HSS) scale is 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. Possible range of the weekly score is therefore 0 to 21. Hives Severity Score scale: 0 - None 1 - Mild (1-6 hives/12 hours) 2 - Moderate (7-12 hives/12 hours) 3 - Severe (\\>12 hives/12 hours).\n\nItch Severity Score (ISS) scale is 0 to 3. Score (ISS7) is derived by adding up average daily scores of 7 days preceding visit. Possible range of weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate).\n\nNegative change from baseline indicates improvement'}], 'secondaryOutcomes': [{'measure': 'Number and Proportion of Subjects With UAS7=0 Response at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents)', 'timeFrame': 'Week 12', 'description': 'The Urticaria Activity Score (UAS) is the sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42. Complete UAS7 response is defined as UAS7 = 0.\n\nNo Statistical analysis was planned for adolescent group.'}, {'measure': 'Mean Change From Baseline in ISS7 at Week 12 (Multiple Imputation) of Adult Subjects (FAS)', 'timeFrame': 'Baseline, Week 12', 'description': 'Improvement of severity of itch assessed as absolute change from baseline in ISS7 score at Week 12\n\nItch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate)\n\nNegative change from baseline indicates improvement.'}, {'measure': 'Mean Change From Baseline in ISS7 at Week 12 (Observed Data) of Adolescent Subjects, (FAS)', 'timeFrame': 'Baseline, Week 12', 'description': 'Improvement of severity of itch assessed as absolute change from baseline in ISS7 score at Week 12\n\nItch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate)\n\nNegative change from baseline indicates improvement.. No Statistical Analysis was planned for adolescent population.'}, {'measure': 'Number and Proportion of Participants With DLQI Score of 0 - 1 at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents)', 'timeFrame': 'Baseline, Week 12', 'description': 'Assessed as percentage of subjects achieving DLQI = 0-1, meaning, no impact on subjects quality of life at Week 12\n\nThe Dermatology life Quality Index (DLQI) score range is 0 to 30, with 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).\n\nNo statistical anaylsis was planned for adolescent group.'}, {'measure': 'Cumulative Number of Weeks of AAS7=0 up to Week 12 (Multiple Imputation) of Adult Subjects (FAS)', 'timeFrame': 'Baseline, Week 12', 'description': 'Cumulative number of weeks that subjects achieve AAS7 = 0 responses between baseline and Week 12\n\nAngioedema Activity Score (AAS7) is a measure of the frequency and intensity of angioedema episodes. The total possible range of scores over 7 days is 0-15 (mean day sum score) where higher scores indicate increased angioedema activity.'}, {'measure': 'Cumulative Number of Weeks of AAS7=0 up to Week 12 (Observed Data) of Adolescent Subjects (FAS)', 'timeFrame': 'Baseline, Week 12', 'description': 'Cumulative number of weeks that subjects achieve AAS7 = 0 responses between baseline and Week 12\n\nAngioedema Activity Score (AAS7) is a measure of the frequency and intensity of angioedema episodes. The total possible range of scores over 7 days is 0-15 (mean day sum score) where higher scores indicate increased angioedema activity.\n\nNo Statistical Analysis was planned.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anti-IgE', 'CSU', 'chronic spontaneous urticaria', 'hives severity score', 'itch severity score', 'urticaria activity score'], 'conditions': ['Chronic Spontaneous Urticaria']}, 'referencesModule': {'references': [{'pmid': '38008109', 'type': 'DERIVED', 'citation': 'Maurer M, Ensina LF, Gimenez-Arnau AM, Sussman G, Hide M, Saini S, Grattan C, Fomina D, Rigopoulos D, Berard F, Canonica GW, Rockmann H, Irani C, Szepietowski JC, Leflein J, Bernstein JA, Peter JG, Kulthanan K, Godse K, Ardusso L, Ukhanova O, Staubach P, Sinclair R, Gogate S, Thomsen SF, Tanus T, Ye YM, Burciu A, Barve A, Modi D, Scosyrev E, Hua E, Letzelter K, Varanasi V, Patekar M, Severin T; PEARL-1 and PEARL-2 trial investigators. Efficacy and safety of ligelizumab in adults and adolescents with chronic spontaneous urticaria: results of two phase 3 randomised controlled trials. Lancet. 2024 Jan 13;403(10422):147-159. doi: 10.1016/S0140-6736(23)01684-7. Epub 2023 Nov 23.'}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1511', 'label': 'A Plain Language Trial Summary is available on novctrd.com.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to establish safety and efficacy of ligelizumab in adolescent and adult subjects with Chronic Spontaneous Urticaria (CSU) who remain symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo.\n\nThe study population consisted of 1,072 male and female subjects aged ≥ 12 years who were diagnosed with CSU and who remained symptomatic despite the use of H1-antihistamines.\n\nThis was a multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There was a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.', 'detailedDescription': 'This was a Phase III multi-center, randomized, double-blind, active and placebo-controlled, parallel-group study. The study consisted of 3 distinct periods:\n\n* Screening period (Day -28 to Day 1): Duration of up to 4 weeks in which subjects who have given informed consent were assessed for eligibility.\n* Double-blind treatment period (52 weeks): The subjects were seen in the clinic every 4 weeks.\n* Post-treatment follow-up period (12 weeks): This period consists of 3 visits (every 4 weeks) with the final visit occurring 16 weeks after the last dose at Week 48.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to participation in the study. The subject's, parent's or legal guardian's signed written informed consent and child's assent, if appropriate, must be obtained before any assessment is performed. Of note, if the subject reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit.\n* Male and female subjects ≥ 12 years of age at the time of screening.\n* CSU diagnosis for ≥ 6 months.\n* Diagnosis of CSU refractory to H1-AH at approved doses at the time of randomization, as defined by all of the following:\n* The presence of itch and hives for ≥ 6 consecutive weeks at any time prior to Visit 1 (Day - 28 to Day -14) despite current use of non-sedating H1-antihistamine\n* UAS7 score (range 0-42) ≥ 16 and HSS7 (range 0-21) ≥ 8 during the 7 days prior to randomization (Visit 110, Day 1)\n* Subjects must be on H1-antihistamine at only locally label approved doses for treatment of CSU starting at Visit 1 (Day -28 to Day -14)\n* Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules.\n\nKey Exclusion Criteria:\n\n* History of hypersensitivity to any of the study drugs or their excipients or to drugs of similar chemical classes (i.e. to murine, chimeric or human antibodies).\n* Subjects having a clearly defined cause of their chronic urticaria, other than CSU. This includes, but is not limited to, the following: symptomatic dermographism (urticaria factitia), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic- or contact-urticaria.\n* Diseases, other than chronic urticaria, with urticarial or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to C1 inhibitor deficiency).\n* Subjects with evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines. All subjects will be screened at Visit 1. If stool testing is positive for pathogenic organism, the subject will not be randomized and will not be allowed to rescreen.\n* Any other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results (e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.).\n* Prior exposure to ligelizumab or omalizumab.\n* H1-AH used as background medication at greater than locally label-approved doses after visit 1"}, 'identificationModule': {'nctId': 'NCT03580369', 'briefTitle': 'A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Active and Placebo-controlled Study to Investigate the Safety and Efficacy of Ligelizumab (QGE031) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines', 'orgStudyIdInfo': {'id': 'CQGE031C2302'}, 'secondaryIdInfos': [{'id': '2018-000839-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ligelizumab 120 mg', 'description': 'Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w', 'interventionNames': ['Biological: Ligelizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Ligelizumab 72 mg', 'description': 'Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w', 'interventionNames': ['Biological: Ligelizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Omalizumab 300 mg', 'description': 'Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w', 'interventionNames': ['Biological: Omalizumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20; 1 injection of 1.0mL of ligelizumab 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Ligelizumab', 'type': 'BIOLOGICAL', 'description': 'Liquid in vial', 'armGroupLabels': ['Ligelizumab 120 mg', 'Ligelizumab 72 mg']}, {'name': 'Omalizumab', 'type': 'BIOLOGICAL', 'description': 'Lyophilized powder for solution in vial', 'armGroupLabels': ['Omalizumab 300 mg']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Liquid in vial', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '85340', 'city': 'Litchfield Park', 'state': 'Arizona', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.49337, 'lon': -112.35794}}, {'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '93301', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '92647', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '90808', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80230', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33467', 'city': 'Greenacres City', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 26.62368, 'lon': -80.12532}}, {'zip': '32308', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '83706', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '47713', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '46256', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '04401', 'city': 'Bangor', 'state': 'Maine', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 44.79884, 'lon': -68.77265}}, {'zip': '20602', 'city': 'Waldorf', 'state': 'Maryland', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.62456, 'lon': -76.93914}}, {'zip': '48346', 'city': 'Clarkston', 'state': 'Michigan', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.73586, 'lon': -83.41883}}, {'zip': '48197', 'city': 'Ypsilanti', 'state': 'Michigan', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.24115, 'lon': -83.61299}}, {'zip': '55441', 'city': 'Plymouth', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.01052, 'lon': -93.45551}}, {'zip': '28801', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '45231', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '74136', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '97504', 'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78660', 'city': 'Pflugerville', 'state': 'Texas', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 30.43937, 'lon': -97.62}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '05403', 'city': 'South Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 44.46699, 'lon': -73.17096}}, {'zip': 'C1056ABJ', 'city': 'CABA', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Novartis Investigative Site'}, {'zip': 'C1414AIF', 'city': 'CABA', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Novartis Investigative Site'}, {'zip': 'C1425BEA', 'city': 'Ciudad Autonoma de Bs As', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Novartis Investigative