Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT05335356
Status:
COMPLETED
Last Update Posted:
2025-09-12
First Post:
2022-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparing Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'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': {'email': 'Sarika.Deodhar@biocon.com', 'phone': '080 2808', 'title': 'Dr Sarika D', 'phoneExt': '5302', 'organization': 'Biocon Biologics Limited'}, 'certainAgreement': {'otherDetails': 'Data are the property of the Sponsor and cannot be published without prior authorization from the Sponsor, but data and publication thereof will not be unduly withheld.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment Emergent Adverse Events (TEAEs) through the Study (Week 52)', 'eventGroups': [{'id': 'EG000', 'title': 'Bmab1200', 'description': 'Bmab 1200 45 mg Bmab 1200 90 mg\n\nBmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40', 'otherNumAtRisk': 191, 'deathsNumAtRisk': 191, 'otherNumAffected': 111, 'seriousNumAtRisk': 191, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Stelara', 'description': 'Stelara 45 mg Stelara 90 mg\n\nStelara: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40; Before dosing at Week 16, patients in the Stelara group were randomly assigned in a 1:1 ratio to receive either Bmab 1200 or Stelara', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 48, 'seriousNumAtRisk': 101, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Stelara-Bmab1200', 'description': 'Bmab 1200 45 mg 90 mg Stelara 45 mg 90 mg\n\nSubject who received Stelara 45 mg dose have received Bmab 1200 dose 45 mg Subject who received Stelara 90 mg dose have received Bmab 1200 dose 90 mg', 'otherNumAtRisk': 92, 'deathsNumAtRisk': 92, 'otherNumAffected': 51, 'seriousNumAtRisk': 92, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 23, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vaginal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Tonsillitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Asymptomatic bacteriuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Bacteriuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Fungal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastrointestinal viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Giardiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Onychomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Peritonsillar abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Sinusitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Tongue fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Urethritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Urinary tract infection fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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'MedDRA 26.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Genital haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Heavy menstrual bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Menstruation irregular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Uterovaginal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Essential hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Endometrial adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Haemangioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Squamous cell carcinoma of the tongue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Eyelid oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Tympanic membrane perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Atrial septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'seriousEvents': [{'term': 'Squamous cell carcinoma of the tongue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Endometrial adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Jaundice cholestatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Uterovaginal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Psoriasis Area and Severity Index (PASI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bmab1200', 'description': 'Bmab 1200 45 mg Bmab 1200 90 mg\n\nBmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40'}, {'id': 'OG001', 'title': 'Stelara', 'description': 'Stelara 45 mg Stelara 90 mg\n\nStelara: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40; Before dosing at Week 16, patients in the Stelara group were randomly assigned in a 1:1 ratio to receive either Bmab 1200 or Stelara'}], 'classes': [{'categories': [{'measurements': [{'value': '-79.87', 'spread': '2.818', 'groupId': 'OG000'}, {'value': '-80.55', 'spread': '2.783', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Percentage change from baseline in the Psoriasis Area and Severity Index score at Week 12', 'unitOfMeasure': 'Percentage change from baseline', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'PASI Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bmab1200', 'description': 'Bmab 1200 45 mg Bmab 1200 90 mg\n\nBmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40'}, {'id': 'OG001', 'title': 'Stelara', 'description': 'Stelara 45 mg Stelara 90 mg\n\nStelara: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40; Before dosing at Week 16, patients in the Stelara group were randomly assigned in a 1:1 ratio to receive either Bmab 1200 or Stelara'}, {'id': 'OG002', 'title': 'Stelara-Bmab 1200', 'description': 'Bmab 1200 45 mg 90 mg Stelara 45 mg 90 mg\n\nSubject who received Stelara 45 mg dose have received Bmab 1200 dose 45 mg Subject who received Stelara 90 mg dose have received Bmab 1200 dose 90 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-95.50', 'spread': '6.068', 'groupId': 'OG000'}, {'value': '-96.01', 'spread': '6.461', 'groupId': 'OG001'}, {'value': '-95.44', 'spread': '7.321', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through Week 28', 'description': 'Percentage change from baseline in the PASI score at Baseline through Week 28.\n\nPASI is a quantitative rating score for measuring the severity of psoriatic lesions based on area coverage, plaque appearance, their response to therapy. 4 regions- head, upper limbs, trunk, and lower limbs are assessed separately for erythema, induration/thickness, and scaling. Degree of involvement is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement) for each region. Total score (sum of erythema, thickness, and scaling) is multiplied by the degree of involvement for each body region and then multiplied by constant. Sum of all lesion scores can range from 0 (no disease) to 72 (maximal disease), with the higher score indicating more severe disease. Change from baseline in PASI score indicates response to therapy. PASI 50 means ≥50% reduction from baseline in the PASI score', 'unitOfMeasure': 'Percentage change from Baseline in Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'PASI Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bmab1200', 'description': 'Bmab 1200 45 mg Bmab 1200 90 mg\n\nBmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40'}, {'id': 'OG001', 'title': 'Stelara-Stelara', 'description': 'Before dosing at Week 16, patients in the Stelara group were randomly assigned in a 1:1 ratio to receive either Bmab 1200 or Stelara Those patients who were randomized to Stelara received a further 2 doses as given below Stelara 45 mg, patients weighing \\<100 kg at Week 16, and 28 ; Stelara 90 mg, patients weighing \\>100 kg at Week 16, and 28 ;'}, {'id': 'OG002', 'title': 'Stelara-Bmab 1200', 'description': 'Those patients who were receiving stelara and randomised to Bmab1200 received a further 1 dose in TP3 as given below Bmab 1200 45 mg, patients weighing \\<100 kg at Week 40 ; Bmab 1200 90 mg, patients weighing \\>100 kg at week 40'}], 'classes': [{'title': 'PASI 50', 'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}]}, {'title': 'PASI 75', 'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}]}, {'title': 'PASI 90', 'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline through Week 28', 'description': 'PASI improvement of ≥50% relative to baseline (PASI 50), PASI improvement of ≥75% relative to baseline (PASI 75), and PASI improvement of ≥90% relative to Baseline through Week 28 and 52\n\nPASI is a quantitative rating score for measuring the severity of psoriatic lesions based on area coverage, plaque appearance, their response to therapy. 