Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-06 @ 2:38 PM
Study NCT ID:
NCT01876251
Status:
TERMINATED
Last Update Posted:
2019-03-15
First Post:
2013-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Evaluating The PF-03084014 In Combination With Docetaxel In Patients With Advanced Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C550722', 'term': 'nirogacestat'}, {'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': '18007181021', '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': {'timeFrame': 'Baseline up to 28-35 days after treatment discontinuation (up to Day 280)', 'description': 'All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'PF-03084014 100 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.', 'otherNumAtRisk': 15, 'otherNumAffected': 15, 'seriousNumAtRisk': 15, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'PF-03084014 100 mg BID + Docetaxel 100 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\\^2) intravenously.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'PF-03084014 150 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.', 'otherNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Ear disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Periorbital oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Oedema mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Local swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Performance status decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Vessel puncture site bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Candida infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, 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'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Laryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Nasal dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 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18.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Hyperkeratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Nail discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Nail disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Onycholysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Onychomadesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 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'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Rash erythematosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Skin discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Lymphoedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}], 'seriousEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Mastitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Dose-limiting Toxicities (DLTs) in Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03084014 100 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}, {'id': 'OG001', 'title': 'PF-03084014 100 mg BID + Docetaxel 100 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\\^2) intravenously.'}, {'id': 'OG002', 'title': 'PF-03084014 150 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 1 Days 1-21', 'description': 'Any DLT event in Cycle 1: Grade 4 neutropenia lasting more than (\\>)7 days; febrile neutropenia (Grade more than or equal to \\[\\>=\\] 3 and body temperature \\>=38.5 degrees Celsius); Grade \\>=3 neutropenic infection; Grade \\>=3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia without bleeding; Grade \\>=3 toxicities (except those that had not been maximally treated); Grade 3 prolongation of time from electrocardiogram (ECG) Q wave to the end of the T wave corresponding to electrical systole (QT) corrected for heart rate (QTc) which persisted after correction of reversible causes; delay of 2 weeks in receiving next scheduled cycle due to persisting treatment-related toxicities; and failure to deliver at least 80% of planned dose during first cycle due to treatment-related toxicities.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who were eligible, received study treatment, and who either experienced DLT during the first cycle, or completed the 1-cycle observation period.'}, {'type': 'PRIMARY', 'title': 'Progression-free Survival (PFS) at 6 Months - Expansion Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03084014 100 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '8.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline till 6 months post-dose', 'description': 'The period from study entry until disease progression, death or date of last contact. Assessment of response was made using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The 6-month PFS was evaluated only for the participants in the expansion cohort (PF-03084014 100 mg BID + docetaxel 75 mg/m\\^2). Due to early study termination, only 7 participants were treated in the expansion cohort.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03084014 100 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}, {'id': 'OG001', 'title': 'PF-03084014 100 mg BID + Docetaxel 100 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\\^2) intravenously.'}, {'id': 'OG002', 'title': 'PF-03084014 150 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}], 'classes': [{'title': 'All causality TEAEs', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Treatment-related (TR) TEAEs', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'All causality SAEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'TR SAEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 or 4 TEAEs, all causality', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 or 4 TEAEs, TR', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Grade 5 TEAEs, all causality', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Grade 5 TEAEs, TR', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Permanent withdrawal due to all causality TEAE(s)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Permanent withdrawal due to TR TEAE(s)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 28-35 days after treatment discontinuation (up to Day 280)', 'description': 'An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent AEs (TEAEs) are defined as newly occurring AEs or those worsening after first dose. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Causality assessment was made by the investigator. Grading was per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) version 3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening, Grade 5=death related to AE.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All 29 participants who received study treatment were included in the AE summarization/analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03084014 100 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}, {'id': 'OG001', 'title': 'PF-03084014 100 mg BID + Docetaxel 100 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\\^2) intravenously.'}, {'id': 'OG002', 'title': 'PF-03084014 150 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 28-35 days after treatment discontinuation (up to Day 280)', 'description': 'Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, clinical chemistry, and urinalysis (dipstick).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All 29 participants who received study treatment were included in the safety analyses.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Objective Response (OR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03084014 100 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}, {'id': 'OG001', 'title': 'PF-03084014 100 mg BID + Docetaxel 100 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\\^2) intravenously.'}, {'id': 'OG002', 'title': 'PF-03084014 150 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '40.5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '70.8'}, {'value': '18.2', 'groupId': 'OG002', 'lowerLimit': '2.3', 'upperLimit': '51.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, every 6 weeks from Cycle 2 onwards up to 26 months', 'description': 'OR was based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than \\[\\<\\] 10 millimeters \\[mm\\]). No new lesions. PR was defined as more than or equal to (\\>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All 29 participants who received study treatment were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve (AUC) From Time 0 to Time of Last Measured Concentration (AUClast) of PF-03084014 in Dose-finding Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03084014 100 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}, {'id': 'OG001', 'title': 'PF-03084014 100 mg BID + Docetaxel 100 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\\^2) intravenously.'}, {'id': 'OG002', 'title': 'PF-03084014 150 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}], 'classes': [{'title': 'C1D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1779', 'spread': '63', 'groupId': 'OG000'}, {'value': '1380', 'spread': '57', 'groupId': 'OG001'}, {'value': '1839', 'spread': '32', 'groupId': 'OG002'}]}]}, {'title': 'C1D21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4119', 'spread': '39', 'groupId': 'OG000'}, {'value': '3234', 'spread': '21', 'groupId': 'OG001'}, {'value': '5575', 'spread': '59', 'groupId': 'OG002'}]}]}, {'title': 'C2D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1983', 'spread': '53', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'There were only 2 participants with reportable AUClast at this time point and summary statistics are not calculated for \\<3 participants. Individual values were 1350 and 1400 ng\\*hr/mL.', 'groupId': 'OG001'}, {'value': '2652', 'spread': '28', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle (C) 1 Days (D) 1, 2, 8, and 21; Day 1 of subsequent cycles and at EOT (max reached: Cycle 12)', 'description': 'Serum PF-03084014 pharmacokinetic (PK) parameters were calculated following twice daily (BID) doses of PF-03084014 given alone (Cycle 1 Day 21) and in combination with docetaxel (Cycle 1 Day 2 and Cycle 2 Day 1).', 'unitOfMeasure': 'nanogram (ng)*hour (hr)/milliliter (mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.'}, {'type': 'SECONDARY', 'title': 'AUClast and AUC From Time 0 Extrapolated to Infinite Time (AUCinf) of Docetaxel in Dose-finding Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03084014 100 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}, {'id': 'OG001', 'title': 'PF-03084014 100 mg BID + Docetaxel 100 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\\^2) intravenously.'}, {'id': 'OG002', 'title': 'PF-03084014 150 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}], 'classes': [{'title': 'AUClast, C1D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3535', 'spread': '113', 'groupId': 'OG000'}, {'value': '4082', 'spread': '36', 'groupId': 'OG001'}, {'value': '2121', 'spread': '49', 'groupId': 'OG002'}]}]}, {'title': 'AUClast, C2D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2377', 'spread': '29', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'There were only 2 participants with reportable AUClast at this time point and summary statistics are not calculated for \\<3 participants. Individual values were 2270 and 1730 ng\\*hr/mL.', 'groupId': 'OG001'}, {'value': '2136', 'spread': '47', 'groupId': 'OG002'}]}]}, {'title': 'AUCinf, C1D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'There were only 2 participants with reportable AUCinf at this time point and summary statistics are not calculated for \\<3 participants. Individual values were 30800 and 3020 ng\\*hr/mL.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'There were only 2 participants with reportable AUCinf at this time point and summary statistics are not calculated for \\<3 participants. Individual values were 2970 and 4490 ng\\*hr/mL.', 'groupId': 'OG001'}, {'value': '2509', 'spread': '63', 'groupId': 'OG002'}]}]}, {'title': 'AUCinf, C2D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2530', 'spread': '30', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'There was only 1 participant with reportable AUCinf at this time point and summary statistics are not calculated for \\<3 participants. Individual value was 2410 ng\\*hr/mL.', 'groupId': 'OG001'}, {'value': '2929', 'spread': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)', 'description': 'Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)', 'unitOfMeasure': 'nanogram (ng)*hour (hr)/milliliter (mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Maximum Serum or Plasma Concentration (Cmax) and Predose Concentration (Ctrough) of PF-03084014 in Dose-finding Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03084014 100 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}, {'id': 'OG001', 'title': 'PF-03084014 100 mg BID + Docetaxel 100 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\\^2) intravenously.'