Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-01-27 @ 5:44 AM
Study NCT ID:
NCT00533702
Status:
COMPLETED
Last Update Posted:
2014-08-01
First Post:
2007-09-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of IMC-1121B (Ramucirumab) With or Without Dacarbazine in Metastatic Malignant Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000096662', 'term': 'Ramucirumab'}, {'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'C029899', 'term': 'imidazole'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and company'}, 'certainAgreement': {'otherDetails': 'Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'IMC-1121B (Ramucirumab) + Dacarbazine', 'description': 'IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.\n\nDacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.', 'otherNumAtRisk': 52, 'otherNumAffected': 52, 'seriousNumAtRisk': 52, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'IMC-1121B (Ramucirumab)', 'description': 'IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.', 'otherNumAtRisk': 50, 'otherNumAffected': 48, 'seriousNumAtRisk': 50, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 22, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 15, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 29, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 54, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 23, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 36, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 19, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 63, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 38, 'numAffected': 28}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Infusion site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Injection site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 27, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 12, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 14, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 18, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 21, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 17, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 12, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 7, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vitiligo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 18, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 19, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cardiac arrest', 'notes': 'Event resulted in death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hepatic failure', 'notes': 'Event resulted in death in both participants', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Metastatic malignant melanoma', 'notes': 'Event resulted in death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Tumour haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pelvic venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMC-1121B (Ramucirumab) + Dacarbazine', 'description': 'IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.\n\nDacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.'}, {'id': 'OG001', 'title': 'IMC-1121B (Ramucirumab)', 'description': 'IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '5.4'}, {'value': '1.7', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '2.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to 36 months', 'description': 'PFS was defined as the time from the first day of therapy to the first evidence of disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) or death from any cause. Progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter (LD) of the target lesions, taking as reference the smallest sum LD recorded since the treatment started in comparison with the measurement of the nadir or the appearance of 1 or more new lesions. In addition, unequivocal progression of existing non-target lesions was considered PD. New or existing pleural effusion/ascites required cytological confirmation for PD according to the protocol. Participants who did not progress and who were alive or did not have documented progression or missed ≥2 visits, or had no post baseline assessment were censored at the day of their last tumor assessment.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug. Censored participants: IMC-1121B (ramucirumab) + dacarbazine=9; IMC-1121B (ramucirumab)=4.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMC-1121B (Ramucirumab) + Dacarbazine', 'description': 'IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.\n\nDacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.'}, {'id': 'OG001', 'title': 'IMC-1121B (Ramucirumab)', 'description': 'IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.'}], 'classes': [{'title': 'Any RAM related TEAE', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'RAM related SAE', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'RAM related ≥ Grade 3 AE', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'RAM related death', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'RAM related TEAE leading to discontinuation of RAM', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Any AE with outcome of death', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 40 months', 'description': 'The number of participants who experienced any IMC-1121B (ramucirumab \\[RAM\\]) treatment-related and treatment emergent AE (TEAE), treatment-related TEAE of Grade ≥3, treatment-related TE serious AEs (SAEs), treatment-related TEAE resulting in death (Grade 5 AE) and any TEAEs resulting in death. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: All enrolled participants who were treated with any quantity of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMC-1121B (Ramucirumab) + Dacarbazine', 'description': 'IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.\n\nDacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.'}, {'id': 'OG001', 'title': 'IMC-1121B (Ramucirumab)', 'description': 'IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.3', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '30.3'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '13.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 1 Day 1 (of 21-day cycle) up to 17.1 months', 'description': 'The ORR was defined as the percentage of all randomized participants with the best overall response of PR or CR using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as the disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug.'