Viewing Study NCT00816361

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Ignite Creation Date: 2025-12-24 @ 12:57 PM
Ignite Modification Date: 2025-12-29 @ 7:06 AM
Study NCT ID: NCT00816361
Status: COMPLETED
Last Update Posted: 2019-03-04
First Post: 2008-12-23
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: A Dose-escalation Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-573 in Subjects With Advanced Solid Tumors
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000601324', 'term': 'dusigitumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '+1 301-398-2827', 'title': 'Susan Perez MD, MSc', 'organization': 'MedImmune LLC'}, 'certainAgreement': {'otherDetails': 'MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years', 'eventGroups': [{'id': 'EG000', 'title': 'MEDI-573 0.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 4, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'MEDI-573 1.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 3, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion', 'description': 'Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 13, 'seriousNumAtRisk': 14, 'deathsNumAffected': 10, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'MEDI-573 10 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 3, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion', 'description': 'Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 13, 'seriousNumAtRisk': 13, 'deathsNumAffected': 9, 'seriousNumAffected': 6}, {'id': 'EG005', 'title': 'MEDI-573 30 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'MEDI-573 45 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 3, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 9, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 7, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cerumen impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Faecaloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gingival pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Glossitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 0.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG001', 'title': 'MEDI-573 1.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG002', 'title': 'MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion', 'description': 'Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG003', 'title': 'MEDI-573 10 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG004', 'title': 'MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion', 'description': 'Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG005', 'title': 'MEDI-573 30 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG006', 'title': 'MEDI-573 45 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}]}, {'title': 'Treatment emergent SAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years', 'description': 'AEs were any unfavorable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with the use of MEDI-573, whether or not considered related to MEDI-573. A SAE was any AE that resulted in: death; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; was life-threatening; was a congenital anomaly/birth defect in the offspring of a study participant; or was an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes above. TEAEs were defined as AEs present at baseline that worsened in intensity after administration of MEDI-573, or events absent at baseline that emerged after administration of MEDI-573, up to 30 days after the last dose.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population included all participants who had received any MEDI-573 treatment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 0.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG001', 'title': 'MEDI-573 1.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG002', 'title': 'MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion', 'description': 'Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG003', 'title': 'MEDI-573 10 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG004', 'title': 'MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion', 'description': 'Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG005', 'title': 'MEDI-573 30 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG006', 'title': 'MEDI-573 45 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}], 'classes': [{'title': 'Anemia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Thrombocytopenia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Leukopenia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Lymphopenia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Red blood cell count decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'White blood cell count decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'White blood cell count increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Blood alkaline phosphatase increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Aspartate aminotransferase increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Alanine aminotransferase increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Blood creatinine increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Weight decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Blood insulin increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Blood creatine increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Blood growth hormone increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Blood bilirubin increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Blood lactate dehydrogenase increased', 'categories': [{'measurements': [{'value': '1', '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'}]}]}, {'title': 'Breath sounds abnormal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Cardiac enzymes increased', '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': '1', 'groupId': 'OG006'}]}]}, {'title': 'Electrocardiogram QT prolonged', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Glomerular filtration rate decreased', 'categories': [{'measurements': [{'value': '1', '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'}]}]}, {'title': 'Heart rate increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Lipase increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Protein total increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Weight increased', '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': '1', 'groupId': 'OG006'}]}]}, {'title': 'Hematuria', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Renal failure', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years', 'description': 'An abnormal laboratory finding that was judged by the investigator to be medically significant was reported as an AE. TEAEs were defined as events present at baseline that worsened in intensity after administration of MEDI-573, or events absent at baseline that emerged after administration of MEDI-573, for the period extending to 30 days after the last dose.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population included all participants who had received any MEDI-573 treatment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 0.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG001', 'title': 'MEDI-573 1.