Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-01-04 @ 5:06 PM
Study NCT ID:
NCT03194867
Status:
COMPLETED
Last Update Posted:
2024-06-14
First Post:
2017-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Isatuximab in Combination With Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000599209', 'term': 'isatuximab'}, {'id': 'C000627974', 'term': 'cemiplimab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'phone': '800-633-1610', 'title': 'Trial Transparency Team', 'phoneExt': '6#', 'organization': 'Sanofi aventis recherche & développement'}, 'certainAgreement': {'otherDetails': 'The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'TEAEs were collected from the first dose up to 30 days after the last dose of study treatment, approximately 50 months. All-Cause Mortality was reported for the whole study duration, approximately 62 months', 'description': 'Analysis was performed on the Safety population (tabulated according to treatment actually received \\[as treated\\]). There were 2 participants randomized in group isatuximab and isatuximab + cemiplimabQ4W respectively and who took another treatment/schedule.', 'eventGroups': [{'id': 'EG000', 'title': 'Phase 1: Isatuximab+Cemiplimab Q2W', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 in all cycles every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Phase 2: Isatuximab', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 31, 'seriousNumAtRisk': 33, 'deathsNumAffected': 20, 'seriousNumAffected': 17}, {'id': 'EG002', 'title': 'Phase 2: Isatuximab + CemiplimabQ2W', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 34, 'seriousNumAtRisk': 37, 'deathsNumAffected': 23, 'seriousNumAffected': 17}, {'id': 'EG003', 'title': 'Phase 2:Isatuximab + CemiplimabQ4W', 'description': 'Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 27, 'seriousNumAtRisk': 35, 'deathsNumAffected': 22, 'seriousNumAffected': 21}], 'otherEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Labyrinthitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Oral Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 9, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 13, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Viral Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 8, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Confusional State', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Peripheral Sensory Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Dyspnoea Exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Productive Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 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'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Cancer Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Colon Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Neuroendocrine Carcinoma Of The Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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{'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Tumour Lysis Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Psychomotor Hyperactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Radicular Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Spinal Cord Compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Cardiac Failure Congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Acute Abdomen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Anal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Obstruction Gastric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Small Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Bone Lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Bone Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Musculoskeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Pathological Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Fanconi Syndrome Acquired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Urinary Tract Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Disease Progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Multiple Organ Dysfunction Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Platelet Count Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Infusion Related Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}, {'term': 'Euthanasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Isatuximab + CemiplimabQ2W', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 in all cycles every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Cycle 1 Day 1 to Day 28', 'description': 'Potential DLTs were defined as the occurrence of any of the following adverse reactions at first treatment cycle, unless due to disease progression or obviously unrelated cause: Hematological DLTs: Grade(G) 4 neutropenia (N) for more than 7 consecutive days, G3 to G4 N complicated by fever (temperature greater than or equal to \\[\\>=\\] 38.5 degree Celsius on more than 1 occasion) or microbiologically/radiographically documented infection, G3 to G4 thrombocytopenia associated with clinically significant bleeding requiring clinical intervention or Non-hematological DLTs: G4 non-hematologic AE, G\\>=2 uveitis, G3 non-hematological AE lasting greater than (\\>)3 days despite optimal care support, delay in initiation of Cycle 2 \\>14 days due to treatment related laboratory abnormalities/AE. Any other AE that the investigator/study committee deemed to be dose-limiting, regardless of grade, was also considered as DLT.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The DLT evaluable population consisted of participants in Phase 1 who received the planned doses of isatuximab and cemiplimab during Cycle 1, and who completed the DLT observation period of Cycle 1 after the first study treatment administration, unless they discontinued the study treatment(s) due to DLT.'}, {'type': 'PRIMARY', 'title': 'Phase 1 and Phase 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Isatuximab + CemiplimabQ2W', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 in all cycles every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}, {'id': 'OG001', 'title': 'Phase 2: Isatuximab', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}, {'id': 'OG002', 'title': 'Phase 2: Isatuximab + CemiplimabQ2W', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}, {'id': 'OG003', 'title': 'Phase 2: Isatuximab + CemiplimabQ4W', 'description': 'Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}]}, {'title': 'TESAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'TEAEs were collected from the first dose up to 30 days after the last dose of study treatment, approximately 50 months', 'description': 'An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product and which did not necessarily have a causal relationship with study treatment. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as an AE which occurred after the first dose of study treatment administration up to 30 days after the last dose of study treatment administration. The DLT observation period was 1 cycle (28 days). However, all AEs during treatment, unless due to disease progression or an obviously unrelated cause, were taken into consideration by the Study Committee for the determination of the maximum tolerated dose and recommended Phase 2 dose.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Safety population (tabulated according to treatment actually received \\[as treated\\]). There were 2 participants randomized in group isatuximab and isatuximab + cemiplimabQ4W respectively and who took another treatment/schedule.'}, {'type': 'PRIMARY', 'title': 'Phase 2: Percentage of Participants With Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Isatuximab', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}, {'id': 'OG001', 'title': 'Phase 2: Isatuximab + CemiplimabQ2W', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}, {'id': 'OG002', 'title': 'Phase 2: Isatuximab + CemiplimabQ4W', 'description': 'Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000', 'lowerLimit': '3.30', 'upperLimit': '27.45'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '12.12', 'upperLimit': '42.20'}, {'value': '22.2', 'groupId': 'OG002', 'lowerLimit': '10.12', 'upperLimit': '39.15'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months', 'description': 'ORR by Investigator using international myeloma working group (IMWG) response criteria:percentage of participants with complete response (CR) (including stringent CR \\[sCR\\]very good partial response \\[VGPR\\] and partial response \\[PR\\]).CR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas,less than (\\<)5% plasma cells in bone marrow (BM) aspirates and normal free light chain(FLC)ratio (0.26-1.65).sCR:CR plus no clonal cells in BM biopsy.VGPR:serum and urine M-protein detectable by immunofixation,not electrophoresis;\\>=90% reduction in serum M-protein plus urine M-protein level\\<100mg/24hour(h);FLC only:\\>=90% decrease in difference between involved and uninvolved FLC levels.PR:\\>=50% reduction of serum M-protein and reduction in 24h urine M-protein by \\>=90% or \\<200mg/24h.In addition to above, if present at baseline,\\>=50% reduction in size (sum of products of maximal perpendicular diameters of measured lesions \\[SPD\\]) of soft tissue plasmacytomas required.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Randomized population consisted of all participants from Phase 2 who gave their informed consent and were assigned a randomization number by the IRT, regardless of whether participants received any study treatment or received a different study treatment from which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Percentage of Participants With Clinical Benefit Rate (CBR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Isatuximab', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}, {'id': 'OG001', 'title': 'Phase 2: Isatuximab + CemiplimabQ2W', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}, {'id': 'OG002', 'title': 'Phase 2: Isatuximab + CemiplimabQ4W', 'description': 'Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.5', 'groupId': 'OG000', 'lowerLimit': '10.75', 'upperLimit': '41.17'}, {'value': '36.1', 'groupId': 'OG001', 'lowerLimit': '20.82', 'upperLimit': '53.78'}, {'value': '38.9', 'groupId': 'OG002', 'lowerLimit': '23.14', 'upperLimit': '56.54'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months', 'description': 'CBR by Investigator using IMWG response criteria: percentage of participants with CR (including sCR), VGPR, PR (all defined in previous OM) or MR. MR was defined as \\>= 25% but \\<= 49% reduction in serum M-protein and reduction in 24h urine M-protein by 50-89%, which still exceeded 200 mg/24h; if present at baseline, \\>=50% reduction in size (SPD) of soft tissue plasmacytomas was also required.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Randomized population consisted of all participants from Phase 2 who gave their informed consent and were assigned a randomization number by the IRT, regardless of whether participants received any study treatment or received a different study treatment from which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Duration of Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Isatuximab', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}, {'id': 'OG001', 'title': 'Phase 2: Isatuximab + CemiplimabQ2W', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}, {'id': 'OG002', 'title': 'Phase 2: Isatuximab + CemiplimabQ4W', 'description': 'Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.28', 'groupId': 'OG000', 'lowerLimit': '8.739', 'upperLimit': '11.368'}, {'value': '8.84', 'groupId': 'OG001', 'lowerLimit': '8.016', 'upperLimit': '11.072'}, {'value': '9.03', 'groupId': 'OG002', 'lowerLimit': '8.016', 'upperLimit': '10.875'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months', 'description': 'Duration of follow-up was defined as the date of randomization to the date of last contact or death, whichever came first. Median duration of follow-up is reported.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Randomized population consisted of all participants from Phase 2 who gave their informed consent and were assigned a randomization number by the IRT, regardless of whether participants received any study treatment or received a different study treatment from which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Isatuximab', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}, {'id': 'OG001', 'title': 'Phase 2: Isatuximab + CemiplimabQ2W', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}, {'id': 'OG002', 'title': 'Phase 2: Isatuximab + CemiplimabQ4W', 'description': 'Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '7'}, {'value': '4.7', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '12'}, {'value': '5.7', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '12'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months', 'description': 'DOR: Time from date of first response (\\>=PR) that was subsequently confirmed to date of first documented progressive disease (PD) or death.DOR was determined only for participants who achieved a response of PR or better.If progression or death not observed, participant was censored at date of last valid disease assessment not showing disease progression performed prior to initiating further anticancer treatment and analysis cut-off date.PD(IMWG criteria):increase of \\>=25% from lowest confirmed value in any 1 of following:serum M-protein (absolute increase\\>=0.5 gram/deciliter\\[g/dL\\]), serum M-protein increase\\>=1g/dL if lowest M component \\>=5g/dL; urine M-component (absolute increase \\>=200mg/24h),appearance of new lesion(s),\\>=50% increase from nadir in SPD of \\>1 lesion or \\>=50% increase in longest diameter of a previous lesion \\>1cm in short axis,\\>=50% increase in circulating plasma cells (minimum 200 cells/microliter\\[c/mcL\\]) if that was the only measure of disease. PR: as defined in OM3.