Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT01653158
Status:
COMPLETED
Last Update Posted:
2013-10-30
First Post:
2012-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
CP-751,871 In Combination With Docetaxel In Advance Non-hematologic Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C525021', 'term': 'figitumumab'}, {'id': 'D000077143', 'term': 'Docetaxel'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'CP-751,871 0.1 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m\\^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'CP-751,871 0.4 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'CP-751,871 0.8 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'CP-751,871 1.5 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'CP-751,871 3 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'CP-751,871 6 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'CP-751,871 10 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).', 'otherNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'seriousNumAffected': 7}, {'id': 'EG007', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.', 'otherNumAtRisk': 19, 'otherNumAffected': 19, 'seriousNumAtRisk': 19, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 9}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 16}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Hearing impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Eye discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Eyelid ptosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Keratoconjunctivitis sicca', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Visual disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, 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'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 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0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Neutropenic sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Syncope vasovagal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Tolerated Dose (MTD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 0.1-20 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1, 0.4, 0.8, 1.5, 3, 6, 10 or 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Two dose limiting toxicities (DLTs) were reported (a Grade 3 fatigue, reported in a subject receiving 10 mg/kg and Grade 4 hyperglycemia reported for a subject receiving 20 mg/kg), but MTD was not reached.', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 1 Day 1 through Cycle 1 Day 21', 'unitOfMeasure': 'mg/kg', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set: all enrolled participants who started treatment, but excluding those who were enrolled in the expansion cohort.'}, {'type': 'PRIMARY', 'title': 'Recommended Phase 2 Dose (RP2D)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 0.1-20 mg/kg + Docetaxel', 'description': 'In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1, 0.4, 0.8, 1.5, 3, 6, 10 or 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 1 Day 1 through Cycle 1 Day 21', 'unitOfMeasure': 'mg/kg', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set: all enrolled participants who started treatment.'}, {'type': 'PRIMARY', 'title': 'Area Under the Curve From Time Zero to 25 Hours Postdose (AUC25) of Docetaxel in Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '2852.11', 'spread': '943.017', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion', 'description': 'Area under the plasma concentration versus time curve (AUC) from time zero to 25 hours post dose, the nominal time of the last sample (24 hours after end of infusion)', 'unitOfMeasure': 'nanogram*hour/millilitre (ng*hr/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'Area Under the Curve From Time Zero to 25 Hours Postdose (AUC25) of Docetaxel in Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '2526.19', 'spread': '925.815', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion', 'description': 'Area under the plasma concentration versus time curve (AUC) from time zero to 25 hours post dose, the nominal time of the last sample (24 hours after end of infusion)', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Docetaxel in Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '2770.71', 'spread': '946.869', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Docetaxel in Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '2438.34', 'spread': '917.884', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast(dn)) of Docetaxel in Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '36.9428', 'spread': '12.6249', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) divided by dose', 'unitOfMeasure': 'ng•hr/mL/(mg/m^2)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast(dn)) of Docetaxel in Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '35.16', 'spread': '11.1288', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) divided by dose', 'unitOfMeasure': 'ng•hr/mL/(mg/m^2)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of Docetaxel in Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '2656.92', 'spread': '607.843', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of Docetaxel in Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '2430', 'spread': '497.343', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'Dose Normalized Maximum Observed Plasma Concentration (Cmax(dn)) of Docetaxel in Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '35.4256', 'spread': '8.1046', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion', 'description': 'Maximum Observed Plasma Concentration (Cmax) divided by dose', 'unitOfMeasure': 'ng/mL/(mg/m^2)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'Dose Normalized Maximum Observed Plasma Concentration (Cmax(dn)) of Docetaxel in Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '35.3', 'spread': '6.0377', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion', 'description': 'Maximum Observed Plasma Concentration (Cmax) divided by dose', 'unitOfMeasure': 'ng/mL/(mg/m^2)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of Docetaxel in Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9179', 'spread': '0.1833', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of Docetaxel in Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8066', 'spread': '0.1296', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Occurrence of Human Anti-human Antibody (HAHA) Response to CP-751,871', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 0.1 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m\\^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG001', 'title': 'CP-751,871 0.4 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG002', 'title': 'CP-751,871 0.8 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG003', 'title': 'CP-751,871 1.5 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG004', 'title': 'CP-751,871 3 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG005', 'title': 'CP-751,871 6 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG006', 'title': 'CP-751,871 10 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG007', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.'}], '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': '30 minutes predose at each cycle, End of Study (28 days after the last CP-751,871 infusion), and 150 days after the last CP-751,871 infusion', 'description': 'The development of HAHA is considered clinically relevant when temporally associated to the onset of adverse events or a significant decrease in the plasma concentrations of CP-751,871. The positive value is defined as ≥3.32.