Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-27 @ 10:54 PM
Study NCT ID:
NCT00873860
Status:
COMPLETED
Last Update Posted:
2017-03-24
First Post:
2009-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Safety and Efficacy of CAT-354
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C574065', 'term': 'tralokinumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jainm@medimmune.com', 'phone': '301-398-0000', 'title': 'Meena Jain, MB BChir/Associate Medical Director', 'organization': 'MedImmune, LLC'}, 'certainAgreement': {'otherDetails': 'MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 to 169', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.', 'otherNumAtRisk': 47, 'otherNumAffected': 17, 'seriousNumAtRisk': 47, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'CAT-354 150 mg', 'description': 'CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.', 'otherNumAtRisk': 47, 'otherNumAffected': 19, 'seriousNumAtRisk': 47, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'CAT-354 300 mg', 'description': 'CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.', 'otherNumAtRisk': 51, 'otherNumAffected': 25, 'seriousNumAtRisk': 51, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'CAT-354 600 mg', 'description': 'CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.', 'otherNumAtRisk': 48, 'otherNumAffected': 25, 'seriousNumAtRisk': 48, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Eosinophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Monocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Monocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Infusion site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Injection site inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 8, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 7, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Injection site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Biliary colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Biliary dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Acute tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bacteriuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Escherichia infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'H1n1 influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pharyngitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urinary tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Vulvovaginitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Muscle rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Blood bilirubin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Blood chloride increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Reticulocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urine analysis abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Muscle tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Lipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Intercostal neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Acute psychosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nightmare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Crystalluria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Leukocyturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nitrituria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urinary tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Breast pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Menopausal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Menstruation irregular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Labile hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'seriousEvents': [{'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Post cholecystectomy syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Brain injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Somatoform disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the Mean Asthma Control Questionnaire (ACQ) Score at Day 92', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG001', 'title': 'CAT-354 150 mg', 'description': 'CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG002', 'title': 'CAT-354 300 mg', 'description': 'CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG003', 'title': 'CAT-354 600 mg', 'description': 'CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}], 'classes': [{'title': 'Day 1 (n=46, 46, 50, 47)', 'categories': [{'measurements': [{'value': '2.63', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '2.72', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '2.62', 'spread': '0.50', 'groupId': 'OG002'}, {'value': '2.72', 'spread': '0.76', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 92 (n= 46, 46, 51, 47)', 'categories': [{'measurements': [{'value': '-0.61', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '-0.73', 'spread': '1.12', 'groupId': 'OG001'}, {'value': '-0.70', 'spread': '0.93', 'groupId': 'OG002'}, {'value': '-0.86', 'spread': '1.09', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.573', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Change at Day 92: p-value was based on analysis of variance (ANOVA).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.640', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'Change at Day 92: p-value was based on ANOVA.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.224', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'Change at Day 92: p-value was based on ANOVA.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and 92', 'description': 'Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued prior to receiving 4 doses due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Time to First Observed Asthma Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG001', 'title': 'CAT-354 150 mg', 'description': 'CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG002', 'title': 'CAT-354 300 mg', 'description': 'CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG003', 'title': 'CAT-354 600 mg', 'description': 'CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}], 'classes': [{'title': 'Day 1 to 92', 'categories': [{'measurements': [{'value': '25.5', 'spread': '5.50', 'groupId': 'OG000', 'lowerLimit': '15.0', 'upperLimit': '71.0'}, {'value': '22.0', 'spread': '5.21', 'groupId': 'OG001', 'lowerLimit': '15.0', 'upperLimit': '43.0'}, {'value': '15.0', 'spread': '4.54', 'groupId': 'OG002', 'lowerLimit': '15.0', 'upperLimit': '43.0'}, {'value': '15.0', 'spread': '4.56', 'groupId': 'OG003', 'lowerLimit': '15.0', 'upperLimit': '36.0'}]}]}, {'title': 'Day 1 to 169', 'categories': [{'measurements': [{'value': '25.5', 'spread': '9.97', 'groupId': 'OG000', 'lowerLimit': '15.0', 'upperLimit': '71.0'}, {'value': '22.0', 'spread': '8.89', 'groupId': 'OG001', 'lowerLimit': '15.0', 'upperLimit': '43.0'}, {'value': '15.0', 'spread': '7.65', 'groupId': 'OG002', 'lowerLimit': '15.0', 'upperLimit': '43.0'}, {'value': '15.0', 'spread': '8.07', 'groupId': 'OG003', 'lowerLimit': '15.0', 'upperLimit': '36.0'}]}]}], 'analyses': [{'pValue': '0.4686', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.', 'groupDescription': 'P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \\>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3170', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.', 'groupDescription': 'P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \\>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.1664', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.', 'groupDescription': 'P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \\>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3234', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.', 'groupDescription': 'P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \\>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3133', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.', 'groupDescription': 'P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \\>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.2108', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.', 'groupDescription': 'P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \\>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 to Day 92 and Day 169', 'description': 'Time to first asthma control was defined as the number of days from Study Day 1 to the post-baseline ACQ score measurement time point when greater than or equal to (\\>=) 0.5 reduction from baseline in mean ACQ score was first observed. Time to first asthma control was analyzed from Day 1 through Day 92 and up to entire study duration through Day 169. The ACQ score is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled).', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population = all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Since, \\>50% participants for each arm achieved improvement through Day 92; the median time-to-first observed achievement is identical for data through Day 92 and Day 169.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG001', 'title': 'CAT-354 150 mg', 'description': 'CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG002', 'title': 'CAT-354 300 mg', 'description': 'CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG003', 'title': 'CAT-354 600 mg', 'description': 'CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}], 'classes': [{'title': 'Day 1 (n=46,46,51,47)', 'categories': [{'measurements': [{'value': '1.949', 'spread': '0.479', 'groupId': 'OG000'}, {'value': '2.178', 'spread': '0.661', 'groupId': 'OG001'}, {'value': '1.907', 'spread': '0.586', 'groupId': 'OG002'}, {'value': '1.977', 'spread': '0.646', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 15 (n=44,46,50,46)', 'categories': [{'measurements': [{'value': '0.019', 'spread': '0.420', 'groupId': 'OG000'}, {'value': '0.122', 'spread': '0.316', 'groupId': 'OG001'}, {'value': '0.116', 'spread': '0.378', 'groupId': 'OG002'}, {'value': '0.134', 'spread': '0.348', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 29 (n=46,46,49,47)', 'categories': [{'measurements': [{'value': '0.051', 'spread': '0.424', 'groupId': 'OG000'}, {'value': '0.138', 'spread': '0.315', 'groupId': 'OG001'}, {'value': '0.149', 'spread': '0.303', 'groupId': 'OG002'}, {'value': '0.222', 'spread': '0.354', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 43 (n=45,44,47,47)', 'categories': [{'measurements': [{'value': '0.125', 'spread': '0.399', 'groupId': 'OG000'}, {'value': '0.131', 'spread': '0.380', 'groupId': 'OG001'}, {'value': '0.164', 'spread': '0.358', 'groupId': 'OG002'}, {'value': '0.147', 'spread': '0.373', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 57 (n=45,46,49,47)', 'categories': [{'measurements': [{'value': '0.043', 'spread': '0.436', 'groupId': 