Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-28 @ 4:24 AM
Study NCT ID:
NCT00701103
Status:
COMPLETED
Last Update Posted:
2018-08-08
First Post:
2008-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dose Escalation Trial of Dalotuzumab (MK-0646) in Advanced Solid Tumors and Multiple Myeloma (MK-0646-001)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Spain']}, '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': 'C569480', 'term': 'dalotuzumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 30 days after last dose of study drug (Up to 25 months)', 'description': 'The population consisted of all participants who received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.', 'otherNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Dalotuzumab 5 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.', 'otherNumAtRisk': 8, 'otherNumAffected': 6, 'seriousNumAtRisk': 8, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Dalotuzumab 10 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.', 'otherNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Dalotuzumab 10 mg/kg Q1W (20 mg/mL)', 'description': 'Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.', 'otherNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'Dalotuzumab 15 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.', 'otherNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'seriousNumAffected': 3}, {'id': 'EG006', 'title': 'Dalotuzumab 15 mg/kg Q1W (20 mg/mL)', 'description': 'Participants received dalotuzumab 15 mg/kg (20 mg/mL) IV infusion Q1W.', 'otherNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'seriousNumAffected': 3}, {'id': 'EG007', 'title': 'Dalotuzumab 20 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.', 'otherNumAtRisk': 7, 'otherNumAffected': 6, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Dalotuzumab 20 mg/kg Q1W (20 mg/mL)', 'description': 'Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q1W.', 'otherNumAtRisk': 9, 'otherNumAffected': 8, 'seriousNumAtRisk': 9, 'seriousNumAffected': 2}, {'id': 'EG009', 'title': 'Dalotuzumab 20 mg/kg Q2W (20 mg/mL)', 'description': 'Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.', 'otherNumAtRisk': 11, 'otherNumAffected': 9, 'seriousNumAtRisk': 11, 'seriousNumAffected': 3}, {'id': 'EG010', 'title': 'Dalotuzumab 30 mg/kg Q3W (20 mg/mL)', 'description': 'Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.', 'otherNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 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'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 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{'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': "Ewing's sarcoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Tumour pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Leukocytoclastic vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Experienced One or More Dose-limiting Toxicities (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG001', 'title': 'Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG002', 'title': 'Dalotuzumab 5 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG003', 'title': 'Dalotuzumab 10 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG004', 'title': 'Dalotuzumab 10 mg/kg Q1W (20 mg/mL)', 'description': 'Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.'}, {'id': 'OG005', 'title': 'Dalotuzumab 15 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG006', 'title': 'Dalotuzumab 15 mg/kg Q1W (20 mg/mL)', 'description': 'Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.'}, {'id': 'OG007', 'title': 'Dalotuzumab 20 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG008', 'title': 'Dalotuzumab 20 mg/kg Q1W (20 mg/mL)', 'description': 'Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.'}, {'id': 'OG009', 'title': 'Dalotuzumab 20 mg/kg Q2W (20 mg/mL)', 'description': 'Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.'}, {'id': 'OG010', 'title': 'Dalotuzumab 30 mg/kg Q3W (20 mg/mL)', 'description': 'Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 weeks', 'description': 'Toxicity was graded and recorded according to National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events version 3.0 (CTCAE 3.0). A DLT was defined as any Grade 3 or 4 toxicity. A Grade 3 toxicity was defined as severe or medically significant but not immediately life-threatening OR hospitalization or prolongation of hospitalization indicated OR disabling OR limiting self care activities of daily living. A Grade 4 toxicity was defined as: life-threatening consequences OR urgent intervention indicated. Participants were monitored for the occurrence of DLTs during the first 3 weeks of dosing with dalotuzumab.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population consisted of all participants who received at least one dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Mean Terminal Half-life (t1/2) of Dalotuzumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG001', 'title': 'Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG002', 'title': 'Dalotuzumab 5 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG003', 'title': 'Dalotuzumab 10 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG004', 'title': 'Dalotuzumab 10 mg/kg Q1W (20 mg/mL)', 'description': 'Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.'