}, {'id': 'OG002', 'title': 'PF-03084014 150 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}], 'classes': [{'title': 'Cmax, C1D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '884.8', 'spread': '56', 'groupId': 'OG000'}, {'value': '744.2', 'spread': '51', 'groupId': 'OG001'}, {'value': '896.6', 'spread': '40', 'groupId': 'OG002'}]}]}, {'title': 'Cmax, C1D21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1053', 'spread': '51', 'groupId': 'OG000'}, {'value': '677.5', 'spread': '37', 'groupId': 'OG001'}, {'value': '1501', 'spread': '44', 'groupId': 'OG002'}]}]}, {'title': 'Ctrough, C1D21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '214.7', 'spread': '39', 'groupId': 'OG000'}, {'value': '170.8', 'spread': '36', 'groupId': 'OG001'}, {'value': '306.1', 'spread': '72', 'groupId': 'OG002'}]}]}, {'title': 'Cmax, C2D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '885.7', 'spread': '95', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'There were only 2 participants with reportable Cmax at this time point and summary statistics are not calculated for \\<3 participants. Individual values were 488 and 559 ng/mL.', 'groupId': 'OG001'}, {'value': '1100', 'spread': '21', 'groupId': 'OG002'}]}]}, {'title': 'Ctrough, C2D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '186.1', 'spread': '42', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'There were only 2 participants with reportable Ctrough at this time point and summary statistics are not calculated for \\<3 participants. Individual values were 116 and 129 ng/mL.', 'groupId': 'OG001'}, {'value': '226.4', 'spread': '65', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)', 'description': 'Serum PF-03084014 PK parameters were calculated following BID doses of PF-03084014 given alone (Cycle 1 Day 21) and in combination with docetaxel (Cycle 1 Day 2 and Cycle 2 Day 1)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Cmax of Docetaxel in Dose-finding Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03084014 100 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}, {'id': 'OG001', 'title': 'PF-03084014 100 mg BID + Docetaxel 100 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\\^2) intravenously.'}, {'id': 'OG002', 'title': 'PF-03084014 150 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}], 'classes': [{'title': 'Cmax, C1D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3711', 'spread': '183', 'groupId': 'OG000'}, {'value': '3447', 'spread': '57', 'groupId': 'OG001'}, {'value': '2103', 'spread': '68', 'groupId': 'OG002'}]}]}, {'title': 'Cmax, C2D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2606', 'spread': '29', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'There were only 2 participants with reportable Cmax at this time point and summary statistics are not calculated for \\<3 participants. Individual values were 2260 and 2200 ng/mL.', 'groupId': 'OG001'}, {'value': '1965', 'spread': '35', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)', 'description': 'Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Time to Cmax (Tmax) of PF-03084014 in Dose-finding Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03084014 100 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}, {'id': 'OG001', 'title': 'PF-03084014 100 mg BID + Docetaxel 100 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\\^2) intravenously.'}, {'id': 'OG002', 'title': 'PF-03084014 150 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}], 'classes': [{'title': 'Tmax, C1D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.500', 'upperLimit': '1.03'}, {'value': '1.02', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '1.00', 'groupId': 'OG002', 'lowerLimit': '0.500', 'upperLimit': '1.03'}]}]}, {'title': 'Tmax, C1D21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.533', 'groupId': 'OG000', 'lowerLimit': '0.417', 'upperLimit': '1.00'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '0.500', 'upperLimit': '4.03'}, {'value': '0.767', 'groupId': 'OG002', 'lowerLimit': '0.500', 'upperLimit': '2.00'}]}]}, {'title': 'Tmax, C2D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.883', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '1.00'}, {'value': '1.03', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '1.05'}, {'value': '0.992', 'groupId': 'OG002', 'lowerLimit': '0.500', 'upperLimit': '1.02'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)', 'description': 'Serum PF-03084014 PK parameters were calculated following BID doses of PF-03084014 given alone (Cycle 1 Day 21) and in combination with docetaxel (Cycle 1 Day 2 and Cycle 2 Day 1)', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Tmax of Docetaxel in Dose-finding Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03084014 100 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}, {'id': 'OG001', 'title': 'PF-03084014 100 mg BID + Docetaxel 100 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\\^2) intravenously.'}, {'id': 'OG002', 'title': 'PF-03084014 150 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}], 'classes': [{'title': 'Tmax, C1D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.500', 'upperLimit': '1.05'}, {'value': '0.917', 'groupId': 'OG001', 'lowerLimit': '0.500', 'upperLimit': '1.00'}, {'value': '0.983', 'groupId': 'OG002', 'lowerLimit': '0.500', 'upperLimit': '1.05'}]}]}, {'title': 'Tmax, C2D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.517', 'upperLimit': '1.03'}, {'value': '0.767', 'groupId': 'OG001', 'lowerLimit': '0.533', 'upperLimit': '1.00'}, {'value': '1.00', 'groupId': 'OG002', 'lowerLimit': '0.500', 'upperLimit': '1.50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)', 'description': 'Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Systemic Clearance (CL) of Docetaxel in Dose-finding Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03084014 100 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}, {'id': 'OG001', 'title': 'PF-03084014 100 mg BID + Docetaxel 100 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\\^2) intravenously.'