Viewing Study NCT00424632

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Ignite Creation Date: 2025-12-24 @ 9:31 PM
Ignite Modification Date: 2025-12-28 @ 1:34 PM
Study NCT ID: NCT00424632
Status: COMPLETED
Last Update Posted: 2012-06-25
First Post: 2007-01-18
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Phase 1 Study Of Aurora Kinase Inhibitor PF-03814735 In Patients With Advanced Solid Tumors
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C550549', 'term': 'N-(2-(6-(4-cyclobutylamino-5-trifluoromethylpyrimidine-2-ylamino)-1,2,3,4-tetrahydro-1,4-epiazano-naphthalen-9-yl)-2-oxo-ethyl)acetamide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.govCallCenter@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment emergent events are reported from the first dose of study treatment up to 28 days after last dose of study treatment.', 'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'PF-03814735 5 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.', 'otherNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PF-03814735 10 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.', 'otherNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'PF-03814735 20 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.', 'otherNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'PF-03814735 40 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'PF-03814735 60 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'PF-03814735 80 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.', 'otherNumAtRisk': 15, 'otherNumAffected': 15, 'seriousNumAtRisk': 15, 'seriousNumAffected': 4}, {'id': 'EG006', 'title': 'PF-03814735 100 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 2}, {'id': 'EG007', 'title': 'PF-03814735 40 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'PF-03814735 50 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.', 'otherNumAtRisk': 16, 'otherNumAffected': 15, 'seriousNumAtRisk': 16, 'seriousNumAffected': 5}, {'id': 'EG009', 'title': 'PF-03814735 60 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Left ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Glare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Anal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Anorectal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 7}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Subclavian vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Vena cava thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With First Cycle Dose Limiting Toxicities (DLTs) Graded According to Common Terminology Criteria Adverse Events (CTCAE), Version 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '16', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03814735 5 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG001', 'title': 'PF-03814735 10 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG002', 'title': 'PF-03814735 20 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG003', 'title': 'PF-03814735 40 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG004', 'title': 'PF-03814735 60 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG005', 'title': 'PF-03814735 80 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG006', 'title': 'PF-03814735 100 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG007', 'title': 'PF-03814735 40 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG008', 'title': 'PF-03814735 50 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG009', 'title': 'PF-03814735 60 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to Day 21 of first cycle', 'description': 'DLT defined as any of the following during the first cycle of treatment and attributable to PF-03814735: Grade (Gr) 4 neutropenia (absolute neutrophil count \\[ANC\\] \\<500 cells/mm\\^3) for \\>7 days or febrile neutropenia (ANC \\<1000/mm\\^3, fever ≥38 degrees Celsius; neutropenic infection (ANC \\<1000/mm\\^3); Gr 4 thrombocytopenia (platelets \\<25,000 cells/mm\\^3); ≥Gr 3 nausea, vomiting, or diarrhea, despite optimal antiemetic, anti-diarrheal support; ≥20% decrease in left ventricular ejection fraction compared to baseline; other non-hematological toxicity; any Gr ≥3 adverse event; or failure to recover.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: Same as the As-treated population, defined as all patients enrolled in the study that received at least 1 dose of the study medication.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Serum Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03814735 5 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG001', 'title': 'PF-03814735 10 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG002', 'title': 'PF-03814735 20 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG003', 'title': 'PF-03814735 40 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG004', 'title': 'PF-03814735 60 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG005', 'title': 'PF-03814735 80 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG006', 'title': 'PF-03814735 100 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG007', 'title': 'PF-03814735 25 mg (Schedule B)', 'description': 'Participant was randomized to receive daily dosing of PF-03814735 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis. However, participant had reduced dose of 25 mg beginning on Cycle 1 Day 1 of treatment.'}, {'id': 'OG008', 'title': 'PF-03814735 40 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG009', 'title': 'PF-03814735 50 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG010', 'title': 'PF-03814735 60 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1920', 'spread': 'NA', 'comment': 'Geometric coefficient of variation (CV) % was not calculated for treatment groups with N \\<3.,', 'groupId': 'OG000'}, {'value': '0.6470', 'spread': 'NA', 'comment': 'Geometric CV % was not calculated for treatment groups with N \\<3.', 'groupId': 'OG001'}, {'value': '0.9010', 'spread': 'NA', 'comment': 'Geometric CV % was not calculated for treatment groups with N \\<3.', 'groupId': 'OG002'}, {'value': '1.965', 'spread': '35', 'groupId': 'OG003'}, {'value': '3.724', 'spread': '30', 'groupId': 'OG004'}, {'value': '3.773', 'spread': '43', 'groupId': 'OG005'}, {'value': '4.106', 'spread': '46', 'groupId': 'OG006'}, {'value': '1.470', 'spread': 'NA', 'comment': 'Geometric CV % was not calculated for treatment groups with N \\<3.', 'groupId': 'OG007'}, {'value': '1.957', 'spread': '36', 'groupId': 'OG008'}, {'value': '2.786', 'spread': '50', 'groupId': 'OG009'}, {'value': '2.087', 'spread': '24', 'groupId': 'OG010'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis set: Enrolled participants who received at least 1 dose of study treatment who had at least 1 of the PK parameters of interest estimated in at least 1 treatment period.'