}, {'id': 'OG005', 'title': 'Dalotuzumab 15 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG006', 'title': 'Dalotuzumab 15 mg/kg Q1W (20 mg/mL)', 'description': 'Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.'}, {'id': 'OG007', 'title': 'Dalotuzumab 20 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG008', 'title': 'Dalotuzumab 20 mg/kg Q1W (20 mg/mL)', 'description': 'Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.'}, {'id': 'OG009', 'title': 'Dalotuzumab 20 mg/kg Q2W (20 mg/mL)', 'description': 'Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.'}, {'id': 'OG010', 'title': 'Dalotuzumab 30 mg/kg Q3W (20 mg/mL)', 'description': 'Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.'}], 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000', 'lowerLimit': '46', 'upperLimit': '121'}, {'value': '79', 'groupId': 'OG001', 'lowerLimit': '53', 'upperLimit': '113'}, {'value': '83', 'groupId': 'OG002', 'lowerLimit': '41', 'upperLimit': '240'}, {'value': '169', 'groupId': 'OG003', 'lowerLimit': '134', 'upperLimit': '265'}, {'value': '100', 'groupId': 'OG004', 'lowerLimit': '81', 'upperLimit': '123'}, {'value': '95', 'groupId': 'OG005', 'lowerLimit': '43', 'upperLimit': '165'}, {'value': '110', 'groupId': 'OG006', 'lowerLimit': '83', 'upperLimit': '215'}, {'value': '129', 'groupId': 'OG007', 'lowerLimit': '74', 'upperLimit': '240'}, {'value': '120', 'groupId': 'OG008', 'lowerLimit': '66', 'upperLimit': '184'}, {'value': '106', 'groupId': 'OG009', 'lowerLimit': '44', 'upperLimit': '134'}, {'value': '142', 'groupId': 'OG010', 'lowerLimit': '73', 'upperLimit': '187'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post-infusion', 'description': 'Terminal half-life is defined as the time it takes for the blood plasma concentration of a substance to halve (plasma half-life). Blood samples for measurement of serum levels of dalotuzumab were obtained at: pre-dose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post infusion. For infusions \\>1 hour in duration, an additional sample was obtained at the mid-point of the infusion. Data presented are for the harmonic mean t1/2 for dalotuzumab.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The population consisted of all evaluable participants who received \\>90% of intended drug volume and had t1/2 pharmacokinetic measurements at Baseline and at least once during treatment.'}, {'type': 'PRIMARY', 'title': 'Area Under the Time-concentration Curve From 0 to Infinity Hours (AUC0-∞) of Dalotuzumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG001', 'title': 'Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG002', 'title': 'Dalotuzumab 5 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG003', 'title': 'Dalotuzumab 10 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG004', 'title': 'Dalotuzumab 10 mg/kg Q1W (20 mg/mL)', 'description': 'Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.'}, {'id': 'OG005', 'title': 'Dalotuzumab 15 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG006', 'title': 'Dalotuzumab 15 mg/kg Q1W (20 mg/mL)', 'description': 'Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.'}, {'id': 'OG007', 'title': 'Dalotuzumab 20 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG008', 'title': 'Dalotuzumab 20 mg/kg Q1W (20 mg/mL)', 'description': 'Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.'}, {'id': 'OG009', 'title': 'Dalotuzumab 20 mg/kg Q2W (20 mg/mL)', 'description': 'Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.'}, {'id': 'OG010', 'title': 'Dalotuzumab 30 mg/kg Q3W (20 mg/mL)', 'description': 'Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '12.9', 'spread': '4.4', 'groupId': 'OG002'}, {'value': '28.9', 'spread': '10.4', 'groupId': 'OG003'}, {'value': '18.4', 'spread': '4.1', 'groupId': 'OG004'}, {'value': '39.4', 'spread': '14.5', 'groupId': 'OG005'}, {'value': '28.8', 'spread': '8.8', 'groupId': 'OG006'}, {'value': '52.7', 'spread': '19.2', 'groupId': 'OG007'}, {'value': '44.3', 'spread': '20.0', 'groupId': 'OG008'}, {'value': '45.9', 'spread': '14.4', 'groupId': 'OG009'}, {'value': '92.6', 'spread': '29.8', 'groupId': 'OG010'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post-infusion', 'description': 'AUC0-∞ represents the total drug exposure over time. Blood samples for measurement of serum levels of dalotuzumab were obtained at: Predose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post-infusion. For infusions \\>1 hour in duration, an additional sample was obtained at the mid-point of the infusion.', 'unitOfMeasure': 'mg*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population consisted of all evaluable participants who received \\>90% of intended drug volume and had AUC0-last pharmacokinetic measurements at Baseline and at least once during treatment.'}, {'type': 'PRIMARY', 'title': 'Mean Serum Clearance of Dalotuzumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG001', 'title': 'Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG002', 'title': 'Dalotuzumab 5 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG003', 'title': 'Dalotuzumab 10 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG004', 'title': 'Dalotuzumab 10 mg/kg Q1W (20 mg/mL)', 'description': 'Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.'