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Randomized population consisted of all participants from Phase 2 who gave their informed consent and were assigned a randomization number by the IRT, regardless of whether participants received any study treatment or received a different study treatment from which they were randomized. Only responders were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Time to Response (TTR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Isatuximab', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}, {'id': 'OG001', 'title': 'Phase 2: Isatuximab + CemiplimabQ2W', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}, {'id': 'OG002', 'title': 'Phase 2: Isatuximab + CemiplimabQ4W', 'description': 'Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '2'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months', 'description': 'TTR was defined as the time from randomization to first response (PR or better) that was subsequently confirmed. PR as per IMWG criteria was defined as \\>=50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \\>=90% or to \\<200 mg/24 hours. In addition to the above listed criteria, if present at baseline, a \\>=50% reduction in the size SPD of soft tissue plasmacytomas was also required.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Randomized population consisted of all participants from Phase 2 who gave their informed consent and were assigned a randomization number by the IRT, regardless of whether participants received any study treatment or received a different study treatment from which they were randomized. Only responders were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Isatuximab', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}, {'id': 'OG001', 'title': 'Phase 2: Isatuximab + CemiplimabQ2W', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}, {'id': 'OG002', 'title': 'Phase 2: Isatuximab + CemiplimabQ4W', 'description': 'Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.89', 'groupId': 'OG000', 'lowerLimit': '1.971', 'upperLimit': '3.811'}, {'value': '3.75', 'groupId': 'OG001', 'lowerLimit': '1.971', 'upperLimit': '5.881'}, {'value': '3.02', 'groupId': 'OG002', 'lowerLimit': '2.793', 'upperLimit': '5.158'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months', 'description': 'PFS: Time interval from the randomization date to the date of the first documented disease progression that is subsequently confirmed or the date of death due to any cause, whichever came first. If progression or death was not observed, participant was censored at date of last valid disease assessment not showing disease progression performed prior to initiation of a further anticancer treatment or the analysis cut-off date. Analysis was performed by Kaplan-Meier method. PD (IMWG) criteria: increase of \\>=25% from lowest confirmed value in any 1 of following: serum M-protein (absolute increase \\>=0.5g/dL), serum M-protein increase \\>=1g/dL if lowest M component was \\>=5g/dL; urine M-component (absolute increase \\>=200mg/24h), appearance of new lesion(s),\\>=50% increase from nadir in SPD of \\>1 lesion or \\>=50% increase in the longest diameter of a previous lesion \\>1 cm in short axis or \\>=50% increase in circulating plasma cells (minimum of 200 c/mcL) if that was the only measure of disease.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Randomized population consisted of all participants from Phase 2 who gave their informed consent and were assigned a randomization number by the IRT, regardless of whether participants received any study treatment or received a different study treatment from which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Isatuximab', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}, {'id': 'OG001', 'title': 'Phase 2: Isatuximab + CemiplimabQ2W', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}, {'id': 'OG002', 'title': 'Phase 2: Isatuximab + CemiplimabQ4W', 'description': 'Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA indicates due to the limited follow-up time, most of participants were still alive, so the median OS and upper limit of confidence interval (CI) was not reached.', 'groupId': 'OG000', 'lowerLimit': '7.622', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA indicates due to the limited follow-up time, most of participants were still alive, so the median OS and upper limit of CI was not reached.', 'groupId': 'OG001', 'lowerLimit': '6.801', 'upperLimit': 'NA'}, {'value': '12.78', 'comment': 'NA indicates due to the limited follow-up time, most of participants were still alive, so upper limit of CI was not reached.', 'groupId': 'OG002', 'lowerLimit': '7.392', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months', 'description': 'OS was defined as the time interval from the date of randomization to death from any cause. Participants without death prior to the analysis cut-off date were censored at the last date the participant was known to be alive or the cut-off date, whichever came first. The results provided below corresponds to descriptive OS information at the time of primary analysis completion date of 09 October 2019.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Randomized population consisted of all participants from Phase 2 who gave their informed consent and were assigned a randomization number by the IRT, regardless of whether participants received any study treatment or received a different study treatment from which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Phase 1 and 2: Plasma Concentration Observed at the End of IV Infusion (Ceoi) of Isatuximab Alone and in Combination With Cemiplimab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Isatuximab', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}, {'id': 'OG001', 'title': 'Phase 1 and 2: Combination Arm: Isatuximab + Cemiplimab', 'description': 'All participants who received isatuximab in combination with cemiplimab were included in this arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '255', 'spread': '72.1', 'groupId': 'OG000'}, {'value': '239', 'spread': '67.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At end of infusion (EOI) on Cycle 1 Day 1', 'description': 'Plasma samples were collected at specified timepoints and those non-impacted by the bioanalytical issue were used for evaluation of Ceoi. It was calculated using non-compartmental analysis (NCA) after the first administration in Cycle 1. The PK population was defined independently for isatuximab and cemiplimab and consisted of all participants from the all-treated (AT) population with at least 1 available concentration post-baseline (whatever the cycle and even if dosing was incomplete) with adequate documentation of dosing and sampling dates and times.', 'unitOfMeasure': 'microgram (mcg)/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the PK population. "Isatuximab + Cemiplimab" arm includes 3 and 27 participants from phase 1 and phase 2, respectively. Same dose of isatuximab was administered to all participants in phase 1 and phase 2 part of study in Isatuximab + Cemiplimab Q2W and Q4W arms. Hence PK analysis was combined for phase 1 and phase 2 Isatuximab + Cemiplimab Q2W and Q4W arms.'