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG002', 'title': 'MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion', 'description': 'Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG003', 'title': 'MEDI-573 10 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG004', 'title': 'MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion', 'description': 'Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG005', 'title': 'MEDI-573 30 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG006', 'title': 'MEDI-573 45 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}], 'classes': [{'title': 'Pyrexia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Tachycardia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Breath sounds abnormal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Hypotension', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Heart rate increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Orthostatic hypotension', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years', 'description': 'Vital signs and physical findings included parameters such as heart rate, blood pressure, temperature, and respiratory rate. TEAEs were defined as events present at baseline that worsened in intensity after administration of MEDI-573 or events absent at baseline that emerged after administration of MEDI-573, for the period extending to 30 days after the last dose.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population included all participants who had received any MEDI-573 treatment.'}, {'type': 'PRIMARY', 'title': 'Maximum Tolerated Dose (MTD) of MEDI-573', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 Dose Escalation', 'description': 'Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) up to 15 mg/kg as a 60-minute intravenous (IV) infusion once every 7 days or up to 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The MTD was not established in the study.', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 1 Day 1 through Cycle 1 Day 21', 'description': 'The MTD was defined as the highest dose that can be safely administered to participants and was determined by the number of participants in each cohort with a dose-limiting toxicity (DLT). The number and proportion of participants in each dose cohort and the number of participants with a DLT was presented using the total number of participants in the MTD Evaluable Population as the denominator. 2 participants from Cohorts 0.5 and 5 mg/kg QWk (1 in each cohort) did not complete the DLT period and therefore not evaluable for MTD.', 'unitOfMeasure': 'mg/kg', 'reportingStatus': 'POSTED', 'populationDescription': 'MTD Evaluable Population included all participants in dose-escalation phase who had received at least 1 full cycle of MEDI-573 and completed safety follow-up through DLT period (Cycle 1 Day 1 through Cycle 1 Day 21), or who experienced a DLT. Two participants did not receive a full cycle of MEDI-573 and therefore excluded from MTD population.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Dose-Limiting Toxicities (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 0.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG001', 'title': 'MEDI-573 1.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG002', 'title': 'MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion', 'description': 'Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG003', 'title': 'MEDI-573 10 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG004', 'title': 'MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion', 'description': 'Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG005', 'title': 'MEDI-573 30 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG006', 'title': 'MEDI-573 45 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}], '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'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 1 Day 1 through Cycle 1 Day 21', 'description': 'A DLT was defined as any grade greater than or equal to (\\>=) 3 treatment-related non-hematologic toxicity that occurred during the DLT assessment period with the following exceptions: Grade less than (\\<) 4 serum-high glucose (fasting) with duration of \\< 24 hours; Grade 3 fever (in the absence of neutropenia) defined as \\> 40.0 degree centigrade (°C) \\[greater than (\\>) 104.0°F\\] that resolved to normal or baseline within 24 hours of treatment and was not considered an SAE; or Grade 3 rigors/chills that responded to optimal therapy; any Grade \\>= 3 treatment-related hematologic toxicity that occurred during the DLT assessment period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population included all participants who had received any MEDI-573 treatment.'}, {'type': 'PRIMARY', 'title': 'Optimal Biologically Effective Dose (OBED) of MEDI-573', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 Dose Escalation', 'description': 'Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) up to 15 mg/kg as a 60-minute intravenous (IV) infusion once every 7 days or up to 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years', 'description': 'The OBED was defined as the dose at which all circulating insulin-like growth factor (IGF)-1 and IGF-2 ligand was sequestered by MEDI-573.', 'unitOfMeasure': 'mg/kg', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: Participants in the dose-escalation phase were analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Serum Concentration (Cmax) After the First Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 0.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG001', 'title': 'MEDI-573 1.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG002', 'title': 'MEDI-573 5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG003', 'title': 'MEDI-573 10 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG004', 'title': 'MEDI-573 15 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG005', 'title': 'MEDI-573 30 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG006', 'title': 'MEDI-573 45 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG007', 'title': 'MEDI-573 5 mg/Kg QWk Dose Expansion', 'description': 'Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG008', 'title': 'MEDI-573 15 mg/Kg QWk Dose Expansion', 'description': 'Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.6', 'spread': '5.54', 'groupId': 'OG000'}, {'value': '71.8', 'spread': '12.5', 'groupId': 'OG001'}, {'value': '166', 'spread': '37.7', 'groupId': 'OG002'}, {'value': '264', 'spread': '121', 'groupId': 'OG003'}, {'value': '560', 'spread': '251', 'groupId': 'OG004'}, {'value': '588', 'spread': '213', 'groupId': 'OG005'}, {'value': '1200', 'spread': '621', 'groupId': 'OG006'}, {'value': '115', 'spread': '42.6', 'groupId': 'OG007'}, {'value': '412', 'spread': '141', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15', 'description': 'The Cmax was the maximum observed serum concentration of MEDI-573.', 'unitOfMeasure': 'microgram per milliliter (mcg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population included all participants who had received any MEDI-573 treatment. Here, "N" is number of participants analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Concentration (Tmax) After the First Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 0.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG001', 'title': 'MEDI-573 1.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG002', 'title': 'MEDI-573 5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG003', 'title': 'MEDI-573 10 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG004', 'title': 'MEDI-573 15 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG005', 'title': 'MEDI-573 30 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG006', 'title': 'MEDI-573 45 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG007', 'title': 'MEDI-573 5 mg/Kg QWk Dose Expansion', 'description': 'Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG008', 'title': 'MEDI-573 15 mg/Kg QWk Dose Expansion', 'description': 'Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '0.04'}, {'value': '0.04', 'groupId': 'OG001', 'lowerLimit': '0.04', 'upperLimit': '0.06'}, {'value': '0.04', 'groupId': 'OG002', 'lowerLimit': '0.04', 'upperLimit': '0.12'}, {'value': '0.04', 'groupId': 'OG003', 'lowerLimit': '0.04', 'upperLimit': '0.14'}, {'value': '0.28', 'groupId': 'OG004', 'lowerLimit': '0.12', 'upperLimit': '0.30'}, {'value': '0.06', 'groupId': 'OG005', 'lowerLimit': '0.06', 'upperLimit': '0.06'}, {'value': '0.06', 'groupId': 'OG006', 'lowerLimit': '0.06', 'upperLimit': '0.06'}, {'value': '0.04', 'groupId': 'OG007', 'lowerLimit': '0.04', 'upperLimit': '0.30'}, {'value': '0.06', 'groupId': 'OG008', 'lowerLimit': '0.04', 'upperLimit': '0.30'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15', 'description': 'The tmax was defined as actual sampling time to reach the maximum observed serum concentration of MEDI-573.', 'unitOfMeasure': 'Day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population included all participants who had received any MEDI-573 treatment. Here, "N" is number of participants analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Trough Serum Concentration (Ctrough) After the First Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 0.