4 regions- head, upper limbs, trunk, and lower limbs are assessed separately for erythema, induration/thickness, and scaling. Degree of involvement is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement) for each region. Total score (sum of erythema, thickness, and scaling) is multiplied by the degree of involvement for each body region and then multiplied by constant. Sum of all lesion scores can range from 0 (no disease) to 72 (maximal disease), with the higher score indicating more severe disease. Change from baseline in PASI score indicates response to therapy. PASI 50 means ≥50% reduction from baseline in the PASI score', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Static Physician's Global Assessment (sPGA)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bmab1200', 'description': 'Bmab 1200 45 mg Bmab 1200 90 mg\n\nBmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40'}, {'id': 'OG001', 'title': 'Stelara', 'description': 'Stelara 45 mg Stelara 90 mg\n\nStelara: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40; Before dosing at Week 16, patients in the Stelara group were randomly assigned in a 1:1 ratio to receive either Bmab 1200 or Stelara'}, {'id': 'OG002', 'title': 'Stelara-Bmab 1200', 'description': 'Bmab 1200 45 mg 90 mg Stelara 45 mg 90 mg\n\nSubject who received Stelara 45 mg dose have received Bmab 1200 dose 45 mg Subject who received Stelara 90 mg dose have received Bmab 1200 dose 90 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.0', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '1.21', 'groupId': 'OG001'}, {'value': '-2.8', 'spread': '1.28', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through Week 28', 'description': "Change from Baseline in sPGA During TP2.\n\nThe sPGA is a quantitative rating score of the patient's psoriasis based on physician's assessment at a given time point according to the following categories: induration, erythema, and scaling. The sPGA is a 6-point scale and patient's psoriasis is graded as clear (0), minimal (1), mild (2), moderate (3), marked (4), severe (5). The sum of the scores for induration, erythema, and scaling will be divided by 3 to obtain a final sPGA score. lower score indicates better disease status", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'sPGA-(averaged over all lesions); Score range: 0-5 Induration (I): 0 (no plaque-elevation) to 5 (severe plaque-elevation); Erythema (E): 0 (no erythema, hyperpigmentation maybe present) to 5 (dusky to deep-red coloration); Scaling (S): 0 (no scaling) to 5 (severe-very thick tenacious scale) sPGA based on Total-Average (I+E+S= /3): 0 (Cleared, except for residual discoloration) to 5 (Severe, majority of lesions have individual scores for I+E+S/3 that averages 5) Refer Apndx3-Protocol V3.0'}, {'type': 'SECONDARY', 'title': 'Affected Body Surface Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bmab1200', 'description': 'Bmab 1200 45 mg Bmab 1200 90 mg\n\nBmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40'}, {'id': 'OG001', 'title': 'Stelara', 'description': 'Stelara 45 mg Stelara 90 mg\n\nStelara: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40; Before dosing at Week 16, patients in the Stelara group were randomly assigned in a 1:1 ratio to receive either Bmab 1200 or Stelara'}, {'id': 'OG002', 'title': 'Stelara-Bmab 1200', 'description': 'Bmab 1200 45 mg 90 mg Stelara 45 mg 90 mg\n\nSubject who received Stelara 45 mg dose have received Bmab 1200 dose 45 mg Subject who received Stelara 90 mg dose have received Bmab 1200 dose 90 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-26.52', 'spread': '15.152', 'groupId': 'OG000'}, {'value': '-25.91', 'spread': '13.323', 'groupId': 'OG001'}, {'value': '-28.33', 'spread': '17.251', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through Week 28', 'description': "Change from baseline in affected body surface area at Weeks 28\n\nTotal % BSA afflicted by psoriasis is estimated using a handprint of the patient at each visit . The entire palmar surface of the patient's handprint is assumed to correspond to approximately 1% of total BSA. Reduction in BSA indicates improvement", 'unitOfMeasure': 'Percentage of total body surface area', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Dermatology Life Quality Index Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bmab1200', 'description': 'Bmab 1200 45 mg Bmab 1200 90 mg\n\nBmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40'}, {'id': 'OG001', 'title': 'Stelara', 'description': 'Stelara 45 mg Stelara 90 mg\n\nStelara: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40; Before dosing at Week 16, patients in the Stelara group were randomly assigned in a 1:1 ratio to receive either Bmab 1200 or Stelara'}, {'id': 'OG002', 'title': 'Stelara-Bmab 1200', 'description': 'Bmab 1200 45 mg 90 mg Stelara 45 mg 90 mg\n\nSubject who received Stelara 45 mg dose have received Bmab 1200 dose 45 mg Subject who received Stelara 90 mg dose have received Bmab 1200 dose 90 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.2', 'spread': '6.84', 'groupId': 'OG000'}, {'value': '-10.5', 'spread': '6.74', 'groupId': 'OG001'}, {'value': '-12.2', 'spread': '7.08', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through Week 28', 'description': 'Change from baseline in quality of life as measured by Dermatology Life Quality Index scores at Weeks 28\n\nIt is a 10-item patient-reported outcome questionnaire that, in addition to evaluating overall QoL, can be used to assess 6 different aspects that may affect QoL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Nine of the 10 questions have response categories including "not relevant" (score of 0), "not at all" (score of 0), "a little" (score of 1), "a lot" (score of 2) and "very much" (score of 3); Question 7 is a "yes"/ "no" question where "yes" is scored as 3. Eight items also have a "Not relevant" option scored "0," which indicates no problems. Total scores range from 0 to 30 (less to more impairment) and a 5-point change from baseline is considered a clinically important difference.