}, {'type': 'SECONDARY', 'title': 'Phase 1 and 2: Maximum Observed Concentration (Cmax) of Isatuximab Alone and in Combination With Cemiplimab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Isatuximab', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}, {'id': 'OG001', 'title': 'Phase 1 and 2: Combination Arm: Isatuximab + Cemiplimab', 'description': 'All participants who received isatuximab in combination with cemiplimab were included in this arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '264', 'spread': '68.0', 'groupId': 'OG000'}, {'value': '247', 'spread': '65.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At start of infusion (SOI), EOI, EOI+4 hours, 72 hours and 168 hours on Day 1 of Cycle 1', 'description': 'Plasma samples were collected at specified timepoints and those non-impacted by the bioanalytical issue were used for evaluation of Cmax. It was calculated using NCA after the first administration in Cycle 1.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the PK population. "Isatuximab + Cemiplimab" arm includes 3 and 27 participants from phase 1 and phase 2, respectively. Same dose of isatuximab was administered to all participants in phase 1 and phase 2 part of study in Isatuximab + Cemiplimab Q2W and Q4W arms. Hence PK analysis was combined for phase 1 and phase 2 Isatuximab + Cemiplimab Q2W and Q4W arms.'}, {'type': 'SECONDARY', 'title': 'Phase 1 and 2: Time to Reach Cmax (Tmax) of Isatuximab Alone and in Combination With Cemiplimab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Isatuximab', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}, {'id': 'OG001', 'title': 'Phase 1 and 2: Combination Arm: Isatuximab + Cemiplimab', 'description': 'All participants who received isatuximab in combination with cemiplimab were included in this arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.56', 'groupId': 'OG000', 'lowerLimit': '3.25', 'upperLimit': '10.50'}, {'value': '4.85', 'groupId': 'OG001', 'lowerLimit': '2.58', 'upperLimit': '13.70'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At SOI, EOI, EOI+4 hours, 72 hours and 168 hours on Day 1 of Cycle 1', 'description': 'Plasma samples were collected at specified timepoints and those non-impacted by the bioanalytical issue were used for evaluation of tmax. It was calculated using NCA after the first administration in Cycle 1.', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the PK population. "Isatuximab + Cemiplimab" arm includes 3 and 27 participants from phase 1 and phase 2, respectively. Same dose of isatuximab was administered to all participants in phase 1 and phase 2 part of study in Isatuximab + Cemiplimab Q2W and Q4W arms. Hence PK analysis was combined for phase 1 and phase 2 Isatuximab + Cemiplimab Q2W and Q4W arms.'}, {'type': 'SECONDARY', 'title': 'Phase 1 and 2: Last Concentration Observed Above the Lower Limit of Quantitation (Clast) of Isatuximab Alone and in Combination With Cemiplimab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Isatuximab', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}, {'id': 'OG001', 'title': 'Phase 1 and 2: Combination Arm: Isatuximab + Cemiplimab', 'description': 'All participants who received isatuximab in combination with cemiplimab were included in this arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '85.7', 'spread': '44.9', 'groupId': 'OG000'}, {'value': '64.1', 'spread': '32.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At SOI, EOI, EOI+4 hours, 72 hours and 168 hours on Day 1 of Cycle 1', 'description': 'Plasma samples were collected at specified timepoints and those non-impacted by the bioanalytical issue were used for evaluation of Clast. It was calculated using NCA after the first administration in Cycle 1.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the PK population. "Isatuximab + Cemiplimab" arm includes 3 and 27 participants from phase 1 and phase 2, respectively. Same dose of isatuximab was administered to all participants in phase 1 and phase 2 part of study in Isatuximab + Cemiplimab Q2W and Q4W arms. Hence PK analysis was combined for phase 1 and phase 2 Isatuximab + Cemiplimab Q2W and Q4W arms.'}, {'type': 'SECONDARY', 'title': 'Phase 1 and 2: Time of Clast (Tlast) of Isatuximab Alone and in Combination With Cemiplimab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Isatuximab', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}, {'id': 'OG001', 'title': 'Phase 1 and 2: Combination Arm: Isatuximab + Cemiplimab', 'description': 'All participants who received isatuximab in combination with cemiplimab were included in this arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '155.00', 'groupId': 'OG000', 'lowerLimit': '72.40', 'upperLimit': '169.00'}, {'value': '165.00', 'groupId': 'OG001', 'lowerLimit': '70.20', 'upperLimit': '239.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At SOI, EOI, EOI+4 hours, 72 hours and 168 hours on Day 1 of Cycle 1', 'description': 'Plasma samples were collected at specified timepoints and those non-impacted by the bioanalytical issue were used for evaluation of tlast. It was calculated using NCA after the first administration in Cycle 1.', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the PK population. "Isatuximab + Cemiplimab" arm includes 3 and 27 participants from phase 1 and phase 2, respectively. Same dose of isatuximab was administered to all participants in phase 1 and phase 2 part of study in Isatuximab + Cemiplimab Q2W and Q4W arms. Hence PK analysis was combined for phase 1 and phase 2 Isatuximab + Cemiplimab Q2W and Q4W arms.'}, {'type': 'SECONDARY', 'title': 'Phase 1 and 2: Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Tlast (AUClast) of Isatuximab Alone and in Combination With Cemiplimab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Isatuximab', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}, {'id': 'OG001', 'title': 'Phase 1 and 2: Combination Arm: Isatuximab + Cemiplimab', 'description': 'All participants who received isatuximab in combination with cemiplimab were included in this arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '21000', 'spread': '7220', 'groupId': 'OG000'}, {'value': '20200', 'spread': '6590', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At SOI, EOI, EOI+4 hours, 72 hours and 168 hours on Day 1 of Cycle 1', 'description': 'AUClast was defined as the area under the plasma concentration versus time curve from time 0 to real time tlast calculated using the trapezoidal method over the dosing interval after the first administration in Cycle 1.', 'unitOfMeasure': '(mcg*hour)/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the PK population. "Isatuximab + Cemiplimab" arm includes 3 and 27 participants from phase 1 and phase 2, respectively. Same dose of isatuximab was administered to all participants in phase 1 and phase 2 part of study in Isatuximab + Cemiplimab Q2W and Q4W arms. Hence PK analysis was combined for phase 1 and phase 2 Isatuximab + Cemiplimab Q2W and Q4W arms.'