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG001', 'title': 'MEDI-573 1.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG002', 'title': 'MEDI-573 5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG003', 'title': 'MEDI-573 10 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG004', 'title': 'MEDI-573 15 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG005', 'title': 'MEDI-573 30 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG006', 'title': 'MEDI-573 45 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG007', 'title': 'MEDI-573 5 mg/Kg QWk Dose Expansion', 'description': 'Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG008', 'title': 'MEDI-573 15 mg/Kg QWk Dose Expansion', 'description': 'Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.04', 'spread': '0.919', 'groupId': 'OG000'}, {'value': '1.98', 'spread': '0.377', 'groupId': 'OG001'}, {'value': '17.3', 'spread': '10.2', 'groupId': 'OG002'}, {'value': '34.6', 'spread': '26.8', 'groupId': 'OG003'}, {'value': '138', 'spread': '77.8', 'groupId': 'OG004'}, {'value': '32.9', 'spread': '28.2', 'groupId': 'OG005'}, {'value': '63.5', 'spread': '59.5', 'groupId': 'OG006'}, {'value': '5.27', 'spread': '4.80', 'groupId': 'OG007'}, {'value': '77.8', 'spread': '33.5', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15', 'description': 'The Ctrough was the lowest serum concentration of MEDI-573 within a dosing interval.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population included all participants who had received any MEDI-573 treatment. Here, "N" is number of participants analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Dose Normalized Cmax (Cmax/Dose) After the First Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 0.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG001', 'title': 'MEDI-573 1.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG002', 'title': 'MEDI-573 5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG003', 'title': 'MEDI-573 10 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG004', 'title': 'MEDI-573 15 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG005', 'title': 'MEDI-573 30 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG006', 'title': 'MEDI-573 45 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG007', 'title': 'MEDI-573 5 mg/Kg QWk Dose Expansion', 'description': 'Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG008', 'title': 'MEDI-573 15 mg/Kg QWk Dose Expansion', 'description': 'Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.319', 'spread': '0.154', 'groupId': 'OG000'}, {'value': '0.593', 'spread': '0.122', 'groupId': 'OG001'}, {'value': '0.401', 'spread': '0.054', 'groupId': 'OG002'}, {'value': '0.393', 'spread': '0.129', 'groupId': 'OG003'}, {'value': '0.422', 'spread': '0.168', 'groupId': 'OG004'}, {'value': '0.240', 'spread': '0.072', 'groupId': 'OG005'}, {'value': '0.352', 'spread': '0.178', 'groupId': 'OG006'}, {'value': '0.267', 'spread': '0.110', 'groupId': 'OG007'}, {'value': '0.314', 'spread': '0.095', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15', 'description': 'The Cmax/dose was the dose-normalized maximum serum concentration of MEDI-573.', 'unitOfMeasure': 'mcg/mL/mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population included all participants who had received any MEDI-573 treatment. Here, "N" is number of participants analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Area Under the Serum Concentration-time Curve Over the First Dosing Interval (AUCτ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 0.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG001', 'title': 'MEDI-573 1.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG002', 'title': 'MEDI-573 5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG003', 'title': 'MEDI-573 10 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG004', 'title': 'MEDI-573 15 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG005', 'title': 'MEDI-573 30 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG006', 'title': 'MEDI-573 45 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG007', 'title': 'MEDI-573 5 mg/Kg QWk Dose Expansion', 'description': 'Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG008', 'title': 'MEDI-573 15 mg/Kg QWk Dose Expansion', 'description': 'Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.59', 'spread': '5.12', 'groupId': 'OG000'}, {'value': '90.8', 'spread': '18.6', 'groupId': 'OG001'}, {'value': '431', 'spread': '135', 'groupId': 'OG002'}, {'value': '631', 'spread': '288', 'groupId': 'OG003'}, {'value': '1950', 'spread': '917', 'groupId': 'OG004'}, {'value': '3510', 'spread': '1230', 'groupId': 'OG005'}, {'value': '5790', 'spread': '3390', 'groupId': 'OG006'}, {'value': '227', 'spread': '99.8', 'groupId': 'OG007'}, {'value': '1280', 'spread': '392', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15', 'description': 'Area under the serum concentration-time curve over the first dosing interval.', 'unitOfMeasure': 'mcg*day/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population included all participants who had received any MEDI-573 treatment. Here, "N" is number of participants analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Dose-normalized Area Under the Serum Concentration Time Curve Over the First Dosing Interval (AUCτ/Dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 0.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG001', 'title': 'MEDI-573 1.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG002', 'title': 'MEDI-573 5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG003', 'title': 'MEDI-573 10 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG004', 'title': 'MEDI-573 15 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG005', 'title': 'MEDI-573 30 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG006', 'title': 'MEDI-573 45 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG007', 'title': 'MEDI-573 5 mg/Kg QWk Dose Expansion', 'description': 'Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG008', 'title': 'MEDI-573 15 mg/Kg QWk Dose Expansion', 'description': 'Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.245', 'spread': '0.145', 'groupId': 'OG000'}, {'value': '0.749', 'spread': '0.176', 'groupId': 'OG001'}, {'value': '0.962', 'spread': '0.041', 'groupId': 'OG002'}, {'value': '0.955', 'spread': '0.401', 'groupId': 'OG003'}, {'value': '1.47', 'spread': '0.624', 'groupId': 'OG004'}, {'value': '1.46', 'spread': '0.526', 'groupId': 'OG005'}, {'value': '1.70', 'spread': '0.976', 'groupId': 'OG006'}, {'value': '0.53', 'spread': '0.233', 'groupId': 'OG007'}, {'value': '0.981', 'spread': '0.275', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15', 'description': 'The AUCtau/dose was a measure of dose-normalized area under the serum concentration-time curve over the first dosing interval.', 'unitOfMeasure': 'mcg*day/mL/mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population included all participants who had received any MEDI-573 treatment. Here, "N" is number of participants analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI-573', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 0.