}, {'id': 'OG005', 'title': 'Dalotuzumab 15 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG006', 'title': 'Dalotuzumab 15 mg/kg Q1W (20 mg/mL)', 'description': 'Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.'}, {'id': 'OG007', 'title': 'Dalotuzumab 20 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG008', 'title': 'Dalotuzumab 20 mg/kg Q1W (20 mg/mL)', 'description': 'Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.'}, {'id': 'OG009', 'title': 'Dalotuzumab 20 mg/kg Q2W (20 mg/mL)', 'description': 'Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.'}, {'id': 'OG010', 'title': 'Dalotuzumab 30 mg/kg Q3W (20 mg/mL)', 'description': 'Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.013', 'spread': '0.004', 'groupId': 'OG000'}, {'value': '0.012', 'spread': '0.003', 'groupId': 'OG001'}, {'value': '0.007', 'spread': '0.003', 'groupId': 'OG002'}, {'value': '0.006', 'spread': '0.002', 'groupId': 'OG003'}, {'value': '0.009', 'spread': '0.002', 'groupId': 'OG004'}, {'value': '0.007', 'spread': '0.004', 'groupId': 'OG005'}, {'value': '0.010', 'spread': '0.004', 'groupId': 'OG006'}, {'value': '0.007', 'spread': '0.003', 'groupId': 'OG007'}, {'value': '0.009', 'spread': '0.004', 'groupId': 'OG008'}, {'value': '0.008', 'spread': '0.003', 'groupId': 'OG009'}, {'value': '0.006', 'spread': '0.003', 'groupId': 'OG010'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post-infusion', 'description': 'Clearance is defined as the volume of serum from which study drug was completely removed per unit of time. Blood samples for measurement of serum levels of dalotuzumab were obtained at: pre-dose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post infusion. For infusions \\>1 hour in duration, an additional sample was obtained at the mid-point of the infusion.', 'unitOfMeasure': 'mL/min/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population consisted of all evaluable participants who received \\>90% of intended drug volume and had mean serum clearance pharmacokinetic measurements at Baseline and at least once during treatment.'}, {'type': 'PRIMARY', 'title': 'Mean Trough Serum Concentration (Ctrough) of Dalotuzumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG001', 'title': 'Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG002', 'title': 'Dalotuzumab 5 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG003', 'title': 'Dalotuzumab 10 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG004', 'title': 'Dalotuzumab 10 mg/kg Q1W (20 mg/mL)', 'description': 'Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.'}, {'id': 'OG005', 'title': 'Dalotuzumab 15 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG006', 'title': 'Dalotuzumab 15 mg/kg Q1W (20 mg/mL)', 'description': 'Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.'}, {'id': 'OG007', 'title': 'Dalotuzumab 20 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG008', 'title': 'Dalotuzumab 20 mg/kg Q1W (20 mg/mL)', 'description': 'Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.'}, {'id': 'OG009', 'title': 'Dalotuzumab 20 mg/kg Q2W (20 mg/mL)', 'description': 'Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.'}, {'id': 'OG010', 'title': 'Dalotuzumab 30 mg/kg Q3W (20 mg/mL)', 'description': 'Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '3.0', 'groupId': 'OG001'}, {'value': '21.2', 'spread': '8.3', 'groupId': 'OG002'}, {'value': '54.8', 'spread': '13.3', 'groupId': 'OG003'}, {'value': '45.2', 'spread': '17.4', 'groupId': 'OG004'}, {'value': '81.2', 'spread': '38.6', 'groupId': 'OG005'}, {'value': '59.6', 'spread': '17.3', 'groupId': 'OG006'}, {'value': '110.5', 'spread': '46.0', 'groupId': 'OG007'}, {'value': '87.3', 'spread': '41.5', 'groupId': 'OG008'}, {'value': '57.0', 'spread': '22.7', 'groupId': 'OG009'}, {'value': '70.4', 'spread': '34.1', 'groupId': 'OG010'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose immediately prior to second infusion: 168 hours for Q1W, 336 hours for Q2W and 504 hours for Q3W dosing', 'description': 'The lowest (trough) concentration of dalotuzumab prior to the next dose of dalotuzumab was measured.', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population consisted of all evaluable participants who received \\>90% of intended drug volume and had mean trough serum concentration pharmacokinetic measurements at Baseline and at least once during treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Insulin-like Growth Factor Receptor Type 1 (IGF-1R) Protein Expression Level H-score in Skin Samples', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG001', 'title': 'Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG002', 'title': 'Dalotuzumab 5 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG003', 'title': 'Dalotuzumab 10 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 10 mg/kg IV infusion Q1W.'}, {'id': 'OG004', 'title': 'Dalotuzumab 15 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 15 mg/kg IV infusion Q1W.'}, {'id': 'OG005', 'title': 'Dalotuzumab 20 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 20 mg/kg IV infusion Q1W or Q2W.'