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Dermatology Life Quality Index Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bmab1200', 'description': 'Bmab 1200 45 mg Bmab 1200 90 mg\n\nBmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40'}, {'id': 'OG001', 'title': 'Stelara', 'description': 'Stelara 45 mg Stelara 90 mg\n\nStelara: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40; Before dosing at Week 16, patients in the Stelara group were randomly assigned in a 1:1 ratio to receive either Bmab 1200 or Stelara'}, {'id': 'OG002', 'title': 'Stelara-Bmab 1200', 'description': 'Bmab 1200 45 mg 90 mg Stelara 45 mg 90 mg\n\nSubject who received Stelara 45 mg dose have received Bmab 1200 dose 45 mg Subject who received Stelara 90 mg dose have received Bmab 1200 dose 90 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.8', 'spread': '6.73', 'groupId': 'OG000'}, {'value': '-11.5', 'spread': '6.35', 'groupId': 'OG001'}, {'value': '-12.7', 'spread': '6.98', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through Week 52', 'description': 'Change from baseline in quality of life as measured by Dermatology Life Quality Index scores at Weeks 52\n\nIt is a 10-item patient-reported outcome questionnaire that, in addition to evaluating overall QoL, can be used to assess 6 different aspects that may affect QoL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Nine of the 10 questions have response categories including "not relevant" (score of 0), "not at all" (score of 0), "a little" (score of 1), "a lot" (score of 2) and "very much" (score of 3); Question 7 is a "yes"/ "no" question where "yes" is scored as 3. Eight items also have a "Not relevant" option scored "0," which indicates no problems. Total scores range from 0 to 30 (less to more impairment) and a 5-point change from baseline is considered a clinically important difference.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Static Physician's Global Assessment (sPGA)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bmab1200', 'description': 'Bmab 1200 45 mg Bmab 1200 90 mg\n\nBmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40'}, {'id': 'OG001', 'title': 'Stelara', 'description': 'Stelara 45 mg Stelara 90 mg\n\nStelara: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40; Before dosing at Week 16, patients in the Stelara group were randomly assigned in a 1:1 ratio to receive either Bmab 1200 or Stelara'}, {'id': 'OG002', 'title': 'Stelara-Bmab 1200', 'description': 'Bmab 1200 45 mg 90 mg Stelara 45 mg 90 mg\n\nSubject who received Stelara 45 mg dose have received Bmab 1200 dose 45 mg Subject who received Stelara 90 mg dose have received Bmab 1200 dose 90 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.1', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '1.29', 'groupId': 'OG001'}, {'value': '-2.9', 'spread': '1.20', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through Week 52', 'description': "Change in Static Physician's Global Assessment (sPGA) at Weeks 52\n\nThe sPGA is a quantitative rating score of the patient's psoriasis based on physician's assessment at a given time point according to the following categories: induration, erythema, and scaling. The sPGA is a 6-point scale and patient's psoriasis is graded as clear (0), minimal (1), mild (2), moderate (3), marked (4), severe (5). The sum of the scores for induration, erythema, and scaling will be divided by 3 to obtain a final sPGA score. lower score indicates better disease status", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'sPGA-(averaged over all lesions); Score range: 0-5 Induration (I): 0 (no plaque-elevation) to 5 (severe plaque-elevation); Erythema (E): 0 (no erythema, hyperpigmentation maybe present) to 5 (dusky to deep-red coloration); Scaling (S): 0 (no scaling) to 5 (severe-very thick tenacious scale) sPGA based on Total-Average (I+E+S= /3): 0 (Cleared, except for residual discoloration) to 5 (Severe, majority of lesions have individual scores for I+E+S/3 that averages 5) Refer Apndx3-Protocol V3.0'}, {'type': 'SECONDARY', 'title': 'Affected Body Surface Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bmab1200', 'description': 'Bmab 1200 45 mg Bmab 1200 90 mg\n\nBmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40'}, {'id': 'OG001', 'title': 'Stelara', 'description': 'Stelara 45 mg Stelara 90 mg\n\nStelara: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40; Before dosing at Week 16, patients in the Stelara group were randomly assigned in a 1:1 ratio to receive either Bmab 1200 or Stelara'}, {'id': 'OG002', 'title': 'Stelara-Bmab 1200', 'description': 'Bmab 1200 45 mg 90 mg Stelara 45 mg 90 mg\n\nSubject who received Stelara 45 mg dose have received Bmab 1200 dose 45 mg Subject who received Stelara 90 mg dose have received Bmab 1200 dose 90 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-27.42', 'spread': '15.119', 'groupId': 'OG000'}, {'value': '-26.50', 'spread': '13.160', 'groupId': 'OG001'}, {'value': '-28.90', 'spread': '17.560', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through Week 52', 'description': "Change from baseline in affected body surface area at Weeks 52\n\nTotal % BSA afflicted by psoriasis is estimated using a handprint of the patient at each visit . The entire palmar surface of the patient's handprint is assumed to correspond to approximately 1% of total BSA. Reduction in BSA indicates improvement", 'unitOfMeasure': 'Change from Baseline in %BSA', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'PASI Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bmab1200', 'description': 'Bmab 1200 45 mg Bmab 1200 90 mg\n\nBmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40'}, {'id': 'OG001', 'title': 'Stelara', 'description': 'Stelara 45 mg Stelara 90 mg\n\nStelara: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40; Before dosing at Week 16, patients in the Stelara group were randomly assigned in a 1:1 ratio to receive either Bmab 1200 or Stelara'}, {'id': 'OG002', 'title': 'Stelara-Bmab 1200', 'description': 'Bmab 1200 45 mg 90 mg Stelara 45 mg 90 mg\n\nSubject who received Stelara 45 mg dose have received Bmab 1200 dose 45 mg Subject who received Stelara 90 mg dose have received Bmab 1200 dose 90 mg'}], 'classes': [{'title': 'PASI 50', 'categories': [{'measurements': [{'value': '163', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}]}, {'title': 'PASI 75', 'categories': [{'measurements': [{'value': '159', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}]}, {'title': 'PASI 90', 'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline through week 52', 'description': 'PASI improvement of ≥50% relative to baseline (PASI 50), PASI improvement of ≥75% relative to baseline (PASI 75), and PASI improvement of ≥90% relative to Week 52', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Safety:-Treatment-emergent Adverse Events Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bmab1200', 'description': 'Bmab 1200 45 mg Bmab 1200 90 mg\n\nBmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40'}, {'id': 'OG001', 'title': 'Stelara', 'description': 'Stelara 45 mg Stelara 90 mg\n\nStelara: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40; Before dosing at Week 16, patients in the Stelara group were randomly assigned in a 1:1 ratio to receive either Bmab 1200 or Stelara'}, {'id': 'OG002', 'title': 'Stelara-Bmab1200', 'description': 'Bmab 1200 45 mg 90 mg Stelara 45 mg 90 mg\n\nSubject who received Stelara 45 mg dose have received Bmab 1200 dose 45 mg Subject who received Stelara 90 mg dose have received Bmab 1200 dose 90 mg'}], 'classes': [{'title': 'Endometrial adenocarcinoma', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Squamous cell carcinoma of the tongue', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Angioedema', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Rash maculo-papular', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Abdominal pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Jaundice cholestatic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Alcohol poisoning', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 52', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Safety:- Injection-site Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bmab1200', 'description': 'Bmab 1200 45 mg Bmab 1200 90 mg\n\nBmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40'}, {'id': 'OG001', 'title': 'Stelara', 'description': 'Stelara 45 mg Stelara 90 mg\n\nStelara: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40; Before dosing at Week 16, patients in the Stelara group were randomly assigned in a 1:1 ratio to receive either Bmab 1200 or Stelara'}, {'id': 'OG002', 'title': 'Stelara-Bmab1200', 'description': 'Bmab 1200 45 mg 90 mg Stelara 45 mg 90 mg\n\nSubject who received Stelara 45 mg dose have received Bmab 1200 dose 45 mg Subject who received Stelara 90 mg dose have received Bmab 1200 dose 90 mg'}], 'timeFrame': 'Baseline through Week 28 and 52', 'description': 'Injection-site reactions at Day 1, Week 4, Week 16, and throughout the study', 'reportingStatus': 'POSTED', 'populationDescription': 'NAb status with no injection site reactions being reported.