'OG000'}, {'value': '0.127', 'spread': '0.339', 'groupId': 'OG001'}, {'value': '0.187', 'spread': '0.349', 'groupId': 'OG002'}, {'value': '0.201', 'spread': '0.344', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 71 (n=45,45,49,47)', 'categories': [{'measurements': [{'value': '0.047', 'spread': '0.397', 'groupId': 'OG000'}, {'value': '0.158', 'spread': '0.314', 'groupId': 'OG001'}, {'value': '0.179', 'spread': '0.381', 'groupId': 'OG002'}, {'value': '0.190', 'spread': '0.335', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 85 (n=45,46,48,47)', 'categories': [{'measurements': [{'value': '0.087', 'spread': '0.397', 'groupId': 'OG000'}, {'value': '0.135', 'spread': '0.342', 'groupId': 'OG001'}, {'value': '0.286', 'spread': '0.393', 'groupId': 'OG002'}, {'value': '0.265', 'spread': '0.473', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 92 (n=42,44,49,44)', 'categories': [{'measurements': [{'value': '0.063', 'spread': '0.476', 'groupId': 'OG000'}, {'value': '0.158', 'spread': '0.348', 'groupId': 'OG001'}, {'value': '0.211', 'spread': '0.374', 'groupId': 'OG002'}, {'value': '0.262', 'spread': '0.408', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 127 (n=44,44,49,47)', 'categories': [{'measurements': [{'value': '0.094', 'spread': '0.489', 'groupId': 'OG000'}, {'value': '0.144', 'spread': '0.263', 'groupId': 'OG001'}, {'value': '0.241', 'spread': '0.381', 'groupId': 'OG002'}, {'value': '0.237', 'spread': '0.285', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 169 (n=42,42,47,47)', 'categories': [{'measurements': [{'value': '0.101', 'spread': '0.442', 'groupId': 'OG000'}, {'value': '0.204', 'spread': '0.378', 'groupId': 'OG001'}, {'value': '0.211', 'spread': '0.394', 'groupId': 'OG002'}, {'value': '0.236', 'spread': '0.366', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169', 'description': 'Forced Expiratory Volume in 1 Second (FEV1) is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Spirometry was performed with the participant in the sitting/standing (kept consistent at each visit) position at study sites by the investigator or qualified designee according to American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines. Multiple forced expiratory efforts (at least 3 but no more than 8) were performed for each office spirometry session and the 2 best efforts that met ATS/ERS acceptability and reproducibility criteria were recorded. The best efforts were based on the highest FEV1. The maximum FEV1 of the 2 best efforts was used for the analysis. Data collected on Day 1 prior to dosing was considered as baseline.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG001', 'title': 'CAT-354 150 mg', 'description': 'CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG002', 'title': 'CAT-354 300 mg', 'description': 'CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG003', 'title': 'CAT-354 600 mg', 'description': 'CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}], 'classes': [{'title': 'Day -7 to 1 (n=46,46,51,47)', 'categories': [{'measurements': [{'value': '282.63', 'spread': '100.65', 'groupId': 'OG000'}, {'value': '351.06', 'spread': '130.41', 'groupId': 'OG001'}, {'value': '291.54', 'spread': '119.46', 'groupId': 'OG002'}, {'value': '325.23', 'spread': '123.90', 'groupId': 'OG003'}]}]}, {'title': 'Change in Day 2 to 8 (n=44,46,51,47)', 'categories': [{'measurements': [{'value': '-5.77', 'spread': '22.74', 'groupId': 'OG000'}, {'value': '1.91', 'spread': '23.81', 'groupId': 'OG001'}, {'value': '-4.53', 'spread': '19.02', 'groupId': 'OG002'}, {'value': '5.94', 'spread': '29.93', 'groupId': 'OG003'}]}]}, {'title': 'Change in Day 9 to 15 (n=45,46,51,47)', 'categories': [{'measurements': [{'value': '-7.46', 'spread': '29.68', 'groupId': 'OG000'}, {'value': '-4.10', 'spread': '28.15', 'groupId': 'OG001'}, {'value': '-2.83', 'spread': '24.40', 'groupId': 'OG002'}, {'value': '5.75', 'spread': '42.34', 'groupId': 'OG003'}]}]}, {'title': 'Change in Day 16 to 22 (n=45,46,51,47)', 'categories': [{'measurements': [{'value': '-8.94', 'spread': '35.72', 'groupId': 'OG000'}, {'value': '-6.53', 'spread': '32.70', 'groupId': 'OG001'}, {'value': '-0.37', 'spread': '33.85', 'groupId': 'OG002'}, {'value': '10.55', 'spread': '51.26', 'groupId': 'OG003'}]}]}, {'title': 'Change in Day 23 to 29 (n=44,46,51,47)', 'categories': [{'measurements': [{'value': '-10.53', 'spread': '40.06', 'groupId': 'OG000'}, {'value': '-6.61', 'spread': '37.95', 'groupId': 'OG001'}, {'value': '-0.79', 'spread': '36.94', 'groupId': 'OG002'}, {'value': '10.61', 'spread': '52.64', 'groupId': 'OG003'}]}]}, {'title': 'Change in Day 30 to 36 (n=45,46,51,47)', 'categories': [{'measurements': [{'value': '-5.69', 'spread': '44.69', 'groupId': 'OG000'}, {'value': '-5.69', 'spread': '41.87', 'groupId': 'OG001'}, {'value': '-1.98', 'spread': '36.06', 'groupId': 'OG002'}, {'value': '6.52', 'spread': '50.15', 'groupId': 'OG003'}]}]}, {'title': 'Change in Day 37 to 43 (n=44,46,50,47)', 'categories': [{'measurements': [{'value': '-11.08', 'spread': '41.52', 'groupId': 'OG000'}, {'value': '-2.00', 'spread': '49.76', 'groupId': 'OG001'}, {'value': '-4.07', 'spread': '39.80', 'groupId': 'OG002'}, {'value': '5.55', 'spread': '54.28', 'groupId': 'OG003'}]}]}, {'title': 'Change in Day 44 to 50 (n=44,46,50,47)', 'categories': [{'measurements': [{'value': '-6.37', 'spread': '41.50', 'groupId': 'OG000'}, {'value': '-9.02', 'spread': '47.51', 'groupId': 'OG001'}, {'value': '-5.30', 'spread': '36.57', 'groupId': 'OG002'}, {'value': '-0.84', 'spread': '50.67', 'groupId': 'OG003'}]}]}, {'title': 'Change in Day 51 to 57 (n=45,46,50,47)', 'categories': [{'measurements': [{'value': '-7.00', 'spread': '41.70', 'groupId': 'OG000'}, {'value': '-6.01', 'spread': '47.36', 'groupId': 'OG001'}, {'value': '-4.85', 'spread': '41.27', 'groupId': 'OG002'}, {'value': '-3.57', 'spread': '52.84', 'groupId': 'OG003'}]}]}, {'title': 'Change in Day 58 to 64 (n=45,46,50,46)', 'categories': [{'measurements': [{'value': '-9.84', 'spread': '38.73', 'groupId': 'OG000'}, {'value': '-2.83', 'spread': '47.42', 'groupId': 'OG001'}, {'value': '-1.42', 'spread': '41.90', 'groupId': 'OG002'}, {'value': '-0.73', 'spread': '55.98', 'groupId': 'OG003'}]}]}, {'title': 'Change in Day 65 to 71 (n=45,46,50,46)', 'categories': [{'measurements': [{'value': '-11.81', 'spread': '43.87', 'groupId': 'OG000'}, {'value': '-3.98', 'spread': '47.20', 'groupId': 'OG001'}, {'value': '-0.92', 'spread': '49.95', 'groupId': 'OG002'}, {'value': '-1.82', 'spread': '49.79', 'groupId': 'OG003'}]}]}, {'title': 'Change in Day 72 to 78 (n=44,45,50,47)', 'categories': [{'measurements': [{'value': '-3.72', 'spread': '44.07', 'groupId': 'OG000'}, {'value': '-3.42', 'spread': '53.55', 'groupId': 'OG001'}, {'value': '2.54', 'spread': '45.58', 'groupId': 'OG002'}, {'value': '1.78', 'spread': '49.45', 'groupId': 'OG003'}]}]}, {'title': 'Change in Day 79 to 85 (n=45,45,50,46)', 'categories': [{'measurements': [{'value': '-10.83', 'spread': '43.99', 'groupId': 'OG000'}, {'value': '-6.67', 'spread': '54.49', 'groupId': 'OG001'}, {'value': '-0.35', 'spread': '40.29', 'groupId': 'OG002'}, {'value': '5.30', 'spread': '60.62', 'groupId': 'OG003'}]}]}, {'title': 'Change in Day 86 to 92 (n=45,46,50,47)', 'categories': [{'measurements': [{'value': '-3.26', 'spread': '47.36', 'groupId': 'OG000'}, {'value': '-6.66', 'spread': '51.23', 'groupId': 'OG001'}, {'value': '5.04', 'spread': '40.52', 'groupId': 'OG002'}, {'value': '0.31', 'spread': '62.86', 'groupId': 'OG003'}]}]}, {'title': 'Change in Day 93 to 99 (n=45,46,50,47)', 'categories': [{'measurements': [{'value': '-2.52', 'spread': '47.94', 'groupId': 'OG000'}, {'value': '-4.99', 'spread': '49.91', 'groupId': 'OG001'}, {'value': '5.16', 'spread': '40.99', 'groupId': 'OG002'}, {'value': '7.81', 'spread': '58.29', 'groupId': 'OG003'}]}]}, {'title': 'Change in Day 100 to 106 (n=44,46,49,47)', 'categories': [{'measurements': [{'value': '-9.60', 'spread': '55.47', 'groupId': 'OG000'}, {'value': '-7.33', 'spread': '52.64', 'groupId': 'OG001'}, {'value': '1.93', 'spread': '43.08', 'groupId': 'OG002'}, {'value': '2.00', 'spread': '62.18', 'groupId': 'OG003'}]}]}, {'title': 'Change in Day 107 to 113 (n=44,45,48,47)', 'categories': [{'measurements': [{'value': '-7.53', 'spread': '56.29', 'groupId': 'OG000'}, {'value': '-11.29', 'spread': '57.33', 'groupId': 'OG001'}, {'value': '0.53', 'spread': '45.60', 'groupId': 'OG002'}, {'value': '0.39', 'spread': '61.52', 'groupId': 'OG003'}]}]}, {'title': 'Change in Day 114 to 120 (n=42,45,47,47)', 'categories': [{'measurements': [{'value': '-2.19', 'spread': '61.74', 'groupId': 'OG000'}, {'value': '-8.97', 'spread': '55.61', 'groupId': 'OG001'}, {'value': '4.85', 'spread': '39.54', 'groupId': 'OG002'}, {'value': '-3.03', 'spread': '59.68', 'groupId': 'OG003'}]}]}, {'title': 'Change in Day 121 to 127 (n=42,46,46,46)', 'categories': [{'measurements': [{'value': '-3.58', 'spread': '65.64', 'groupId': 'OG000'}, {'value': '-8.99', 'spread': '64.60', 'groupId': 'OG001'}, {'value': '3.61', 'spread': '46.18', 'groupId': 'OG002'}, {'value': '-4.21', 'spread': '57.88', 'groupId': 'OG003'}]}]}, {'title': 'Change in Day 128 to 134 (n=42,45,45,47)', 'categories': [{'measurements': [{'value': '-4.39', 'spread': '61.22', 'groupId': 'OG000'}, {'value': '-14.81', 'spread': '61.39', 'groupId': 'OG001'}, {'value': '4.62', 'spread': '44.65', 'groupId': 'OG002'}, {'value': '-2.64', 'spread': '56.87', 'groupId': 'OG003'}]}]}, {'title': 'Change in Day 135 to 141 (n=40,45,47,47)', 'categories': [{'measurements': [{'value': '-0.26', 'spread': '58.83', 'groupId': 'OG000'}, {'value': '-17.03', 'spread': '58.99', 'groupId': 'OG001'}, {'value': '1.11', 'spread': '44.36', 'groupId': 'OG002'}, {'value': '-6.03', 'spread': '63.13', 'groupId': 'OG003'}]}]}, {'title': 'Change in Day 142 to 148 (n=40,45,47,47)', 'categories': [{'measurements': [{'value': '5.16', 'spread': '66.54', 'groupId': 'OG000'}, {'value': '-11.63', 'spread': '61.02', 'groupId': 'OG001'}, {'value': '-2.69', 'spread': '51.65', 'groupId': 'OG002'}, {'value': '-9.65', 'spread': '65.62', 'groupId': 'OG003'}]}]}, {'title': 'Change in Day 149 to 155 (n=40,45,46,47)', 'categories': [{'measurements': [{'value': '0.43', 'spread': '60.53', 'groupId': 'OG000'}, {'value': '-9.56', 'spread': '60.13', 'groupId': 'OG001'}, {'value': '-7.65', 'spread': '47.44', 'groupId': 'OG002'}, {'value': '-11.07', 'spread': '62.16', 'groupId': 'OG003'}]}]}, {'title': 'Change in Day 156 to 162 (n=40,45,46,46)', 'categories': [{'measurements': [{'value': '-1.38', 'spread': '65.53', 'groupId': 'OG000'}, {'value': '-11.60', 'spread': '62.14', 'groupId': 'OG001'}, {'value': '-10.05', 'spread': '43.11', 'groupId': 'OG002'}, {'value': '-10.68', 'spread': '66.86', 'groupId': 'OG003'}]}]}, {'title': 'Change in Day 163 to 169 (n=37,41,42,40)', 'categories': [{'measurements': [{'value': '-0.36', 'spread': '58.66', 'groupId': 'OG000'}, {'value': '-5.68', 'spread': '60.69', 'groupId': 'OG001'}, {'value': '-4.71', 'spread': '49.29', 'groupId': 'OG002'}, {'value': '-3.23', 'spread': '66.84', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -7 to 1 (predose), Day 2 to 169', 'description': "The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. Home peak flow testing for PEF was performed every morning while sitting or standing prior to using any medication (if needed) for asthma. Mean of the data was collected over 1 week prior to dosing on Day 1 was considered as baseline. Mean PEF values for each week were used to calculate the change from baseline values starting from Day 2 to 169.", 'unitOfMeasure': 'liters/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively."}, {'type': 'SECONDARY', 'title': 'Number of Puffs of Rescue Beta-2 Agonist Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG001', 'title': 'CAT-354 150 mg', 'description': 'CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG002', 'title': 'CAT-354 300 mg', 'description': 'CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG003', 'title': 'CAT-354 600 mg', 'description': 'CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}], 'classes': [{'title': 'Day -7 to 1 (n=46,46, 51,47)', 'categories': [{'measurements': [{'value': '2.58', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '2.84', 'spread': '2.03', 'groupId': 'OG001'}, {'value': '2.04', 'spread': '1.51', 'groupId': 'OG002'}, {'value': '2.62', 'spread': '1.96', 'groupId': 'OG003'}]}]}, {'title': 'Day 2 to 8 (n=45,46, 51,47)', 'categories': [{'measurements': [{'value': '2.5', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '1.5', 'groupId': 'OG002'}, {'value': '2.3', 'spread': '2.0', 'groupId': 'OG003'}]}]}, {'title': 'Day 9 to 15 (n=46,46, 51,47)', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '1.5', 'groupId': 'OG002'}, {'value': '2.2', 'spread': '2.0', 'groupId': 'OG003'}]}]}, {'title': 'Day 16 to 22 (n=46,46, 51,47)', 'categories': [{'measurements': [{'value': '2.6', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '1.7', 'groupId': 'OG002'}, {'value': '2.3', 'spread': '2.2', 'groupId': 'OG003'}]}]}, {'title': 'Day 23 to 29 (n=45,46, 51,47)', 'categories': [{'measurements': [{'value': '2.7', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '1.9', 'groupId': 'OG002'}, {'value': '2.2', 'spread': '2.1', 'groupId': 'OG003'}]}]}, {'title': 'Day 30 to 36 (n=46,46, 51,47)', 'categories': [{'measurements': [{'value': '2.5', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '2.0', 'groupId': 'OG002'}, {'value': '2.0', 'spread': '1.9', 'groupId': 'OG003'}]}]}, {'title': 'Day 37 to 43 (n=45,46, 50,47)', 'categories': [{'measurements': [{'value': '2.4', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '2.0', 'groupId': 'OG002'}, {'value': '2.0', 'spread': '2.0', 'groupId': 'OG003'}]}]}, {'title': 'Day 44 to 50 (n=45,46, 50,47)', 'categories': [{'measurements': [{'value': '2.5', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '2.0', 'groupId': 'OG002'}, {'value': '2.0', 'spread': '2.0', 'groupId': 'OG003'}]}]}, {'title': 'Day 51 to 57 (n=45,46, 50,47)', 'categories': [{'measurements': [{'value': '2.5', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '1.9', 'groupId': 'OG002'}, {'value': '2.0', 'spread': '2.1', 'groupId': 'OG003'}]}]}, {'title': 'Day 58 to 64 (n=46,46, 49,46)', 'categories': [{'measurements': [{'value': '2.5', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '2.0', 'groupId': 'OG002'}, {'value': '1.8', 'spread': '2.0', 'groupId': 'OG003'}]}]}, {'title': 'Day 65 to 71 (n=46,46, 50,47)', 'categories': [{'measurements': [{'value': '2.7', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '2.0', 'groupId': 'OG002'}, {'value': '2.0', 'spread': '1.9', 'groupId': 'OG003'}]}]}, {'title': 'Day 72 to 78 (n=45,45, 50,46)', 'categories': [{'measurements': [{'value': '2.5', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '2.1', 'groupId': 'OG002'}, {'value': '1.9', 'spread': '1.8', 'groupId': 'OG003'}]}]}, {'title': 'Day 79 to 85 (n=46,46, 50,46)', 'categories': [{'measurements': [{'value': '2.6', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '2.0', 'groupId': 'OG002'}, {'value': '1.8', 'spread': '1.8', 'groupId': 'OG003'}]}]}, {'title': 'Day 86 to 92 (n=46,46, 50,47)', 'categories': [{'measurements': [{'value': '2.5', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '2.0', 'groupId': 'OG002'}, {'value': '1.7', 'spread': '1.7', 'groupId': 'OG003'}]}]}, {'title': 'Day 93 to 99 (n=46,46, 50,47)', 'categories': [{'measurements': [{'value': '2.4', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '2.1', 'groupId': 'OG002'}, {'value': '1.6', 'spread': '1.8', 'groupId': 'OG003'}]}]}, {'title': 'Day 100 to 106 (n=45,46, 49,47)', 'categories': [{'measurements': [{'value': '2.3', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '2.2', 'groupId': 'OG002'}, {'value': '1.8', 'spread': '1.8', 'groupId': 'OG003'}]}]}, {'title': 'Day 107 to 113 (n=45,45, 48,47)', 'categories': [{'measurements': [{'value': '2.4', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '1.9', 'groupId': 'OG002'}, {'value': '1.7', 'spread': '1.6', 'groupId': 'OG003'}]}]}, {'title': 'Day 114 to 120 (n=43,45, 47,47)', 'categories': [{'measurements': [{'value': '2.3', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '1.9', 'groupId': 'OG002'}, {'value': '1.7', 'spread': '1.7', 'groupId': 'OG003'}]}]}, {'title': 'Day 121 to 127 (n=43,46, 46,47)', 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '2.0', 'groupId': 'OG002'}, {'value': '1.6', 'spread': '1.6', 'groupId': 'OG003'}]}]}, {'title': 'Day 128 to 134 (n=44,45, 47,47)', 'categories': [{'measurements': [{'value': '2.2', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '1.9', 'groupId': 'OG002'}, {'value': '1.6', 'spread': '1.7', 'groupId': 'OG003'}]}]}, {'title': 'Day 135 to 141 (n=42,45, 47,47)', 'categories': [{'measurements': [{'value': '2.2', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '2.0', 'groupId': 'OG002'}, {'value': '1.7', 'spread': '1.8', 'groupId': 'OG003'}]}]}, {'title': 'Day 142 to 148 (n=42,45, 47,47)', 'categories': [{'measurements': [{'value': '2.3', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '2.0', 'groupId': 'OG002'}, {'value': '1.8', 'spread': '1.8', 'groupId': 'OG003'}]}]}, {'title': 'Day 149 to 155 (n=42,45, 46,47)', 'categories': [{'measurements': [{'value': '2.4', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '2.0', 'groupId': 'OG002'}, {'value': '1.8', 'spread': '1.8', 'groupId': 'OG003'}]}]}, {'title': 'Day 156 to 162 (n=42,45, 46,46)', 'categories': [{'measurements': [{'value': '2.3', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '2.2', 'groupId': 'OG002'}, {'value': '2.0', 'spread': '2.0', 'groupId': 'OG003'}]}]}, {'title': 'Day 163 to 169 (n=39,41,42,40)', 'categories': [{'measurements': [{'value': '2.7', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '1.8', 'groupId': 'OG002'}, {'value': '1.7', 'spread': '1.9', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -7 to 169', 'description': 'Number of Puffs of Rescue Beta-2 Agonist Per Week Rescue beta-2 agonist use (total number of puffs for the preceding week) was collected daily in the morning by the participants in the daily diary provided to them. Average values for each week were reported starting from Day -7 to Day 169.', 'unitOfMeasure': 'puffs per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively."}, {'type': 'SECONDARY', 'title': 'Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG001', 'title': 'CAT-354 150 mg', 'description': 'CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG002', 'title': 'CAT-354 300 mg', 'description': 'CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG003', 'title': 'CAT-354 600 mg', 'description': 'CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}], 'classes': [{'title': 'Overall : Day 1 (n=41,41,44,39)', 'categories': [{'measurements': [{'value': '4.22', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '3.96', 'spread': '0.89', 'groupId': 'OG001'}, {'value': '4.12', 'spread': '0.80', 'groupId': 'OG002'}, {'value': '4.11', 'spread': '0.94', 'groupId': 'OG003'}]}]}, {'title': 'Overall: Day 29 (n=43,41,44,40)', 'categories': [{'measurements': [{'value': '4.39', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '4.39', 'spread': '1.01', 'groupId': 'OG001'}, {'value': '4.47', 'spread': '0.97', 'groupId': 'OG002'}, {'value': '4.60', 'spread': '0.91', 'groupId': 'OG003'}]}]}, {'title': 'Overall: Day 57 (n=44,40,43,45)', 'categories': [{'measurements': [{'value': '4.57', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '4.56', 'spread': '1.15', 'groupId': 'OG001'}, {'value': '4.47', 'spread': '1.05', 'groupId': 'OG002'}, {'value': '4.73', 'spread': '0.96', 'groupId': 'OG003'}]}]}, {'title': 'Overall: Day 92 (n=40,42,40,38)', 'categories': [{'measurements': [{'value': '4.70', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '4.88', 'spread': '1.31', 'groupId': 'OG001'}, {'value': '4.74', 'spread': '1.15', 'groupId': 'OG002'}, {'value': '4.87', 'spread': '0.99', 'groupId': 'OG003'}]}]}, {'title': 'Overall: Day 127 (n=41,42,44,42)', 'categories': [{'measurements': [{'value': '4.69', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '4.76', 'spread': '1.29', 'groupId': 'OG001'}, {'value': '4.64', 'spread': '1.11', 'groupId': 'OG002'}, {'value': '4.85', 'spread': '1.13', 'groupId': 'OG003'}]}]}, {'title': 'Overall: Day 169 (n=41,44,45,44)', 'categories': [{'measurements': [{'value': '4.72', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '4.73', 'spread': '1.26', 'groupId': 'OG001'}, {'value': '4.61', 'spread': '1.27', 'groupId': 'OG002'}, {'value': '4.76', 'spread': '1.13', 'groupId': 'OG003'}]}]}, {'title': 'Symptom: Day 1 (n=41,41,44,39)', 'categories': [{'measurements': [{'value': '4.15', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '3.89', 'spread': '0.84', 'groupId': 'OG001'}, {'value': '4.11', 'spread': '0.71', 'groupId': 'OG002'}, {'value': '4.08', 'spread': '1.06', 'groupId': 'OG003'}]}]}, {'title': 'Symptom: Day 29 (n=43,41,44,40)', 'categories': [{'measurements': [{'value': '4.32', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '4.44', 'spread': '1.07', 'groupId': 'OG001'}, {'value': '4.48', 'spread': '0.94', 'groupId': 'OG002'}, {'value': '4.56', 'spread': '1.01', 'groupId': 'OG003'}]}]}, {'title': 'Symptom: Day 57 (n=44,40,43,45)', 'categories': [{'measurements': [{'value': '4.61', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '4.68', 'spread': '1.23', 'groupId': 'OG001'}, {'value': '4.49', 'spread': '1.05', 'groupId': 'OG002'}, {'value': '4.73', 'spread': '1.05', 'groupId': 'OG003'}]}]}, {'title': 