}, {'id': 'OG002', 'title': 'PF-03084014 150 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}], 'classes': [{'title': 'CL, C1D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'There were only 2 participants with reportable CL at this time point and summary statistics are not calculated for \\<3 participants. Individual values were 5.59 and 41.8 L/hr.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'There were only 2 participants with reportable CL at this time point and summary statistics are not calculated for \\<3 participants. Individual values were 55.3 and 40.5 L/hr.', 'groupId': 'OG001'}, {'value': '55.51', 'spread': '70', 'groupId': 'OG002'}]}]}, {'title': 'CL, C2D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '51.97', 'spread': '23', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'There was only 1 participant with reportable CL at this time point and summary statistics are not calculated for \\<3 participants. Individual value was 68.1 L/hr.', 'groupId': 'OG001'}, {'value': '45.40', 'spread': '5', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)', 'description': 'Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)', 'unitOfMeasure': 'liter (L)/hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Terminal Half-life (t1/2) of Docetaxel in Dose-finding Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03084014 100 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}, {'id': 'OG001', 'title': 'PF-03084014 100 mg BID + Docetaxel 100 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\\^2) intravenously.'}, {'id': 'OG002', 'title': 'PF-03084014 150 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}], 'classes': [{'title': 't1/2, C1D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18.35', 'spread': 'NA', 'comment': 'There were only 2 participants with reportable t1/2 at this time point so standard deviation is not calculated for. Individual values were 20.8 and 15.9 hrs.', 'groupId': 'OG000'}, {'value': '6.555', 'spread': 'NA', 'comment': 'There were only 2 participants with reportable t1/2 at this time point so standard deviation is not calculated for. Individual values were 10.1 and 3.01 hrs.', 'groupId': 'OG001'}, {'value': '7.624', 'spread': '5.368', 'groupId': 'OG002'}]}]}, {'title': 't1/2, C2D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.500', 'spread': '7.259', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'There was only 1 participant with reportable t1/2 at this time point and summary statistics are not calculated for \\<3 participants. Individual value was 3.84 hr.', 'groupId': 'OG001'}, {'value': '14.27', 'spread': '3.420', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)', 'description': 'Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Volume of Distribution (Vss) of Docetaxel in Dose-finding Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03084014 100 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}, {'id': 'OG001', 'title': 'PF-03084014 100 mg BID + Docetaxel 100 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\\^2) intravenously.'}, {'id': 'OG002', 'title': 'PF-03084014 150 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}], 'classes': [{'title': 'Vss, C1D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'There were only 2 participants with reportable Vss at this time point and summary statistics are not calculated for \\<3 participants. Individual values were 5.54 and 288 L.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'There were only 2 participants with reportable Vss at this time point and summary statistics are not calculated for \\<3 participants. Individual values were 301 and 27.8 L.', 'groupId': 'OG001'}, {'value': '97.34', 'spread': '73', 'groupId': 'OG002'}]}]}, {'title': 'Vss, C2D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '57.37', 'spread': '127', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'There was only 1 participant with reportable Vss at this time point and summary statistics are not calculated for \\<3 participants. Individual value was 85.4 L.', 'groupId': 'OG001'}, {'value': '231.5', 'spread': '25', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)', 'description': 'Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)', 'unitOfMeasure': 'L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.'}, {'type': 'SECONDARY', 'title': 'AUClast of PF-03084014 in the Expansion Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03084014 100 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}], 'classes': [{'title': 'AUClast, C1D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1098', 'spread': '47', 'groupId': 'OG000'}]}]}, {'title': 'AUClast, C1D21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1955', 'spread': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12)', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All 7 participants who received treatment in the expansion cohort were included in the analysis. n=number of evaluable participants at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Cmax of PF-03084014 in the Expansion Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03084014 100 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}], 'classes': [{'title': 'Cmax, C1D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '496.7', 'spread': '70', 'groupId': 'OG000'}]}]}, {'title': 'Cmax, C1D21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '982.1', 'spread': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All 7 participants who received treatment in the expansion cohort were included in the analysis. n=number of evaluable participants at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Tmax of PF-03084014 in the Expansion Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03084014 100 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}], 'classes': [{'title': 'Tmax, C1D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.983', 'groupId': 'OG000', 'lowerLimit': '0.500', 'upperLimit': '1.00'}]}]}, {'title': 'Tmax, C1D21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.483', 'upperLimit': '1.