}, {'type': 'SECONDARY', 'title': 'Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMC-1121B (Ramucirumab) + Dacarbazine', 'description': 'IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.\n\nDacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.'}, {'id': 'OG001', 'title': 'IMC-1121B (Ramucirumab)', 'description': 'IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.0', 'groupId': 'OG000', 'lowerLimit': '3.9', 'upperLimit': '17.1'}, {'value': 'NA', 'comment': 'Median was not calculated since there are only 2 data points.', 'groupId': 'OG001', 'lowerLimit': '3.2', 'upperLimit': '14.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 Day 1 (of 21-day cycle) up to 17.1 months', 'description': 'The duration of overall response was defined as the time from first assessment of complete response (CR) or partial response (PR) to the first date of progressive disease (PD) using Response Evaluation Criteria in Solid Tumors (RECIST v1.0), initiation of other or additional antitumor therapy, or death from any cause. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met. PD was defined as at least 20% increase in sum of longest diameter of target lesions. Participants who did not relapse were censored at the day of their last objective tumor assessment.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug and who had CR or PR. Censored participants: IMC-1121B (ramucirumab) + dacarbazine=2; IMC-1121B (ramucirumab)=0.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Stable Disease (SD) or Better (Disease Control Rate) at 6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMC-1121B (Ramucirumab) + Dacarbazine', 'description': 'IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.\n\nDacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.'}, {'id': 'OG001', 'title': 'IMC-1121B (Ramucirumab)', 'description': 'IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks (2 cycles of treatment)', 'description': 'Disease Control Rate (DCR) was defined as complete response (CR) plus partial response (PR) plus SD using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as the disappearance of all target and non-target lesions and the normalization of non-target lesion tumor marker levels. PR was defined as at least a 30% decrease from baseline in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met. SD was defined as: neither sufficient increase to qualify for progressive disease (PD) nor sufficient shrinkage to qualify for PR, taking as reference the smallest sum of the longest diameters recorded since treatment began. PD was defined as at least 20% increase in sum of longest diameter of target lesions.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Stable Disease (SD) or Better (Disease Control Rate) at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMC-1121B (Ramucirumab) + Dacarbazine', 'description': 'IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.\n\nDacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.'}, {'id': 'OG001', 'title': 'IMC-1121B (Ramucirumab)', 'description': 'IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks (4 cycles of treatment)', 'description': 'Disease Control Rate (DCR) was defined as complete response (CR) plus partial response (PR) plus SD using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as the disappearance of all target and non-target lesions and the normalization of non-target lesion tumor marker levels. PR was defined as at least a 30% decrease from baseline in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met. Stable Disease (SD) was defined as: neither sufficient increase to qualify for progressive disease (PD) nor sufficient shrinkage to qualify for PR, taking as reference the smallest sum of the longest diameters recorded since treatment began. PD was defined as at least 20% increase in sum of longest diameter of target lesions.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Response Rate) at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMC-1121B (Ramucirumab) + Dacarbazine', 'description': 'IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.\n\nDacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.'}, {'id': 'OG001', 'title': 'IMC-1121B (Ramucirumab)', 'description': 'IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.5', 'groupId': 'OG000'}, {'value': '4.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks (4 cycles of treatment)', 'description': 'Response rate was defined as a CR or a PR using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as the disappearance of all target and non-target lesions and the normalization of non-target lesion tumor marker levels. PR was defined as at least a 30% decrease from baseline in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug.'}, {'type': 'SECONDARY', 'title': 'Maximum Concentration (Cmax) for Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMC-1121B (Ramucirumab) + Dacarbazine', 'description': 'IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.\n\nDacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.'}, {'id': 'OG001', 'title': 'IMC-1121B (Ramucirumab)', 'description': 'IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.'}], 'timeFrame': 'Cycle 1 Day 1 (21-day cycle) 1-hour post infusion', 'description': 'Cmax was not calculated due to sparse sampling.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants were analyzed.'}, {'type': 'SECONDARY', 'title': 'Maximum Concentration (Cmax) for Cycle 1 Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMC-1121B (Ramucirumab) + Dacarbazine', 'description': 'IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.\n\nDacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.'}, {'id': 'OG001', 'title': 'IMC-1121B (Ramucirumab)', 'description': 'IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.'}], 'timeFrame': 'Cycle 1 Day 7 (21-day cycle)', 'description': 'Cmax was not calculated due to sparse sampling.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants were analyzed.'}, {'type': 'SECONDARY', 'title': 'Maximum Concentration (Cmax) for Cycle 1 Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMC-1121B (Ramucirumab) + Dacarbazine', 'description': 'IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.