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Safety:- Hypersensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bmab1200', 'description': 'Bmab 1200 45 mg Bmab 1200 90 mg\n\nBmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40'}, {'id': 'OG001', 'title': 'Stelara', 'description': 'Stelara 45 mg Stelara 90 mg\n\nStelara: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40; Before dosing at Week 16, patients in the Stelara group were randomly assigned in a 1:1 ratio to receive either Bmab 1200 or Stelara'}, {'id': 'OG002', 'title': 'Stelara-Bmab 1200', 'description': 'Bmab 1200 45 mg 90 mg Stelara 45 mg 90 mg\n\nSubject who received Stelara 45 mg dose have received Bmab 1200 dose 45 mg Subject who received Stelara 90 mg dose have received Bmab 1200 dose 90 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 52', 'description': 'Hypersensitivity at Day 1, Week 4, Week 16, and throughout the study', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Immunogenicity:-Developing Antidrug Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bmab1200', 'description': 'Bmab 1200 45 mg Bmab 1200 90 mg\n\nBmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40'}, {'id': 'OG001', 'title': 'Stelara', 'description': 'Stelara 45 mg Stelara 90 mg\n\nStelara: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40; Before dosing at Week 16, patients in the Stelara group were randomly assigned in a 1:1 ratio to receive either Bmab 1200 or Stelara'}, {'id': 'OG002', 'title': 'Stelara-Bmab 1200', 'description': 'Bmab 1200 45 mg 90 mg Stelara 45 mg 90 mg\n\nSubject who received Stelara 45 mg dose have received Bmab 1200 dose 45 mg Subject who received Stelara 90 mg dose have received Bmab 1200 dose 90 mg'}], 'classes': [{'title': 'ADA positive', 'categories': [{'measurements': [{'value': '162', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}]}, {'title': 'ADA negative', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Patients with no post baseline ADA result', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 28', 'description': 'Proportion of patients developing antidrug antibodies', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'n = number of patients with available data'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Immunogenicity:-Developing Antidrug Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bmab1200', 'description': 'Bmab 1200 45 mg Bmab 1200 90 mg\n\nBmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40'}, {'id': 'OG001', 'title': 'Stelara', 'description': 'Stelara 45 mg Stelara 90 mg\n\nStelara: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40; Before dosing at Week 16, patients in the Stelara group were randomly assigned in a 1:1 ratio to receive either Bmab 1200 or Stelara'}, {'id': 'OG002', 'title': 'Stelara-Bmab 1200', 'description': 'Bmab 1200 45 mg 90 mg Stelara 45 mg 90 mg\n\nSubject who received Stelara 45 mg dose have received Bmab 1200 dose 45 mg Subject who received Stelara 90 mg dose have received Bmab 1200 dose 90 mg'}], 'classes': [{'title': 'ADA positive', 'categories': [{'measurements': [{'value': '131', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}]}, {'title': 'ADA negative', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Patients with no post baseline ADA result', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Postdosing Week 52', 'description': 'Proportion of patients developing antidrug antibodies', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'n = number of patients with available data'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Developing Neutralizing Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bmab1200', 'description': 'Bmab 1200 45 mg Bmab 1200 90 mg\n\nBmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40'}, {'id': 'OG001', 'title': 'Stelara', 'description': 'Stelara 45 mg Stelara 90 mg\n\nStelara: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40; Before dosing at Week 16, patients in the Stelara group were randomly assigned in a 1:1 ratio to receive either Bmab 1200 or Stelara'}, {'id': 'OG002', 'title': 'Stelara-Bmab 1200', 'description': 'Bmab 1200 45 mg 90 mg Stelara 45 mg 90 mg\n\nSubject who received Stelara 45 mg dose have received Bmab 1200 dose 45 mg Subject who received Stelara 90 mg dose have received Bmab 1200 dose 90 mg'}], 'classes': [{'title': 'Nab reactive', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}, {'title': 'Nab negative', 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 28', 'description': 'Proportion of patients neutralizing antibodies', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'n = number of patients with available data'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Developing Neutralizing Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bmab1200', 'description': 'Bmab 1200 45 mg Bmab 1200 90 mg\n\nBmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40'}, {'id': 'OG001', 'title': 'Stelara', 'description': 'Stelara 45 mg Stelara 90 mg\n\nStelara: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40; Before dosing at Week 16, patients in the Stelara group were randomly assigned in a 1:1 ratio to receive either Bmab 1200 or Stelara'}, {'id': 'OG002', 'title': 'Stelara-Bmab 1200', 'description': 'Bmab 1200 45 mg 90 mg Stelara 45 mg 90 mg\n\nSubject who received Stelara 45 mg dose have received Bmab 1200 dose 45 mg Subject who received Stelara 90 mg dose have received Bmab 1200 dose 90 mg'}], 'classes': [{'title': 'Nab reactive', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Nab negative', 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Postdosing Week 52', 'description': 'Proportion of patients neutralizing antibodies', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'n = number of patients with available data'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Pharmacokinetic:-Serum Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Bmab 1200 (1 Injection)', 'description': 'Patients who weigh ≤100 kg: Stelara® 45 mg (1 injection of 45 mg PFS)'}, {'id': 'OG001', 'title': 'Stelara-Stelara (1 Injection)', 'description': 'Patients who weigh ≤100 kg: Stelara® 45 mg (1 injection of 45 mg PFS)'}, {'id': 'OG002', 'title': 'Stelara-Bmab 1200 (1 Injection)', 'description': 'Patients who weigh ≤100 kg: Stelara® 45 mg (1 injection of 45 mg PFS)'}, {'id': 'OG003', 'title': 'Bmab 1200 (2 Injection)', 'description': 'Patients who weigh \\>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)'}, {'id': 'OG004', 'title': 'Stelara-Stelara (2 Injection)', 'description': 'Patients who weigh \\>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)'}, {'id': 'OG005', 'title': 'Stelara-Bmab 1200 ((2 Injection)', 'description': 'Patients who weigh \\>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)'}], 'classes': [{'categories': [{'measurements': [{'value': '678.308', 'spread': '444.7791', 'groupId': 'OG000'}, {'value': '589.780', 'spread': '418.9308', 'groupId': 