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who started treatment and had evaluable HAHA data'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Objective Response (OR)', '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'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 0.1 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m\\^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG001', 'title': 'CP-751,871 0.4 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG002', 'title': 'CP-751,871 0.8 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG003', 'title': 'CP-751,871 1.5 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG004', 'title': 'CP-751,871 3 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG005', 'title': 'CP-751,871 6 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG006', 'title': 'CP-751,871 10 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG007', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.'}], 'timeFrame': 'Baseline, every 2 months (approximately 7-10 days prior to the start of the next dose) up to Cycle 17 (1 cycle = 21 days)', 'description': 'Number of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not reported because data was available in individual participant listing only and not statistically summarized for the analysis.'}, {'type': 'SECONDARY', 'title': 'Time to Tumor Progression (TTP)', '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'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 0.1 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m\\^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG001', 'title': 'CP-751,871 0.4 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG002', 'title': 'CP-751,871 0.8 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG003', 'title': 'CP-751,871 1.5 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG004', 'title': 'CP-751,871 3 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG005', 'title': 'CP-751,871 6 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG006', 'title': 'CP-751,871 10 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG007', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.'}], 'timeFrame': 'Baseline, every 2 months (approximately 7-10 days prior to the start of the next dose) up to Cycle 17 (1 cycle = 21 days)', 'description': 'Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \\[PD\\])', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure (OM) was not analyzed due to incomplete progression reporting, which could not permit accurate estimate of time to tumor progression (TTP).'}, {'type': 'SECONDARY', 'title': 'Circulating Tumor Cells (CTCs), CTCs Expressing Insulin-like Growth Factor 1 Receptor (IGF-1R), and Circulating Endothelial Cells (CECs)', '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'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 0.1 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m\\^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG001', 'title': 'CP-751,871 0.4 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG002', 'title': 'CP-751,871 0.8 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG003', 'title': 'CP-751,871 1.5 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG004', 'title': 'CP-751,871 3 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG005', 'title': 'CP-751,871 6 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG006', 'title': 'CP-751,871 10 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG007', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.'}], 'timeFrame': 'Predose on Day 1 and on Day 8 of each cycle, and End of Study (28 days after the last CP-751,871 infusion)', 'reportingStatus': 'POSTED', 'populationDescription': 'The data of CTCs and CTCs expressing IGF-IR were limited. Analyses of these biomarkers in the aggregate population were not feasible due to insufficient numbers. The data of CECs were not analyzed due to insufficient levels for quantification.'}, {'type': 'SECONDARY', 'title': 'Systemic Clearance (CL) of CP-751,871 in Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 0.1 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m\\^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG001', 'title': 'CP-751,871 0.4 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG002', 'title': 'CP-751,871 0.8 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG003', 'title': 'CP-751,871 1.5 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG004', 'title': 'CP-751,871 3 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG005', 'title': 'CP-751,871 6 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG006', 'title': 'CP-751,871 10 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG007', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG001'}, {'value': '7.00', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG002'}, {'value': '6.67', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG003'}, {'value': '9.23', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG004'}, {'value': '5.17', 'spread': '0.99', 'groupId': 'OG006'}, {'value': '3.53', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)', 'description': 'CL is a quantitative measure of the rate at which a drug substance is removed from the body.', 'unitOfMeasure': 'mL/day/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort'}, {'type': 'SECONDARY', 'title': 'Systemic Clearance (CL) of CP-751,871 in Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 0.1 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m\\^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG001', 'title': 'CP-751,871 0.4 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG002', 'title': 'CP-751,871 0.8 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG003', 'title': 'CP-751,871 1.5 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG004', 'title': 'CP-751,871 3 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG005', 'title': 'CP-751,871 6 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG006', 'title': 'CP-751,871 10 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG007', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '70.6', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG000'}, {'value': '12.90', 'spread': '0.59', 'groupId': 'OG001'}, {'value': '6.84', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG002'}, {'value': '3.05', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG003'}, {'value': '2.74', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG004'}, {'value': '2.68', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG005'}, {'value': '4.01', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG006'}, {'value': '2.70', 'spread': '1.97', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)', 'description': 'CL is a quantitative measure of the rate at which a drug substance is removed from the body.', 'unitOfMeasure': 'mL/day/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of CP-751,871 in Cycle 1', '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': '3', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 0.1 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m\\^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG001', 'title': 'CP-751,871 0.4 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG002', 'title': 'CP-751,871 0.8 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG003', 'title': 'CP-751,871 1.5 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG004', 'title': 'CP-751,871 3 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG005', 'title': 'CP-751,871 6 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG006', 'title': 'CP-751,871 10 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG007', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.34', 'spread': '0.365', 'groupId': 'OG000'}, {'value': '7.81', 'spread': '0.475', 'groupId': 'OG001'}, {'value': '17.9', 'spread': '6.79', 'groupId': 'OG002'}, {'value': '33.4', 'spread': '5.97', 'groupId': 'OG003'}, {'value': '57.7', 'spread': '23.7', 'groupId': 'OG004'}, {'value': '129', 'spread': '23.6', 'groupId': 'OG005'}, {'value': '205', 'spread': '39.5', 'groupId': 'OG006'}, {'value': '382', 'spread': '156', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of CP-751,871 in Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 0.1 