Site'}, {'zip': 'B1902COS', 'city': 'La Plata', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -34.92126, 'lon': -57.95442}}, {'zip': 'B6500BWQ', 'city': 'Buenos Aires', 'state': 'Nueve De Julio', 'country': 'Argentina', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'B8000JRB', 'city': 'Bahía Blanca', 'country': 'Argentina', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -38.7176, 'lon': -62.26545}}, {'zip': 'C1125ABE', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1023AAB', 'city': 'Capital Federal', 'country': 'Argentina', 'facility': 'Novartis Investigative Site'}, {'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': 'A 1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '29025 023', 'city': 'Vitória', 'state': 'Espírito Santo', 'country': 'Brazil', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -20.31944, 'lon': -40.33778}}, {'zip': '06454010', 'city': 'Alphaville Barueri', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Novartis Investigative Site'}, {'zip': '09060 650', 'city': 'Santo André', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -23.66389, 'lon': -46.53833}}, {'zip': '05403 000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '5800', 'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'zip': '1407', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1431', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1606', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '9000', 'city': 'Varna', 'country': 'Bulgaria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.21912, 'lon': 27.91024}}, {'zip': 'L8N 3Z5', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'K7L 2V7', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'zip': 'L5A 3V4', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'M3B 3S6', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'N2J 1C4', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}, {'zip': 'H2V 2K1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1V 4W2', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': '0050010', 'city': 'Medellín', 'state': 'Antioquia', 'country': 'Colombia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}, {'zip': '110221', 'city': 'Bogotá', 'country': 'Colombia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'zip': '10000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '415 01', 'city': 'Teplice', 'state': 'CZE', 'country': 'Czechia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.6404, 'lon': 13.82451}}, {'zip': '11000', 'city': 'Prague', 'state': 'Prague 1', 'country': 'Czechia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '775 20', 'city': 'Olomouc', 'country': 'Czechia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'zip': '305 99', 'city': 'Pilsen', 'country': 'Czechia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.74747, 'lon': 13.37759}}, {'zip': '2400', 'city': 'Copenhagen NV', 'country': 'Denmark', 'facility': 'Novartis Investigative Site'}, {'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'zip': '33075', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '31400', 'city': 'Toulouse', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '90400', 'city': 'Trévenans', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.56667, 'lon': 6.86667}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '44791', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '44793', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '91054', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '07740', 'city': 'Jena', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '89129', 'city': 'Langenau', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.49616, 'lon': 10.11849}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '35039', 'city': 'Marburg', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}, {'zip': '87700', 'city': 'Memmingen', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.98372, 'lon': 10.18527}}, {'zip': '81377', 'city': 'München', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '26133', 'city': 'Oldenburg', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.14039, 'lon': 8.21479}}, {'zip': '115 27', 'city': 'Athens', 'state': 'GR', 'country': 'Greece', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '115 27', 'city': 'Athens', 'country': 'Greece', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '12462', 'city': 'Athens', 'country': 'Greece', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '161 21', 'city': 'Athens', 'country': 'Greece', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '01010', 'city': 'Guatemala City', 'country': 'Guatemala', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 14.64072, 'lon': -90.51327}}, {'zip': '1015', 'city': 'Guatemala City', 'country': 'Guatemala', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 14.64072, 'lon': -90.51327}}, {'zip': '6000', 'city': 'Kecskemét', 'state': 'Bács-Kiskun county', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 46.90618, 'lon': 19.69128}}, {'zip': '6720', 'city': 'Szeged', 'state': 'Csongrád megye', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'zip': '4032', 'city': 'Debrecen', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '7623', 'city': 'Pécs', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'zip': '590010', 'city': 'Belagavi', 'state': 'Karnataka', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 15.85212, 'lon': 74.50447}}, {'zip': '422 101', 'city': 'Nashik', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 19.99727, 'lon': 73.79096}}, {'zip': '422005', 'city': 'Nashik', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 19.99727, 'lon': 73.79096}}, {'zip': '400 706', 'city': 'Navi Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 19.03681, 'lon': 73.01582}}, {'zip': '110029', 'city': 'New