}, {'id': 'OG006', 'title': 'Dalotuzumab 30 mg/kg Q3W (20 mg/mL)', 'description': 'Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '186.7', 'spread': '35.1', 'groupId': 'OG000'}, {'value': '203.3', 'spread': '55.1', 'groupId': 'OG001'}, {'value': '218.6', 'spread': '57.9', 'groupId': 'OG002'}, {'value': '171.8', 'spread': '40.2', 'groupId': 'OG003'}, {'value': '182.0', 'spread': '33.9', 'groupId': 'OG004'}, {'value': '146.3', 'spread': '76.9', 'groupId': 'OG005'}]}]}, {'title': 'Change from Baseline', 'categories': [{'measurements': [{'value': '-1.7', 'spread': '42.5', 'groupId': 'OG000'}, {'value': '-11.7', 'spread': '48.6', 'groupId': 'OG001'}, {'value': '-20.0', 'spread': '68.6', 'groupId': 'OG002'}, {'value': '-2.7', 'spread': '42.2', 'groupId': 'OG003'}, {'value': '-39.0', 'spread': '36.3', 'groupId': 'OG004'}, {'value': '-27.0', 'spread': '54.1', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose in Cycle 1 (Baseline) and predose in Cycle 3 (Week 4)', 'description': 'IGF-1R expression was measured in pre- and post-dose skin biopsy samples using an immunohistochemistry (IHC) assay as a function of time and dose. Results were expressed as an IGF-1R membrane H-score which could range from 0 to 300; with a score of 0 representing the absence of IGF-1R expression and an H-score of 300 representing maximum IGF-1R expression. Changes in IGF-1R expression levels from Baseline are summarized for all participants for whom these paired data were available. A post-dose decrease in IGF-1R membrane H-score was an indication of target engagement by dalotuzumab. A larger decrease in H-score correlated with a greater target engagement.', 'unitOfMeasure': 'H-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population consisted of all evaluable participants who received \\>90% of intended drug volume and had skin IGF-1R pharmacodynamics measurements at Baseline and at least once during treatment. No data were available for the Dalotuzumab 30 mg/kg Q3W treatment group.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in IGF-1R Protein Expression Level H-score in Tumor Samples', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG001', 'title': 'Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG002', 'title': 'Dalotuzumab 5 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG003', 'title': 'Dalotuzumab 10 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 10 mg/kg IV infusion Q1W.'}, {'id': 'OG004', 'title': 'Dalotuzumab 15 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 15 mg/kg IV infusion Q1W.'}, {'id': 'OG005', 'title': 'Dalotuzumab 20 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 20 mg/kg IV infusion Q1W or Q2W.'}, {'id': 'OG006', 'title': 'Dalotuzumab 30 mg/kg Q3W (20 mg/mL)', 'description': 'Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '145.0', 'spread': '91.9', 'groupId': 'OG000'}, {'value': '84.0', 'spread': '59.0', 'groupId': 'OG002'}, {'value': '110.0', 'spread': '46.9', 'groupId': 'OG003'}, {'value': '134.3', 'spread': '77.0', 'groupId': 'OG004'}, {'value': '152.5', 'spread': '72.4', 'groupId': 'OG005'}]}]}, {'title': 'Change from Baseline', 'categories': [{'measurements': [{'value': '-80.0', 'spread': '28.3', 'groupId': 'OG000'}, {'value': '-16.0', 'spread': '27.0', 'groupId': 'OG002'}, {'value': '10.0', 'spread': '76.2', 'groupId': 'OG003'}, {'value': '-30.0', 'spread': '40.0', 'groupId': 'OG004'}, {'value': '-40.8', 'spread': '108.1', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose in Cycle 1 (Baseline) and predose in Cycle 3 (Week 4)', 'description': 'IGF-1R expression was measured in pre- and post-dose tumor biopsy samples using an IHC assay as a function of time and dose. Results were expressed as an IGF-1R membrane H-score which could range from 0 to 300; with a score of 0 representing the absence of IGF-1R expression and an H-score of 300 representing maximum IGF-1R expression. Changes in IGF-1R expression levels from Baseline are summarized for all participants for whom these paired data were available. A post-dose decrease in IGF-1R membrane H-score was an indication of target engagement by dalotuzumab. A larger decrease in H-score correlated with a greater target engagement.', 'unitOfMeasure': 'H-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population consisted of all evaluable participants who received \\>90% of intended drug volume and had IGF-1R tumor pharmacodynamics measurements at Baseline and at least once during treatment. No data were available for the Dalotuzumab 2.5 mg/kg Q1W and Dalotuzumab 30 mg/kg Q3W treatment groups.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Developed a Serum Human-anti-humanized-antibody (HAHA) Response to Dalotuzumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG001', 'title': 'Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG002', 'title': 'Dalotuzumab 5 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG003', 'title': 'Dalotuzumab 10 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG004', 'title': 'Dalotuzumab 10 mg/kg Q1W (20 mg/mL)', 'description': 'Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.'