\n\nDacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.'}, {'id': 'OG001', 'title': 'IMC-1121B (Ramucirumab)', 'description': 'IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.'}], 'timeFrame': 'Cycle 1 Day 14 (21-day cycle)', 'description': 'Cmax was not calculated due to sparse sampling.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IMC-1121B (Ramucirumab) + Dacarbazine', 'description': 'IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.\n\nDacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.'}, {'id': 'FG001', 'title': 'IMC-1121B (Ramucirumab)', 'description': 'IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'Received Any Quantity of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Found ineligible after randomization', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Participants who completed the study were those who died or were alive but off treatment at the end of the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'IMC-1121B (Ramucirumab) + Dacarbazine', 'description': 'IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.\n\nDacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.'}, {'id': 'BG001', 'title': 'IMC-1121B (Ramucirumab)', 'description': 'IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All enrolled participants who were treated with any quantity of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'dispFirstSubmitDate': '2010-09-14', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-29', 'studyFirstSubmitDate': '2007-09-17', 'dispFirstSubmitQcDate': '2010-09-14', 'resultsFirstSubmitDate': '2014-05-16', 'studyFirstSubmitQcDate': '2007-09-19', 'dispFirstPostDateStruct': {'date': '2010-09-16', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-08-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-16', 'studyFirstPostDateStruct': {'date': '2007-09-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Baseline up to 36 months', 'description': 'PFS was defined as the time from the first day of therapy to the first evidence of disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) or death from any cause. Progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter (LD) of the target lesions, taking as reference the smallest sum LD recorded since the treatment started in comparison with the measurement of the nadir or the appearance of 1 or more new lesions. In addition, unequivocal progression of existing non-target lesions was considered PD. New or existing pleural effusion/ascites required cytological confirmation for PD according to the protocol. Participants who did not progress and who were alive or did not have documented progression or missed ≥2 visits, or had no post baseline assessment were censored at the day of their last tumor assessment.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AE)', 'timeFrame': 'Baseline up to 40 months', 'description': 'The number of participants who experienced any IMC-1121B (ramucirumab \\[RAM\\]) treatment-related and treatment emergent AE (TEAE), treatment-related TEAE of Grade ≥3, treatment-related TE serious AEs (SAEs), treatment-related TEAE resulting in death (Grade 5 AE) and any TEAEs resulting in death. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.'}, {'measure': 'Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]', 'timeFrame': 'Cycle 1 Day 1 (of 21-day cycle) up to 17.1 months', 'description': 'The ORR was defined as the percentage of all randomized participants with the best overall response of PR or CR using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as the disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met.'}, {'measure': 'Duration of Response', 'timeFrame': 'Cycle 1 Day 1 (of 21-day cycle) up to 17.1 months', 'description': 'The duration of overall response was defined as the time from first assessment of complete response (CR) or partial response (PR) to the first date of progressive disease (PD) using Response Evaluation Criteria in Solid Tumors (RECIST v1.0), initiation of other or additional antitumor therapy, or death from any cause. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met. PD was defined as at least 20% increase in sum of longest diameter of target lesions. Participants who did not relapse were censored at the day of their last objective tumor assessment.'}, {'measure': 'Percentage of Participants With Stable Disease (SD) or Better (Disease Control Rate) at 6 Weeks', 'timeFrame': '6 weeks (2 cycles of treatment)', 'description': 'Disease Control Rate (DCR) was defined as complete response (CR) plus partial response (PR) plus SD using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as the disappearance of all target and non-target lesions and the normalization of non-target lesion tumor marker levels. PR was defined as at least a 30% decrease from baseline in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met. SD was defined as: neither sufficient increase to qualify for progressive disease (PD) nor sufficient shrinkage to qualify for PR, taking as reference the smallest sum of the longest diameters recorded since treatment began. PD was defined as at least 20% increase in sum of longest diameter of target lesions.'}, {'measure': 'Percentage of Participants With Stable Disease (SD) or Better (Disease Control Rate) at 12 Weeks', 'timeFrame': '12 weeks (4 cycles of treatment)', 'description': 'Disease Control Rate (DCR) was defined as complete response (CR) plus partial response (PR) plus SD using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as the disappearance of all target and non-target lesions and the normalization of non-target lesion tumor marker levels. PR was defined as at least a 30% decrease from baseline in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met. Stable Disease (SD) was defined as: neither sufficient increase to qualify for progressive disease (PD) nor sufficient shrinkage to qualify for PR, taking as reference the smallest sum of the longest diameters recorded since treatment began. PD was defined as at least 20% increase in sum of longest diameter of target lesions.'}, {'measure': 'Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Response Rate) at 12 Weeks', 'timeFrame': '12 weeks (4 cycles of treatment)', 'description': 'Response rate was defined as a CR or a PR using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as the disappearance of all target and non-target lesions and the normalization of non-target lesion tumor marker levels. PR was defined as at least a 30% decrease from baseline in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met.'