}, {'type': 'SECONDARY', 'title': 'Phase 1 and 2: AUC From Time 0 to Week 1 (AUC1week) of Isatuximab Alone and in Combination With Cemiplimab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Isatuximab', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}, {'id': 'OG001', 'title': 'Phase 1 and 2: Combination Arm: Isatuximab + Cemiplimab', 'description': 'All participants who received isatuximab in combination with cemiplimab were included in this arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '23000', 'spread': '7250', 'groupId': 'OG000'}, {'value': '21100', 'spread': '6450', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At SOI, EOI, EOI+4 hours, 72 hours and 168 hours on Day 1 of Cycle 1', 'description': 'AUC1week was defined as the area under the plasma concentration versus time curve from time 0 to 1 week post dose calculated using the trapezoidal method over the dosing interval after the first administration in Cycle 1.', 'unitOfMeasure': '(mcg*hour)/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the PK population. "Isatuximab + Cemiplimab" arm includes 3 and 27 participants from phase 1 and phase 2, respectively. Same dose of isatuximab was administered to all participants in phase 1 and phase 2 part of study in Isatuximab + Cemiplimab Q2W and Q4W arms. Hence PK analysis was combined for phase 1 and phase 2 Isatuximab + Cemiplimab Q2W and Q4W arms. Only those participants with data available were analyzed.'}, {'type': 'SECONDARY', 'title': 'Phase 1 and 2: Number of Participants With Anti-Drug Antibodies (ADA) to Isatuximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Isatuximab', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}, {'id': 'OG001', 'title': 'Phase 1 and 2: Isatuximab + CemiplimabQ2W', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}, {'id': 'OG002', 'title': 'Phase 2: Isatuximab + CemiplimabQ4W', 'description': 'Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}], 'classes': [{'title': 'Pre-existing ADA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Treatment-induced', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Treatment boosted', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 20 months', 'description': 'ADA responses were categorized as treatment-induced ADA and treatment boosted ADA. Pre-existing ADA was defined as ADA that were present in samples drawn during the pre-treatment period. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period in participants without pre-existing ADA. Treatment boosted ADA was defined as pre-existing ADAs with a significant increase in the ADA titer during the study compared to the Baseline titer. The ADA evaluable population was defined independently for isatuximab and cemiplimab and consisted of all participants from AT population with at least 1 ADA result (negative, positive, or inconclusive) post-baseline.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the ADA evaluable population."Isatuximab + CemiplimabQ2W" arm includes 3 and 36 participants from phase 1 and phase 2, respectively. Same dose of isatuximab was administered to all participants in phase 1 and phase 2 part of study in Isatuximab + Cemiplimab Q2W arms. Hence analysis was combined for phase 1 and phase 2 Isatuximab + Cemiplimab Q2W arms.'}, {'type': 'SECONDARY', 'title': 'Phase 1 and 2: Number of Participants With ADA to Cemiplimab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 and 2: Isatuximab + CemiplimabQ2W', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}, {'id': 'OG001', 'title': 'Phase 2: Isatuximab + CemiplimabQ4W', 'description': 'Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}], 'classes': [{'title': 'Pre-existing ADA', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-induced', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Treatment boosted', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 20 months', 'description': 'ADA responses were categorized as treatment-induced ADA and treatment boosted ADA. Pre-existing ADA was defined as ADA that were present in samples drawn during the pre-treatment period. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period in participants without pre-existing ADA. Treatment boosted ADA was defined as pre-existing ADAs with a significant increase in the ADA titer during the study compared to the Baseline titer.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the ADA evaluable population. "Isatuximab + CemiplimabQ2W" arm includes 3 and 36 participants from phase 1 and phase 2, respectively. Same dose of isatuximab was administered to all participants in phase 1 and phase 2 part of study in Isatuximab + Cemiplimab Q2W arms. Hence analysis was combined for phase 1 and phase 2 Isatuximab + Cemiplimab Q2W arms.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase 1: Isatuximab + Cemiplimab Once Every 2 Weeks (Q2W)', 'description': 'Participants received isatuximab 10 milligram/ kilogram (mg/kg) intravenous (IV) infusion once weekly for 4 weeks (QWx4) followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable adverse events (AEs), consent withdrawal, or any other reason.'}, {'id': 'FG001', 'title': 'Phase 2: Isatuximab', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}, {'id': 'FG002', 'title': 'Phase 2: Isatuximab + CemiplimabQ2W', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}, {'id': 'FG003', 'title': 'Phase 2: Isatuximab + Cemiplimab Once Every 4 Weeks (Q4W)', 'description': 'Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Enrolled for Phase 1; randomized for Phase 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '36'}, {'groupId': 'FG003', 'numSubjects': '36'}]}, {'type': 'Randomized and Treated', 'comment': 'Enrolled for Phase1; randomized for Phase 2. Phase 2 Isatuximab + CemiplimabQ2W, one participant was randomized but not treated.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '35'}, {'groupId': 'FG003', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'comment': 'Participants with end of study or death from any cause forms completed.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '35'}, {'groupId': 'FG003', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Incorrect completion of end of study form', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were screened at 30 sites. The study was conducted i.e. participants were randomized at 29 sites in 10 countries. A total of 3 participants in Phase 1 and 106 participants in Phase 2 were enrolled (Phase 1)/randomized (Phase 2) from 21 Feb 2018 to 20 Mar 2019.', 'preAssignmentDetails': 'The study consisted of 2 phases: Phase 1 confirmed the feasibility of isatuximab/cemiplimab combination and Phase 2 further evaluated safety, efficacy and pharmacokinetics (PK) of combination versus isatuximab monotherapy. Participants in Phase 2 were randomized in a 1:1:1 ratio to receive either isatuximab monotherapy or combination therapy. The duration of study for a participant included a screening period (up to 21 days) and 3-month post treatment follow-up. Each cycle duration was 28 days.