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG001', 'title': 'MEDI-573 1.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG002', 'title': 'MEDI-573 5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG003', 'title': 'MEDI-573 10 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG004', 'title': 'MEDI-573 15 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG005', 'title': 'MEDI-573 30 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG006', 'title': 'MEDI-573 45 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG007', 'title': 'MEDI-573 5 mg/Kg QWk Dose Expansion', 'description': 'Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG008', 'title': 'MEDI-573 15 mg/Kg QWk Dose Expansion', 'description': 'Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}], '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-infusion on Day 1 of each cycle, end of treatment, and 90 days after last dose MEDI-573 (up to 3.5 years)', 'description': 'Two methods were used to assess the immunogenicity data: an ECL-based method and measurement of neutralizing ADA. The titer was calculated by multiplying the minimum assay dilution factor by the reciprocal of the highest dilution factor which yielded an ECL multiple equal to or greater than the screening assay cut-point factor.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population included all participants who had received any MEDI-573 treatment. Here, "N" is number of participants analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 0.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG001', 'title': 'MEDI-573 1.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG002', 'title': 'MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion', 'description': 'Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG003', 'title': 'MEDI-573 10 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG004', 'title': 'MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion', 'description': 'Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG005', 'title': 'MEDI-573 30 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG006', 'title': 'MEDI-573 45 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}], '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'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From study entry through the end of the study, up to 3.5 years', 'description': 'The ORR was defined as the proportion of participants with confirmed complete response (CR) or partial response (PR) according to the RECIST criteria The CR was defined as disappearance of all target and nontarget lesions and no new lesions; and PR was definded as \\>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline \\[screening\\]) and no new lesions.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Evaluable Population included all participants who received MEDI-573 and had at least one tumor assessment after the initiation of treatment. Participants in the dose-expansion phase were to have at least 1 lesion that was measurable using RECIST criteria, and a histologically confirmed diagnosis of advanced urothelial carcinoma.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 0.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG001', 'title': 'MEDI-573 1.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG002', 'title': 'MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion', 'description': 'Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG003', 'title': 'MEDI-573 10 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG004', 'title': 'MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion', 'description': 'Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG005', 'title': 'MEDI-573 30 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG006', 'title': 'MEDI-573 45 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '1.5'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '2.8'}, {'value': '1.4', 'groupId': 'OG002', 'lowerLimit': '1.2', 'upperLimit': '2.8'}, {'value': '1.5', 'groupId': 'OG003', 'lowerLimit': '0.7', 'upperLimit': '4.7'}, {'value': '1.3', 'groupId': 'OG004', 'lowerLimit': '0.7', 'upperLimit': '4.2'}, {'value': 'NA', 'comment': 'Median and upper limit of 95 % confidence interval was not applicable, as only 1 participant was evaluable.', 'groupId': 'OG005', 'lowerLimit': '1.2', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From study entry through the end of the study, up to 3.5 years', 'description': 'Progression-free survival (PFS) was defined as the duration from the start of treatment with MEDI-573 until the documentation of disease progression or death due to any cause, whichever occurred first.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Evaluable Population included all participants who received MEDI-573 and had at least 1 tumor assessment after initiation of treatment. Participants in dose-expansion phase had at least 1 measurable lesion and histologically diagnosis of advanced urothelial carcinoma. Here, "N" is number of participants analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time to Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 0.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG001', 'title': 'MEDI-573 1.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG002', 'title': 'MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion', 'description': 'Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG003', 'title': 'MEDI-573 10 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG004', 'title': 'MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion', 'description': 'Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG005', 'title': 'MEDI-573 30 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG006', 'title': 'MEDI-573 45 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '1.5'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '2.8'}, {'value': '1.4', 'groupId': 'OG002', 'lowerLimit': '1.2', 'upperLimit': '2.8'}, {'value': '1.5', 'groupId': 'OG003', 'lowerLimit': '0.7', 'upperLimit': '4.7'}, {'value': '1.3', 'groupId': 'OG004', 'lowerLimit': '0.7', 'upperLimit': '4.2'}, {'value': 'NA', 'comment': 'Median and upper limit of 95 % confidence interval was not applicable, as only 1 participant was evaluable.', 'groupId': 'OG005', 'lowerLimit': '1.2', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From study entry through the end of the study, up to 3.5 years', 'description': 'Time to disease progression (TTP) was defined as the duration from the start of treatment with MEDI-573 until the documentation of disease progression.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Evaluable Population included all participants who received MEDI-573 and had at least 1 tumor assessment after initiation of treatment. Participants in dose-expansion phase had at least 1 measurable lesion and histologically diagnosis of advanced urothelial carcinoma. Here, "N" is number of participants analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 0.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG001', 'title': 'MEDI-573 1.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG002', 'title': 'MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion', 'description': 'Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG003', 'title': 'MEDI-573 10 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG004', 'title': 'MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion', 'description': 'Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG005', 'title': 'MEDI-573 30 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG006', 'title': 'MEDI-573 45 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '8.7'}, {'value': '13.6', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '20.2'}, {'value': '12.3', 'groupId': 'OG002', 'lowerLimit': '1.4', 'upperLimit': '37.3'}, {'value': '2.5', 'groupId': 'OG003', 'lowerLimit': '1.3', 'upperLimit': '8.6'}, {'value': '4.0', 'groupId': 'OG004', 'lowerLimit': '1.1', 'upperLimit': '33.0'}, {'value': '7.9', 'groupId': 'OG005', 'lowerLimit': '1.4', 'upperLimit': '7.9'}, {'value': '4.7', 'groupId': 'OG006', 'lowerLimit': '4.7', 'upperLimit': '4.