'Symptom: Day 92 (n=40,42,40,38)', 'categories': [{'measurements': [{'value': '4.77', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '4.88', 'spread': '1.40', 'groupId': 'OG001'}, {'value': '4.78', 'spread': '1.17', 'groupId': 'OG002'}, {'value': '4.92', 'spread': '1.01', 'groupId': 'OG003'}]}]}, {'title': 'Symptom: Day 127 (n=41,42,44,42)', 'categories': [{'measurements': [{'value': '4.74', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '4.79', 'spread': '1.31', 'groupId': 'OG001'}, {'value': '4.69', 'spread': '1.09', 'groupId': 'OG002'}, {'value': '4.95', 'spread': '1.31', 'groupId': 'OG003'}]}]}, {'title': 'Symptom: Day 169 (n=41,44,45,44)', 'categories': [{'measurements': [{'value': '4.82', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '4.76', 'spread': '1.29', 'groupId': 'OG001'}, {'value': '4.63', 'spread': '1.26', 'groupId': 'OG002'}, {'value': '4.77', 'spread': '1.31', 'groupId': 'OG003'}]}]}, {'title': 'Activity Limitation: Day 1 (n=41,41,44,39)', 'categories': [{'measurements': [{'value': '4.38', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '4.07', 'spread': '0.88', 'groupId': 'OG001'}, {'value': '4.13', 'spread': '0.97', 'groupId': 'OG002'}, {'value': '4.15', 'spread': '0.91', 'groupId': 'OG003'}]}]}, {'title': 'Activity Limitation: Day 29 (n=43,41,44,40)', 'categories': [{'measurements': [{'value': '4.47', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '4.37', 'spread': '1.07', 'groupId': 'OG001'}, {'value': '4.42', 'spread': '1.08', 'groupId': 'OG002'}, {'value': '4.59', 'spread': '0.92', 'groupId': 'OG003'}]}]}, {'title': 'Activity Limitation: Day 57 (n=44,40,43,45)', 'categories': [{'measurements': [{'value': '4.57', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '4.42', 'spread': '1.09', 'groupId': 'OG001'}, {'value': '4.41', 'spread': '1.14', 'groupId': 'OG002'}, {'value': '4.74', 'spread': '0.99', 'groupId': 'OG003'}]}]}, {'title': 'Activity Limitation: Day 92 (n=40,42,40,38)', 'categories': [{'measurements': [{'value': '4.68', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '4.89', 'spread': '1.29', 'groupId': 'OG001'}, {'value': '4.73', 'spread': '1.15', 'groupId': 'OG002'}, {'value': '4.91', 'spread': '1.04', 'groupId': 'OG003'}]}]}, {'title': 'Activity Limitation: Day 127 (n=41,42,44,42)', 'categories': [{'measurements': [{'value': '4.64', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '4.77', 'spread': '1.32', 'groupId': 'OG001'}, {'value': '4.62', 'spread': '1.13', 'groupId': 'OG002'}, {'value': '4.66', 'spread': '1.08', 'groupId': 'OG003'}]}]}, {'title': 'Activity Limitation: Day 169 (n=41,44,45,44)', 'categories': [{'measurements': [{'value': '4.68', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '4.76', 'spread': '1.26', 'groupId': 'OG001'}, {'value': '4.54', 'spread': '1.31', 'groupId': 'OG002'}, {'value': '4.70', 'spread': '1.14', 'groupId': 'OG003'}]}]}, {'title': 'Emotional Function: Day 1 (n=41,41,44,39)', 'categories': [{'measurements': [{'value': '4.30', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '4.20', 'spread': '1.18', 'groupId': 'OG001'}, {'value': '4.45', 'spread': '1.10', 'groupId': 'OG002'}, {'value': '4.29', 'spread': '1.24', 'groupId': 'OG003'}]}]}, {'title': 'Emotional Function: Day 29 (n=43,41,44,40)', 'categories': [{'measurements': [{'value': '4.64', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '4.82', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '4.82', 'spread': '1.22', 'groupId': 'OG002'}, {'value': '4.88', 'spread': '1.17', 'groupId': 'OG003'}]}]}, {'title': 'Emotional Function: Day 57 (n=44,40,43,45)', 'categories': [{'measurements': [{'value': '4.85', 'spread': '1.36', 'groupId': 'OG000'}, {'value': '4.98', 'spread': '1.42', 'groupId': 'OG001'}, {'value': '4.87', 'spread': '1.24', 'groupId': 'OG002'}, {'value': '4.99', 'spread': '1.13', 'groupId': 'OG003'}]}]}, {'title': 'Emotional Function: Day 92 (n=40,42,40,38)', 'categories': [{'measurements': [{'value': '5.00', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '5.24', 'spread': '1.33', 'groupId': 'OG001'}, {'value': '4.99', 'spread': '1.45', 'groupId': 'OG002'}, {'value': '4.98', 'spread': '1.02', 'groupId': 'OG003'}]}]}, {'title': 'Emotional Function: Day 127 (n=41,42,44,42)', 'categories': [{'measurements': [{'value': '5.08', 'spread': '1.40', 'groupId': 'OG000'}, {'value': '5.06', 'spread': '1.48', 'groupId': 'OG001'}, {'value': '4.98', 'spread': '1.40', 'groupId': 'OG002'}, {'value': '5.28', 'spread': '1.29', 'groupId': 'OG003'}]}]}, {'title': 'Emotional Function: Day 169 (n=41,44,45,44)', 'categories': [{'measurements': [{'value': '5.05', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '5.00', 'spread': '1.50', 'groupId': 'OG001'}, {'value': '5.06', 'spread': '1.39', 'groupId': 'OG002'}, {'value': '5.13', 'spread': '1.28', 'groupId': 'OG003'}]}]}, {'title': 'Environment stimuli: Day 1 (n=41,41,44,39)', 'categories': [{'measurements': [{'value': '3.88', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '3.55', 'spread': '1.43', 'groupId': 'OG001'}, {'value': '3.70', 'spread': '1.11', 'groupId': 'OG002'}, {'value': '3.85', 'spread': '1.10', 'groupId': 'OG003'}]}]}, {'title': 'Environment stimuli: Day 29 (n=43,41,44,40)', 'categories': [{'measurements': [{'value': '4.06', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '3.75', 'spread': '1.48', 'groupId': 'OG001'}, {'value': '4.13', 'spread': '1.41', 'groupId': 'OG002'}, {'value': '4.40', 'spread': '1.20', 'groupId': 'OG003'}]}]}, {'title': 'Environment stimuli: Day 57 (n=44,40,43,45)', 'categories': [{'measurements': [{'value': '4.07', 'spread': '1.34', 'groupId': 'OG000'}, {'value': '4.04', 'spread': '1.36', 'groupId': 'OG001'}, {'value': '4.09', 'spread': '1.43', 'groupId': 'OG002'}, {'value': '4.37', 'spread': '1.49', 'groupId': 'OG003'}]}]}, {'title': 'Environment stimuli: Day 92 (n=40,42,40,38)', 'categories': [{'measurements': [{'value': '4.16', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '4.44', 'spread': '1.63', 'groupId': 'OG001'}, {'value': '4.31', 'spread': '1.43', 'groupId': 'OG002'}, {'value': '4.47', 'spread': '1.47', 'groupId': 'OG003'}]}]}, {'title': 'Environment stimuli: Day 127 (n=41,42,44,42)', 'categories': [{'measurements': [{'value': '4.18', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '4.30', 'spread': '1.57', 'groupId': 'OG001'}, {'value': '4.15', 'spread': '1.56', 'groupId': 'OG002'}, {'value': '4.51', 'spread': '1.64', 'groupId': 'OG003'}]}]}, {'title': 'Environment stimuli: Day 169 (n=41,44,45,44)', 'categories': [{'measurements': [{'value': '4.13', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '4.26', 'spread': '1.50', 'groupId': 'OG001'}, {'value': '4.18', 'spread': '1.76', 'groupId': 'OG002'}, {'value': '4.45', 'spread': '1.51', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, 29, 57, 92, 127 and 169', 'description': 'Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ\\[S\\]): a 32-item questionnaire that measures the functional impairments experienced by adult participants including 4 domains (Symptoms, Activity Limitations, Emotional Function, and Environmental Stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG001', 'title': 'CAT-354 150 mg', 'description': 'CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG002', 'title': 'CAT-354 300 mg', 'description': 'CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG003', 'title': 'CAT-354 600 mg', 'description': 'CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}], 'classes': [{'title': 'Overall: Day 29 (n=34,35,37,31)', 'categories': [{'measurements': [{'value': '0.32', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '0.38', 'spread': '0.64', 'groupId': 'OG001'}, {'value': '0.39', 'spread': '0.88', 'groupId': 'OG002'}, {'value': '0.66', 'spread': '0.76', 'groupId': 'OG003'}]}]}, {'title': 'Overall: Day 57 (n=33,33,35,34)', 'categories': [{'measurements': [{'value': '0.45', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '0.99', 'groupId': 'OG001'}, {'value': '0.38', 'spread': '0.95', 'groupId': 'OG002'}, {'value': '0.77', 'spread': '1.04', 'groupId': 'OG003'}]}]}, {'title': 'Overall: Day 92 (n=31,34,35,27)', 'categories': [{'measurements': [{'value': '0.63', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '0.94', 'spread': '1.21', 'groupId': 'OG001'}, {'value': '0.52', 'spread': '1.07', 'groupId': 'OG002'}, {'value': '1.05', 'spread': '1.25', 'groupId': 'OG003'}]}]}, {'title': 'Overall: Day 127 (n=32,36,34,31)', 'categories': [{'measurements': [{'value': '0.71', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '1.21', 'groupId': 'OG001'}, {'value': '0.49', 'spread': '1.14', 'groupId': 'OG002'}, {'value': '1.05', 'spread': '1.15', 'groupId': 'OG003'}]}]}, {'title': 'Overall: Day 169 (n=31,37,37,34)', 'categories': [{'measurements': [{'value': '0.64', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '1.19', 'groupId': 'OG001'}, {'value': '0.56', 'spread': '1.09', 'groupId': 'OG002'}, {'value': '0.75', 'spread': '1.26', 'groupId': 'OG003'}]}]}, {'title': 'Symptom: Day 29 (n=34,35,37,31)', 'categories': [{'measurements': [{'value': '0.31', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '0.49', 'spread': '0.83', 'groupId': 'OG001'}, {'value': '0.43', 'spread': '0.83', 'groupId': 'OG002'}, {'value': '0.62', 'spread': '0.80', 'groupId': 'OG003'}]}]}, {'title': 'Symptom: Day 57 (n=33,33,35,34)', 'categories': [{'measurements': [{'value': '0.52', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '0.87', 'spread': '1.10', 'groupId': 'OG001'}, {'value': '0.44', 'spread': '0.85', 'groupId': 'OG002'}, {'value': '0.81', 'spread': '1.11', 'groupId': 'OG003'}]}]}, {'title': 'Symptom: Day 92 (n=31,34,35,27)', 'categories': [{'measurements': [{'value': '0.76', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '1.32', 'groupId': 'OG001'}, {'value': '0.61', 'spread': '1.11', 'groupId': 'OG002'}, {'value': '1.14', 'spread': '1.39', 'groupId': 'OG003'}]}]}, {'title': 'Symptom: Day 127 (n=32,36,34,31)', 'categories': [{'measurements': [{'value': '0.85', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '0.87', 'spread': '1.24', 'groupId': 'OG001'}, {'value': '0.56', 'spread': '1.14', 'groupId': 'OG002'}, {'value': '1.24', 'spread': '1.23', 'groupId': 'OG003'}]}]}, {'title': 'Symptom: Day 169 (n=31,37,37,34)', 'categories': [{'measurements': [{'value': '0.80', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '0.86', 'spread': '1.22', 'groupId': 'OG001'}, {'value': '0.62', 'spread': '1.17', 'groupId': 'OG002'}, {'value': '0.77', 'spread': '1.34', 'groupId': 'OG003'}]}]}, {'title': 'Activity Limitation: Day 29 (n=34,35,37,31)', 'categories': [{'measurements': [{'value': '0.21', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '0.69', 'groupId': 'OG001'}, {'value': '0.32', 'spread': '0.96', 'groupId': 