}, {'id': 'OG005', 'title': 'Dalotuzumab 15 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG006', 'title': 'Dalotuzumab 15 mg/kg Q1W (20 mg/mL)', 'description': 'Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.'}, {'id': 'OG007', 'title': 'Dalotuzumab 20 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG008', 'title': 'Dalotuzumab 20 mg/kg Q1W (20 mg/mL)', 'description': 'Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.'}, {'id': 'OG009', 'title': 'Dalotuzumab 20 mg/kg Q2W (20 mg/mL)', 'description': 'Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.'}, {'id': 'OG010', 'title': 'Dalotuzumab 30 mg/kg Q3W (20 mg/mL)', 'description': 'Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2 years', 'description': 'It is thought that the formation of HAHAs may block efficacy by prematurely clearing dalotuzumab and limit the possibility of future dalotuzumab therapy. Blood samples for the measurement of serum levels of HAHAs were obtained prior to treatment with dalotuzumab, and pre-dose Week 2 (Q1W), pre-dose Week 3 (Q2W), pre-dose Week 4 (QW3), pre-dose Week 5 (Q1W/Q2W), pre-dose Week 7 (Q2W/Q3W), pre-dose Week 9 (Q2W), pre-dose Week 10 (QW3) and pre-dose every 4 subsequent weeks and end of treatment (post-study: 4 weeks after last dose of study drug).', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population consisted of all participants who received \\>90% of intended drug volume and had measurements at Baseline and at least once during treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Experienced a Complete Response (CR) or Partial Response (PR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG001', 'title': 'Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG002', 'title': 'Dalotuzumab 5 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG003', 'title': 'Dalotuzumab 10 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG004', 'title': 'Dalotuzumab 10 mg/kg Q1W (20 mg/mL)', 'description': 'Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.'}, {'id': 'OG005', 'title': 'Dalotuzumab 15 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG006', 'title': 'Dalotuzumab 15 mg/kg Q1W (20 mg/mL)', 'description': 'Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.'}, {'id': 'OG007', 'title': 'Dalotuzumab 20 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'OG008', 'title': 'Dalotuzumab 20 mg/kg Q1W (20 mg/mL)', 'description': 'Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.'}, {'id': 'OG009', 'title': 'Dalotuzumab 20 mg/kg Q2W (20 mg/mL)', 'description': 'Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.'}, {'id': 'OG010', 'title': 'Dalotuzumab 30 mg/kg Q3W (20 mg/mL)', 'description': 'Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2 years', 'description': 'Tumor responses were measured by using Response Evaluation Criteria in Solid Tumors (RECIST) criteria in participants with solid tumors and using European Group for Blood and Marrow Transplantation (EBMT) criteria in participants with multiple myeloma. RECIST criteria for CR: Disappearance of all target lesions. RECIST criteria for PR: ≥30% decrease in the sum of diameters of target lesions. EBMT criteria for CR: Disappearance of the original mAb protein from the blood and urine AND \\<5% plasma cells in the bone marrow AND no increase in the size or number of lytic bone lesions AND disappearance of soft tissue plasmacytomas AND normal serum calcium levels. EMBT criteria for PR: ≥50% reduction in the serum mAb protein level AND if a urine M-component is present, a reduction in 24-hour urinary light chain excretion by either ≥90% or to \\<200 mg AND ≥50% reduction in the size of soft tissue plasmacytomas AND no increase in size or number of lytic bone lesions.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population consisted of all evaluable participants who received \\>90% of intended drug volume and had efficacy measurements at Baseline and at least once during treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) intravenous (IV) infusion 1 time every 1 week (Q1W).'}, {'id': 'FG001', 'title': 'Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'FG002', 'title': 'Dalotuzumab 5 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'FG003', 'title': 'Dalotuzumab 10 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'FG004', 'title': 'Dalotuzumab 10 mg/kg Q1W (20 mg/mL)', 'description': 'Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.'}, {'id': 'FG005', 'title': 'Dalotuzumab 15 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'FG006', 'title': 'Dalotuzumab 15 mg/kg Q1W (20 mg/mL)', 'description': 'Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.'}, {'id': 'FG007', 'title': 'Dalotuzumab 20 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'FG008', 'title': 'Dalotuzumab 20 mg/kg Q1W (20 mg/mL)', 'description': 'Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.'}, {'id': 'FG009', 'title': 'Dalotuzumab 20 mg/kg Q2W (20 mg/mL)', 'description': 'Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion 1 time every 2 weeks (Q2W).'}, {'id': 'FG010', 'title': 'Dalotuzumab 30 mg/kg Q3W (20 mg/mL)', 'description': 'Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion 1 time every 3 weeks (Q3W).