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m\\^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG001', 'title': 'CP-751,871 0.4 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG002', 'title': 'CP-751,871 0.8 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG003', 'title': 'CP-751,871 1.5 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG004', 'title': 'CP-751,871 3 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG005', 'title': 'CP-751,871 6 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG006', 'title': 'CP-751,871 10 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG007', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.29', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG000'}, {'value': '6.91', 'spread': '1.75', 'groupId': 'OG001'}, {'value': '17.8', 'spread': '2.13', 'groupId': 'OG002'}, {'value': '54.7', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG003'}, {'value': '103', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG004'}, {'value': '188', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG005'}, {'value': '311', 'spread': '65.5', 'groupId': 'OG006'}, {'value': '658', 'spread': '185', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) of CP-751,871 in Cycle 1', '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': '3', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 0.1 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m\\^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG001', 'title': 'CP-751,871 0.4 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG002', 'title': 'CP-751,871 0.8 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG003', 'title': 'CP-751,871 1.5 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG004', 'title': 'CP-751,871 3 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG005', 'title': 'CP-751,871 6 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG006', 'title': 'CP-751,871 10 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG007', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '38.4', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '1045', 'spread': '236', 'groupId': 'OG001'}, {'value': '2040', 'spread': '621', 'groupId': 'OG002'}, {'value': '5026', 'spread': '2516', 'groupId': 'OG003'}, {'value': '10570', 'spread': '3369', 'groupId': 'OG004'}, {'value': '26215', 'spread': '2520', 'groupId': 'OG005'}, {'value': '38160', 'spread': '7757', 'groupId': 'OG006'}, {'value': '84916', 'spread': '25982', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)', 'description': 'Area under the plasma concentration versus time curve (AUC) from time zero (Day 1) to Day 22, where Day 22 is the nominal time (504 hours) of the predose sample for the next cycle.', 'unitOfMeasure': 'mg*hr/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) of CP-751,871 in Cycle 4', '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'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 0.1 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m\\^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG001', 'title': 'CP-751,871 0.4 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG002', 'title': 'CP-751,871 0.8 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG003', 'title': 'CP-751,871 1.5 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG004', 'title': 'CP-751,871 3 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG005', 'title': 'CP-751,871 6 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG006', 'title': 'CP-751,871 10 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG007', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}], 'timeFrame': '30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)', 'description': 'Area under the plasma concentration versus time curve (AUC) from time zero (Day 1) to Day 22, where Day 22 is the nominal time (504 hours) of the predose sample for the next cycle.', 'reportingStatus': 'POSTED', 'populationDescription': 'This OM was not reported since the actual dosing interval (tau) was longer than 3 weeks in some patients and AUC(0-d22) may not accurately represent multiple-dose exposure for these patients. Therefore only AUCtau, which represents exposure for the actual Cycle 4 interval, was reported for Cycle 4 (OM 40).'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of CP-751,871 in Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 0.1 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m\\^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG001', 'title': 'CP-751,871 0.4 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG002', 'title': 'CP-751,871 0.8 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG003', 'title': 'CP-751,871 1.5 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG004', 'title': 'CP-751,871 3 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG005', 'title': 'CP-751,871 6 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG006', 'title': 'CP-751,871 10 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG007', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '949', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG001'}, {'value': '2744', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG002'}, {'value': '6532', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG003'}, {'value': '7799', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG004'}, {'value': '47711', 'spread': '9305', 'groupId': 'OG006'}, {'value': '136026', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)', 'description': 'Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).', 'unitOfMeasure': 'mg*hr/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of CP-751,871 in Cycle 4', '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'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 0.1 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m\\^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG001', 'title': 'CP-751,871 0.4 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG002', 'title': 'CP-751,871 0.8 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG003', 'title': 'CP-751,871 1.5 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG004', 'title': 'CP-751,871 3 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG005', 'title': 'CP-751,871 6 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG006', 'title': 'CP-751,871 10 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG007', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}], 'timeFrame': '30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)', 'description': 'Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).', 'reportingStatus': 'POSTED', 'populationDescription': 'This OM was not reported due to registration error. AUCinf is not scientifically appropriate for repeated dosing (Cycle 4).'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-751,871 in Cycle 1', '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': '3', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 0.1 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m\\^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG001', 'title': 'CP-751,871 0.4 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG002', 'title': 'CP-751,871 0.8 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG003', 'title': 'CP-751,871 1.5 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG004', 'title': 'CP-751,871 3 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG005', 'title': 'CP-751,871 6 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG006', 'title': 'CP-751,871 10 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG007', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '22.3', 'spread': '4.45', 'groupId': 'OG000'}, {'value': '673', 'spread': '127', 'groupId': 'OG001'}, {'value': '1685', 'spread': '879', 'groupId': 'OG002'}, {'value': '4568', 'spread': '2953', 'groupId': 'OG003'}, {'value': '10712', 'spread': '3147', 'groupId': 'OG004'}, {'value': '26215', 'spread': '2520', 'groupId': 'OG005'}, {'value': '39724', 