'OG002'}, {'value': '0.57', 'spread': '0.90', 'groupId': 'OG003'}]}]}, {'title': 'Activity Limitation: Day 57 (n=33,33,35,34)', 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '0.44', 'spread': '0.89', 'groupId': 'OG001'}, {'value': '0.30', 'spread': '1.08', 'groupId': 'OG002'}, {'value': '0.71', 'spread': '1.07', 'groupId': 'OG003'}]}]}, {'title': 'Activity Limitation: Day 92 (n=31,34,35,27)', 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '0.80', 'spread': '1.12', 'groupId': 'OG001'}, {'value': '0.51', 'spread': '1.12', 'groupId': 'OG002'}, {'value': '1.04', 'spread': '1.26', 'groupId': 'OG003'}]}]}, {'title': 'Activity Limitation: Day 127 (n=32,36,34,31)', 'categories': [{'measurements': [{'value': '0.43', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '0.65', 'spread': '1.20', 'groupId': 'OG001'}, {'value': '0.45', 'spread': '1.14', 'groupId': 'OG002'}, {'value': '0.72', 'spread': '1.28', 'groupId': 'OG003'}]}]}, {'title': 'Activity Limitation: Day 169 (n=31,37,37,34)', 'categories': [{'measurements': [{'value': '0.38', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '0.68', 'spread': '1.16', 'groupId': 'OG001'}, {'value': '0.44', 'spread': '1.09', 'groupId': 'OG002'}, {'value': '0.65', 'spread': '1.37', 'groupId': 'OG003'}]}]}, {'title': 'Emotional Function: Day 29 (n=34,35,37,31)', 'categories': [{'measurements': [{'value': '0.50', 'spread': '0.93', 'groupId': 'OG000'}, {'value': '0.57', 'spread': '0.76', 'groupId': 'OG001'}, {'value': '0.36', 'spread': '1.04', 'groupId': 'OG002'}, {'value': '0.86', 'spread': '0.97', 'groupId': 'OG003'}]}]}, {'title': 'Emotional Function: Day 57 (n=33,33,35,34)', 'categories': [{'measurements': [{'value': '0.69', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '0.95', 'spread': '1.16', 'groupId': 'OG001'}, {'value': '0.42', 'spread': '1.15', 'groupId': 'OG002'}, {'value': '0.86', 'spread': '1.21', 'groupId': 'OG003'}]}]}, {'title': 'Emotional Function: Day 92 (n=31,34,35,27)', 'categories': [{'measurements': [{'value': '0.87', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '1.06', 'spread': '1.25', 'groupId': 'OG001'}, {'value': '0.43', 'spread': '1.26', 'groupId': 'OG002'}, {'value': '0.93', 'spread': '1.39', 'groupId': 'OG003'}]}]}, {'title': 'Emotional Function: Day 127 (n=32,36,34,31)', 'categories': [{'measurements': [{'value': '1.02', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '0.87', 'spread': '1.38', 'groupId': 'OG001'}, {'value': '0.41', 'spread': '1.32', 'groupId': 'OG002'}, {'value': '1.32', 'spread': '1.42', 'groupId': 'OG003'}]}]}, {'title': 'Emotional Function: Day 169 (n=31,37,37,34)', 'categories': [{'measurements': [{'value': '0.88', 'spread': '1.42', 'groupId': 'OG000'}, {'value': '0.88', 'spread': '1.36', 'groupId': 'OG001'}, {'value': '0.63', 'spread': '1.20', 'groupId': 'OG002'}, {'value': '0.95', 'spread': '1.40', 'groupId': 'OG003'}]}]}, {'title': 'Environmental Stimuli: Day 29 (n=34,35,37,31)', 'categories': [{'measurements': [{'value': '0.40', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.78', 'groupId': 'OG001'}, {'value': '0.47', 'spread': '1.18', 'groupId': 'OG002'}, {'value': '0.76', 'spread': '0.80', 'groupId': 'OG003'}]}]}, {'title': 'Environmental Stimuli: Day 57 (n=33,33,35,34)', 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '0.58', 'spread': '1.39', 'groupId': 'OG001'}, {'value': '0.38', 'spread': '1.27', 'groupId': 'OG002'}, {'value': '0.65', 'spread': '1.40', 'groupId': 'OG003'}]}]}, {'title': 'Environmental Stimuli: Day 92 (n=31,34,35,27)', 'categories': [{'measurements': [{'value': '0.54', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '1.68', 'groupId': 'OG001'}, {'value': '0.42', 'spread': '1.17', 'groupId': 'OG002'}, {'value': '0.94', 'spread': '1.28', 'groupId': 'OG003'}]}]}, {'title': 'Environmental Stimuli: Day 127 (n=32,36,34,31)', 'categories': [{'measurements': [{'value': '0.64', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '0.74', 'spread': '1.68', 'groupId': 'OG001'}, {'value': '0.48', 'spread': '1.45', 'groupId': 'OG002'}, {'value': '1.02', 'spread': '1.22', 'groupId': 'OG003'}]}]}, {'title': 'Environmental Stimuli: Day 169 (n=31,37,37,34)', 'categories': [{'measurements': [{'value': '0.52', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '0.75', 'spread': '1.55', 'groupId': 'OG001'}, {'value': '0.58', 'spread': '1.30', 'groupId': 'OG002'}, {'value': '0.74', 'spread': '1.39', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, 29, 57, 92, 127 and 169', 'description': 'Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ\\[S\\]): a 32-item questionnaire that measures the functional impairments experienced by adult participants including 4 domains (Symptoms, Activity Limitations, Emotional Function, and Environmental Stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment). Data collected on Day 1 prior to dosing was considered as baseline', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively."}, {'type': 'SECONDARY', 'title': 'Patient Global Impression of Change (PGIC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG001', 'title': 'CAT-354 150 mg', 'description': 'CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG002', 'title': 'CAT-354 300 mg', 'description': 'CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG003', 'title': 'CAT-354 600 mg', 'description': 'CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}], 'classes': [{'title': 'Day 92 (n=40,42,40,38)', 'categories': [{'measurements': [{'value': '5.1', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '5.3', 'spread': '1.0', 'groupId': 'OG002'}, {'value': '5.2', 'spread': '1.2', 'groupId': 'OG003'}]}]}, {'title': 'Day 169 (n=42,44,45,44)', 'categories': [{'measurements': [{'value': '5.1', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '5.0', 'spread': '1.0', 'groupId': 'OG002'}, {'value': '5.1', 'spread': '1.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 92 and 169', 'description': "Patient Global Impression of Change (PGIC): participant rated instrument to measure participant's change in overall status compared to baseline on a 7-point scale; range from 1 (very much worse) to 7 (very much better).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Mean Asthma Control Questionnaire (ACQ) Score Less Than or Equal to 0.75 or ACQ Score Greater Than 0.75 But Less Than 1.5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG001', 'title': 'CAT-354 150 mg', 'description': 'CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG002', 'title': 'CAT-354 300 mg', 'description': 'CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG003', 'title': 'CAT-354 600 mg', 'description': 'CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}], 'classes': [{'title': 'ACQ score<=0.75: Day 92', 'categories': [{'measurements': [{'value': '13.0', 'spread': '19.6', 'groupId': 'OG000'}, {'value': '19.6', 'groupId': 'OG001'}, {'value': '11.8', 'groupId': 'OG002'}, {'value': '17.0', 'groupId': 'OG003'}]}]}, {'title': 'ACQ score>0.75 and <1.5: Day 92', 'categories': [{'measurements': [{'value': '15.2', 'groupId': 'OG000'}, {'value': '13.0', 'groupId': 'OG001'}, {'value': '15.7', 'groupId': 'OG002'}, {'value': '19.1', 'groupId': 'OG003'}]}]}, {'title': 'ACQ score<=0.75: Day 169', 'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000'}, {'value': '19.6', 'groupId': 'OG001'}, {'value': '13.7', 'groupId': 'OG002'}, {'value': '19.1', 'groupId': 'OG003'}]}]}, {'title': 'ACQ score>0.75 and <1.5: Day 169', 'categories': [{'measurements': [{'value': '21.7', 'groupId': 'OG000'}, {'value': '10.9', 'groupId': 'OG001'}, {'value': '17.6', 'groupId': 'OG002'}, {'value': '19.1', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.934', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'pValueComment': 'ACQ score \\<=0.75, Day 92: Fisher exact test was used to compare all arms.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.592', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'pValueComment': 'ACQ score \\<=0.75, Day 169: Fisher exact test was used to compare all arms.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 92 and 169', 'description': 'Percentage of participants with mean Asthma Control Questionnaire (ACQ) score less than or equal to (\\<=) 0.75 or mean ACQ score greater than (\\>) 0.75 and less than (\\<) 1.5 were analyzed. The ACQ is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Mean ACQ scores of less than or equal to (\\<=) 0.75 indicated well-controlled asthma, mean ACQ scores greater than (\\>) 0.75 but less than (\\<) 1.5 indicated partly controlled asthma.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons.'}, {'type': 'SECONDARY', 'title': 'Serum Concentration for CAT-354', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CAT-354 150 mg', 'description': 'CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG001', 'title': 'CAT-354 300 mg', 'description': 'CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG002', 'title': 'CAT-354 600 mg', 'description': 'CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}], 'classes': [{'title': 'Day 15 (n=46,48,48)', 'categories': [{'measurements': [{'value': '14.5', 'spread': '5.57', 'groupId': 'OG000'}, {'value': '27.8', 'spread': '10.3', 'groupId': 'OG001'}, {'value': '56.4', 'spread': '16.0', 'groupId': 'OG002'}]}]}, {'title': 'Day 29 (n=45,51,47)', 'categories': [{'measurements': [{'value': '20.8', 'spread': '7.20', 'groupId': 'OG000'}, {'value': '40.2', 'spread': '15.0', 'groupId': 'OG001'}, {'value': '81.9', 'spread': '23.5', 'groupId': 'OG002'}]}]}, {'title': 'Day 43 (n=46,50,47)', 'categories': [{'measurements': [{'value': '26.9', 'spread': '12.7', 'groupId': 'OG000'}, {'value': '51.0', 'spread': '16.0', 'groupId': 'OG001'}, {'value': '98.5', 'spread': '33.4', 'groupId': 'OG002'}]}]}, {'title': 'Day 57 (n=46,48,46)', 'categories': [{'measurements': [{'value': '28.4', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '58.8', 'spread': '20.2', 'groupId': 'OG001'}, {'value': '108', 'spread': '35.8', 'groupId': 'OG002'}]}]}, {'title': 'Day 71 (n=46,49,47)', 'categories': [{'measurements': [{'value': '29.3', 'spread': '11.9', 'groupId': 'OG000'}, {'value': '61.0', 'spread': '21.4', 'groupId': 'OG001'}, {'value': '112', 'spread': '41.2', 'groupId': 'OG002'}]}]}, {'title': 'Day 85 (n=45,49,47)', 'categories': [{'measurements': [{'value': '31.1', 'spread': '12.5', 'groupId': 'OG000'}, {'value': '62.0', 'spread': '23.8', 'groupId': 'OG001'}, {'value': '120', 'spread': '44.5', 'groupId': 'OG002'}]}]}, {'title': 'Day 88 (n=46,48,45)', 'categories': [{'measurements': [{'value': '43.4', 'spread': '15.8', 'groupId': 'OG000'}, {'value': '85.7', 'spread': '32.7', 'groupId': 'OG001'}, {'value': '157', 'spread': '56.5', 'groupId': 'OG002'}]}]}, {'title': 'Day 92 (n=45,46,45)', 'categories': [{'measurements': [{'value': '42.0', 'spread': '16.3', 'groupId': 'OG000'}, {'value': '86.8', 'spread': '33.1', 'groupId': 'OG001'}, {'value': '156', 'spread': '46.6', 'groupId': 'OG002'}]}]}, {'title': 'Day 99 (n=46,50,46)', 'categories': [{'measurements': [{'value': '31.3', 'spread': '13.0', 'groupId': 'OG000'}, {'value': '69.3', 'spread': '27.2', 'groupId': 'OG001'}, {'value': '125', 'spread': '41.9', 'groupId': 'OG002'}]}]}, {'title': 'Day 127 (n=47,48,47)', 'categories': [{'measurements': [{'value': '11.5', 'spread': '6.02', 'groupId': 'OG000'}, {'value': '22.9', 'spread': '12.0', 'groupId': 'OG001'}, {'value': '43.7', 'spread': '20.5', 'groupId': 'OG002'}]}]}, {'title': 'Day 169 (n=47,48,46)', 'categories': [{'measurements': [{'value': '2.94', 'spread': '2.23', 'groupId': 'OG000'}, {'value': '5.87', 'spread': '3.69', 'groupId': 'OG001'}, {'value': '10.1', 'spread': '6.71', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose on Day 15, 29, 43, 57, 71 and 85; Day 88, 92, 99, 127, and 169', 'unitOfMeasure': 'microgram per milliliter (mcg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacokinetic (PK) population included participants who received CAT-354 and had a sufficient number of serum concentration measurements for computing PK parameters. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-Drug Antibodies to CAT-354 at Any Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG001', 'title': 'CAT-354 150 mg', 'description': 'CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG002', 'title': 'CAT-354 300 mg', 'description': 'CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG003', 'title': 'CAT-354 600 mg', 'description': 'CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1, 92 and 169', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all participants who received any dose of the investigational product. Here, 'N'(number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Positive Serum Antibodies to CAT-354 at Any Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG001', 'title': 'CAT-354 150 mg', 'description': 'CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG002', 'title': 'CAT-354 300 mg', 'description': 'CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG003', 'title': 'CAT-354 600 mg', 'description': 'CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1, 92 and 169', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all participants who received any dose of the investigational product. Here, 'N'(number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG001', 'title': 'CAT-354 150 mg', 'description': 'CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG002', 'title': 'CAT-354 300 mg', 'description': 'CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG003', 'title': 'CAT-354 600 mg', 'description': 'CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}]}, {'title': 'TESAEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to 169', 'description': 'An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Day 169 that were absent before treatment or that worsened relative to pretreatment state.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received any dose of the investigational product.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least 1 Moderate or Severe Exacerbation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG001', 'title': 'CAT-354 150 mg', 'description': 'CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG002', 'title': 'CAT-354 300 mg', 'description': 'CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG003', 'title': 'CAT-354 600 mg', 'description': 'CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}], 'classes': [{'title': 'Day 92', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000'}, {'value': '2.2', 'groupId': 'OG001'}, {'value': '2.0', 'groupId': 'OG002'}, {'value': '4.3', 'groupId': 'OG003'}]}]}, {'title': 'Day 169', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000'}, {'value': '4.3', 'groupId': 'OG001'}, {'value': '3.9', 'groupId': 'OG002'}, {'value': '6.4', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '1.0000', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Day 92: Fisher exact test was used for the analysis.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.6022', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'Day 92: Fisher exact test was used for the analysis.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '1.0000', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'Day 92: Fisher exact test was used for the analysis.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '1.0000', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Day 169: Fisher exact test was used for the analysis.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '1.0000', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'Day 169: Fisher exact test was used for the analysis.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '1.0000', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'Day 169: Fisher exact test was used for the analysis.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 92 and 169', 'description': 'Asthma exacerbation was defined as either a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) or a reduction of \\>= 20 percent (%) in PEF or FEV1 from baseline that did not resolve after the initiation of rescue medications and resulted in an administration of systemic corticosteroids by the investigator or health care provider. Asthma exacerbation severity was classified as: 1) Moderate-worsening symptoms that required systemic corticosteroids. 2) Severe-worsening symptoms that required systemic corticosteroids and hospital admission.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. No separate analyses were performed for moderate and severe exacerbations since only 1 participant had a severe exacerbation.'}, {'type': 'SECONDARY', 'title': 'Moderate or Severe Asthma Exacerbations Per Person Per Annum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG001', 'title': 'CAT-354 150 mg', 'description': 'CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG002', 'title': 'CAT-354 300 mg', 'description': 'CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG003', 'title': 'CAT-354 600 mg', 'description': 'CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}], 'classes': [{'title': 'Day 1 to 92', 'categories': [{'measurements': [{'value': '0.26', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '0.08', 'spread': '0.08', 'groupId': 'OG002'}, {'value': '0.25', 'spread': '0.19', 'groupId': 'OG003'}]}]}, {'title': 'Day 1 to 169', 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.10', 'groupId': 'OG001'}, {'value': '0.08', 'spread': '0.06', 'groupId': 'OG002'}, {'value': '0.19', 'spread': '0.11', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.551', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Day 1 to 92: P-value was calculated against placebo group from Van Elteren Test.', 'statisticalMethod': 'Van Elteren Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.492', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'Day 1 to 92: P-value was calculated against placebo group from Van Elteren Test.', 'statisticalMethod': 'Van Elteren Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.983', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'Day 1 to 92: P-value was calculated against placebo group from Van Elteren Test.', 'statisticalMethod': 'Van Elteren Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.991', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Day 1 to 169: P-value was calculated against placebo group from Van Elteren Test.', 'statisticalMethod': 'Van Elteren Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.900', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'Day 1 to 169: P-value was calculated against placebo group from Van Elteren Test.', 'statisticalMethod': 'Van Elteren Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.673', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'Day 1 to 169: P-value was calculated against placebo group from Van Elteren Test.', 'statisticalMethod': 'Van Elteren Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to Day 92 and Day 169', 'description': 'Asthma exacerbation was defined as either a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) or a reduction of \\>=20% in PEF or FEV1 from baseline that did not resolve after the initiation of rescue medications and resulted in an administration of systemic corticosteroids by the investigator or health care provider. Asthma exacerbation rate, calculated as total asthma exacerbations per person per annum, was assessed based on asthma exacerbation data up to Day 92 and 169 (Rate = mean asthma exacerbations for all participants/X days\\*365 days, where X = 92 or 169).', 'unitOfMeasure': 'asthma exacerbations/person/annum', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons.'}, {'type': 'SECONDARY', 'title': 'Time to First Moderate or Severe Asthma Exacerbation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG001', 'title': 'CAT-354 150 mg', 'description': 'CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG002', 'title': 'CAT-354 300 mg', 'description': 'CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'OG003', 'title': 'CAT-354 600 mg', 'description': 'CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}], 'classes': [{'title': 'Day 1 to 92', 'categories': [{'measurements': [{'value': '89.67', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '90.43', 'spread': '1.32', 'groupId': 'OG001'}, {'value': '88.16', 'spread': '2.12', 'groupId': 'OG002'}, {'value': '89.94', 'spread': '1.36', 'groupId': 'OG003'}]}]}, {'title': 'Day 1 to 169', 'categories': [{'measurements': [{'value': '162.24', 'spread': '3.79', 'groupId': 'OG000'}, {'value': '163.50', 'spread': '3.24', 'groupId': 'OG001'}, {'value': '158.29', 'spread': '4.41', 'groupId': 'OG002'}, {'value': '161.21', 'spread': '3.71', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.546', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.534', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.847', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.987', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.992', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.688', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to Day 92 and Day 169', 'description': 'Time to first moderate or severe asthma exacerbation was defined as time to first observed progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) or a reduction of \\>=20% in PEF or FEV1 from baseline that did not resolve after the initiation of rescue medications and resulted in an administration of systemic corticosteroids by the investigator or health care provider.