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '8'}, {'groupId': 'FG007', 'numSubjects': '7'}, {'groupId': 'FG008', 'numSubjects': '9'}, {'groupId': 'FG009', 'numSubjects': '11'}, {'groupId': 'FG010', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '8'}, {'groupId': 'FG007', 'numSubjects': '7'}, {'groupId': 'FG008', 'numSubjects': '9'}, {'groupId': 'FG009', 'numSubjects': '11'}, {'groupId': 'FG010', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '7'}, {'groupId': 'FG008', 'numSubjects': '8'}, {'groupId': 'FG009', 'numSubjects': '8'}, {'groupId': 'FG010', 'numSubjects': '11'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants who were ≥18 years old, had metastatic or locally advanced solid tumors (including multiple myeloma) and failed to respond to standard therapy, or had progressed despite standard therapy, or for whom standard therapy did not exist were recruited for this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '9', 'groupId': 'BG008'}, {'value': '11', 'groupId': 'BG009'}, {'value': '11', 'groupId': 'BG010'}, {'value': '80', 'groupId': 'BG011'}]}], 'groups': [{'id': 'BG000', 'title': 'Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'BG001', 'title': 'Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'BG002', 'title': 'Dalotuzumab 5 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'BG003', 'title': 'Dalotuzumab 10 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'BG004', 'title': 'Dalotuzumab 10 mg/kg Q1W (20 mg/mL)', 'description': 'Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.'}, {'id': 'BG005', 'title': 'Dalotuzumab 15 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'BG006', 'title': 'Dalotuzumab 15 mg/kg Q1W (20 mg/mL)', 'description': 'Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.'}, {'id': 'BG007', 'title': 'Dalotuzumab 20 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.'}, {'id': 'BG008', 'title': 'Dalotuzumab 20 mg/kg Q1W (20 mg/mL)', 'description': 'Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.'}, {'id': 'BG009', 'title': 'Dalotuzumab 20 mg/kg Q2W (20 mg/mL)', 'description': 'Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.'}, {'id': 'BG010', 'title': 'Dalotuzumab 30 mg/kg Q3W (20 mg/mL)', 'description': 'Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.'}, {'id': 'BG011', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69', 'spread': '9', 'groupId': 'BG000', 'lowerLimit': '59', 'upperLimit': '81'}, {'value': '60', 'spread': '9', 'groupId': 'BG001', 'lowerLimit': '50', 'upperLimit': '68'}, {'value': '68', 'spread': '9', 'groupId': 'BG002', 'lowerLimit': '51', 'upperLimit': '80'}, {'value': '56', 'spread': '10', 'groupId': 'BG003', 'lowerLimit': '40', 'upperLimit': '68'}, {'value': '53', 'spread': '17', 'groupId': 'BG004', 'lowerLimit': '26', 'upperLimit': '70'}, {'value': '49', 'spread': '22', 'groupId': 'BG005', 'lowerLimit': '23', 'upperLimit': '70'}, {'value': '54', 'spread': '18', 'groupId': 'BG006', 'lowerLimit': '29', 'upperLimit': '64'}, {'value': '46', 'spread': '13', 'groupId': 'BG007', 'lowerLimit': '27', 'upperLimit': '78'}, {'value': '52', 'spread': '18', 'groupId': 'BG008', 'lowerLimit': '22', 'upperLimit': '69'}, {'value': '55', 'spread': '17', 'groupId': 'BG009', 'lowerLimit': '23', 'upperLimit': '77'}, {'value': '52', 'spread': '15', 'groupId': 'BG010', 'lowerLimit': '19', 'upperLimit': '73'}, {'value': '55', 'spread': '16', 'groupId': 'BG011', 'lowerLimit': '19', 'upperLimit': '81'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '6', 'groupId': 'BG010'}, {'value': '40', 'groupId': 'BG011'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '5', 'groupId': 'BG010'}, {'value': '40', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The population consisted of all participants who received at least one dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2009-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-12', 'studyFirstSubmitDate': '2008-06-17', 'resultsFirstSubmitDate': '2017-01-31', 'studyFirstSubmitQcDate': '2008-06-18', 'lastUpdatePostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-31', 'studyFirstPostDateStruct': {'date': '2008-06-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Experienced One or More Dose-limiting Toxicities (DLTs)', 'timeFrame': 'Up to 3 weeks', 'description': 'Toxicity was graded and recorded according to National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events version 3.0 (CTCAE 3.0). A DLT was defined as any Grade 3 or 4 toxicity. A Grade 3 toxicity was defined as severe or medically significant but not immediately life-threatening OR hospitalization or prolongation of hospitalization indicated OR disabling OR limiting self care activities of daily living. A Grade 4 toxicity was defined as: life-threatening consequences OR urgent intervention indicated. Participants were monitored for the occurrence of DLTs during the first 3 weeks of dosing with dalotuzumab.'}, {'measure': 'Mean Terminal Half-life (t1/2) of Dalotuzumab', 'timeFrame': 'Predose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post-infusion', 'description': 'Terminal half-life is defined as the time it takes for the blood plasma concentration of a substance to halve (plasma half-life). Blood samples for measurement of serum levels of dalotuzumab were obtained at: pre-dose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post infusion. For infusions \\>1 hour in duration, an additional sample was obtained at the mid-point of the infusion. Data presented are for the harmonic mean t1/2 for dalotuzumab.'