'spread': '8380', 'groupId': 'OG006'}, {'value': '78106', 'spread': '37097', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)', 'unitOfMeasure': 'mg*hr/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-751,871 in Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 0.1 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m\\^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG001', 'title': 'CP-751,871 0.4 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG002', 'title': 'CP-751,871 0.8 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG003', 'title': 'CP-751,871 1.5 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG004', 'title': 'CP-751,871 3 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG005', 'title': 'CP-751,871 6 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG006', 'title': 'CP-751,871 10 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG007', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '20.6', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG000'}, {'value': '521', 'spread': '37.1', 'groupId': 'OG001'}, {'value': '1728', 'spread': '596', 'groupId': 'OG002'}, {'value': '11802', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG003'}, {'value': '26329', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG004'}, {'value': '55466', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG005'}, {'value': '45521', 'spread': '18562', 'groupId': 'OG006'}, {'value': '197090', 'spread': '122305', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)', 'unitOfMeasure': 'mg*hr/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort'}, {'type': 'SECONDARY', 'title': 'Plasma Decay Half-Life (t1/2) of CP-751,871 in Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 0.1 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m\\^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG001', 'title': 'CP-751,871 0.4 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG002', 'title': 'CP-751,871 0.8 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG003', 'title': 'CP-751,871 1.5 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG004', 'title': 'CP-751,871 3 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG005', 'title': 'CP-751,871 6 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG006', 'title': 'CP-751,871 10 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG007', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '68.5', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG001'}, {'value': '97.4', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG002'}, {'value': '151', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG003'}, {'value': '150', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG004'}, {'value': '224', 'spread': '67', 'groupId': 'OG006'}, {'value': '174', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort'}, {'type': 'SECONDARY', 'title': 'Plasma Decay Half-Life (t1/2) of CP-751,871 in Cycle 4', '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'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 0.1 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m\\^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG001', 'title': 'CP-751,871 0.4 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG002', 'title': 'CP-751,871 0.8 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG003', 'title': 'CP-751,871 1.5 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG004', 'title': 'CP-751,871 3 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG005', 'title': 'CP-751,871 6 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG006', 'title': 'CP-751,871 10 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG007', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}], 'timeFrame': '30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.', 'reportingStatus': 'POSTED', 'populationDescription': 'This OM was not reported due to insufficient data: the parameter was estimable in only 3 of 25 subjects.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-751,871 in Cycle 1', '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': '3', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 0.1 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m\\^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG001', 'title': 'CP-751,871 0.4 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG002', 'title': 'CP-751,871 0.8 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG003', 'title': 'CP-751,871 1.5 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG004', 'title': 'CP-751,871 3 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG005', 'title': 'CP-751,871 6 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG006', 'title': 'CP-751,871 10 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG007', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.54', 'spread': '0.067', 'groupId': 'OG000'}, {'value': '8.76', 'spread': '12.0', 'groupId': 'OG001'}, {'value': '1.70', 'spread': '0.146', 'groupId': 'OG002'}, {'value': '9.41', 'spread': '12.7', 'groupId': 'OG003'}, {'value': '1.98', 'spread': '0.060', 'groupId': 'OG004'}, {'value': '3.21', 'spread': '0.336', 'groupId': 'OG005'}, {'value': '11.1', 'spread': '11.5', 'groupId': 'OG006'}, {'value': '8.67', 'spread': '7.51', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-751,871 in Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 0.1 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m\\^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG001', 'title': 'CP-751,871 0.4 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG002', 'title': 'CP-751,871 0.8 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG003', 'title': 'CP-751,871 1.5 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG004', 'title': 'CP-751,871 3 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG005', 'title': 'CP-751,871 6 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG006', 'title': 'CP-751,871 10 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG007', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.53', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG000'}, {'value': '1.65', 'spread': '0.109', 'groupId': 'OG001'}, {'value': '1.59', 'spread': '0.119', 'groupId': 'OG002'}, {'value': '2.25', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG003'}, {'value': '11.1', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG004'}, {'value': '3.23', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG005'}, {'value': '9.68', 'spread': '10.71', 'groupId': 'OG006'}, {'value': '5.97', 'spread': '0.296', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort'}, {'type': 'SECONDARY', 'title': 'Volume of Distribution at Steady State (Vss) of CP-751,871 in Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 0.1 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m\\^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG001', 'title': 'CP-751,871 0.4 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG002', 'title': 'CP-751,871 0.8 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG003', 'title': 'CP-751,871 1.5 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG004', 'title': 'CP-751,871 3 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG005', 'title': 'CP-751,871 6 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG006', 'title': 'CP-751,871 10 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG007', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '43.3', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG001'}, {'value': '40.1', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG002'}, {'value': '52.9', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG003'}, {'value': '83.2', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG004'}, {'value': '67.5', 'spread': '15.2', 'groupId': 'OG006'}, {'value': '37.5', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.', 'unitOfMeasure': 'mL/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort'}, {'type': 'SECONDARY', 'title': 'Volume of Distribution at Steady State (Vss) of CP-751,871 in Cycle 4', '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'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 0.1 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m\\^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG001', 'title': 'CP-751,871 0.4 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG002', 'title': 'CP-751,871 0.8 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG003', 'title': 'CP-751,871 1.5 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG004', 'title': 'CP-751,871 3 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG005', 'title': 'CP-751,871 6 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG006', 'title': 'CP-751,871 10 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG007', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}], 'timeFrame': '30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.', 'reportingStatus': 'POSTED', 'populationDescription': 'This OM was not reported due to insufficient data: the parameter was estimable in only 3 of 25 subjects.'