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From study entry through the end of the study, up to 3.5 years', 'description': 'Overall survival (OS) was defined as the time from the start of treatment with MEDI-573 until death.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Evaluable Population included all participants who received MEDI-573 and had at least 1 tumor assessment after initiation of treatment. Participants in dose-expansion phase had at least 1 measurable lesion and histologically diagnosis of advanced urothelial carcinoma. Here, "N" is number of participants analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time to Response (TTR)', 'denoms': [{'units': 'Participants', 'counts': [{'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'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 0.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG001', 'title': 'MEDI-573 1.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG002', 'title': 'MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion', 'description': 'Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG003', 'title': 'MEDI-573 10 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG004', 'title': 'MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion', 'description': 'Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG005', 'title': 'MEDI-573 30 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG006', 'title': 'MEDI-573 45 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}], 'timeFrame': 'From study entry through the end of the study, up to 3.5 years', 'description': 'Time to response was defined as the duration from the start of treatment with MEDI-573 to the first documentation of objective response (confirmed CR or PR) and was only assessed in participants who had achieved objective response.', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in efficacy evaluable population and who achieved objective response were analyzed. As no participants achieved objective response in this study, number of participants analyzed for this outcome measure were zero.'}, {'type': 'SECONDARY', 'title': 'Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'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'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 0.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG001', 'title': 'MEDI-573 1.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG002', 'title': 'MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion', 'description': 'Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG003', 'title': 'MEDI-573 10 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG004', 'title': 'MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion', 'description': 'Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG005', 'title': 'MEDI-573 30 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG006', 'title': 'MEDI-573 45 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}], 'timeFrame': 'From study entry through the end of the study, up to 3.5 years', 'description': 'Duration of response was defined as the duration from the first documentation of objective response (confirmed CR or PR) to the first documented disease progression.', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in efficacy evaluable population and who achieved objective response were analyzed. As no participants achieved objective response in this study, number of participants analyzed for this outcome measure were zero.'}, {'type': 'SECONDARY', 'title': 'Suppression Profiles of IGF-I and IGF-II Post-Administration of MEDI-573', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 0.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG001', 'title': 'MEDI-573 1.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG002', 'title': 'MEDI-573 5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG003', 'title': 'MEDI-573 10 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG004', 'title': 'MEDI-573 15 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG005', 'title': 'MEDI-573 30 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG006', 'title': 'MEDI-573 45 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG007', 'title': 'MEDI-573 5 mg/Kg QWk Dose Expansion', 'description': 'Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'OG008', 'title': 'MEDI-573 15 mg/Kg QWk Dose Expansion', 'description': 'Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}], 'classes': [{'title': 'IGF-I at 0.000', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '4.014', 'spread': '2.177', 'groupId': 'OG000'}, {'value': '9.264', 'spread': '7.401', 'groupId': 'OG001'}, {'value': '4.655', 'spread': '3.437', 'groupId': 'OG002'}, {'value': '1.721', 'spread': '2.710', 'groupId': 'OG003'}, {'value': '1.440', 'spread': '0.812', 'groupId': 'OG004'}, {'value': '2.693', 'spread': '2.855', 'groupId': 'OG005'}, {'value': '1.925', 'spread': '1.374', 'groupId': 'OG006'}, {'value': '1.749', 'spread': '0.643', 'groupId': 'OG007'}, {'value': '2.099', 'spread': '1.128', 'groupId': 'OG008'}]}]}, {'title': 'IGF-I at 0.042', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG000'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG001'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG002'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG003'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG004'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG007'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG008'}]}]}, {'title': 'IGF-I at 0.063', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG005'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG006'}]}]}, {'title': 'IGF-I at 0.125', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.252', 'spread': '0.111', 'groupId': 'OG000'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG001'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG002'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG003'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG004'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG007'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG008'}]}]}, {'title': 'IGF-I at 0.292', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.345', 'spread': '0.227', 'groupId': 'OG000'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG001'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG002'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG003'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG004'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG007'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG008'}]}]}, {'title': 'IGF-I at 1.000', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '2.088', 'spread': '0.964', 'groupId': 'OG000'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG001'}, {'value': '0.215', 'spread': '0.117', 'groupId': 'OG002'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG003'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG004'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG005'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG006'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG007'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG008'}]}]}, {'title': 'IGF-I at 7.000', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.223', 'spread': '0.115', 'groupId': 'OG003'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG004'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG005'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG006'}, {'value': '0.641', 