Viewing Study NCT01708603

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Ignite Creation Date: 2025-12-24 @ 7:32 PM
Ignite Modification Date: 2025-12-30 @ 8:32 PM
Study NCT ID: NCT01708603
Status: TERMINATED
Last Update Posted: 2020-01-06
First Post: 2012-09-12
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571216', 'term': 'brodalumab'}, {'id': 'D000069549', 'term': 'Ustekinumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '510-259-5284', 'title': 'Study Director', 'organization': 'Bausch Health'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '210 mg Brodalumab', 'description': 'Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.\n\n210 mg brodalumab: 210 mg brodalumab administered SC', 'otherNumAtRisk': 612, 'otherNumAffected': 354, 'seriousNumAtRisk': 612, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': '140 mg Brodalumab', 'description': 'Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.\n\n140 mg brodalumab: 140 mg brodalumab administered SC', 'otherNumAtRisk': 610, 'otherNumAffected': 365, 'seriousNumAtRisk': 610, 'seriousNumAffected': 13}, {'id': 'EG002', 'title': 'Ustekinumab', 'description': 'Administered by subcutaneous (SC) injection per the labeled dosing regimen.\n\nustekinumab: 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.', 'otherNumAtRisk': 300, 'otherNumAffected': 177, 'seriousNumAtRisk': 300, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.\n\n210 mg brodalumab: 210 mg brodalumab administered SC\n\nplacebo: Placebo administered SC', 'otherNumAtRisk': 309, 'otherNumAffected': 165, 'seriousNumAtRisk': 309, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory Tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral Upper respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oral Herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjuncitvitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tooth Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Otitis Media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Psoriatic Arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muskuloskelital Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neck Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Joint Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Groin Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus Generalized', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Seborrhoeic Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Intertrigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Migrane', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Odema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle Strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Joint Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Pancreatitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood Glucose Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetes Mellitus Inadequate Control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysponea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Escherichia Urinary tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hip Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ligament Rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Noncardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Alcohol Abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Carbon Monoxide Poisining', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerbebral Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chondromalacia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chondropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Drug Detoxification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fibromyalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Joint Capsule Rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ligament Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Prostate Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Coronary Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 612, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 610, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '612', 'groupId': 'OG000'}, {'value': '610', 'groupId': 'OG001'}, {'value': '309', 'groupId': 'OG002'}, {'value': '300', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '210 mg Brodalumab', 'description': 'Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.\n\n210 mg brodalumab: 210 mg brodalumab administered SC'}, {'id': 'OG001', 'title': '140 mg Brodalumab', 'description': 'Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.\n\n140 mg brodalumab: 140 mg brodalumab administered SC'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.\n\n210 mg brodalumab: 210 mg brodalumab administered SC\n\nplacebo: Placebo administered SC'}, {'id': 'OG003', 'title': 'Ustekinumab', 'description': 'Administered by subcutaneous (SC) injection until week 12. Participants using Ustekinumab were not rerandomized at week 12, and continued to receive ustekinumab.'}], 'classes': [{'categories': [{'measurements': [{'value': '481', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '183', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': "Measures the physician's impression of the disease at a single point, and a dynamic form in which the physician assesses the global improvement from baseline. Success is defined by a score of 0 or 1 (clear to almost clear).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '612', 'groupId': 'OG000'}, {'value': '610', 'groupId': 'OG001'}, {'value': '309', 'groupId': 'OG002'}, {'value': '300', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '210 mg Brodalumab', 'description': 'Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.\n\n210 mg brodalumab: 210 mg brodalumab administered SC'}, {'id': 'OG001', 'title': '140 mg Brodalumab', 'description': 'Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.\n\n140 mg brodalumab: 140 mg brodalumab administered SC'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Brodalumab Placebo'}, {'id': 'OG003', 'title': 'Ustekinumab', 'description': 'Administered by subcutaneous (SC) injection until week 12. Participants using Ustekinumab were not rerandomized at week 12, and continued to receive ustekinumab.'