}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution (Vz/F) of CP-751,871 in Cycle 1', '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'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 0.1 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m\\^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG001', 'title': 'CP-751,871 0.4 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG002', 'title': 'CP-751,871 0.8 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG003', 'title': 'CP-751,871 1.5 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG004', 'title': 'CP-751,871 3 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG005', 'title': 'CP-751,871 6 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG006', 'title': 'CP-751,871 10 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG007', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}], 'timeFrame': '30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.', 'reportingStatus': 'POSTED', 'populationDescription': 'This OM was not reported due to registration error: apparent volume of distribution (Vz/F) is for oral dose. Volume of Distribution (Vz) of CP-751,871 after intravenous dosing in Cycle 1 (OM 36) was the correct outcome measure to be registered.'}, {'type': 'SECONDARY', 'title': 'Volume of Distribution (Vz) of CP-751,871 in Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 0.1 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m\\^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG001', 'title': 'CP-751,871 0.4 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG002', 'title': 'CP-751,871 0.8 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG003', 'title': 'CP-751,871 1.5 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG004', 'title': 'CP-751,871 3 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG005', 'title': 'CP-751,871 6 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG006', 'title': 'CP-751,871 10 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG007', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '41.7', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG001'}, {'value': '40.9', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG002'}, {'value': '55.1', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG003'}, {'value': '83.1', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG004'}, {'value': '67.9', 'spread': '15.5', 'groupId': 'OG006'}, {'value': '36.8', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.', 'unitOfMeasure': 'mL/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort'}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution (Vz/F) of CP-751,871 in Cycle 4', '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'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 0.1 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m\\^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG001', 'title': 'CP-751,871 0.4 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG002', 'title': 'CP-751,871 0.8 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG003', 'title': 'CP-751,871 1.5 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG004', 'title': 'CP-751,871 3 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG005', 'title': 'CP-751,871 6 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG006', 'title': 'CP-751,871 10 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG007', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}], 'timeFrame': '30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.', 'reportingStatus': 'POSTED', 'populationDescription': 'This OM was not reported due to registration error: apparent volume of distribution (Vz/F) is for oral dose. Volume of Distribution (Vz) of CP-751,871 after intravenous dosing in Cycle 4 (OM 38) was the correct outcome measure to be registered.'}, {'type': 'SECONDARY', 'title': 'Volume of Distribution (Vz) of CP-751,871 in Cycle 4', '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'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 0.1 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m\\^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG001', 'title': 'CP-751,871 0.4 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG002', 'title': 'CP-751,871 0.8 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG003', 'title': 'CP-751,871 1.5 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG004', 'title': 'CP-751,871 3 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG005', 'title': 'CP-751,871 6 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG006', 'title': 'CP-751,871 10 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG007', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}], 'timeFrame': '30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.', 'reportingStatus': 'POSTED', 'populationDescription': 'This OM was not reported due to insufficient data: the parameter was estimable in only 3 of 25 subjects.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of CP-751,871 in Cycle 1', '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'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 0.1 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m\\^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG001', 'title': 'CP-751,871 0.4 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG002', 'title': 'CP-751,871 0.8 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG003', 'title': 'CP-751,871 1.5 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG004', 'title': 'CP-751,871 3 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG005', 'title': 'CP-751,871 6 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG006', 'title': 'CP-751,871 10 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG007', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}], 'timeFrame': '30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)', 'description': 'Area under the plasma concentration versus time curve (AUC) from time zero to tau, the dosing interval, where tao is the actual time of the predose sample for the next cycle.', 'reportingStatus': 'POSTED', 'populationDescription': 'This OM was not reported because it is the same as Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) in Cycle 1 (OM 23), for both represented the planned 21-day dosing interval.