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'FG001', 'title': 'CAT-354 150 mg', 'description': 'CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'FG002', 'title': 'CAT-354 300 mg', 'description': 'CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'FG003', 'title': 'CAT-354 600 mg', 'description': 'CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '51'}, {'groupId': 'FG003', 'numSubjects': '48'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '51'}, {'groupId': 'FG003', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '48'}, {'groupId': 'FG003', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 357 participants were screened in this study, out of which 194 participants me the eligibility criteria and were enrolled and randomized into the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '194', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'BG001', 'title': 'CAT-354 150 mg', 'description': 'CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'BG002', 'title': 'CAT-354 300 mg', 'description': 'CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'BG003', 'title': 'CAT-354 600 mg', 'description': 'CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.2', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '43.4', 'spread': '11.1', 'groupId': 'BG001'}, {'value': '48.7', 'spread': '11.0', 'groupId': 'BG002'}, {'value': '49.8', 'spread': '10.4', 'groupId': 'BG003'}, {'value': '47.3', 'spread': '10.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '116', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '78', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-Treat (ITT) population included all participants who were randomized.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 357}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-21', 'studyFirstSubmitDate': '2009-04-01', 'resultsFirstSubmitDate': '2016-08-26', 'studyFirstSubmitQcDate': '2009-04-01', 'lastUpdatePostDateStruct': {'date': '2017-03-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-03', 'studyFirstPostDateStruct': {'date': '2009-04-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the Mean Asthma Control Questionnaire (ACQ) Score at Day 92', 'timeFrame': 'Day 1 and 92', 'description': 'Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score.'}], 'secondaryOutcomes': [{'measure': 'Time to First Observed Asthma Control', 'timeFrame': 'Day 1 to Day 92 and Day 169', 'description': 'Time to first asthma control was defined as the number of days from Study Day 1 to the post-baseline ACQ score measurement time point when greater than or equal to (\\>=) 0.5 reduction from baseline in mean ACQ score was first observed. Time to first asthma control was analyzed from Day 1 through Day 92 and up to entire study duration through Day 169. The ACQ score is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled).'}, {'measure': 'Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169', 'timeFrame': 'Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169', 'description': 'Forced Expiratory Volume in 1 Second (FEV1) is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Spirometry was performed with the participant in the sitting/standing (kept consistent at each visit) position at study sites by the investigator or qualified designee according to American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines. Multiple forced expiratory efforts (at least 3 but no more than 8) were performed for each office spirometry session and the 2 best efforts that met ATS/ERS acceptability and reproducibility criteria were recorded. The best efforts were based on the highest FEV1. The maximum FEV1 of the 2 best efforts was used for the analysis. Data collected on Day 1 prior to dosing was considered as baseline.'}, {'measure': 'Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169', 'timeFrame': 'Day -7 to 1 (predose), Day 2 to 169', 'description': "The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. Home peak flow testing for PEF was performed every morning while sitting or standing prior to using any medication (if needed) for asthma. Mean of the data was collected over 1 week prior to dosing on Day 1 was considered as baseline. Mean PEF values for each week were used to calculate the change from baseline values starting from Day 2 to 169."}, {'measure': 'Number of Puffs of Rescue Beta-2 Agonist Per Week', 'timeFrame': 'Day -7 to 169', 'description': 'Number of Puffs of Rescue Beta-2 Agonist Per Week Rescue beta-2 agonist use (total number of puffs for the preceding week) was collected daily in the morning by the participants in the daily diary provided to them. Average values for each week were reported starting from Day -7 to Day 169.'}, {'measure': 'Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores', 'timeFrame': 'Day 1, 29, 57, 92, 127 and 169', 'description': 'Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ\\[S\\]): a 32-item questionnaire that measures the functional impairments experienced by adult participants including 4 domains (Symptoms, Activity Limitations, Emotional Function, and Environmental Stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment).'}, {'measure': 'Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169', 'timeFrame': 'Day 1, 29, 57, 92, 127 and 169', 'description': 'Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ\\[S\\]): a 32-item questionnaire that measures the functional impairments experienced by adult participants including 4 domains (Symptoms, Activity Limitations, Emotional Function, and Environmental Stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment). Data collected on Day 1 prior to dosing was considered as baseline'}, {'measure': 'Patient Global Impression of Change (PGIC)', 'timeFrame': 'Day 92 and 169', 'description': "Patient Global Impression of Change (PGIC): participant rated instrument to measure participant's change in overall status compared to baseline on a 7-point scale; range from 1 (very much worse) to 7 (very much better)."}, {'measure': 'Percentage of Participants With Mean Asthma Control Questionnaire (ACQ) Score Less Than or Equal to 0.75 or ACQ Score Greater Than 0.75 But Less Than 1.5', 'timeFrame': 'Day 92 and 169', 'description': 'Percentage of participants with mean Asthma Control Questionnaire (ACQ) score less than or equal to (\\<=) 0.75 or mean ACQ score greater than (\\>) 0.75 and less than (\\<) 1.5 were analyzed. The ACQ is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Mean ACQ scores of less than or equal to (\\<=) 0.75 indicated well-controlled asthma, mean ACQ scores greater than (\\>) 0.75 but less than (\\<) 1.5 indicated partly controlled asthma.'}, {'measure': 'Serum Concentration for CAT-354', 'timeFrame': 'Predose on Day 15, 29, 43, 57, 71 and 85; Day 88, 92, 99, 127, and 169'}, {'measure': 'Number of Participants With Anti-Drug Antibodies to CAT-354 at Any Visit', 'timeFrame': 'Day 1, 92 and 169'}, {'measure': 'Percentage of Participants With Positive Serum Antibodies to CAT-354 at Any Visit', 'timeFrame': 'Day 1, 92 and 169'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'Day 1 to 169', 'description': 'An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Day 169 that were absent before treatment or that worsened relative to pretreatment state.'}, {'measure': 'Percentage of Participants With at Least 1 Moderate or Severe Exacerbation', 'timeFrame': 'Day 92 and 169', 'description': 'Asthma exacerbation was defined as either a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) or a reduction of \\>= 20 percent (%) in PEF or FEV1 from baseline that did not resolve after the initiation of rescue medications and resulted in an administration of systemic corticosteroids by the investigator or health care provider. Asthma exacerbation severity was classified as: 1) Moderate-worsening symptoms that required systemic corticosteroids. 2) Severe-worsening symptoms that required systemic corticosteroids and hospital admission.'}, {'measure': 'Moderate or Severe Asthma Exacerbations Per Person Per Annum', 'timeFrame': 'Day 1 to Day 92 and Day 169', 'description': 'Asthma exacerbation was defined as either a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) or a reduction of \\>=20% in PEF or FEV1 from baseline that did not resolve after the initiation of rescue medications and resulted in an administration of systemic corticosteroids by the investigator or health care provider. Asthma exacerbation rate, calculated as total asthma exacerbations per person per annum, was assessed based on asthma exacerbation data up to Day 92 and 169 (Rate = mean asthma exacerbations for all participants/X days\\*365 days, where X = 92 or 169).'}, {'measure': 'Time to First Moderate or Severe Asthma Exacerbation', 'timeFrame': 'Day 1 to Day 92 and Day 169', 'description': 'Time to first moderate or severe asthma exacerbation was defined as time to first observed progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) or a reduction of \\>=20% in PEF or FEV1 from baseline that did not resolve after the initiation of rescue medications and resulted in an administration of systemic corticosteroids by the investigator or health care provider.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CAT-354', 'Tralokinumab', 'Asthma'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '22743678', 'type': 'BACKGROUND', 'citation': 'Piper E, Brightling C, Niven R, Oh C, Faggioni R, Poon K, She D, Kell C, May RD, Geba GP, Molfino NA. A phase II placebo-controlled study of tralokinumab in moderate-to-severe asthma. Eur Respir J. 2013 Feb;41(2):330-8. doi: 10.1183/09031936.00223411. Epub 2012 Jun 27.'}, {'pmid': '28758192', 'type': 'DERIVED', 'citation': 'Baverel PG, White N, Vicini P, Karlsson MO, Agoram B. Dose-Exposure-Response Relationship of the Investigational Anti-Interleukin-13 Monoclonal Antibody Tralokinumab in Patients With Severe, Uncontrolled Asthma. Clin Pharmacol Ther. 2018 May;103(5):826-835. doi: 10.1002/cpt.803. Epub 2017 Sep 28.'}, {'pmid': '25614165', 'type': 'DERIVED', 'citation': 'Wilkes DS, Chew T, Flaherty KR, Frye S, Gibson KF, Kaminski N, Klemsz MJ, Lange W, Noth I, Rothhaar K. Oral immunotherapy with type V collagen in idiopathic pulmonary fibrosis. Eur Respir J. 2015 May;45(5):1393-402. doi: 10.1183/09031936.00105314. Epub 2015 Jan 22.