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12)', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All 7 participants who received treatment in the expansion cohort were included in the analysis. n=number of evaluable participants at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Ctrough of PF-03084014 in the Expansion Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03084014 100 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}], 'classes': [{'categories': [{'measurements': [{'value': '89.22', 'spread': '51', 'groupId': 'OG000', 'lowerLimit': '0.500', 'upperLimit': '1.00'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All 7 participants who received treatment in the expansion cohort were included in the analysis. At Cycle 1 Day 21, only 5 participants had available data for Ctrough.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03084014 100 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}, {'id': 'OG001', 'title': 'PF-03084014 150 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Summary statistics not provided as there were 2 participants with PR/CR. Individual DRs were 2.79 and 5.55 months.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Summary statistics not provided as there were 2 participants with PR/CR. Individual DRs were 3.19 and 4.20 months.', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 28-35 days after treatment discontinuation (up to Day 280)', 'description': 'Duration of response (DR) defined as time from start of first documented objective tumor response \\[Complete Response (CR) or Partial Response (PR)\\] to first documented objective tumor progression or death due to any cause, whichever occurs first. DR = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.02. CR: disappearance of all target lesions. PR: at least 30% decrease in the sum of diameters of target lesions.', 'unitOfMeasure': 'months', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 4 participants had CR or PR, 2 each in the PF-03084014 100 mg BID + docetaxel 75 mg/m\\^2 and PF-03084014 150 mg BID + docetaxel 75 mg/m\\^2 groups.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With QTc Values Meeting Categorical Summarization Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03084014 100 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}, {'id': 'OG001', 'title': 'PF-03084014 100 mg BID + Docetaxel 100 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\\^2) intravenously.'}, {'id': 'OG002', 'title': 'PF-03084014 150 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}], 'classes': [{'title': 'QTcB <=450 msec', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'QTcB 450 to <=480 msec', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'QTcB 480 to <=500 msec', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'QTcB >500 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'QTcF <=450 msec', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'QTcF 450 to <=480 msec', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'QTcF 480 to <=500 msec', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'QTcF >500 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'QTcB increase from BL <30 msec', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'QTcB increase from BL 30-<60 msec', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'QTcB increase from BL >=60 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'QTcF increase from BL <30 msec', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'QTcF increase from BL 30-<60 msec', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'QTcF increase from BL >=60 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'QTcB decrease from BL <30 msec', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'QTcB decrease from BL 30-<60 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'QTcB decrease from BL >=60msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'QTcF decrease from BL <30 msec', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'QTcF decrease from BL 30-<60 msec', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'QTcF decrease from BL >=60 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Screening, C1D1, C1D21, Day 1 of subsequent cycles, and EOT (maximum reached: C12)', 'description': "Criteria for categorical summarization of the time corresponding to the beginning of depolarization to repolarization of the ventricles (QT) corrected for heart rate (QTc) using Bazett's correction (QTcB) or Fridericia's correction (QTcF) included: maximum QTcB or QTcF less than or equal to (\\<=) 450 milliseconds (msec), 450 to \\<=480 msec, 480 to \\<=500 msec, more than (\\>) 500 msec; maximum QTcB or QTcF changes (increases/decreases) from baseline (BL) less than (\\<) 30 msec, 30 to \\<60 msec, more than or equal to (\\>=) 60 msec.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All 29 participants who received study treatment were analyzed for safety.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Notch 1 to 4 Ribonucleic Acid (RNA) in Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03084014 100 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}, {'id': 'OG001', 'title': 'PF-03084014 100 mg BID + Docetaxel 100 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\\^2) intravenously.'