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of CP-751,871 in Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 0.1 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m\\^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG001', 'title': 'CP-751,871 0.4 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG002', 'title': 'CP-751,871 0.8 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG003', 'title': 'CP-751,871 1.5 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG004', 'title': 'CP-751,871 3 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG005', 'title': 'CP-751,871 6 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG006', 'title': 'CP-751,871 10 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG007', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '36.1', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG000'}, {'value': '745', 'spread': '34.8', 'groupId': 'OG001'}, {'value': '2978', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG002'}, {'value': '11802', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG003'}, {'value': '26329', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG004'}, {'value': '55466', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG005'}, {'value': '65711', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG006'}, {'value': '233578', 'spread': '105208', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)', 'description': 'Area under the plasma concentration versus time curve (AUC) from time zero to tau, the dosing interval, where tao is the actual time of the predose sample for the next cycle.', 'unitOfMeasure': 'mg*hr/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort'}, {'type': 'SECONDARY', 'title': 'Observed Accumulation Ratio (Rac) of CP-751,871', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 0.1 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m\\^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG001', 'title': 'CP-751,871 0.4 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG002', 'title': 'CP-751,871 0.8 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG003', 'title': 'CP-751,871 1.5 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG004', 'title': 'CP-751,871 3 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG005', 'title': 'CP-751,871 6 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG006', 'title': 'CP-751,871 10 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG007', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.852', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG000'}, {'value': '0.714', 'spread': '0.236', 'groupId': 'OG001'}, {'value': '1.48', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG002'}, {'value': '1.50', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG003'}, {'value': '2.16', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG004'}, {'value': '2.04', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG005'}, {'value': '1.95', 'spread': 'NA', 'comment': 'Number of participants analyzed was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG006'}, {'value': '2.00', 'spread': '0.35', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes prior to CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of CP-751,871 infusion; and 30 minutes prior to the next cycle CP-751,871 infusion (Day 22) in Cycle 1 and Cycle 4', 'description': 'AUCtao of Cycle 4 divided by AUC(0-d22) of Cycle 1', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Dose Normalized Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)(dn)) of CP-751,871 in Cycle 1', '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'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 0.1 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m\\^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG001', 'title': 'CP-751,871 0.4 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG002', 'title': 'CP-751,871 0.8 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG003', 'title': 'CP-751,871 1.5 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG004', 'title': 'CP-751,871 3 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG005', 'title': 'CP-751,871 6 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG006', 'title': 'CP-751,871 10 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG007', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}], 'timeFrame': '30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)', 'description': 'Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) divided by total dose', 'reportingStatus': 'POSTED', 'populationDescription': 'This OM was not reported due to registration error. This parameter was not planned or analyzed for this study.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Dose Normalized Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)(dn)) of CP-751,871 in Cycle 4', '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'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 0.1 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m\\^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG001', 'title': 'CP-751,871 0.4 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG002', 'title': 'CP-751,871 0.8 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG003', 'title': 'CP-751,871 1.5 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG004', 'title': 'CP-751,871 3 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG005', 'title': 'CP-751,871 6 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG006', 'title': 'CP-751,871 10 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG007', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}], 'timeFrame': '30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)', 'description': 'Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) divided by total dose', 'reportingStatus': 'POSTED', 'populationDescription': 'This OM was not reported due to registration error. This parameter was not planned or analyzed for this study.'}, {'type': 'SECONDARY', 'title': 'Observed Concentration of CP-751,871 at Day 22 (Cday22) of Cycle 1 and 4', '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': '3', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 0.1 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m\\^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG001', 'title': 'CP-751,871 0.4 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG002', 'title': 'CP-751,871 0.8 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG003', 'title': 'CP-751,871 1.5 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG004', 'title': 'CP-751,871 3 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG005', 'title': 'CP-751,871 6 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG006', 'title': 'CP-751,871 10 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG007', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}], 'classes': [{'title': 'Day 22 of Cycle 1', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}, {'value': '0.185', 'spread': '0.320', 'groupId': 'OG002'}, {'value': '2.11', 'spread': '2.71', 'groupId': 'OG003'}, {'value': '9.07', 'spread': '7.17', 'groupId': 'OG004'}, {'value': '30.4', 'spread': '4.95', 'groupId': 'OG005'}, {'value': '37.7', 'spread': '15.4', 'groupId': 'OG006'}, {'value': '84.5', 'spread': '12.3', 'groupId': 'OG007'}]}]}, {'title': 'Day 22 of Cycle 4', 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'Number of participants analyzed was 2, which was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}, {'value': '0.144', 'spread': 'NA', 'comment': 'Number of participants analyzed was 2, which was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG002'}, {'value': '12.5', 'spread': 'NA', 'comment': 'Number of participants analyzed was 1, which was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG003'}, {'value': '32.2', 'spread': 'NA', 'comment': 'Number of participants analyzed was 2, which was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG004'}, {'value': '47.2', 'spread': 'NA', 'comment': 'Number of participants analyzed was 2, which was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG005'}, {'value': '79.3', 'spread': 'NA', 'comment': 'Number of participants analyzed was 2, which was less than 3, and thus standard deviation was not calculated.', 'groupId': 'OG006'}, {'value': '199', 'spread': '72.9', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1: 30 minutes prior to the Cycle 2 CP-751,871 infusion (this is Day 22 for Cycle 1); Cycle 4: 30 minutes prior to the Cycle 5 CP-751,871 infusion (this is Day 22 for Cycle 4)', 'description': 'Cday22 is the measured CP-751,871 plasma concentration in blood sample collected at Day 22.