'spread': '0.546', 'groupId': 'OG007'}, {'value': '0.196', 'spread': '0.078', 'groupId': 'OG008'}]}]}, {'title': 'IGF-I at 7.042', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.201', 'spread': '0.087', 'groupId': 'OG000'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG001'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG002'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG003'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG004'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG007'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG008'}]}]}, {'title': 'IGF-I at 14.000', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.232', 'spread': '0.130', 'groupId': 'OG003'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG004'}, {'value': '0.360', 'spread': '0.166', 'groupId': 'OG007'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG008'}]}]}, {'title': 'IGF-I at 14.042', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG000'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG001'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG002'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG003'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG004'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG007'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG008'}]}]}, {'title': 'IGF-I at 21.000', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.334', 'spread': 'NA', 'comment': 'Standard deviation can not be calculated as only one participant evaluated.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG004'}, {'value': '0.265', 'spread': '0.189', 'groupId': 'OG005'}, {'value': '0.241', 'spread': '0.147', 'groupId': 'OG006'}, {'value': '0.336', 'spread': '0.177', 'groupId': 'OG007'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.313 ng/mL).', 'groupId': 'OG008'}]}]}, {'title': 'IGF-II at 0.000', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '2.773', 'spread': '0.320', 'groupId': 'OG000'}, {'value': '2.984', 'spread': '1.753', 'groupId': 'OG001'}, {'value': '2.431', 'spread': '0.139', 'groupId': 'OG002'}, {'value': '1.879', 'spread': '1.020', 'groupId': 'OG003'}, {'value': '1.872', 'spread': '0.862', 'groupId': 'OG004'}, {'value': '2.780', 'spread': '0.694', 'groupId': 'OG005'}, {'value': '4.093', 'spread': '1.039', 'groupId': 'OG006'}, {'value': '2.689', 'spread': '0.882', 'groupId': 'OG007'}, {'value': '2.213', 'spread': '0.752', 'groupId': 'OG008'}]}]}, {'title': 'IGF-II at 0.042', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG000'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG001'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG002'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG003'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG004'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG007'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG008'}]}]}, {'title': 'IGF-II at 0.063', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL)', 'groupId': 'OG005'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL)', 'groupId': 'OG006'}]}]}, {'title': 'IGF-II at 0.125', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL)', 'groupId': 'OG000'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL)', 'groupId': 'OG001'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL)', 'groupId': 'OG002'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL)', 'groupId': 'OG003'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL)', 'groupId': 'OG004'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL)', 'groupId': 'OG007'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL)', 'groupId': 'OG008'}]}]}, {'title': 'IGF-II at 0.292', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG000'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG001'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG002'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG003'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG004'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG007'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG008'}]}]}, {'title': 'IGF-II at 1.000', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '1.060', 'spread': '0.828', 'groupId': 'OG000'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG001'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG002'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG003'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG004'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG005'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG006'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG007'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG008'}]}]}, {'title': 'IGF-II at 7.000', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG003'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG004'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG005'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG006'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG007'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG008'}]}]}, {'title': 'IGF-II at 7.042', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG000'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG001'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG002'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG003'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG004'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG007'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG008'}]}]}, {'title': 'IGF-II at 14.000', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG003'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG004'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG007'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG008'}]}]}, {'title': 'IGF-II at 14.042', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG000'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG001'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG002'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG003'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG004'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG007'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG008'}]}]}, {'title': 'IGF-II at 21.000', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Mean was below the limit of quantitation (0.626 ng/mL). Standard deviation can not be calculated as only one participant evaluated.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG004'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG005'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG006'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG007'}, {'value': 'NA', 'spread': '0.000', 'comment': 'Below the limit of quantitation (0.626 ng/mL).', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years', 'description': 'The suppression profiles of both IGF-1 and IGF-2 post administration of MEDI-573 in relation to time course of antibody concentrations in serum were evaluated during treatment.', 'unitOfMeasure': 'nanogram per milliliter (ng/ml)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population included all participants who had received any MEDI-573 treatment. Here, "N" and "n" represent number of participants analyzed for this outcome measure and at specific time points, respectively.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MEDI-573 0.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'FG001', 'title': 'MEDI-573 1.