}, {'measure': 'Area Under the Time-concentration Curve From 0 to Infinity Hours (AUC0-∞) of Dalotuzumab', 'timeFrame': 'Predose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post-infusion', 'description': 'AUC0-∞ represents the total drug exposure over time. Blood samples for measurement of serum levels of dalotuzumab were obtained at: Predose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post-infusion. For infusions \\>1 hour in duration, an additional sample was obtained at the mid-point of the infusion.'}, {'measure': 'Mean Serum Clearance of Dalotuzumab', 'timeFrame': 'Predose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post-infusion', 'description': 'Clearance is defined as the volume of serum from which study drug was completely removed per unit of time. Blood samples for measurement of serum levels of dalotuzumab were obtained at: pre-dose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post infusion. For infusions \\>1 hour in duration, an additional sample was obtained at the mid-point of the infusion.'}, {'measure': 'Mean Trough Serum Concentration (Ctrough) of Dalotuzumab', 'timeFrame': 'Pre-dose immediately prior to second infusion: 168 hours for Q1W, 336 hours for Q2W and 504 hours for Q3W dosing', 'description': 'The lowest (trough) concentration of dalotuzumab prior to the next dose of dalotuzumab was measured.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Insulin-like Growth Factor Receptor Type 1 (IGF-1R) Protein Expression Level H-score in Skin Samples', 'timeFrame': 'Predose in Cycle 1 (Baseline) and predose in Cycle 3 (Week 4)', 'description': 'IGF-1R expression was measured in pre- and post-dose skin biopsy samples using an immunohistochemistry (IHC) assay as a function of time and dose. Results were expressed as an IGF-1R membrane H-score which could range from 0 to 300; with a score of 0 representing the absence of IGF-1R expression and an H-score of 300 representing maximum IGF-1R expression. Changes in IGF-1R expression levels from Baseline are summarized for all participants for whom these paired data were available. A post-dose decrease in IGF-1R membrane H-score was an indication of target engagement by dalotuzumab. A larger decrease in H-score correlated with a greater target engagement.'}, {'measure': 'Change From Baseline in IGF-1R Protein Expression Level H-score in Tumor Samples', 'timeFrame': 'Predose in Cycle 1 (Baseline) and predose in Cycle 3 (Week 4)', 'description': 'IGF-1R expression was measured in pre- and post-dose tumor biopsy samples using an IHC assay as a function of time and dose. Results were expressed as an IGF-1R membrane H-score which could range from 0 to 300; with a score of 0 representing the absence of IGF-1R expression and an H-score of 300 representing maximum IGF-1R expression. Changes in IGF-1R expression levels from Baseline are summarized for all participants for whom these paired data were available. A post-dose decrease in IGF-1R membrane H-score was an indication of target engagement by dalotuzumab. A larger decrease in H-score correlated with a greater target engagement.'}, {'measure': 'Percentage of Participants Who Developed a Serum Human-anti-humanized-antibody (HAHA) Response to Dalotuzumab', 'timeFrame': 'Up to 2 years', 'description': 'It is thought that the formation of HAHAs may block efficacy by prematurely clearing dalotuzumab and limit the possibility of future dalotuzumab therapy. Blood samples for the measurement of serum levels of HAHAs were obtained prior to treatment with dalotuzumab, and pre-dose Week 2 (Q1W), pre-dose Week 3 (Q2W), pre-dose Week 4 (QW3), pre-dose Week 5 (Q1W/Q2W), pre-dose Week 7 (Q2W/Q3W), pre-dose Week 9 (Q2W), pre-dose Week 10 (QW3) and pre-dose every 4 subsequent weeks and end of treatment (post-study: 4 weeks after last dose of study drug).'}, {'measure': 'Percentage of Participants Who Experienced a Complete Response (CR) or Partial Response (PR)', 'timeFrame': 'Up to 2 years', 'description': 'Tumor responses were measured by using Response Evaluation Criteria in Solid Tumors (RECIST) criteria in participants with solid tumors and using European Group for Blood and Marrow Transplantation (EBMT) criteria in participants with multiple myeloma. RECIST criteria for CR: Disappearance of all target lesions. RECIST criteria for PR: ≥30% decrease in the sum of diameters of target lesions. EBMT criteria for CR: Disappearance of the original mAb protein from the blood and urine AND \\<5% plasma cells in the bone marrow AND no increase in the size or number of lytic bone lesions AND disappearance of soft tissue plasmacytomas AND normal serum calcium levels. EMBT criteria for PR: ≥50% reduction in the serum mAb protein level AND if a urine M-component is present, a reduction in 24-hour urinary light chain excretion by either ≥90% or to \\<200 mg AND ≥50% reduction in the size of soft tissue plasmacytomas AND no increase in size or number of lytic bone lesions.