'OG001'}, {'value': '620.793', 'spread': '398.1352', 'groupId': 'OG002'}, {'value': '796.833', 'spread': '392.6448', 'groupId': 'OG003'}, {'value': '1070.600', 'spread': '522.0039', 'groupId': 'OG004'}, {'value': '861.665', 'spread': '549.4014', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Postdosing on Week 28', 'description': 'Serum concentrations of ustekinumab', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Pharmacokinetic:-Serum Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Bmab 1200 (1 Injection)', 'description': 'Patients who weigh ≤100 kg: Stelara® 45 mg (1 injection of 45 mg PFS)'}, {'id': 'OG001', 'title': 'Stelara-Stelara (1 Injection)', 'description': 'Patients who weigh ≤100 kg: Stelara® 45 mg (1 injection of 45 mg PFS)'}, {'id': 'OG002', 'title': 'Stelara-Bmab 1200 (1 Injection)', 'description': 'Patients who weigh ≤100 kg: Stelara® 45 mg (1 injection of 45 mg PFS)'}, {'id': 'OG003', 'title': 'Bmab 1200 (2 Injection)', 'description': 'Patients who weigh \\>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)'}, {'id': 'OG004', 'title': 'Stelara-Stelara (2 Injection)', 'description': 'Patients who weigh \\>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)'}, {'id': 'OG005', 'title': 'Stelara-Bmab 1200 (2 Injection)', 'description': 'Patients who weigh \\>100 kg: Stelara® 90 mg (2 injections of 45 mg PFS)'}], 'classes': [{'categories': [{'measurements': [{'value': '728.029', 'spread': '477.1775', 'groupId': 'OG000'}, {'value': '665.403', 'spread': '379.9506', 'groupId': 'OG001'}, {'value': '653.908', 'spread': '415.8309', 'groupId': 'OG002'}, {'value': '881.343', 'spread': '510.0086', 'groupId': 'OG003'}, {'value': '1008.382', 'spread': '671.8667', 'groupId': 'OG004'}, {'value': '898.450', 'spread': '551.4494', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Postdosing on Week 52', 'description': 'Serum concentrations of Ustekinumab', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'PASI Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bmab1200', 'description': 'Bmab 1200 45 mg Bmab 1200 90 mg\n\nBmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40'}, {'id': 'OG001', 'title': 'Stelara', 'description': 'Stelara 45 mg Stelara 90 mg\n\nStelara: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40; Before dosing at Week 16, patients in the Stelara group were randomly assigned in a 1:1 ratio to receive either Bmab 1200 or Stelara'}, {'id': 'OG002', 'title': 'Stelara-Bmab 1200', 'description': 'Bmab 1200 45 mg 90 mg Stelara 45 mg 90 mg\n\nSubject who received Stelara 45 mg dose have received Bmab 1200 dose 45 mg Subject who received Stelara 90 mg dose have received Bmab 1200 dose 90 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-95.50', 'spread': '7.507', 'groupId': 'OG000'}, {'value': '-96.60', 'spread': '5.671', 'groupId': 'OG001'}, {'value': '-94.71', 'spread': '7.950', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through Week 52', 'description': 'Percentage change from baseline in the PASI score at Baseline through Week 52.\n\nThe PASI (Psoriasis Area and Severity Index) is a score from 0 to 72 that measures psoriasis severity based on lesion redness, thickness, scaling, and body area affected. The body is divided into four regions, each scored separately. Scores are calculated using severity and area involvement, and are used to assess treatment response (e.g., PASI 50 = 50% improvement).', 'unitOfMeasure': 'Percentage change from Baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bmab1200', 'description': 'Eligible patients were randomly assigned in a 1:1 ratio to receive Bmab 1200 or Stelara based on predefined stratification factors of geographic region (US vs Europe), body weight (≤100 kg vs \\>100 kg), previous exposure to biologic-based therapies (Yes vs No), and concomitant psoriatic arthritis (Yes vs No). Patients received study treatment at the baseline visit and Week 4. Patients weighing ≤100 kg received a subcutaneous dose of 45 mg of either drug at each of the above visits, while patients weighing \\>100 kg received a subcutaneous dose of 90 mg (45 mg × 2).'}, {'id': 'FG001', 'title': 'Stelara', 'description': 'Eligible patients were randomly assigned in a 1:1 ratio to receive Bmab 1200 or Stelara based on predefined stratification factors of geographic region (US vs Europe), body weight (≤100 kg vs \\>100 kg), previous exposure to biologic-based therapies (Yes vs No), and concomitant psoriatic arthritis (Yes vs No). Patients received study treatment at the baseline visit and Week 4. Patients weighing ≤100 kg received a subcutaneous dose of 45 mg of either drug at each of the above visits, while patients weighing \\>100 kg received a subcutaneous dose of 90 mg (45 mg × 2).'}, {'id': 'FG002', 'title': 'Bmab 1200- Bmab 1200', 'description': 'Before dosing at Week 16, patients in the Stelara group were randomly assigned in a 1:1 ratio to receive either Bmab 1200. This was done to obtain data after a single switch in patients who had been treated with Stelara.\n\nAll continuing patients who received study treatment with Bmab 1200 at the baseline visit and Week 4 and achieved at least PASI 50 response by Week 12 were rerandomized before receiving study treatment at Week 16. This was done to maintain the study blinding, i.e. the patients in the original Bmab 1200 group went through the rerandomization procedure; however, they were assigned and continued to receive Bmab 1200.'}, {'id': 'FG003', 'title': 'Stelara-Stelara', 'description': 'Before dosing at Week 16, patients in the Stelara group were randomly assigned in a 1:1 ratio to receive either Bmab 1200. This was done to obtain data after a single switch in patients who had been treated with Stelara.\n\nAll continuing patients who received study treatment with Bmab 1200 at the baseline visit and Week 4 and achieved at least PASI 50 response by Week 12 were rerandomized before receiving study treatment at Week 16. This was done to maintain the study blinding, i.e. the patients in the original Bmab 1200 group went through the rerandomization procedure; however, they were assigned and continued to receive Bmab 1200.'}, {'id': 'FG004', 'title': 'Stelara-Bmab 1200', 'description': 'Before dosing at Week 16, patients in the Stelara group were randomly assigned in a 1:1 ratio to receive either Bmab 1200. This was done to obtain data after a single switch in patients who had been treated with Stelara.\n\nAll continuing patients who received study treatment with Bmab 1200 at the baseline visit and Week 4 and achieved at least PASI 50 response by Week 12 were rerandomized before receiving study treatment at Week 16. This was done to maintain the study blinding, i.e. the patients in the original Bmab 1200 group went through the rerandomization procedure; however, they were assigned and continued to receive Bmab 1200.'}, {'id': 'FG005', 'title': 'Bmab 1200/Bmab 1200', 'description': 'All continuing patients who completed TP2 (received study treatment at the baseline visit and Weeks 4 and 16) and achieved at least PASI 75 response at Week 28 were offered to enter TP3 of the study to continue the same treatment that they were rerandomized to receive during TP2 (Bmab 1200 or Stelara) in a blinded manner. For patients not eligible to enter TP3, the end of study (EOS) visit occurred at Week 28.'}, {'id': 'FG006', 'title': 'Stelara/Stelara', 'description': 'All continuing patients who completed TP2 (received study treatment at the baseline visit and Weeks 4 and 16) and achieved at least PASI 75 response at Week 28 were offered to enter TP3 of the study to continue the same treatment that they were rerandomized to receive during TP2 (Bmab 1200 or Stelara) in a blinded manner. For patients not eligible to enter TP3, the end of study (EOS) visit occurred at Week 28.'