}, {'id': 'OG002', 'title': 'PF-03084014 150 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}], 'classes': [{'title': 'Notch 1 RNA, C1D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.240', 'spread': '0.5164', 'groupId': 'OG000'}, {'value': '3.990', 'spread': '0.4581', 'groupId': 'OG001'}, {'value': '4.431', 'spread': '1.1781', 'groupId': 'OG002'}]}]}, {'title': 'Notch 1 RNA, C1D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-5.797', 'spread': '11.0169', 'groupId': 'OG000'}, {'value': '-7.358', 'spread': '14.6569', 'groupId': 'OG001'}, {'value': '-10.647', 'spread': '19.1488', 'groupId': 'OG002'}]}]}, {'title': 'Notch 1 RNA, C1D8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '32.557', 'spread': '22.0342', 'groupId': 'OG000'}, {'value': '60.199', 'spread': 'NA', 'comment': 'Only 1 participant was evaluable at this time point.', 'groupId': 'OG001'}, {'value': '35.305', 'spread': '19.4523', 'groupId': 'OG002'}]}]}, {'title': 'Notch 1 RNA, C1D21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.118', 'spread': '17.0382', 'groupId': 'OG000'}, {'value': '17.047', 'spread': '15.6705', 'groupId': 'OG001'}, {'value': '11.214', 'spread': '7.9496', 'groupId': 'OG002'}]}]}, {'title': 'Notch 1 RNA, EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.653', 'spread': '12.0722', 'groupId': 'OG000'}, {'value': '18.066', 'spread': '9.4153', 'groupId': 'OG001'}, {'value': '4.177', 'spread': '14.6678', 'groupId': 'OG002'}]}]}, {'title': 'Notch 2 RNA, C1D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.139', 'spread': '0.4344', 'groupId': 'OG000'}, {'value': '3.856', 'spread': '0.8869', 'groupId': 'OG001'}, {'value': '4.351', 'spread': '0.7672', 'groupId': 'OG002'}]}]}, {'title': 'Notch 2 RNA, C1D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-12.830', 'spread': '8.1864', 'groupId': 'OG000'}, {'value': '-9.617', 'spread': '16.7632', 'groupId': 'OG001'}, {'value': '-15.441', 'spread': '20.3566', 'groupId': 'OG002'}]}]}, {'title': 'Notch 2 RNA, C1D8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.426', 'spread': '22.0876', 'groupId': 'OG000'}, {'value': '43.069', 'spread': 'NA', 'comment': 'Only 1 participant was evaluable at this time point.', 'groupId': 'OG001'}, {'value': '17.234', 'spread': '18.0896', 'groupId': 'OG002'}]}]}, {'title': 'Notch 2 RNA, C1D21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.161', 'spread': '9.7434', 'groupId': 'OG000'}, {'value': '9.756', 'spread': '22.6330', 'groupId': 'OG001'}, {'value': '4.985', 'spread': '7.6829', 'groupId': 'OG002'}]}]}, {'title': 'Notch 2 RNA, EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.250', 'spread': '11.6223', 'groupId': 'OG000'}, {'value': '9.478', 'spread': '28.0500', 'groupId': 'OG001'}, {'value': '-1.558', 'spread': '10.9137', 'groupId': 'OG002'}]}]}, {'title': 'Notch 3 RNA, C1D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14.250', 'spread': 'NA', 'comment': 'Only 1 participant was evaluable at this time point.', 'groupId': 'OG000'}, {'value': '14.673', 'spread': 'NA', 'comment': 'Only 1 participant was evaluable at this time point.', 'groupId': 'OG001'}, {'value': '14.765', 'spread': '1.3469', 'groupId': 'OG002'}]}]}, {'title': 'Notch 3 RNA, C1D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.311', 'spread': 'NA', 'comment': 'Only 1 participant was evaluable at this time point.', 'groupId': 'OG001'}, {'value': '-1.186', 'spread': '2.9388', 'groupId': 'OG002'}]}]}, {'title': 'Notch 3 RNA, C1D8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.532', 'spread': 'NA', 'comment': 'Only 1 participant was evaluable at this time point.', 'groupId': 'OG000'}, {'value': '4.608', 'spread': 'NA', 'comment': 'Only 1 participant was evaluable at this time point.', 'groupId': 'OG001'}, {'value': '-0.154', 'spread': '11.1968', 'groupId': 'OG002'}]}]}, {'title': 'Notch 3 RNA, C1D21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.362', 'spread': 'NA', 'comment': 'Only 1 participant was evaluable at this time point.', 'groupId': 'OG001'}, {'value': '-11.274', 'spread': '19.4623', 'groupId': 'OG002'}]}]}, {'title': 'Notch 4 RNA, C1D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13.903', 'spread': '0.5575', 'groupId': 'OG000'}, {'value': '13.228', 'spread': 'NA', 'comment': 'Only 1 participant was evaluable at this time point.', 'groupId': 'OG001'}, {'value': '14.309', 'spread': '1.3340', 'groupId': 'OG002'}]}]}, {'title': 'Notch 4 RNA, C1D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.215', 'spread': 'NA', 'comment': 'Only 1 participant was evaluable at this time point.', 'groupId': 'OG001'}, {'value': '2.484', 'spread': '5.9621', 'groupId': 'OG002'}]}]}, {'title': 'Notch 4 RNA, C1D8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-13.264', 'spread': '3.5374', 'groupId': 'OG000'}, {'value': '-9.427', 'spread': '9.8077', 'groupId': 'OG002'}]}]}, {'title': 'Notch 4 RNA, C1D21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.927', 'spread': 'NA', 'comment': 'Only 1 participant was evaluable at this time point.', 'groupId': 'OG000'}, {'value': '5.616', 'spread': 'NA', 'comment': 'Only 1 participant was evaluable at this time point.', 'groupId': 'OG001'}, {'value': '-0.500', 'spread': '6.4382', 'groupId': 'OG002'}]}]}, {'title': 'Notch 4 RNA, EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.634', 'spread': '9.0629', 'groupId': 'OG000'}, {'value': '11.821', 'spread': 'NA', 'comment': 'Only 1 participant was evaluable at this time point.', 'groupId': 'OG001'}, {'value': '-9.975', 'spread': '9.8833', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'C1D1, C1D2, C1D8, C1D21 and EOT (maximum reached: C12)', 'description': 'As PF-03084014 acts on the Notch pathway as an inhibitor, it is of interest to investigate its effects, if any, on the Notch family of receptors, mainly Notch 1-4.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants who had at least 1 screening and post treatment biomarker assessment. n=number of evaluable participants for the specified biomarker at the specified time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PF-03084014 100 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}, {'id': 'FG001', 'title': 'PF-03084014 100 mg BID + Docetaxel 100 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\\^2) intravenously.'}, {'id': 'FG002', 'title': 'PF-03084014 150 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Clinical progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Participant started new treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Participant refused further follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Study terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Objective progression or relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '8'}]}]}], 'preAssignmentDetails': '30 participants were enrolled of whom 1 was not treated and therefore 29 participants are stated below as starting the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'PF-03084014 100 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}, {'id': 'BG001', 'title': 'PF-03084014 100 mg BID + Docetaxel 100 mg/m^2', 'description': 'PF-03084014 100 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 100 mg/square meters (m\\^2) intravenously.'