Delhi', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '520002', 'city': 'Vijayawada', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 16.50745, 'lon': 80.6466}}, {'zip': '50586', 'city': 'Kuala Lumpur', 'state': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'zip': '30450', 'city': 'Ipoh', 'state': 'Perak', 'country': 'Malaysia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 4.5841, 'lon': 101.0829}}, {'zip': '10990', 'city': 'George Town', 'state': 'Pulau Pinang', 'country': 'Malaysia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 5.41123, 'lon': 100.33543}}, {'zip': '123', 'city': 'Muscat', 'country': 'Oman', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 23.58413, 'lon': 58.40778}}, {'zip': '15074', 'city': 'Miraflores', 'state': 'Lima region', 'country': 'Peru', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -12.11331, 'lon': -77.03274}}, {'zip': '41', 'city': 'San Borja', 'state': 'Lima region', 'country': 'Peru', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -12.09841, 'lon': -77.01107}}, {'zip': '95-054', 'city': 'Ksawerów', 'state': 'POL', 'country': 'Poland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.68288, 'lon': 19.4028}}, {'zip': '25-155', 'city': 'Kielce', 'country': 'Poland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.87033, 'lon': 20.62752}}, {'zip': '31-530', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '20-080', 'city': 'Lublin', 'country': 'Poland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '35 055', 'city': 'Rzeszów', 'country': 'Poland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.04132, 'lon': 21.99901}}, {'zip': '50 566', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '00927', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '123182', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '344022', 'city': 'Rostov-on-Don', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.21997, 'lon': 39.70769}}, {'zip': '390046', 'city': 'Ryazan', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 54.62696, 'lon': 39.70415}}, {'zip': '193231', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '194354', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '410012', 'city': 'Saratov', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.54048, 'lon': 45.9901}}, {'zip': '214019', 'city': 'Smolensk', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 54.77826, 'lon': 32.05088}}, {'zip': '119074', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '169608', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '229899', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '308205', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '7700', 'city': 'Cape Town', 'state': 'Western Province', 'country': 'South Africa', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '7700', 'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '3630', 'city': 'Durban', 'country': 'South Africa', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'zip': '42602', 'city': 'Daegu', 'state': 'Dalseo Gu', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '26426', 'city': 'Wŏnju', 'state': 'Gangwon-do', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}, {'zip': '13620', 'city': 'Bundang Gu', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Novartis Investigative Site'}, {'zip': '18450', 'city': 'Hwaseong-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.20682, 'lon': 126.8169}}, {'zip': '16499', 'city': 'Suwon', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'zip': '08308', 'city': 'Seoul', 'state': 'Korea', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06591', 'city': 'Seoul', 'state': 'Seocho Gu', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '405 760', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06973', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '07061', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '150-950', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '29009', 'city': 'Málaga', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '41009', 'city': 'Seville', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': '48013', 'city': 'Bilbao', 'state': 'Basque Country', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'zip': '08003', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '03010', 'city': 'Alicante', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '08041', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': 'SE-205 02', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'zip': '10700', 'city': 'Bangkoknoi', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Novartis Investigative Site'}, {'zip': '10400', 'city': 'Bangkok', 'state': 'Phayathai', 'country': 'Thailand', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10400', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '348999', 'city': 'Istanbul', 'state': 'Pendik', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34098', 'city': 'Istanbul', 'state': 'TUR', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '09100', 'city': 'Aydin', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.84501, 'lon': 27.83963}}, {'zip': '20070', 'city': 'Denizli', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.77417, 'lon': 29.0875}}, {'zip': '27310', 'city': 'Gaziantep', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.05944, 'lon': 37.3825}}, {'zip': '35380', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'zip': '34370', 'city': 'Okmeydanı', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.05449, 'lon': 28.9639}}, {'zip': '55139', 'city': 'Samsun', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}]}, 'ipdSharingStatementModule': {'url': 'https://www.clinicalstudydatarequest.com', 'ipdSharing': 'YES', 'description': 'Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}