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '109', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase 1: Isatuximab + CemiplimabQ2W', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 in all cycles every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}, {'id': 'BG001', 'title': 'Phase 2: Isatuximab', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}, {'id': 'BG002', 'title': 'Phase 2: Isatuximab + CemiplimabQ2W', 'description': 'Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}, {'id': 'BG003', 'title': 'Phase 2: Isatuximab + CemiplimabQ4W', 'description': 'Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.7', 'spread': '2.9', 'groupId': 'BG000'}, {'value': '66.1', 'spread': '9.3', 'groupId': 'BG001'}, {'value': '63.7', 'spread': '10.0', 'groupId': 'BG002'}, {'value': '66.4', 'spread': '9.2', 'groupId': 'BG003'}, {'value': '65.4', 'spread': '9.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '47', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '91', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Phase 1:The Safety population: All screened participants who received at least 1 dose or a part of a dose of study treatments (isatuximab or cemiplimab), regardless of the amount of treatment administered. Phase 2: The Randomized population: All participants who gave informed consent, were assigned randomization number by interactive response technology (IRT), regardless of whether they received any study treatment or received a different study treatment from which they were randomized.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-21', 'size': 1821085, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-03-26T15:43', 'hasProtocol': True}, {'date': '2019-03-05', 'size': 655329, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-03-26T15:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-21', 'studyFirstSubmitDate': '2017-06-19', 'resultsFirstSubmitDate': '2024-04-02', 'studyFirstSubmitQcDate': '2017-06-19', 'lastUpdatePostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-21', 'studyFirstPostDateStruct': {'date': '2017-06-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs)', 'timeFrame': 'Cycle 1 Day 1 to Day 28', 'description': 'Potential DLTs were defined as the occurrence of any of the following adverse reactions at first treatment cycle, unless due to disease progression or obviously unrelated cause: Hematological DLTs: Grade(G) 4 neutropenia (N) for more than 7 consecutive days, G3 to G4 N complicated by fever (temperature greater than or equal to \\[\\>=\\] 38.5 degree Celsius on more than 1 occasion) or microbiologically/radiographically documented infection, G3 to G4 thrombocytopenia associated with clinically significant bleeding requiring clinical intervention or Non-hematological DLTs: G4 non-hematologic AE, G\\>=2 uveitis, G3 non-hematological AE lasting greater than (\\>)3 days despite optimal care support, delay in initiation of Cycle 2 \\>14 days due to treatment related laboratory abnormalities/AE. Any other AE that the investigator/study committee deemed to be dose-limiting, regardless of grade, was also considered as DLT.'}, {'measure': 'Phase 1 and Phase 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'TEAEs were collected from the first dose up to 30 days after the last dose of study treatment, approximately 50 months', 'description': 'An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product and which did not necessarily have a causal relationship with study treatment. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as an AE which occurred after the first dose of study treatment administration up to 30 days after the last dose of study treatment administration. The DLT observation period was 1 cycle (28 days). However, all AEs during treatment, unless due to disease progression or an obviously unrelated cause, were taken into consideration by the Study Committee for the determination of the maximum tolerated dose and recommended Phase 2 dose.'}, {'measure': 'Phase 2: Percentage of Participants With Overall Response Rate (ORR)', 'timeFrame': 'From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months', 'description': 'ORR by Investigator using international myeloma working group (IMWG) response criteria:percentage of participants with complete response (CR) (including stringent CR \\[sCR\\]very good partial response \\[VGPR\\] and partial response \\[PR\\]).CR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas,less than (\\<)5% plasma cells in bone marrow (BM) aspirates and normal free light chain(FLC)ratio (0.26-1.65).sCR:CR plus no clonal cells in BM biopsy.VGPR:serum and urine M-protein detectable by immunofixation,not electrophoresis;\\>=90% reduction in serum M-protein plus urine M-protein level\\<100mg/24hour(h);FLC only:\\>=90% decrease in difference between involved and uninvolved FLC levels.PR:\\>=50% reduction of serum M-protein and reduction in 24h urine M-protein by \\>=90% or \\<200mg/24h.In addition to above, if present at baseline,\\>=50% reduction in size (sum of products of maximal perpendicular diameters of measured lesions \\[SPD\\]) of soft tissue plasmacytomas required.'}], 'secondaryOutcomes': [{'measure': 'Phase 2: Percentage of Participants With Clinical Benefit Rate (CBR)', 'timeFrame': 'From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months', 'description': 'CBR by Investigator using IMWG response criteria: percentage of participants with CR (including sCR), VGPR, PR (all defined in previous OM) or MR. MR was defined as \\>= 25% but \\<= 49% reduction in serum M-protein and reduction in 24h urine M-protein by 50-89%, which still exceeded 200 mg/24h; if present at baseline, \\>=50% reduction in size (SPD) of soft tissue plasmacytomas was also required.'}, {'measure': 'Phase 2: Duration of Follow-up', 'timeFrame': 'From the date of randomization up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months', 'description': 'Duration of follow-up was defined as the date of randomization to the date of last contact or death, whichever came first. Median duration of follow-up is reported.'