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'FG002', 'title': 'MEDI-573 5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'FG003', 'title': 'MEDI-573 10 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'FG004', 'title': 'MEDI-573 15 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'FG005', 'title': 'MEDI-573 30 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'FG006', 'title': 'MEDI-573 45 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'FG007', 'title': 'MEDI-573 5 mg/Kg QWk Dose Expansion', 'description': 'Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'FG008', 'title': 'MEDI-573 15 mg/Kg QWk Dose Expansion', 'description': 'Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '10'}, {'groupId': 'FG008', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '7'}, {'groupId': 'FG008', 'numSubjects': '8'}]}, {'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'}]}]}], 'recruitmentDetails': 'A total of 43 participants ((23 participants in dose-escalation phase and 20 participants in dose-expansion phase) were entered in the study and received the study treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '43', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'MEDI-573 0.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'BG001', 'title': 'MEDI-573 1.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'BG002', 'title': 'MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion', 'description': 'Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'BG003', 'title': 'MEDI-573 10 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'BG004', 'title': 'MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion', 'description': 'Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'BG005', 'title': 'MEDI-573 30 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'BG006', 'title': 'MEDI-573 45 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.'}, {'id': 'BG007', 'title': 'TOTAL', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.8', 'spread': '12.2', 'groupId': 'BG000'}, {'value': '67.0', 'spread': '8.7', 'groupId': 'BG001'}, {'value': '64.5', 'spread': '13.7', 'groupId': 'BG002'}, {'value': '68.0', 'spread': '13.2', 'groupId': 'BG003'}, {'value': '61.2', 'spread': '8.6', 'groupId': 'BG004'}, {'value': '58.3', 'spread': '18.5', 'groupId': 'BG005'}, {'value': '65.7', 'spread': '4.5', 'groupId': 'BG006'}, {'value': '62.6', 'spread': '11.5', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '18', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '25', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '42', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '39', 'groupId': 'BG007'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Population included all participants who had received any MEDI-573 treatment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2012-09-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-31', 'studyFirstSubmitDate': '2008-12-23', 'resultsFirstSubmitDate': '2018-02-05', 'studyFirstSubmitQcDate': '2008-12-30', 'lastUpdatePostDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-31', 'studyFirstPostDateStruct': {'date': '2009-01-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-09-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)', 'timeFrame': 'From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years', 'description': 'AEs were any unfavorable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with the use of MEDI-573, whether or not considered related to MEDI-573. A SAE was any AE that resulted in: death; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; was life-threatening; was a congenital anomaly/birth defect in the offspring of a study participant; or was an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes above. TEAEs were defined as AEs present at baseline that worsened in intensity after administration of MEDI-573, or events absent at baseline that emerged after administration of MEDI-573, up to 30 days after the last dose.'}, {'measure': 'Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs', 'timeFrame': 'From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years', 'description': 'An abnormal laboratory finding that was judged by the investigator to be medically significant was reported as an AE. TEAEs were defined as events present at baseline that worsened in intensity after administration of MEDI-573, or events absent at baseline that emerged after administration of MEDI-573, for the period extending to 30 days after the last dose.'}, {'measure': 'Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as TEAEs', 'timeFrame': 'From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years', 'description': 'Vital signs and physical findings included parameters such as heart rate, blood pressure, temperature, and respiratory rate. TEAEs were defined as events present at baseline that worsened in intensity after administration of MEDI-573 or events absent at baseline that emerged after administration of MEDI-573, for the period extending to 30 days after the last dose.'}, {'measure': 'Maximum Tolerated Dose (MTD) of MEDI-573', 'timeFrame': 'Cycle 1 Day 1 through Cycle 1 Day 21', 'description': 'The MTD was defined as the highest dose that can be safely administered to participants and was determined by the number of participants in each cohort with a dose-limiting toxicity (DLT). The number and proportion of participants in each dose cohort and the number of participants with a DLT was presented using the total number of participants in the MTD Evaluable Population as the denominator. 2 participants from Cohorts 0.5 and 5 mg/kg QWk (1 in each cohort) did not complete the DLT period and therefore not evaluable for MTD.'}, {'measure': 'Number of Participants With Dose-Limiting Toxicities (DLTs)', 'timeFrame': 'Cycle 1 Day 1 through Cycle 1 Day 21', 'description': 'A DLT was defined as any grade greater than or equal to (\\>=) 3 treatment-related non-hematologic toxicity that occurred during the DLT assessment period with the following exceptions: Grade less than (\\<) 4 serum-high glucose (fasting) with duration of \\< 24 hours; Grade 3 fever (in the absence of neutropenia) defined as \\> 40.0 degree centigrade (°C) \\[greater than (\\>) 104.0°F\\] that resolved to normal or baseline within 24 hours of treatment and was not considered an SAE; or Grade 3 rigors/chills that responded to optimal therapy; any Grade \\>= 3 treatment-related hematologic toxicity that occurred during the DLT assessment period.'}, {'measure': 'Optimal Biologically Effective Dose (OBED) of MEDI-573', 'timeFrame': 'From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years', 'description': 'The OBED was defined as the dose at which all circulating insulin-like growth factor (IGF)-1 and IGF-2 ligand was sequestered by MEDI-573.'}], 'secondaryOutcomes': [{'measure': 'Maximum Observed Serum Concentration (Cmax) After the First Dose', 'timeFrame': 'For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15', 'description': 'The Cmax was the maximum observed serum concentration of MEDI-573.'}, {'measure': 'Time to Reach Maximum Observed Concentration (Tmax) After the First Dose', 'timeFrame': 'For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15', 'description': 'The tmax was defined as actual sampling time to reach the maximum observed serum concentration of MEDI-573.'}, {'measure': 'Trough Serum Concentration (Ctrough) After the First Dose', 'timeFrame': 'For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15', 'description': 'The Ctrough was the lowest serum concentration of MEDI-573 within a dosing interval.'}, {'measure': 'Dose Normalized Cmax (Cmax/Dose) After the First Dose', 'timeFrame': 'For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15', 'description': 'The Cmax/dose was the dose-normalized maximum serum concentration of MEDI-573.'}, {'measure': 'Area Under the Serum Concentration-time Curve Over the First Dosing Interval (AUCτ)', 'timeFrame': 'For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15', 'description': 'Area under the serum concentration-time curve over the first dosing interval.'