}], 'classes': [{'categories': [{'measurements': [{'value': '528', 'groupId': 'OG000'}, {'value': '406', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '210', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': 'to evaluate the efficacy of Brodalumab (210mg every 2 weeks, and 140mg every 2 weeks) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75 at week 12.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '612', 'groupId': 'OG000'}, {'value': '610', 'groupId': 'OG001'}, {'value': '309', 'groupId': 'OG002'}, {'value': '300', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Brodalumab 210mg', 'description': 'Brodalumab 210mg Q2W'}, {'id': 'OG001', 'title': 'Brodalumab 140mg', 'description': 'Brodalumab 140mg Q2W'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Brodalumab placebo'}, {'id': 'OG003', 'title': 'Ustekinumab', 'description': 'Ustekinumab administered in a dose of 45mg in a prefilled syringe of 0.5mL'}], 'classes': [{'categories': [{'measurements': [{'value': '272', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Weeks', 'description': 'to evaluate the efficacy of Brodalumab (210mg Q2W) in clearing psoriasis as measured by the proportion of subjects achieving PASI 100 at week 12.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '210 mg Brodalumab', 'description': 'Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.\n\n210 mg brodalumab: 210 mg brodalumab administered SC'}, {'id': 'FG001', 'title': '140 mg Brodalumab', 'description': 'Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.\n\n140 mg brodalumab: 140 mg brodalumab administered SC'}, {'id': 'FG002', 'title': 'Ustekinumab', 'description': 'Administered by subcutaneous (SC) injection per the labeled dosing regimen.\n\nustekinumab: 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.\n\n210 mg brodalumab: 210 mg brodalumab administered SC\n\nplacebo: Placebo administered SC'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '612'}, {'groupId': 'FG001', 'numSubjects': '610'}, {'groupId': 'FG002', 'numSubjects': '300'}, {'groupId': 'FG003', 'numSubjects': '309'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '597'}, {'groupId': 'FG001', 'numSubjects': '588'}, {'groupId': 'FG002', 'numSubjects': '291'}, {'groupId': 'FG003', 'numSubjects': '300'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '612', 'groupId': 'BG000'}, {'value': '610', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}, {'value': '309', 'groupId': 'BG003'}, {'value': '1831', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '210 mg Brodalumab', 'description': 'Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.\n\n210 mg brodalumab: 210 mg brodalumab administered SC'}, {'id': 'BG001', 'title': '140 mg Brodalumab', 'description': 'Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.\n\n140 mg brodalumab: 140 mg brodalumab administered SC'}, {'id': 'BG002', 'title': 'Ustekinumab', 'description': 'Administered by subcutaneous (SC) injection per the labeled dosing regimen.\n\nustekinumab: 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.\n\n210 mg brodalumab: 210 mg brodalumab administered SC\n\nplacebo: Placebo administered SC'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.5', 'spread': '12.7', 'groupId': 'BG000'}, {'value': '44.8', 'spread': '12.8', 'groupId': 'BG001'}, {'value': '45.4', 'spread': '13.0', 'groupId': 'BG002'}, {'value': '43.7', 'spread': '12.9', 'groupId': 'BG003'}, {'value': '44.6', 'spread': '12.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '191', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}, {'value': '573', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '421', 'groupId': 'BG000'}, {'value': '413', 'groupId': 'BG001'}, {'value': '205', 'groupId': 'BG002'}, {'value': '219', 'groupId': 'BG003'}, {'value': '1258', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '551', 'groupId': 'BG000'}, {'value': '557', 'groupId': 'BG001'}, {'value': '271', 'groupId': 'BG002'}, {'value': '273', 'groupId': 'BG003'}, {'value': '1652', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '195', 'groupId': 'BG004'}]}]}, {'title': 'Czechia', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '286', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}, {'value': '851', 'groupId': 'BG004'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}, {'value': '391', 'groupId': 'BG004'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '118', 'groupId': 'BG004'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}]}]}, {'title': 'Portugal', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '59', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1831}}, 'statusModule': {'whyStopped': 'Sponsor decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'dispFirstSubmitDate': '2015-04-20', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-03', 'studyFirstSubmitDate': '2012-09-12', 'dispFirstSubmitQcDate': '2015-04-20', 'resultsFirstSubmitDate': '2016-10-31', 'studyFirstSubmitQcDate': '2012-10-15', 'dispFirstPostDateStruct': {'date': '2015-05-07', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-03', 'studyFirstPostDateStruct': {'date': '2012-10-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12', 'timeFrame': '12 weeks', 'description': "Measures the physician's impression of the disease at a single point, and a dynamic form in which the physician assesses the global improvement from baseline. Success is defined by a score of 0 or 1 (clear to almost clear)."}, {'measure': 'Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12', 'timeFrame': '12 weeks', 'description': 'to evaluate the efficacy of Brodalumab (210mg every 2 weeks, and 140mg every 2 weeks) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75 at week 12.'}, {'measure': 'Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12', 'timeFrame': '12 Weeks', 'description': 'to evaluate the efficacy of Brodalumab (210mg Q2W) in clearing psoriasis as measured by the proportion of subjects achieving PASI 100 at week 12.