}, {'measure': 'Phase 2: Duration of Response (DOR)', 'timeFrame': 'From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months', 'description': 'DOR: Time from date of first response (\\>=PR) that was subsequently confirmed to date of first documented progressive disease (PD) or death.DOR was determined only for participants who achieved a response of PR or better.If progression or death not observed, participant was censored at date of last valid disease assessment not showing disease progression performed prior to initiating further anticancer treatment and analysis cut-off date.PD(IMWG criteria):increase of \\>=25% from lowest confirmed value in any 1 of following:serum M-protein (absolute increase\\>=0.5 gram/deciliter\\[g/dL\\]), serum M-protein increase\\>=1g/dL if lowest M component \\>=5g/dL; urine M-component (absolute increase \\>=200mg/24h),appearance of new lesion(s),\\>=50% increase from nadir in SPD of \\>1 lesion or \\>=50% increase in longest diameter of a previous lesion \\>1cm in short axis,\\>=50% increase in circulating plasma cells (minimum 200 cells/microliter\\[c/mcL\\]) if that was the only measure of disease. PR: as defined in OM3.'}, {'measure': 'Phase 2: Time to Response (TTR)', 'timeFrame': 'From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months', 'description': 'TTR was defined as the time from randomization to first response (PR or better) that was subsequently confirmed. PR as per IMWG criteria was defined as \\>=50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \\>=90% or to \\<200 mg/24 hours. In addition to the above listed criteria, if present at baseline, a \\>=50% reduction in the size SPD of soft tissue plasmacytomas was also required.'}, {'measure': 'Phase 2: Progression Free Survival (PFS)', 'timeFrame': 'From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months', 'description': 'PFS: Time interval from the randomization date to the date of the first documented disease progression that is subsequently confirmed or the date of death due to any cause, whichever came first. If progression or death was not observed, participant was censored at date of last valid disease assessment not showing disease progression performed prior to initiation of a further anticancer treatment or the analysis cut-off date. Analysis was performed by Kaplan-Meier method. PD (IMWG) criteria: increase of \\>=25% from lowest confirmed value in any 1 of following: serum M-protein (absolute increase \\>=0.5g/dL), serum M-protein increase \\>=1g/dL if lowest M component was \\>=5g/dL; urine M-component (absolute increase \\>=200mg/24h), appearance of new lesion(s),\\>=50% increase from nadir in SPD of \\>1 lesion or \\>=50% increase in the longest diameter of a previous lesion \\>1 cm in short axis or \\>=50% increase in circulating plasma cells (minimum of 200 c/mcL) if that was the only measure of disease.'}, {'measure': 'Phase 2: Overall Survival (OS)', 'timeFrame': 'From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months', 'description': 'OS was defined as the time interval from the date of randomization to death from any cause. Participants without death prior to the analysis cut-off date were censored at the last date the participant was known to be alive or the cut-off date, whichever came first. The results provided below corresponds to descriptive OS information at the time of primary analysis completion date of 09 October 2019.'}, {'measure': 'Phase 1 and 2: Plasma Concentration Observed at the End of IV Infusion (Ceoi) of Isatuximab Alone and in Combination With Cemiplimab', 'timeFrame': 'At end of infusion (EOI) on Cycle 1 Day 1', 'description': 'Plasma samples were collected at specified timepoints and those non-impacted by the bioanalytical issue were used for evaluation of Ceoi. It was calculated using non-compartmental analysis (NCA) after the first administration in Cycle 1. The PK population was defined independently for isatuximab and cemiplimab and consisted of all participants from the all-treated (AT) population with at least 1 available concentration post-baseline (whatever the cycle and even if dosing was incomplete) with adequate documentation of dosing and sampling dates and times.'}, {'measure': 'Phase 1 and 2: Maximum Observed Concentration (Cmax) of Isatuximab Alone and in Combination With Cemiplimab', 'timeFrame': 'At start of infusion (SOI), EOI, EOI+4 hours, 72 hours and 168 hours on Day 1 of Cycle 1', 'description': 'Plasma samples were collected at specified timepoints and those non-impacted by the bioanalytical issue were used for evaluation of Cmax. It was calculated using NCA after the first administration in Cycle 1.'}, {'measure': 'Phase 1 and 2: Time to Reach Cmax (Tmax) of Isatuximab Alone and in Combination With Cemiplimab', 'timeFrame': 'At SOI, EOI, EOI+4 hours, 72 hours and 168 hours on Day 1 of Cycle 1', 'description': 'Plasma samples were collected at specified timepoints and those non-impacted by the bioanalytical issue were used for evaluation of tmax. It was calculated using NCA after the first administration in Cycle 1.'}, {'measure': 'Phase 1 and 2: Last Concentration Observed Above the Lower Limit of Quantitation (Clast) of Isatuximab Alone and in Combination With Cemiplimab', 'timeFrame': 'At SOI, EOI, EOI+4 hours, 72 hours and 168 hours on Day 1 of Cycle 1', 'description': 'Plasma samples were collected at specified timepoints and those non-impacted by the bioanalytical issue were used for evaluation of Clast. It was calculated using NCA after the first administration in Cycle 1.'}, {'measure': 'Phase 1 and 2: Time of Clast (Tlast) of Isatuximab Alone and in Combination With Cemiplimab', 'timeFrame': 'At SOI, EOI, EOI+4 hours, 72 hours and 168 hours on Day 1 of Cycle 1', 'description': 'Plasma samples were collected at specified timepoints and those non-impacted by the bioanalytical issue were used for evaluation of tlast. It was calculated using NCA after the first administration in Cycle 1.'}, {'measure': 'Phase 1 and 2: Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Tlast (AUClast) of Isatuximab Alone and in Combination With Cemiplimab', 'timeFrame': 'At SOI, EOI, EOI+4 hours, 72 hours and 168 hours on Day 1 of Cycle 1', 'description': 'AUClast was defined as the area under the plasma concentration versus time curve from time 0 to real time tlast calculated using the trapezoidal method over the dosing interval after the first administration in Cycle 1.'}, {'measure': 'Phase 1 and 2: AUC From Time 0 to Week 1 (AUC1week) of Isatuximab Alone and in Combination With Cemiplimab', 'timeFrame': 'At SOI, EOI, EOI+4 hours, 72 hours and 168 hours on Day 1 of Cycle 1', 'description': 'AUC1week was defined as the area under the plasma concentration versus time curve from time 0 to 1 week post dose calculated using the trapezoidal method over the dosing interval after the first administration in Cycle 1.'}, {'measure': 'Phase 1 and 2: Number of Participants With Anti-Drug Antibodies (ADA) to Isatuximab', 'timeFrame': 'From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 20 months', 'description': 'ADA responses were categorized as treatment-induced ADA and treatment boosted ADA. Pre-existing ADA was defined as ADA that were present in samples drawn during the pre-treatment period. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period in participants without pre-existing ADA. Treatment boosted ADA was defined as pre-existing ADAs with a significant increase in the ADA titer during the study compared to the Baseline titer. The ADA evaluable population was defined independently for isatuximab and cemiplimab and consisted of all participants from AT population with at least 1 ADA result (negative, positive, or inconclusive) post-baseline.'}, {'measure': 'Phase 1 and 2: Number of Participants With ADA to Cemiplimab', 'timeFrame': 'From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 20 months', 'description': 'ADA responses were categorized as treatment-induced ADA and treatment boosted ADA. Pre-existing ADA was defined as ADA that were present in samples drawn during the pre-treatment period. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period in participants without pre-existing ADA. Treatment boosted ADA was defined as pre-existing ADAs with a significant increase in the ADA titer during the study compared to the Baseline titer.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anti-CD38 monoclonal antibody'], 'conditions': ['Plasma Cell Myeloma']}, 'descriptionModule': {'briefSummary': 'Primary Objectives:\n\n* To evaluate the safety and tolerability of the combination of isatuximab (also known as SAR650984) and cemiplimab (also known as REGN2810) in patients with relapse/refractory multiple myeloma.\n* To compare the overall response of the combination of isatuximab and cemiplimab versus isatuximab alone in patients with RRMM based on International Myeloma Working Group (IMWG) criteria.\n\nSecondary Objectives:\n\n* To evaluate the efficacy as assessed by clinical benefit rate (CBR), duration of response (DOR), time to response (TTR), progression free survival (PFS), and overall survival (OS).\n* To assess the pharmacokinetics (PK) of isatuximab and cemiplimab when given in combination.\n* To assess the immunogenicity of isatuximab and cemiplimab when given in combination.', 'detailedDescription': 'The duration of the study for a patient will include a period for screening of up to 21 days and 3-month post treatment follow up. The cycle duration is 28 days. Patients will continue treatment until disease progression, unacceptable adverse events, consent withdrawal, or any other reason.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Patients must have a known diagnosis of multiple myeloma with evidence of measurable disease, as defined below:\n\n * Serum M-protein ≥1 g/dL (≥0.5 g/dL in case of immunoglobulin A \\[IgA\\] disease), AND/OR\n * Urine M-protein ≥200 mg/24 hours, OR\n * In the absence of measurable M-protein, serum immunoglobulin free light chain ≥10 mg/dL, and abnormal serum immunoglobulin kappa lambda free light chain ratio (\\<0.26 or \\>1.65).\n* Patients must have received prior treatment with an immunomodulatory drug (IMiD) (for ≥2 cycles or ≥2 months of treatment) and a proteasome inhibitor (PI) (for ≥2 cycles or ≥2 months of treatment).\n* Patients must have received at least 3 prior lines of therapy (Note: Induction therapy and stem cell transplant ± maintenance will be considered as one line).\n* Patient must have achieved MR or better with any anti-myeloma therapy (ie, primary refractory disease is not eligible).\n\nExclusion criteria:\n\n* Prior exposure to isatuximab or participated clinical studies with isatuximab.\n* Prior exposure to any agent (approved or investigational) that blocks the programmed cell death-1 (PD-1)/PD-L1 pathway.\n* Evidence of other immune related disease/conditions.\n* History of non-infectious pneumonitis requiring steroids or current pneumonitis; history of the thoracic radiation.\n* Has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.\n* Has allogenic haemopoietic stem cell (HSC) transplant.\n* Prior treatment with idelalisib (a PI3K inhibitor).\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) \\>2.\n* Poor bone marrow reserve.\n* Poor organ function.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT03194867', 'briefTitle': 'Isatuximab in Combination With Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics and Efficacy of Isatuximab in Combination With Cemiplimab in Patients With Relapsed/Refractory Multiple Myeloma', 'orgStudyIdInfo': {'id': 'TCD14906'}, 'secondaryIdInfos': [{'id': '2017-001431-39', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1189-4706', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Isatuximab/cemiplimab (Regimen 1)', 'description': 'Isatuximab on Days 1, 8, 15, and 22, then Days 1 and 15 in 28-day cycles up to disease progression.\n\nCemiplimab on Days 1 and 15 in 28-day cycle up to disease progression.', 'interventionNames': ['Drug: Isatuximab SAR650984', 'Drug: Cemiplimab REGN2810']}, {'type': 'EXPERIMENTAL', 'label': 'Isatuximab/cemiplimab (Regimen 2)', 'description': 'Isatuximab on Days 1, 8, 15, and 22, then Days 1 and 15 in 28-day cycles up to disease progression.\n\nCemiplimab on Day 1 in 28-day cycle up to disease progression.', 'interventionNames': ['Drug: Isatuximab SAR650984', 'Drug: Cemiplimab REGN2810']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Isatuximab', 'description': 'Isatuximab on Days 1, 8, 15 and 22, then Day 1 and 15 in 28-day cycles up to disease progression.', 'interventionNames': ['Drug: Isatuximab SAR650984']}], 'interventions': [{'name': 'Isatuximab SAR650984', 'type': 'DRUG', 'otherNames': ['Sarclisa'], 'description': 'Pharmaceutical form: solution for infusion\n\nRoute of administration: intravenous', 'armGroupLabels': ['Isatuximab', 'Isatuximab/cemiplimab (Regimen 1)', 'Isatuximab/cemiplimab (Regimen 2)']}, {'name': 'Cemiplimab REGN2810', 'type': 'DRUG', 'description': 'Pharmaceutical form: solution for infusion\n\nRoute of administration: intravenous', 'armGroupLabels': ['Isatuximab/cemiplimab (Regimen 1)', 'Isatuximab/cemiplimab (Regimen 2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80262', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado-Site Number:8400001', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '66160-7321', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center-Site Number:8400003', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center-Site Number:8400002', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center-Site Number:8400004', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '2500', 'city': 'Wollongong', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Investigational Site Number :0360003', 'geoPoint': {'lat': -34.424, 'lon': 150.89345}}, {'zip': '3121', 'city': 'Richmond', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Investigational Site Number :0360002', 'geoPoint': {'lat': -37.81819, 'lon': 145.00176}}, {'zip': '6005', 'city': 'West Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Investigational Site Number :0360001', 'geoPoint': {'lat': -31.94896, 'lon': 115.84199}}, {'zip': 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