}, {'measure': 'Dose-normalized Area Under the Serum Concentration Time Curve Over the First Dosing Interval (AUCτ/Dose)', 'timeFrame': 'For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15', 'description': 'The AUCtau/dose was a measure of dose-normalized area under the serum concentration-time curve over the first dosing interval.'}, {'measure': 'Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI-573', 'timeFrame': 'Pre-infusion on Day 1 of each cycle, end of treatment, and 90 days after last dose MEDI-573 (up to 3.5 years)', 'description': 'Two methods were used to assess the immunogenicity data: an ECL-based method and measurement of neutralizing ADA. The titer was calculated by multiplying the minimum assay dilution factor by the reciprocal of the highest dilution factor which yielded an ECL multiple equal to or greater than the screening assay cut-point factor.'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'From study entry through the end of the study, up to 3.5 years', 'description': 'The ORR was defined as the proportion of participants with confirmed complete response (CR) or partial response (PR) according to the RECIST criteria The CR was defined as disappearance of all target and nontarget lesions and no new lesions; and PR was definded as \\>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline \\[screening\\]) and no new lesions.'}, {'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'From study entry through the end of the study, up to 3.5 years', 'description': 'Progression-free survival (PFS) was defined as the duration from the start of treatment with MEDI-573 until the documentation of disease progression or death due to any cause, whichever occurred first.'}, {'measure': 'Time to Progression', 'timeFrame': 'From study entry through the end of the study, up to 3.5 years', 'description': 'Time to disease progression (TTP) was defined as the duration from the start of treatment with MEDI-573 until the documentation of disease progression.'}, {'measure': 'Overall Survival', 'timeFrame': 'From study entry through the end of the study, up to 3.5 years', 'description': 'Overall survival (OS) was defined as the time from the start of treatment with MEDI-573 until death.'}, {'measure': 'Time to Response (TTR)', 'timeFrame': 'From study entry through the end of the study, up to 3.5 years', 'description': 'Time to response was defined as the duration from the start of treatment with MEDI-573 to the first documentation of objective response (confirmed CR or PR) and was only assessed in participants who had achieved objective response.'}, {'measure': 'Duration of Response', 'timeFrame': 'From study entry through the end of the study, up to 3.5 years', 'description': 'Duration of response was defined as the duration from the first documentation of objective response (confirmed CR or PR) to the first documented disease progression.'}, {'measure': 'Suppression Profiles of IGF-I and IGF-II Post-Administration of MEDI-573', 'timeFrame': 'From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years', 'description': 'The suppression profiles of both IGF-1 and IGF-2 post administration of MEDI-573 in relation to time course of antibody concentrations in serum were evaluated during treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=17&filename=MEDI-573_CP-184_Protocol_Redacted_16Jul14.pdf', 'label': 'MEDI-573\\_CP-184\\_Protocol\\_Redacted\\_16Jul14'}]}, 'descriptionModule': {'briefSummary': 'Evaluate the safety and tolerability of MEDI-573 in adult subjects with advanced solid tumors refractory to standard therapy or for which no standard therapy exists.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed advanced solid tumor for which no curative or standard therapies exist.\n* Karnofsky Performance Status ≥60.\n* Adequate hematological function.\n* Adequate organ function.\n* Women of non-child-bearing potential (defined as being \\>1 year post-menopausal) or using effective contraception, e.g., use of oral contraceptives with an additional barrier method (since the investigational product may impair the effectiveness of oral contraceptives), double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), Depo-Provera, partner vasectomy, or total abstinence, from the time the informed consent is signed through 30 days after the last dose of MEDI-573. Male subjects with partners of child-bearing potential must be surgically sterile or use contraceptive method as described above from the time of the initiation of MEDI-573 through 30 days after the last dose of MEDI-573.\n\nExclusion Criteria:\n\n* No prior treatment within 4 weeks of study drug administration.\n* No concurrent therapy for treatment of cancer.\n* No uncontrolled diabetes.\n* New York Heart Association Grade ≥ 2 congestive heart failure.\n* History of myocardial infarction, unstable angina, transient ischemic attack or stroke within the previous 6 months prior to study entry.\n* Documented brain metastasis.\n* Pregnancy or lactation or plans to become pregnant while on study.\n* Clinically significant abnormality on ECG.'}, 'identificationModule': {'nctId': 'NCT00816361', 'briefTitle': 'A Dose-escalation Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-573 in Subjects With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedImmune LLC'}, 'officialTitle': 'A Phase 1, Multicenter, Open-label, Single-arm, Dose-escalation Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-573, a Fully Human Monoclonal Antibody Directed Against Insulin-like Growth Factors I and II, in Subjects With Advanced Solid Tumors Refractory to Standard Therapy or for Which No Standard Therapy Exists', 'orgStudyIdInfo': {'id': 'MI-CP184'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MEDI-573 0.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.', 'interventionNames': ['Drug: MEDI-573']}, {'type': 'EXPERIMENTAL', 'label': 'MEDI-573 1.5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.', 'interventionNames': ['Drug: MEDI-573']}, {'type': 'EXPERIMENTAL', 'label': 'MEDI-573 5 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.', 'interventionNames': ['Drug: MEDI-573']}, {'type': 'EXPERIMENTAL', 'label': 'MEDI-573 10 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.', 'interventionNames': ['Drug: MEDI-573']}, {'type': 'EXPERIMENTAL', 'label': 'MEDI-573 15 mg/Kg QWk Dose Escalation', 'description': 'Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.', 'interventionNames': ['Drug: MEDI-573']}, {'type': 'EXPERIMENTAL', 'label': 'MEDI-573 30 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.', 'interventionNames': ['Drug: MEDI-573']}, {'type': 'EXPERIMENTAL', 'label': 'MEDI-573 45 mg/Kg Q3Wk Dose Escalation', 'description': 'Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.', 'interventionNames': ['Drug: MEDI-573']}, {'type': 'EXPERIMENTAL', 'label': 'MEDI-573 5 mg/Kg QWk Dose Expansion', 'description': 'Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.', 'interventionNames': ['Drug: MEDI-573']}, {'type': 'EXPERIMENTAL', 'label': 'MEDI-573 15 mg/Kg QWk Dose Expansion', 'description': 'Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.', 'interventionNames': ['Drug: MEDI-573']}], 'interventions': [{'name': 'MEDI-573', 'type': 'DRUG', 'description': "Administered at a dose determined by the subject's enrollment cohort as an IV infusion as part of a 21 day treatment cycle.", 'armGroupLabels': ['MEDI-573 0.5 mg/Kg QWk Dose Escalation', 'MEDI-573 1.5 mg/Kg QWk Dose Escalation', 'MEDI-573 10 mg/Kg QWk Dose Escalation', 'MEDI-573 15 mg/Kg QWk Dose Escalation', 'MEDI-573 15 mg/Kg QWk Dose Expansion', 'MEDI-573 30 mg/Kg Q3Wk Dose Escalation', 'MEDI-573 45 mg/Kg Q3Wk Dose Escalation', 'MEDI-573 5 mg/Kg QWk Dose Escalation', 'MEDI-573 5 mg/Kg QWk Dose Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Susan Perez, MD, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MedImmune LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MedImmune LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}