}, {'id': 'BG002', 'title': 'PF-03084014 150 mg BID + Docetaxel 75 mg/m^2', 'description': 'PF-03084014 150 milligrams (mg) was given orally via tablets twice daily (BID) in 21-day cycles. On Day 1 of each cycle, participants were administered docetaxel 75 mg/square meters (m\\^2) intravenously.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.3', 'spread': '13.9', 'groupId': 'BG000'}, {'value': '43.3', 'spread': '17.9', 'groupId': 'BG001'}, {'value': '46.2', 'spread': '12.6', 'groupId': 'BG002'}, {'value': '49.6', 'spread': '13.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'whyStopped': 'The study was terminated on June 24th, 2015 due to change in strategy of PF-03084014 development. There were no safety/efficacy concerns behind the decision.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2015-12-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-14', 'studyFirstSubmitDate': '2013-06-10', 'resultsFirstSubmitDate': '2017-07-31', 'studyFirstSubmitQcDate': '2013-06-10', 'lastUpdatePostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-14', 'studyFirstPostDateStruct': {'date': '2013-06-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Dose-limiting Toxicities (DLTs) in Cycle 1', 'timeFrame': 'Cycle 1 Days 1-21', 'description': 'Any DLT event in Cycle 1: Grade 4 neutropenia lasting more than (\\>)7 days; febrile neutropenia (Grade more than or equal to \\[\\>=\\] 3 and body temperature \\>=38.5 degrees Celsius); Grade \\>=3 neutropenic infection; Grade \\>=3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia without bleeding; Grade \\>=3 toxicities (except those that had not been maximally treated); Grade 3 prolongation of time from electrocardiogram (ECG) Q wave to the end of the T wave corresponding to electrical systole (QT) corrected for heart rate (QTc) which persisted after correction of reversible causes; delay of 2 weeks in receiving next scheduled cycle due to persisting treatment-related toxicities; and failure to deliver at least 80% of planned dose during first cycle due to treatment-related toxicities.'}, {'measure': 'Progression-free Survival (PFS) at 6 Months - Expansion Cohort', 'timeFrame': 'Baseline till 6 months post-dose', 'description': 'The period from study entry until disease progression, death or date of last contact. Assessment of response was made using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs', 'timeFrame': 'Baseline up to 28-35 days after treatment discontinuation (up to Day 280)', 'description': 'An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent AEs (TEAEs) are defined as newly occurring AEs or those worsening after first dose. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Causality assessment was made by the investigator. Grading was per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) version 3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening, Grade 5=death related to AE.'}, {'measure': 'Number of Participants With Laboratory Abnormalities', 'timeFrame': 'Baseline up to 28-35 days after treatment discontinuation (up to Day 280)', 'description': 'Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, clinical chemistry, and urinalysis (dipstick).'}, {'measure': 'Percentage of Participants With Objective Response (OR)', 'timeFrame': 'Baseline, every 6 weeks from Cycle 2 onwards up to 26 months', 'description': 'OR was based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than \\[\\<\\] 10 millimeters \\[mm\\]). No new lesions. PR was defined as more than or equal to (\\>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.'}, {'measure': 'Area Under the Concentration-time Curve (AUC) From Time 0 to Time of Last Measured Concentration (AUClast) of PF-03084014 in Dose-finding Cohort', 'timeFrame': 'Cycle (C) 1 Days (D) 1, 2, 8, and 21; Day 1 of subsequent cycles and at EOT (max reached: Cycle 12)', 'description': 'Serum PF-03084014 pharmacokinetic (PK) parameters were calculated following twice daily (BID) doses of PF-03084014 given alone (Cycle 1 Day 21) and in combination with docetaxel (Cycle 1 Day 2 and Cycle 2 Day 1).'}, {'measure': 'AUClast and AUC From Time 0 Extrapolated to Infinite Time (AUCinf) of Docetaxel in Dose-finding Cohort', 'timeFrame': 'C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)', 'description': 'Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)'}, {'measure': 'Maximum Serum or Plasma Concentration (Cmax) and Predose Concentration (Ctrough) of PF-03084014 in Dose-finding Cohort', 'timeFrame': 'C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)', 'description': 'Serum PF-03084014 PK parameters were calculated following BID doses of PF-03084014 given alone (Cycle 1 Day 21) and in combination with docetaxel (Cycle 1 Day 2 and Cycle 2 Day 1)'}, {'measure': 'Cmax of Docetaxel in Dose-finding Cohort', 'timeFrame': 'C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)', 'description': 'Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)'}, {'measure': 'Time to Cmax (Tmax) of PF-03084014 in Dose-finding Cohort', 'timeFrame': 'C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)', 'description': 'Serum PF-03084014 PK parameters were calculated following BID doses of PF-03084014 given alone (Cycle 1 Day 21) and in combination with docetaxel (Cycle 1 Day 2 and Cycle 2 Day 1)'}, {'measure': 'Tmax of Docetaxel in Dose-finding Cohort', 'timeFrame': 'C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)', 'description': 'Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)'}, {'measure': 'Systemic Clearance (CL) of Docetaxel in Dose-finding Cohort', 'timeFrame': 'C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)', 'description': 'Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)'}, {'measure': 'Terminal Half-life (t1/2) of Docetaxel in Dose-finding Cohort', 'timeFrame': 'C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)', 'description': 'Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)'}, {'measure': 