}, {'id': 'FG007', 'title': 'Stelara/Bmab 1200', 'description': 'All continuing patients who completed TP2 (received study treatment at the baseline visit and Weeks 4 and 16) and achieved at least PASI 75 response at Week 28 were offered to enter TP3 of the study to continue the same treatment that they were rerandomized to receive during TP2 (Bmab 1200 or Stelara) in a blinded manner. For patients not eligible to enter TP3, the end of study (EOS) visit occurred at Week 28.'}], 'periods': [{'title': 'Treatment Period 1 (Baseline to Week 16)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '191'}, {'groupId': 'FG001', 'numSubjects': '193'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '190'}, {'groupId': 'FG001', 'numSubjects': '192'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 2 (Week 16 to Week 28)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '185'}, {'groupId': 'FG003', 'numSubjects': '94'}, {'groupId': 'FG004', 'numSubjects': '92'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '171'}, {'groupId': 'FG003', 'numSubjects': '87'}, {'groupId': 'FG004', 'numSubjects': '86'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 3 (Week 28 to Week 52)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '168'}, {'groupId': 'FG006', 'numSubjects': '81'}, {'groupId': 'FG007', 'numSubjects': '84'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '163'}, {'groupId': 'FG006', 'numSubjects': '79'}, {'groupId': 'FG007', 'numSubjects': '82'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'The study was conducted in Europe and North America and enrolled patients across 41 sites in 5 countries.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'BG000'}, {'value': '193', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bmab1200', 'description': 'Bmab 1200 45 mg Bmab 1200 90 mg\n\nBmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40'}, {'id': 'BG001', 'title': 'Stelara', 'description': 'Stelara 45 mg Stelara 90 mg\n\nStelara: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40; Before dosing at Week 16, patients in the Stelara group were randomly assigned in a 1:1 ratio to receive either Bmab 1200 or Stelara'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.5', 'spread': '13.09', 'groupId': 'BG000'}, {'value': '43.9', 'spread': '13.58', 'groupId': 'BG001'}, {'value': '43.2', 'spread': '13.34', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '257', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '185', 'groupId': 'BG000'}, {'value': '187', 'groupId': 'BG001'}, {'value': '372', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '190', 'groupId': 'BG000'}, {'value': '192', 'groupId': 'BG001'}, {'value': '382', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Subject'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Europe', 'categories': [{'measurements': [{'value': '189', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '378', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Subject'}], 'populationDescription': 'Patient demographics and baseline characteristics provided on FAS which consist of all participants who signed the ICF and were randomized'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-12', 'size': 17447806, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-26T00:48', 'hasProtocol': True}, {'date': '2023-06-29', 'size': 6517021, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-06-26T00:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double Blinded (Patient, Investigator),'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 384}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'dispFirstSubmitDate': '2023-11-16', 'completionDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2022-04-13', 'resultsFirstSubmitDate': '2025-06-26', 'studyFirstSubmitQcDate': '2022-04-13', 'dispFirstPostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-26', 'studyFirstPostDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety:-Treatment-emergent Adverse Events Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period', 'timeFrame': 'Baseline to Week 52'}, {'measure': 'Safety:- Injection-site Reactions', 'timeFrame': 'Baseline through Week 28 and 52', 'description': 'Injection-site reactions at Day 1, Week 4, Week 16, and throughout the study'}, {'measure': 'Safety:- Hypersensitivity', 'timeFrame': 'Baseline through Week 52', 'description': 'Hypersensitivity at Day 1, Week 4, Week 16, and throughout the study'}, {'measure': 'Immunogenicity:-Developing Antidrug Antibodies', 'timeFrame': 'Baseline through Week 28', 'description': 'Proportion of patients developing antidrug antibodies'}, {'measure': 'Immunogenicity:-Developing Antidrug Antibodies', 'timeFrame': 'Postdosing Week 52', 'description': 'Proportion of patients developing antidrug antibodies'}, {'measure': 'Developing Neutralizing Antibodies', 'timeFrame': 'Baseline through Week 28', 'description': 'Proportion of patients neutralizing antibodies'}, {'measure': 'Developing Neutralizing Antibodies', 'timeFrame': 'Postdosing Week 52', 'description': 'Proportion of patients neutralizing antibodies'}, {'measure': 'Pharmacokinetic:-Serum Concentrations', 'timeFrame': 'Postdosing on Week 28', 'description': 'Serum concentrations of ustekinumab'}, {'measure': 'Pharmacokinetic:-Serum Concentrations', 'timeFrame': 'Postdosing on Week 52', 'description': 'Serum concentrations of Ustekinumab'}], 'primaryOutcomes': [{'measure': 'Psoriasis Area and Severity Index (PASI)', 'timeFrame': 'Baseline to Week 12', 'description': 'Percentage change from baseline in the Psoriasis Area and Severity Index score at Week 12'}], 'secondaryOutcomes': [{'measure': 'PASI Score', 'timeFrame': 'Baseline through Week 28', 'description': 'Percentage change from baseline in the PASI score at Baseline through Week 28.\n\nPASI is a quantitative rating score for measuring the severity of psoriatic lesions based on area coverage, plaque appearance, their response to therapy. 4 regions- head, upper limbs, trunk, and lower limbs are assessed separately for erythema, induration/thickness, and scaling. Degree of involvement is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement) for each region. Total score (sum of erythema, thickness, and scaling) is multiplied by the degree of involvement for each body region and then multiplied by constant. Sum of all lesion scores can range from 0 (no disease) to 72 (maximal disease), with the higher score indicating more severe disease. Change from baseline in PASI score indicates response to therapy. PASI 50 means ≥50% reduction from baseline in the PASI score'}, {'measure': 'PASI Improvement', 'timeFrame': 'Baseline through Week 28', 'description': 'PASI improvement of ≥50% relative to baseline (PASI 50), PASI improvement of ≥75% relative to baseline (PASI 75), and PASI improvement of ≥90% relative to Baseline through Week 28 and 52\n\nPASI is a quantitative rating score for measuring the severity of psoriatic lesions based on area coverage, plaque appearance, their response to therapy. 4 regions- head, upper limbs, trunk, and lower limbs are assessed separately for erythema, induration/thickness, and scaling. Degree of involvement is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement) for each region. Total score (sum of erythema, thickness, and scaling) is multiplied by the degree of involvement for each body region and then multiplied by constant. Sum of all lesion scores can range from 0 (no disease) to 72 (maximal disease), with the higher score indicating more severe disease. Change from baseline in PASI score indicates response to therapy. PASI 50 means ≥50% reduction from baseline in the PASI score'}, {'measure': "Static Physician's Global Assessment (sPGA)", 'timeFrame': 'Baseline through Week 28', 'description': "Change from Baseline in sPGA During TP2.