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort.'}, {'type': 'SECONDARY', 'title': 'Time of Last Quantifiable Time Point (Tlast) of CP-751,871 in Cycle 1 and Cycle 4', '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'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-751,871 0.1 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m\\^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG001', 'title': 'CP-751,871 0.4 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG002', 'title': 'CP-751,871 0.8 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG003', 'title': 'CP-751,871 1.5 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG004', 'title': 'CP-751,871 3 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG005', 'title': 'CP-751,871 6 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG006', 'title': 'CP-751,871 10 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'OG007', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}], 'timeFrame': 'Cycle 1 and 4: prior to CP-751,871 infusion, at 1 hour post CP-751,871 infusion, and at 1, 3, 7 days post end of docetaxel infusion', 'description': 'Blood samples were collected at timepoints prespecified in the study protocol. Tlast of CP-751,871 was the last time point when blood sample collected was quantifiable for CP-751,871.', 'reportingStatus': 'POSTED', 'populationDescription': 'This OM was not reported due to registration error. This parameter was not planned or analyzed for this study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CP-751,871 0.1 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m\\^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'FG001', 'title': 'CP-751,871 0.4 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'FG002', 'title': 'CP-751,871 0.8 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'FG003', 'title': 'CP-751,871 1.5 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'FG004', 'title': 'CP-751,871 3 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'FG005', 'title': 'CP-751,871 6 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'FG006', 'title': 'CP-751,871 10 mg/kg + Docetaxel', 'description': 'Single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).'}, {'id': 'FG007', 'title': 'CP-751,871 20 mg/kg + Docetaxel', 'description': 'In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days).\n\nIn the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '9'}, {'comment': 'Six (6) and 13 participants were enrolled in dose escalation and expansion cohorts, respectively.', 'groupId': 'FG007', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '3'}]}, {'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': '1'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '9'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'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'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Entire Study Population', 'description': 'Includes all enrolled participants who received single dose of docetaxel infusion up to 75 mg/m\\^2 over 1 hour intravenously and single dose of CP-751,871 infusion 0.1, 0.4, 0.8, 1.5, 3, 6, 10 or 20 mg/kg intravenously at each cycle (1 cycle = 21 days).'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.4', 'spread': '11.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-04', 'studyFirstSubmitDate': '2012-07-26', 'resultsFirstSubmitDate': '2013-01-18', 'studyFirstSubmitQcDate': '2012-07-27', 'lastUpdatePostDateStruct': {'date': '2013-10-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-06-07', 'studyFirstPostDateStruct': {'date': '2012-07-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Dose Normalized Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)(dn)) of CP-751,871 in Cycle 1', 'timeFrame': '30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)', 'description': 'Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) divided by total dose'}, {'measure': 'Dose Normalized Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)(dn)) of CP-751,871 in Cycle 4', 'timeFrame': '30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)', 'description': 'Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) divided by total dose'}], 'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose (MTD)', 'timeFrame': 'Cycle 1 Day 1 through Cycle 1 Day 21'}, {'measure': 'Recommended Phase 2 Dose (RP2D)', 'timeFrame': 'Cycle 1 Day 1 through Cycle 1 Day 21'}, {'measure': 'Area Under the Curve From Time Zero to 25 Hours Postdose (AUC25) of Docetaxel in Cycle 1', 'timeFrame': '30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion', 'description': 'Area under the plasma concentration versus time curve (AUC) from time zero to 25 hours post dose, the nominal time of the last sample (24 hours after end of infusion)'}, {'measure': 'Area Under the Curve From Time Zero to 25 Hours Postdose (AUC25) of Docetaxel in Cycle 4', 'timeFrame': '30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion', 'description': 'Area under the plasma concentration versus time curve (AUC) from time zero to 25 hours post dose, the nominal time of the last sample (24 hours after end of infusion)'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Docetaxel in Cycle 1', 'timeFrame': '30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Docetaxel in Cycle 4', 'timeFrame': '30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)'}, {'measure': 'Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast(dn)) of Docetaxel in Cycle 1', 'timeFrame': '30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) divided by dose'}, {'measure': 'Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast(dn)) of Docetaxel in Cycle 4', 'timeFrame': '30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) divided by dose'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of Docetaxel in Cycle 1', 'timeFrame': '30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of Docetaxel in Cycle 4', 'timeFrame': '30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion'}, {'measure': 'Dose Normalized Maximum Observed Plasma Concentration (Cmax(dn)) of Docetaxel in Cycle 1', 'timeFrame': '30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion', 'description': 'Maximum Observed Plasma Concentration (Cmax) divided by dose'}, {'measure': 'Dose Normalized Maximum Observed Plasma Concentration (Cmax(dn)) of Docetaxel in Cycle 4', 'timeFrame': '30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion', 'description': 'Maximum Observed Plasma Concentration (Cmax) divided by dose'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of Docetaxel in Cycle 1', 'timeFrame': '30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of Docetaxel in Cycle 4', 'timeFrame': '30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With the Occurrence of Human Anti-human Antibody (HAHA) Response to CP-751,871', 'timeFrame': '30 minutes predose at each cycle, End of Study (28 days after the last CP-751,871 infusion), and 150 days after the last CP-751,871 infusion', 'description': 'The development of HAHA is considered clinically relevant when temporally associated to the onset of adverse events or a significant decrease in the plasma concentrations of CP-751,871. The positive value is defined as ≥3.32.'}, {'measure': 'Number of Participants With Objective Response (OR)', 'timeFrame': 'Baseline, every 2 months (approximately 7-10 days prior to the start of the next dose) up to Cycle 17 (1 cycle = 21 days)', 'description': 'Number of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.'