'Volume of Distribution (Vss) of Docetaxel in Dose-finding Cohort', 'timeFrame': 'C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)', 'description': 'Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)'}, {'measure': 'AUClast of PF-03084014 in the Expansion Cohort', 'timeFrame': 'C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12)'}, {'measure': 'Cmax of PF-03084014 in the Expansion Cohort', 'timeFrame': 'C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12)'}, {'measure': 'Tmax of PF-03084014 in the Expansion Cohort', 'timeFrame': 'C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12)'}, {'measure': 'Ctrough of PF-03084014 in the Expansion Cohort', 'timeFrame': 'C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12)'}, {'measure': 'Duration of Response (DR)', 'timeFrame': 'Baseline up to 28-35 days after treatment discontinuation (up to Day 280)', 'description': 'Duration of response (DR) defined as time from start of first documented objective tumor response \\[Complete Response (CR) or Partial Response (PR)\\] to first documented objective tumor progression or death due to any cause, whichever occurs first. DR = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.02. CR: disappearance of all target lesions. PR: at least 30% decrease in the sum of diameters of target lesions.'}, {'measure': 'Number of Participants With QTc Values Meeting Categorical Summarization Criteria', 'timeFrame': 'Screening, C1D1, C1D21, Day 1 of subsequent cycles, and EOT (maximum reached: C12)', 'description': "Criteria for categorical summarization of the time corresponding to the beginning of depolarization to repolarization of the ventricles (QT) corrected for heart rate (QTc) using Bazett's correction (QTcB) or Fridericia's correction (QTcF) included: maximum QTcB or QTcF less than or equal to (\\<=) 450 milliseconds (msec), 450 to \\<=480 msec, 480 to \\<=500 msec, more than (\\>) 500 msec; maximum QTcB or QTcF changes (increases/decreases) from baseline (BL) less than (\\<) 30 msec, 30 to \\<60 msec, more than or equal to (\\>=) 60 msec."}, {'measure': 'Percentage Change From Baseline in Notch 1 to 4 Ribonucleic Acid (RNA) in Blood', 'timeFrame': 'C1D1, C1D2, C1D8, C1D21 and EOT (maximum reached: C12)', 'description': 'As PF-03084014 acts on the Notch pathway as an inhibitor, it is of interest to investigate its effects, if any, on the Notch family of receptors, mainly Notch 1-4.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breast cancer metastatic', 'docetaxel', 'PF-03084014'], 'conditions': ['Breast Cancer Metastatic']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8641016&StudyName=A%20Study%20Evaluating%20The%20PF-03084014%20In%20Combination%20With%20Docetaxel%20In%20Patients%20With%20Advanced%20Breast%20Cancer', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study is aimed to determine the tolerability of the PF-03084014 plus docetaxel combination in patients with advanced breast cancer. Preliminary information about the efficacy of the combination will also be collected.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of breast cancer with evidence of a) metastatic or b) locally recurrent/advanced disease.\n\nExclusion Criteria:\n\n* Prior treatment with a gamma secretase inhibitors or other Notch signaling inhibitors.'}, 'identificationModule': {'nctId': 'NCT01876251', 'briefTitle': 'A Study Evaluating The PF-03084014 In Combination With Docetaxel In Patients With Advanced Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Phase 1b Study Of Docetaxel + Pf 03084014 In Metastatic Or Locally Recurrent/Advanced Triple Negative Breast Cancer', 'orgStudyIdInfo': {'id': 'A8641016'}, 'secondaryIdInfos': [{'id': '2013-000659-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-03084014 plus docetaxel', 'description': 'PF 03084014 will be administered orally, continuously, twice daily at doses from 80 to 150 mg in combination with docetaxel given every 3 weeks at doses from 75 to 100 mg/m\\^2', 'interventionNames': ['Drug: PF-03084014', 'Drug: Docetaxel']}], 'interventions': [{'name': 'PF-03084014', 'type': 'DRUG', 'description': 'Tablet, 10 mg, twice a day', 'armGroupLabels': ['PF-03084014 plus docetaxel']}, {'name': 'PF-03084014', 'type': 'DRUG', 'description': 'Tablet, 50 mg, twice a day', 'armGroupLabels': ['PF-03084014 plus docetaxel']}, {'name': 'PF-03084014', 'type': 'DRUG', 'description': 'Tablet, 100 mg, twice a day', 'armGroupLabels': ['PF-03084014 plus docetaxel']}, {'name': 'Docetaxel', 'type': 'DRUG', 'otherNames': ['Taxotere'], 'description': 'Solution for IV infusion 75 mg/m\\^2, every 3 weeks', 'armGroupLabels': ['PF-03084014 plus docetaxel']}, {'name': 'Docetaxel', 'type': 'DRUG', 'description': 'Solution for IV infusion 100 mg/m\\^2, every 3 weeks', 'armGroupLabels': ['PF-03084014 plus docetaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham, IDS Pharmacy', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Cancer Institute', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Hospital & Clinics-DRUG SHIPMENT ADDRESS only', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Hospital & Clinics', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': "Stanford Women's Cancer Center", 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Barbara Ann Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Karmanos Cancer Institute (KCI)', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Cancer Hospital Infusion Pharmacy', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27599-7600', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Hospitals, The University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Jules Bordet Institut', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '6000', 'city': 'Charleroi', 'country': 'Belgium', 'facility': 'Grand Hopital de Charleroi', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'zip': '20141', 'city': 'Milan', 'country': 'Italy', 'facility': 'Instituto Europeo di Oncologia', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '08908', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Instituto Catalan de Oncologia de L'Hospitalet de Llobregat(ICO)", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}