\n\nThe sPGA is a quantitative rating score of the patient's psoriasis based on physician's assessment at a given time point according to the following categories: induration, erythema, and scaling. The sPGA is a 6-point scale and patient's psoriasis is graded as clear (0), minimal (1), mild (2), moderate (3), marked (4), severe (5). The sum of the scores for induration, erythema, and scaling will be divided by 3 to obtain a final sPGA score. lower score indicates better disease status"}, {'measure': 'Affected Body Surface Area', 'timeFrame': 'Baseline through Week 28', 'description': "Change from baseline in affected body surface area at Weeks 28\n\nTotal % BSA afflicted by psoriasis is estimated using a handprint of the patient at each visit . The entire palmar surface of the patient's handprint is assumed to correspond to approximately 1% of total BSA. Reduction in BSA indicates improvement"}, {'measure': 'Dermatology Life Quality Index Scores', 'timeFrame': 'Baseline through Week 28', 'description': 'Change from baseline in quality of life as measured by Dermatology Life Quality Index scores at Weeks 28\n\nIt is a 10-item patient-reported outcome questionnaire that, in addition to evaluating overall QoL, can be used to assess 6 different aspects that may affect QoL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Nine of the 10 questions have response categories including "not relevant" (score of 0), "not at all" (score of 0), "a little" (score of 1), "a lot" (score of 2) and "very much" (score of 3); Question 7 is a "yes"/ "no" question where "yes" is scored as 3. Eight items also have a "Not relevant" option scored "0," which indicates no problems. Total scores range from 0 to 30 (less to more impairment) and a 5-point change from baseline is considered a clinically important difference.'}, {'measure': 'Dermatology Life Quality Index Scores', 'timeFrame': 'Baseline through Week 52', 'description': 'Change from baseline in quality of life as measured by Dermatology Life Quality Index scores at Weeks 52\n\nIt is a 10-item patient-reported outcome questionnaire that, in addition to evaluating overall QoL, can be used to assess 6 different aspects that may affect QoL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Nine of the 10 questions have response categories including "not relevant" (score of 0), "not at all" (score of 0), "a little" (score of 1), "a lot" (score of 2) and "very much" (score of 3); Question 7 is a "yes"/ "no" question where "yes" is scored as 3. Eight items also have a "Not relevant" option scored "0," which indicates no problems. Total scores range from 0 to 30 (less to more impairment) and a 5-point change from baseline is considered a clinically important difference.'}, {'measure': "Static Physician's Global Assessment (sPGA)", 'timeFrame': 'Baseline through Week 52', 'description': "Change in Static Physician's Global Assessment (sPGA) at Weeks 52\n\nThe sPGA is a quantitative rating score of the patient's psoriasis based on physician's assessment at a given time point according to the following categories: induration, erythema, and scaling. The sPGA is a 6-point scale and patient's psoriasis is graded as clear (0), minimal (1), mild (2), moderate (3), marked (4), severe (5). The sum of the scores for induration, erythema, and scaling will be divided by 3 to obtain a final sPGA score. lower score indicates better disease status"}, {'measure': 'Affected Body Surface Area', 'timeFrame': 'Baseline through Week 52', 'description': "Change from baseline in affected body surface area at Weeks 52\n\nTotal % BSA afflicted by psoriasis is estimated using a handprint of the patient at each visit . The entire palmar surface of the patient's handprint is assumed to correspond to approximately 1% of total BSA. Reduction in BSA indicates improvement"}, {'measure': 'PASI Improvement', 'timeFrame': 'Baseline through week 52', 'description': 'PASI improvement of ≥50% relative to baseline (PASI 50), PASI improvement of ≥75% relative to baseline (PASI 75), and PASI improvement of ≥90% relative to Week 52'}, {'measure': 'PASI Score', 'timeFrame': 'Baseline through Week 52', 'description': 'Percentage change from baseline in the PASI score at Baseline through Week 52.\n\nThe PASI (Psoriasis Area and Severity Index) is a score from 0 to 72 that measures psoriasis severity based on lesion redness, thickness, scaling, and body area affected. The body is divided into four regions, each scored separately. Scores are calculated using severity and area involvement, and are used to assess treatment response (e.g., PASI 50 = 50% improvement).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Moderate to Severe Chronic Plaque Psoriasis']}, 'referencesModule': {'references': [{'pmid': '41100115', 'type': 'DERIVED', 'citation': 'Szepietowski JC, Reich A, Feldman SR, Pulka G, Mekokishvili L, Tsiskarishvili N, Svarca I, Poder A, Singh G, Deodhar S, Kumar K, Marwah A, Loganathan S, Wolff-Holz E, Athalye SN. Comparative efficacy and safety of biosimilar Bmab 1200 versus reference ustekinumab in moderate-to-severe plaque psoriasis: 52-week findings from the Phase 3 STELLAR-2 trial. Expert Opin Biol Ther. 2025 Oct;25(10):1121-1133. doi: 10.1080/14712598.2025.2576506. Epub 2025 Oct 21.'}, {'pmid': '40708530', 'type': 'DERIVED', 'citation': 'Szepietowski JC, Reich A, Feldman SR, Pulka G, Mekokishvili L, Tsiskarishvili N, Svarca I, Poder A, Singh G, Deodhar S, Kumar K, Marwah A, Loganathan S, Athalye SN, Wolff-Holz E. Efficacy and safety of the ustekinumab biosimilar, Bmab 1200, versus reference ustekinumab in moderate-to-severe plaque psoriasis: 28-week results of the randomized, double-blind, Phase 3 STELLAR-2 study. Expert Opin Biol Ther. 2025 Aug;25(8):913-924. doi: 10.1080/14712598.2025.2538608. Epub 2025 Jul 29.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, active-controlled, parallel-group, multicenter study designed to compare the efficacy, safety, immunogenicity, and PK(Pharmacokinetic) of Bmab 1200 with Stelara in adult patients with moderate to severe chronic plaque psoriasis.', 'detailedDescription': 'Approximately 384 patients with moderate to severe plaque psoriasis will be enrolled and randomly assigned to one of the 2 treatment groups in a 1:1 ratio (192 patients in the Bmab 1200 group and 192 patients in the Stelara group). Patients who are diagnosed as moderate to severe chronic plaque psoriasis for at least 6 months and are candidate for systemic therapy or phototherapy at the time of the screening visit will be enrolled. The study is planned to be conducted in Europe and North America across approximately 48 sites in 5 countries. The study will be conducted in an outpatient setting, and the participation for each patient will consist of a screening period (up to 4 weeks/28 days) and a double-blind, active-controlled treatment period (52 weeks) with a rerandomization step for switching therapy (Bmab 1200 with Stelara ) before Week 16 dosing. The treatment period before the switch is TP1(Treatment Period1) and post switch is TP2(Treatment Period 2) (from Week 16 dosing to prior to Week 28 dosing) and TP3 (Treatment Period3)(from Week 28 dosing to Week 52). The total duration of the study (excluding the screening period) will be 52 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient is willing and able to provide informed consent form (ICF), able to follow study instructions, and comply with the protocol requirements as per the investigator's opinion.