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel-arm study to evaluate the efficacy and safety of 3 subcutaneous (SC) treatment regimens of CAT-354 in adult subjects with uncontrolled, moderate-to-severe, persistent asthma.', 'detailedDescription': 'Study MI-CP199, a Phase 2a, randomized, double-blind, placebo-controlled, parallel-arm, multicenter study will evaluate the effect of 3 SC treatment regimens of CAT-354 on asthma control in adults with uncontrolled, moderate-to-severe, persistent asthma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female subjects\n* Age 18 to 65 years at the time of Screening\n* Subjects must have a body mass index (BMI) between 18 and 40 kilogram per square meter (kg/m\\^2)\n* Written informed consent obtained from the subject prior to performing any protocol related procedures, including Screening evaluations\n* Physician-diagnosed moderate-to-severe, persistent asthma requiring treatment with appropriate asthma controller medication\n* Shows forced expiratory volume in 1 second (FEV1) reversibility postbronchodilator of greater than or equal to (\\>=)12 percent and \\>=200 milliliter (mL) or have shown such values in a previous test within the last year, or have a positive airway hyperresponsiveness (AHR) test result in the last year\n* Pre-bronchodilator FEV 1 value \\>=40 percent of individual predicted value at Visits 1 and 3\n* Uncontrolled asthma consistent with Expert Panel Report (EPR)-3. In the 2 to 4 weeks preceding Screening, subjects should have a history of 1 or more of the following: Daytime asthma symptoms \\>=2 days/week, Nighttime awakening \\>=1 night/week, Salbutamol use \\>=2 days/week\n* An Asthma control questionnaire (ACQ) score \\>=1.5 at Visits 1 and 3\n* At least 1 occurrence of asthma exacerbation in the past year that required an unscheduled medical encounter\n* Men, unless surgically sterile, must likewise practice 2 effective methods of birth control (condom with spermicide) and must use such precautions from Day 1 through Study Day 169\n* Otherwise healthy by medical history and physical examination for that age group\n* A chest x-ray or computed tomography (CT) scan within the previous 12 months with no findings suggestive of acute or chronic respiratory pathology other than asthma\n* Ability and willingness to complete the follow-up period until Day 169 as required by the protocol.\n\nExclusion Criteria:\n\n* Known history of allergy or reaction to any component of the investigational product formulation\n* Acute illness other than asthma at the start of the study\n* History of an active infection within 4 weeks prior to Screening, or evidence of clinically significant active infection, including ongoing chronic infection\n* History of ingestion of untreated water in a location known to be infected with parasites, resulting in acute or chronic diarrhea; or a diagnosis of parasitic infection within 6 months prior to Screening\n* Use of immunosuppressive medication (except oral prednisone up to 10 milligram/day (mg/day) and inhaled and topical corticosteroids) within 30 days before randomization into the study\n* Receipt of immunoglobulin or blood products within 30 days before randomization into the study\n* Receipt of any investigational drug therapy or use of any biologicals including omalizumab within 6 months before the first dose of investigational product in this study or within 5 half-lives of an investigational agent or biologic, whichever is longer\n* History of any known immunodeficiency disorder\n* A positive hepatitis B surface antigen, or hepatitis C virus antibody\n* A positive human immunodeficiency virus test or is taking antiretroviral medications, as determined by medical history and/or subject's verbal report\n* A live or attenuated vaccination received within 4 weeks prior to Screening\n* Previous medical history, or evidence, of an intercurrent illness that may compromise the safety of the subject in the study\n* History of clinically significant abnormality on electrocardiogram (ECG) in the opinion of the investigator\n* Lactation (women)\n* History of treatment for alcohol or drug abuse within the past year\n* History suggestive of chronic obstructive pulmonary disease (COPD) and of cigarette smoking \\>=10 pack-years\n* Evidence of any systemic disease on physical examination\n* History of cancer, apart from basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy less than or equal to (\\<=)1 year prior to Study Day 1 or other malignancies treated with apparent success with curative therapy \\<=5 years prior to entry\n* Known exposure to inhaled occupational agents or fumes\n* Any condition (eg, cystic fibrosis \\[CF\\] or COPD) that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of study results\n* Individuals who are legally institutionalized\n* Employees of the clinical study site or any other individuals involved with the conduct of the study, or family members of such individuals."}, 'identificationModule': {'nctId': 'NCT00873860', 'briefTitle': 'Study to Evaluate the Safety and Efficacy of CAT-354', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedImmune LLC'}, 'officialTitle': 'A Phase 2a, Randomized, Double-blind, Placebo-Controlled, Parallel-Arm, Multicenter Study to Evaluate the Efficacy and Safety of CAT-354, a Recombinant Human Monoclonal Antibody Directed Against Interleukin-13 (IL-13), on Asthma Control in Adults With Uncontrolled, Moderate-to-severe, Persistent Asthma', 'orgStudyIdInfo': {'id': 'MI-CP199'}, 'secondaryIdInfos': [{'id': '2008-007844-33', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'CAT-354 150 mg', 'description': 'CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.', 'interventionNames': ['Biological: CAT-354 150 mg']}, {'type': 'EXPERIMENTAL', 'label': 'CAT-354 300 mg', 'description': 'CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.', 'interventionNames': ['Biological: CAT-354 300 mg']}, {'type': 'EXPERIMENTAL', 'label': 'CAT-354 600 mg', 'description': 'CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.', 'interventionNames': ['Biological: CAT-354 600 mg']}], 'interventions': [{'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.', 'armGroupLabels': ['Placebo']}, {'name': 'CAT-354 150 mg', 'type': 'BIOLOGICAL', 'otherNames': ['Tralokinumab'], 'description': 'CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.', 'armGroupLabels': ['CAT-354 150 mg']}, {'name': 'CAT-354 300 mg', 'type': 'BIOLOGICAL', 'otherNames': ['Tralokinumab'], 'description': 'CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.', 'armGroupLabels': ['CAT-354 300 mg']}, {'name': 'CAT-354 600 mg', 'type': 'BIOLOGICAL', 'otherNames': ['Tralokinumab'], 'description': 'CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.', 'armGroupLabels': ['CAT-354 600 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Burgas', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 42.50651, 'lon': 27.46886}}, {'zip': '4000', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '7000', 'city': 'Rousse', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 43.84872, 'lon': 25.9534}}, {'city': 'Rousse', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 43.84872, 'lon': 25.9534}}, {'zip': '1000', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1431', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1606', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Sofia III', 'country': 'Bulgaria', 'facility': 'Research Site'}, {'city': 'Sofia II', 'country': 'Bulgaria', 'facility': 'Research Site'}, {'zip': '6000', 'city': 'Stara Zagora', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 42.43205, 'lon': 25.64262}}, {'city': 'Stara Zagora', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 42.43205, 'lon': 25.64262}}, {'zip': '9000', 'city': 'Varna', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 43.21912, 'lon': 27.91024}}, {'city': 'Varna', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 43.21912, 'lon': 27.91024}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14057', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '60389', 'city': 'Frankfurt am Main', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'city': 'Frankfurt am Main', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'city': 'Landsberg A. Lech', 'country': 'Germany', 'facility': 'Research Site'}, {'zip': '86899', 'city': 'Lich', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.52085, 'lon': 8.81567}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'city': 'Mainz', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'city': 'Bielsko-Biala', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 49.82245, 'lon': 19.04686}}, {'zip': '80-211', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '90-153', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'city': 'Lodz', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'city': 'Pikary Slaskie', 'country': 'Poland', 'facility': 'Research Site'}, {'zip': '41-940', 'city': 'Skalskie', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 50.28467, 'lon': 19.58882}}, {'zip': '00-909', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '01-138', 'city': 'Warsazawa', 'country': 'Poland', 'facility': 'Research Site'}, {'city': 'Warszawa II', 'country': 'Poland', 'facility': 'Research Site'}, {'zip': '54-239', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '41-800', 'city': 'Zabrze', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 50.32492, 'lon': 18.78576}}, {'city': 'Zabrze', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 50.32492, 'lon': 18.78576}}, {'city': 'Zabrze II', 'country': 'Poland', 'facility': 'Research Site'}, {'zip': '310011', 'city': 'Arad', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 46.18333, 'lon': 21.31667}}, {'zip': '310085', 'city': 'Arad', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 46.18333, 'lon': 21.31667}}, {'city': 'Arad', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 46.18333, 'lon': 21.31667}}, {'zip': '030303', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '050159', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '050554', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '400371', 'city': 'Cluj-Napoca', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'city': 'Cluj-Napoca', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'zip': '050554', 'city': 'Deva', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 45.88333, 'lon': 22.9}}, {'city': 'Deva', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 45.88333, 'lon': 22.9}}, {'zip': '300310', 'city': 'Timisoara Timis', 'country': 'Romania', 'facility': 'Research Site'}, {'city': 'Timișoara', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}, {'zip': 'M23 9QZ', 'city': 'Wythenshawe', 'state': 'Manchester', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.38027, 'lon': -2.2654}}, {'zip': 'CB23 2TN', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'LE3 9QP', 'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'MedImmune LLC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MedImmune LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MedImmune LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}