}, {'measure': 'Time to Tumor Progression (TTP)', 'timeFrame': 'Baseline, every 2 months (approximately 7-10 days prior to the start of the next dose) up to Cycle 17 (1 cycle = 21 days)', 'description': 'Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \\[PD\\])'}, {'measure': 'Circulating Tumor Cells (CTCs), CTCs Expressing Insulin-like Growth Factor 1 Receptor (IGF-1R), and Circulating Endothelial Cells (CECs)', 'timeFrame': 'Predose on Day 1 and on Day 8 of each cycle, and End of Study (28 days after the last CP-751,871 infusion)'}, {'measure': 'Systemic Clearance (CL) of CP-751,871 in Cycle 1', 'timeFrame': '30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)', 'description': 'CL is a quantitative measure of the rate at which a drug substance is removed from the body.'}, {'measure': 'Systemic Clearance (CL) of CP-751,871 in Cycle 4', 'timeFrame': '30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)', 'description': 'CL is a quantitative measure of the rate at which a drug substance is removed from the body.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of CP-751,871 in Cycle 1', 'timeFrame': '30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of CP-751,871 in Cycle 4', 'timeFrame': '30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)'}, {'measure': 'Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) of CP-751,871 in Cycle 1', 'timeFrame': '30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)', 'description': 'Area under the plasma concentration versus time curve (AUC) from time zero (Day 1) to Day 22, where Day 22 is the nominal time (504 hours) of the predose sample for the next cycle.'}, {'measure': 'Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) of CP-751,871 in Cycle 4', 'timeFrame': '30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)', 'description': 'Area under the plasma concentration versus time curve (AUC) from time zero (Day 1) to Day 22, where Day 22 is the nominal time (504 hours) of the predose sample for the next cycle.'}, {'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of CP-751,871 in Cycle 1', 'timeFrame': '30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)', 'description': 'Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).'}, {'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of CP-751,871 in Cycle 4', 'timeFrame': '30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)', 'description': 'Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-751,871 in Cycle 1', 'timeFrame': '30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-751,871 in Cycle 4', 'timeFrame': '30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)'}, {'measure': 'Plasma Decay Half-Life (t1/2) of CP-751,871 in Cycle 1', 'timeFrame': '30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.'}, {'measure': 'Plasma Decay Half-Life (t1/2) of CP-751,871 in Cycle 4', 'timeFrame': '30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-751,871 in Cycle 1', 'timeFrame': '30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-751,871 in Cycle 4', 'timeFrame': '30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)'}, {'measure': 'Volume of Distribution at Steady State (Vss) of CP-751,871 in Cycle 1', 'timeFrame': '30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.'}, {'measure': 'Volume of Distribution at Steady State (Vss) of CP-751,871 in Cycle 4', 'timeFrame': '30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.'}, {'measure': 'Apparent Volume of Distribution (Vz/F) of CP-751,871 in Cycle 1', 'timeFrame': '30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.'}, {'measure': 'Volume of Distribution (Vz) of CP-751,871 in Cycle 1', 'timeFrame': '30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.'}, {'measure': 'Apparent Volume of Distribution (Vz/F) of CP-751,871 in Cycle 4', 'timeFrame': '30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.'}, {'measure': 'Volume of Distribution (Vz) of CP-751,871 in Cycle 4', 'timeFrame': '30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.'}, {'measure': 'Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of CP-751,871 in Cycle 1', 'timeFrame': '30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)', 'description': 'Area under the plasma concentration versus time curve (AUC) from time zero to tau, the dosing interval, where tao is the actual time of the predose sample for the next cycle.'}, {'measure': 'Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of CP-751,871 in Cycle 4', 'timeFrame': '30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)', 'description': 'Area under the plasma concentration versus time curve (AUC) from time zero to tau, the dosing interval, where tao is the actual time of the predose sample for the next cycle.'}, {'measure': 'Observed Accumulation Ratio (Rac) of CP-751,871', 'timeFrame': '30 minutes prior to CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of CP-751,871 infusion; and 30 minutes prior to the next cycle CP-751,871 infusion (Day 22) in Cycle 1 and Cycle 4', 'description': 'AUCtao of Cycle 4 divided by AUC(0-d22) of Cycle 1'}, {'measure': 'Observed Concentration of CP-751,871 at Day 22 (Cday22) of Cycle 1 and 4', 'timeFrame': 'Cycle 1: 30 minutes prior to the Cycle 2 CP-751,871 infusion (this is Day 22 for Cycle 1); Cycle 4: 30 minutes prior to the Cycle 5 CP-751,871 infusion (this is Day 22 for Cycle 4)', 'description': 'Cday22 is the measured CP-751,871 plasma concentration in blood sample collected at Day 22.'}, {'measure': 'Time of Last Quantifiable Time Point (Tlast) of CP-751,871 in Cycle 1 and Cycle 4', 'timeFrame': 'Cycle 1 and 4: prior to CP-751,871 infusion, at 1 hour post CP-751,871 infusion, and at 1, 3, 7 days post end of docetaxel infusion', 'description': 'Blood samples were collected at timepoints prespecified in the study protocol. Tlast of CP-751,871 was the last time point when blood sample collected was quantifiable for CP-751,871.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['non-hematologic cancer', 'advanced solid tumors', 'prostrate cancer'], 'conditions': ['Advanced Non-Hematologic Malignancies']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4021003&StudyName=CP-751%2C871%20In%20Combination%20With%20Docetaxel%20In%20Advance%20Non-hematologic%20Malignancies', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial is designed to determine the safety, tolerability, pharmacokinetics and pharmacodynamic effects of escalating doses of CP 751,871 given in combination with docetaxel in patients with non-hematologic malignancies for whom docetaxel is a reasonable treatment option.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than 18 years\n* Documented advanced-stage non-hematologic malignancy for whom docetaxel monotherapy is a reasonable treatment option\n* Eastern Cooperative Oncology Group \\[ECOG\\] performance status 0-1\n\nExclusion Criteria:\n\n* Significant active cardiac disease\n* Chemotherapy, biological or investigational agents within 4 weeks prior to dosing\n* Inadequate bone marrow, renal, cardiac or liver function'}, 'identificationModule': {'nctId': 'NCT01653158', 'briefTitle': 'CP-751,871 In Combination With Docetaxel In Advance Non-hematologic Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1b Dose Escalation, Open-label Study Of CP-751,871 In Combination With Docetaxel In Advanced Non-hematologic Malignancies', 'orgStudyIdInfo': {'id': 'A4021003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CP-751,871 combined with docetaxel', 'interventionNames': ['Drug: CP-751,871', 'Drug: Docetaxel']}], 'interventions': [{'name': 'CP-751,871', 'type': 'DRUG', 'description': 'CP-751,871 was given intravenously \\[IV\\] every 3 weeks in escalating doses ranging from 0.1 mg/kg up to 20 mg/kg.\n\nStandard doses of Docetaxel were given every 3 weeks with CP-751,871. Study therapy was continued until disease progression, lack of tolerability for up to 17 cycles (approximately 1 year).', 'armGroupLabels': ['CP-751,871 combined with docetaxel']}, {'name': 'Docetaxel', 'type': 'DRUG', 'description': 'Docetaxel up to 75 mg/m\\^2 was administered intravenously \\[IV\\] on Day 1 of each 3-week dosing cycle.', 'armGroupLabels': ['CP-751,871 combined with docetaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SM2 5PT', 'city': 'Sutton', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}