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Solid Tumor', 'Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '21810918', 'type': 'RESULT', 'citation': 'Atzori F, Tabernero J, Cervantes A, Prudkin L, Andreu J, Rodriguez-Braun E, Domingo A, Guijarro J, Gamez C, Rodon J, Di Cosimo S, Brown H, Clark J, Hardwick JS, Beckman RA, Hanley WD, Hsu K, Calvo E, Rosello S, Langdon RB, Baselga J. A phase I pharmacokinetic and pharmacodynamic study of dalotuzumab (MK-0646), an anti-insulin-like growth factor-1 receptor monoclonal antibody, in patients with advanced solid tumors. Clin Cancer Res. 2011 Oct 1;17(19):6304-12. doi: 10.1158/1078-0432.CCR-10-3336. Epub 2011 Aug 2.'}]}, 'descriptionModule': {'briefSummary': 'This study will look for the highest tolerated dose of dalotuzumab (MK-0646) given as weekly, every other week. or a every three week infusion.\n\nThe hypothesis of this study is that administration of dalotuzumab as a one- to two-hour weekly, every other week, or every three week infusion in participants with advanced cancer will be generally safe and tolerated at a dose which achieves a trough concentration ≥3 μg/mL.', 'detailedDescription': 'Trial Duration of Treatment: Participants can be treated for up to two years if their disease has not progressed and they are not having unmanageable side effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant has metastatic or locally advanced solid tumor or multiple myeloma\n* Tumor specimen has IGF-1R expression\n* Participant agrees to use birth control throughout study\n\nExclusion Criteria:\n\n* Participant must not be recovering from antineoplastic therapy in the last 4 weeks\n* Participant has participated in a clinical trial in the last 4 weeks\n* Participant has a history of heart problems such as congestive heart failure, angina, heart attack or stroke in the last 3 months\n* Participant is taking growth hormone or growth hormone inhibitors\n* If female, participant is pregnant or breastfeeding\n* Participant is human immunodeficiency virus (HIV) positive\n* Participant has a history of hepatitis B or C'}, 'identificationModule': {'nctId': 'NCT00701103', 'briefTitle': 'Dose Escalation Trial of Dalotuzumab (MK-0646) in Advanced Solid Tumors and Multiple Myeloma (MK-0646-001)', 'nctIdAliases': ['NCT00282737'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'An Open-Label, Dose Escalation Phase I Trial of MK-0646 Given as a Once Weekly, Every Other Week, or Every Three Week Infusion in Patients With Advanced Solid Tumors and Multiple Myeloma', 'orgStudyIdInfo': {'id': '0646-001'}, 'secondaryIdInfos': [{'id': '2007_660', 'type': 'OTHER', 'domain': 'Merck Telerex Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) intravenous (IV) infusion 1 time every 1 week (Q1W).', 'interventionNames': ['Drug: Dalotuzumab']}, {'type': 'EXPERIMENTAL', 'label': 'Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.', 'interventionNames': ['Drug: Dalotuzumab']}, {'type': 'EXPERIMENTAL', 'label': 'Dalotuzumab 5 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.', 'interventionNames': ['Drug: Dalotuzumab']}, {'type': 'EXPERIMENTAL', 'label': 'Dalotuzumab 10 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.', 'interventionNames': ['Drug: Dalotuzumab']}, {'type': 'EXPERIMENTAL', 'label': 'Dalotuzumab 10 mg/kg Q1W (20 mg/mL)', 'description': 'Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.', 'interventionNames': ['Drug: Dalotuzumab']}, {'type': 'EXPERIMENTAL', 'label': 'Dalotuzumab 15 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.', 'interventionNames': ['Drug: Dalotuzumab']}, {'type': 'EXPERIMENTAL', 'label': 'Dalotuzumab 15 mg/kg Q1W (20 mg/mL)', 'description': 'Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.', 'interventionNames': ['Drug: Dalotuzumab']}, {'type': 'EXPERIMENTAL', 'label': 'Dalotuzumab 20 mg/kg Q1W (10 mg/mL)', 'description': 'Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.', 'interventionNames': ['Drug: Dalotuzumab']}, {'type': 'EXPERIMENTAL', 'label': 'Dalotuzumab 20 mg/kg Q1W (20 mg/mL)', 'description': 'Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.', 'interventionNames': ['Drug: Dalotuzumab']}, {'type': 'EXPERIMENTAL', 'label': 'Dalotuzumab 20 mg/kg Q2W (20 mg/mL)', 'description': 'Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion 1 time every 2 weeks (Q2W).', 'interventionNames': ['Drug: Dalotuzumab']}, {'type': 'EXPERIMENTAL', 'label': 'Dalotuzumab 30 mg/kg Q3W (20 mg/mL)', 'description': 'Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion1 time every 3 weeks (Q3W).', 'interventionNames': ['Drug: Dalotuzumab']}], 'interventions': [{'name': 'Dalotuzumab', 'type': 'DRUG', 'otherNames': ['MK-0646'], 'description': 'IV infusion', 'armGroupLabels': ['Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)', 'Dalotuzumab 10 mg/kg Q1W (10 mg/mL)', 'Dalotuzumab 10 mg/kg Q1W (20 mg/mL)', 'Dalotuzumab 15 mg/kg Q1W (10 mg/mL)', 'Dalotuzumab 15 mg/kg Q1W (20 mg/mL)', 'Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)', 'Dalotuzumab 20 mg/kg Q1W (10 mg/mL)', 'Dalotuzumab 20 mg/kg Q1W (20 mg/mL)', 'Dalotuzumab 20 mg/kg Q2W (20 mg/mL)', 'Dalotuzumab 30 mg/kg Q3W (20 mg/mL)', 'Dalotuzumab 5 mg/kg Q1W (10 mg/mL)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}