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['psoriasis, brodalumab, AMG 827'], 'conditions': ['Moderate to Severe Plaque Psoriasis']}, 'referencesModule': {'references': [{'pmid': '39264399', 'type': 'DERIVED', 'citation': 'Lebwohl MG, Armstrong AW, Alexis AF, Lain EL, Jacobson AA. Efficacy of Brodalumab in Patients with Psoriasis and Risk Factors for Treatment Failure: A Review of Post Hoc Analyses. Dermatol Ther (Heidelb). 2024 Oct;14(10):2709-2726. doi: 10.1007/s13555-024-01264-3. Epub 2024 Sep 12.'}, {'pmid': '34606048', 'type': 'DERIVED', 'citation': 'Kokolakis G, Vadstrup K, Hansen JB, Carrascosa JM. Increased Skin Clearance and Quality of Life Improvement with Brodalumab Compared with Ustekinumab in Psoriasis Patients with Aggravating Lifestyle Factors. Dermatol Ther (Heidelb). 2021 Dec;11(6):2027-2042. doi: 10.1007/s13555-021-00618-5. Epub 2021 Oct 2.'}, {'pmid': '32207067', 'type': 'DERIVED', 'citation': 'Gottlieb A, Lebwohl M, Liu C, Israel RJ, Jacobson A. Malignancy Rates in Brodalumab Clinical Studies for Psoriasis. Am J Clin Dermatol. 2020 Jun;21(3):421-430. doi: 10.1007/s40257-020-00512-4.'}, {'pmid': '30471012', 'type': 'DERIVED', 'citation': 'McMichael A, Desai SR, Qureshi A, Rastogi S, Alexis AF. Efficacy and Safety of Brodalumab in Patients with Moderate-to-Severe Plaque Psoriasis and Skin of Color: Results from the Pooled AMAGINE-2/-3 Randomized Trials. Am J Clin Dermatol. 2019 Apr;20(2):267-276. doi: 10.1007/s40257-018-0408-z.'}, {'pmid': '30328108', 'type': 'DERIVED', 'citation': 'Langley RG, Armstrong AW, Lebwohl MG, Blauvelt A, Hsu S, Tyring S, Rastogi S, Pillai R, Israel R. Efficacy and safety of brodalumab in patients with psoriasis who had inadequate responses to ustekinumab: subgroup analysis of two randomized phase III trials. Br J Dermatol. 2019 Feb;180(2):306-314. doi: 10.1111/bjd.17318. Epub 2018 Dec 27.'}, {'pmid': '26422722', 'type': 'DERIVED', 'citation': 'Lebwohl M, Strober B, Menter A, Gordon K, Weglowska J, Puig L, Papp K, Spelman L, Toth D, Kerdel F, Armstrong AW, Stingl G, Kimball AB, Bachelez H, Wu JJ, Crowley J, Langley RG, Blicharski T, Paul C, Lacour JP, Tyring S, Kircik L, Chimenti S, Callis Duffin K, Bagel J, Koo J, Aras G, Li J, Song W, Milmont CE, Shi Y, Erondu N, Klekotka P, Kotzin B, Nirula A. Phase 3 Studies Comparing Brodalumab with Ustekinumab in Psoriasis. N Engl J Med. 2015 Oct;373(14):1318-28. doi: 10.1056/NEJMoa1503824.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses', 'detailedDescription': '.The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis. A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis. A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject has had stable moderate to severe plaque psoriasis for at least 6 months\n* Subject has involved body surface area (BSA) ≥ 10%, PASI ≥ 12, and sPGA ≥ 3 at screening and at baseline\n\nExclusion Criteria:\n\n* Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at (eg, eczema) that would interfere with study evaluations\n* Subject has known history of Crohn's disease\n* Subject has any other significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol\n* Subject has not stopped using certain psoriasis therapies as defined in the study protocol\n* Subject has previously used ustekinumab or any anti-IL-17 biologic therapy\n* Subject is pregnant or breastfeeding, or planning to become pregnant while enrolled in the study\n* Female subject is unwilling to use highly effective methods of birth control unless 2 years post-menopausal or surgically sterile"}, 'identificationModule': {'nctId': 'NCT01708603', 'acronym': 'AMAGINE-2', 'briefTitle': 'P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch Health Americas, Inc.'}, 'officialTitle': 'A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-2', 'orgStudyIdInfo': {'id': '20120103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '210 mg brodalumab', 'description': 'Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.', 'interventionNames': ['Drug: 210 mg brodalumab']}, {'type': 'EXPERIMENTAL', 'label': '140 mg brodalumab', 'description': 'Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.', 'interventionNames': ['Drug: 140 mg brodalumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ustekinumab', 'description': 'Administered by subcutaneous (SC) injection per the labeled dosing regimen.', 'interventionNames': ['Drug: ustekinumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.', 'interventionNames': ['Drug: 210 mg brodalumab', 'Drug: placebo']}], 'interventions': [{'name': '210 mg brodalumab', 'type': 'DRUG', 'description': '210 mg brodalumab administered SC', 'armGroupLabels': ['210 mg brodalumab', 'Placebo']}, {'name': '140 mg brodalumab', 'type': 'DRUG', 'description': '140 mg brodalumab administered SC', 'armGroupLabels': ['140 mg brodalumab']}, {'name': 'ustekinumab', 'type': 'DRUG', 'description': '45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.', 'armGroupLabels': ['ustekinumab']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Placebo administered SC', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85710', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92697', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90045', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92083', 'city': 'Vista', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.20004, 'lon': -117.24254}}, {'zip': '80209', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80210', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80239', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33028', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30263', 'city': 'Newnan', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.38067, 'lon': -84.79966}}, {'zip': '30078', 'city': 'Snellville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.85733, 'lon': -84.01991}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60654', 'city': 'Chicago', 'state': 'Illinois', 'country': 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