}, {'measure': 'Maximum Concentration (Cmax) for Cycle 1 Day 1', 'timeFrame': 'Cycle 1 Day 1 (21-day cycle) 1-hour post infusion', 'description': 'Cmax was not calculated due to sparse sampling.'}, {'measure': 'Maximum Concentration (Cmax) for Cycle 1 Day 7', 'timeFrame': 'Cycle 1 Day 7 (21-day cycle)', 'description': 'Cmax was not calculated due to sparse sampling.'}, {'measure': 'Maximum Concentration (Cmax) for Cycle 1 Day 14', 'timeFrame': 'Cycle 1 Day 14 (21-day cycle)', 'description': 'Cmax was not calculated due to sparse sampling.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Phase II', 'Melanoma', 'IMC-1121B', 'ImClone'], 'conditions': ['Metastatic Malignant Melanoma']}, 'referencesModule': {'references': [{'pmid': '24930625', 'type': 'DERIVED', 'citation': 'Carvajal RD, Wong MK, Thompson JA, Gordon MS, Lewis KD, Pavlick AC, Wolchok JD, Rojas PB, Schwartz JD, Bedikian AY. A phase 2 randomised study of ramucirumab (IMC-1121B) with or without dacarbazine in patients with metastatic melanoma. Eur J Cancer. 2014 Aug;50(12):2099-107. doi: 10.1016/j.ejca.2014.03.289. Epub 2014 Jun 12.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine the progression-free survival (PFS) of participants with previously untreated metastatic malignant melanoma when treated with IMC-1121B (ramucirumab) alone or in combination with dacarbazine.', 'detailedDescription': 'The purpose of this study is to determine the antitumor activity and safety profile of IMC-1121B (ramucirumab) when used alone or in combination with dacarbazine in participants with metastatic melanoma who have not received prior chemotherapy for this disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The participant has histologically or cytologically confirmed melanoma that is stage IV (metastatic)\n* The participant has an Eastern Cooperative Oncology Performance Status (ECOG PS) of 0-1\n* The participant has completed any prior radiotherapy, biologic/immunotherapy or vaccine therapy (for adjuvant or advanced disease) at least six weeks prior to the first dose of study therapy\n* The participant has adequate hematological functions \\[absolute neutrophil count (ANC) ≥ 1500 cells/microliter (μL), hemoglobin ≥ 9 grams/deciliter (g/dL) and platelets ≥ 100,000 cells/μL\\].\n* The participant has adequate hepatic function \\[bilirubin within normal limits (WNL), aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤ 2.5 times the upper limit of normal (ULN), or ≤ 5.0 times the ULN if the transaminase elevation is due to liver metastases\\]\n* The participant has serum creatinine ≤ 1.5 x ULN \\[or a calculated creatinine clearance \\> 60 milliliters/minute (mL/min)\\]\n* The participant's urinary protein ≤ 1+ on dipstick or routine urinalysis \\[(UA); if urine dipstick or routine analysis is ≥ 2+, a 24-hour urine for protein must demonstrate \\< 1000 milligrams (mg) of protein in 24 hours to allow participation in the study\\]\n* The participant must have adequate coagulation function as defined by International Normalized Ratio (INR) ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 1.5 X ULN\n\nExclusion Criteria\n\n* The participant has mucosal or intra-ocular melanoma\n* The participant has known or suspected brain or leptomeningeal metastases\n* The participant has had prior cytotoxic chemotherapy for metastatic malignant melanoma\n* The participant has had more than one line of biologic, immunologic or vaccine-based therapy for metastatic malignant melanoma (including therapy for adjuvant or advanced disease)\n* The participant has a nonhealing wound or ulcer\n* The participant has a known alcohol or drug dependency\n* The participant is pregnant or breastfeeding\n* The participant has a coexisting medical or psychiatric problem of sufficient severity to limit compliance with the study and/or increase the risks associated with study participation or study drug administration or interfere with the interpretation of study results\n* The participant has an ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders in the opinion of the investigator"}, 'identificationModule': {'nctId': 'NCT00533702', 'briefTitle': 'A Study of IMC-1121B (Ramucirumab) With or Without Dacarbazine in Metastatic Malignant Melanoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Phase II Randomized, Open-Label Study of IMC-1121B With or Without Dacarbazine in Patients With Metastatic Malignant Melanoma', 'orgStudyIdInfo': {'id': '13920'}, 'secondaryIdInfos': [{'id': 'CP12-0604', 'type': 'OTHER', 'domain': 'ImClone Systems'}, {'id': 'I4T-IE-JVBO', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IMC-1121B (ramucirumab)', 'description': 'IMC-1121B (ramucirumab)', 'interventionNames': ['Biological: IMC-1121B (ramucirumab)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IMC-1121B (ramucirumab) + dacarbazine', 'description': 'IMC-1121B (ramucirumab) + dacarbazine', 'interventionNames': ['Biological: IMC-1121B (ramucirumab)', 'Drug: Dacarbazine']}], 'interventions': [{'name': 'IMC-1121B (ramucirumab)', 'type': 'BIOLOGICAL', 'otherNames': ['ramucirumab', 'LY3009806'], 'description': '10 milligrams/kilogram (mg/kg) intravenously every 3 weeks in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.', 'armGroupLabels': ['IMC-1121B (ramucirumab)', 'IMC-1121B (ramucirumab) + dacarbazine']}, {'name': 'Dacarbazine', 'type': 'DRUG', 'otherNames': ['DIC', 'Imidazole', 'Carboxamide'], 'description': '1000 milligrams/square meter (mg/m2) intravenously every 3 weeks in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.', 'armGroupLabels': ['IMC-1121B (ramucirumab) + dacarbazine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35601', 'city': 'Decatur', 'state': 'Alabama', 'country': 'United States', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 34.60593, 'lon': -86.98334}}, {'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85260', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'ImClone Investigational Site', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '94109', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'ImClone Investigational Site', 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