\n2. Patient is aged 18 to 80 years, both inclusive, and weighing \\<130 kg at the time of the screening visit.\n3. Patient has a diagnosis of chronic plaque psoriasis for at least 6 months and is a candidate for systemic therapy or phototherapy at the time of the screening visit.\n4. Patient with moderate to severe chronic plaque psoriasis as defined by BSA (Body surface area)involvement\n\n * 10%, PASI score ≥12, and sPGA ≥3 at the screening and baseline visits.\n5. Patient has stable disease for at least 2 months before the baseline visit (ie, without clinically significant changes in the investigator's opinion).\n6. Patient has adequate renal and hepatic function at the screening\n7. Women of childbearing potential must have a negative serum pregnancy test during screening and a negative urine pregnancy test at baseline. A female patient is considered not of childbearing potential when postmenopausal or surgically sterilized\n8. Women of childbearing potential and male patients with a female partner of childbearing potential must be willing to use highly effective contraceptive precautions.\n\nExclusion Criteria:\n\n1. Patient has nonplaque psoriasis, such as erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, other skin conditions (eg, eczema), other current or chronic systemic autoimmune or inflammatory disease at the time of screening visit that would interfere with the evaluation of the effect of the study treatment on psoriasis. Patients with concurrent psoriatic arthritis will be allowed to participate.\n2. Patient who has a current or past history of any of the following infections:\n\n 1. Current or past history of congenital or acquired immunodeficiency or patient is positive for the human immunodeficiency virus (HIV) antibodies (HIV-1 or HIV-2) at screening.\n 2. Patient has current infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) as per serological tests at screening.\n\n * For HBV, patients who test positive to hepatitis B surface antigen (HBsAg) will be excluded. Patients who test positive to hepatitis B core antibody (HBcAb) only (HBsAg negative), may be enrolled if they also test positive to hepatitis B surface antibody (HBsAb).\n * For HCV, patient who test positive to HCV antibody will be excluded unless they test negative for HCV RNA.\n 3. Presence of active infection at screening or history of infection requiring intravenous antibiotics and/or hospitalization ≤8 weeks before baseline visit, or oral/intramuscular antibiotics ≤4 weeks before baseline visit, or topical antibiotics ≤2 weeks before baseline visit. Minor localized fungal infections or topical antibiotics for facial acne may be allowed.\n 4. Any recurrent bacterial, fungal, opportunistic or viral infection including recurrent/disseminated herpes zoster that, based on the investigator´s clinical assessment, causes a safety risk and makes the patient unsuitable for the study.\n 5. History of invasive/systemic fungal infection (eg, histoplasmosis) or nontubercular mycobacterial infection.\n3. Patient meeting any of the following tuberculosis (TB)-related conditions:\n\n 1. Patient who has current or history of active TB.\n 2. Patient who has signs or symptoms suggestive of active TB upon medical history or physical examination including chest radiography at screening. If a chest radiography performed within the past 3 months before screening is available, it does not need to be repeated at screening.\n 3. Patients with current latent TB (defined as a positive result of interferon-γ release assay \\[IGRA\\] with a negative examination of chest radiography \\[posterior-anterior and lateral views, or per country regulations where applicable\\] and absence of symptoms). Patients with positive IGRA (Interferon Gamma Release Assay) may be enrolled if they have documentation of completed appropriate country-specific TB prophylaxis within the past 5 years or have received at least 1 month of country-specific TB prophylaxis before the baseline visit and are willing to complete its entire course, and do not have other risk factors, radiologic findings, or physical evidence supporting latent or active TB. If a patient's initial IGRA test result is indeterminate, the test can be repeated once. If the test result is again indeterminate, the patient will be excluded from the study.\n 4. Patient who has had exposure to a person with active TB, such as first-degree family members or coworkers within 16 weeks before the baseline visit.\n4. Patient has an underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic including central nervous system demyelinating disease, endocrine, cardiac, infection, or gastrointestinal) which, in the opinion of the investigator, significantly immune-compromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy.\n5. Patient had a major surgical intervention within 12 weeks of the baseline or planned major surgery during the study period.\n6. Patient who has prior exposure to more than 1 biologic agent for the treatment of psoriasis or psoriatic arthritis.\n7. Patient who has received or plans to receive any of the prohibited medications or treatment that could affect psoriasis:\n8. Patient has received a live or live-attenuated vaccine within 4 weeks before the baseline visit. Patient must agree not to receive a live or live-attenuated vaccine during the study and up to 15 weeks after the last dose of the study treatment.\n9. Patient who has had Bacillus Calmette-Guérin (BCG) vaccination within 1 year before the baseline visit. Patients must agree not to receive a BCG vaccination during the study and at least 1 year after the last dose of the study treatment.\n10. Have a transplanted organ/tissue or stem cell transplantation.\n11. TP3 specific criteria:\n\n 1. Patient is willing and able to provide revised informed consent form (ICF), able to follow study instructions, and comply with the protocol requirements as per the investigator's opinion\n 2. Patient has not developed any condition/ or met study discontinuation or treatment"}, 'identificationModule': {'nctId': 'NCT05335356', 'acronym': 'STELLAR-2', 'briefTitle': 'Comparing Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biocon Limited'}, 'officialTitle': 'A Randomized, Double-Blind, Parallel Group, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis', 'orgStudyIdInfo': {'id': 'BM12H-PSO-03-G-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bmab1200', 'description': 'Bmab 1200 45 mg Bmab 1200 90 mg', 'interventionNames': ['Biological: Bmab1200']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stelara', 'description': 'Stelara 45 mg Stelara 90 mg', 'interventionNames': ['Biological: Stelara']}], 'interventions': [{'name': 'Stelara', 'type': 'BIOLOGICAL', 'description': '45 mg , 90 mg at Week 0, 4, 16, 28 and 40;During the study after receiving 2 doses , before dosing at Week 16 patients were re-randomised in a 1:1 ratio to receive either Bmab 1200 or Stelara .', 'armGroupLabels': ['Stelara']}, {'name': 'Bmab1200', 'type': 'BIOLOGICAL', 'description': '45 mg , 90 mg at Week 0, 4, 16, 28 and 40', 'armGroupLabels': ['Bmab1200']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44124', 'city': 'Mayfield Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'Apex Clinical Research Center', 'geoPoint': {'lat': 41.51922, 'lon': -81.4579}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biocon Biologics UK Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}