}, {'type': 'SECONDARY', 'title': 'Time for Maximum Observed Serum Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03814735 5 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG001', 'title': 'PF-03814735 10 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG002', 'title': 'PF-03814735 20 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG003', 'title': 'PF-03814735 40 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG004', 'title': 'PF-03814735 60 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG005', 'title': 'PF-03814735 80 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG006', 'title': 'PF-03814735 100 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG007', 'title': 'PF-03814735 25 mg (Schedule B)', 'description': 'Participant was randomized to receive daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis. However, participant had reduced dose of 25 mg beginning on Cycle 1 Day 1 of treatment.'}, {'id': 'OG008', 'title': 'PF-03814735 40 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG009', 'title': 'PF-03814735 50 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG010', 'title': 'PF-03814735 60 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'spread': 'NA', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '2.00'}, {'value': '1.00', 'spread': 'NA', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '1.00'}, {'value': '24.0', 'spread': 'NA', 'groupId': 'OG002', 'lowerLimit': '24.0', 'upperLimit': '24.0'}, {'value': '1.50', 'spread': '144', 'groupId': 'OG003', 'lowerLimit': '0.500', 'upperLimit': '6.00'}, {'value': '2.00', 'spread': '79', 'groupId': 'OG004', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '2.00', 'spread': '63', 'groupId': 'OG005', 'lowerLimit': '0.500', 'upperLimit': '4.00'}, {'value': '2.00', 'spread': '56', 'groupId': 'OG006', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '2.00', 'spread': 'NA', 'groupId': 'OG007', 'lowerLimit': '2.00', 'upperLimit': '2.00'}, {'value': '1.00', 'spread': '79', 'groupId': 'OG008', 'lowerLimit': '0.500', 'upperLimit': '2.00'}, {'value': '2.00', 'spread': '59', 'groupId': 'OG009', 'lowerLimit': '1.00', 'upperLimit': '6.00'}, {'value': '1.50', 'spread': '61', 'groupId': 'OG010', 'lowerLimit': '1.00', 'upperLimit': '4.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis set'}, {'type': 'SECONDARY', 'title': 'Area Under the Serum Concentration Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03814735 5 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG001', 'title': 'PF-03814735 10 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG002', 'title': 'PF-03814735 20 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG003', 'title': 'PF-03814735 40 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG004', 'title': 'PF-03814735 60 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG005', 'title': 'PF-03814735 80 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG006', 'title': 'PF-03814735 100 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG007', 'title': 'PF-03814735 25 mg (Schedule B)', 'description': 'Participant was randomized to receive daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis. However, participant had reduced dose of 25 mg beginning on Cycle 1 Day 1 of treatment.'}, {'id': 'OG008', 'title': 'PF-03814735 40 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG009', 'title': 'PF-03814735 50 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG010', 'title': 'PF-03814735 60 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose', 'description': 'Area under the serum concentration time-curve from zero to the last measured concentration.', 'unitOfMeasure': 'mcg*hr/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not summarized as the development of the compound was discontinued.'}, {'type': 'SECONDARY', 'title': 'Area Under the Serum Concentration Time Profile From Time 0 to Time Tau (τ), the Dosing Interval, Where τ = 24 Hours (AUCτ).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03814735 5 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG001', 'title': 'PF-03814735 10 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG002', 'title': 'PF-03814735 20 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG003', 'title': 'PF-03814735 40 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG004', 'title': 'PF-03814735 60 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG005', 'title': 'PF-03814735 80 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG006', 'title': 'PF-03814735 100 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG007', 'title': 'PF-03814735 25 mg (Schedule B)', 'description': 'Participant was randomized to receive daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis. However, participant had reduced dose of 25 mg beginning on Cycle 1 Day 1 of treatment.'}, {'id': 'OG008', 'title': 'PF-03814735 40 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG009', 'title': 'PF-03814735 50 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG010', 'title': 'PF-03814735 60 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.957', 'spread': 'NA', 'comment': 'Geometric CV % was not calculated for treatment groups with N \\<3.', 'groupId': 'OG000'}, {'value': '10.09', 'spread': 'NA', 'comment': 'Geometric CV % was not calculated for treatment groups with N \\<3.', 'groupId': 'OG001'}, {'value': '17.68', 'spread': 'NA', 'comment': 'Geometric CV % was not calculated for treatment groups with N \\<3.', 'groupId': 'OG002'}, {'value': '22.99', 'spread': '17', 'groupId': 'OG003'}, {'value': '47.95', 'spread': '62', 'groupId': 'OG004'}, {'value': '49.33', 'spread': '58', 'groupId': 'OG005'}, {'value': '57.96', 'spread': '45', 'groupId': 'OG006'}, {'value': '22.69', 'spread': 'NA', 'comment': 'Geometric CV % was not calculated for treatment groups with N \\<3.', 'groupId': 'OG007'}, {'value': '22.08', 'spread': '90', 'groupId': 'OG008'}, {'value': '37.15', 'spread': '66', 'groupId': 'OG009'}, {'value': '24.12', 'spread': '24', 'groupId': 'OG010'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose', 'unitOfMeasure': 'mcg*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis set'}, {'type': 'SECONDARY', 'title': 'Minimum Observed Serum Trough Concentration (Cmin)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03814735 5 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG001', 'title': 'PF-03814735 10 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG002', 'title': 'PF-03814735 20 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG003', 'title': 'PF-03814735 40 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG004', 'title': 'PF-03814735 60 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG005', 'title': 'PF-03814735 80 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG006', 'title': 'PF-03814735 100 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG007', 'title': 'PF-03814735 25 mg (Schedule B)', 'description': 'Participant was randomized to receive daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis. However, participant had reduced dose of 25 mg beginning on Cycle 1 Day 1 of treatment.'}, {'id': 'OG008', 'title': 'PF-03814735 40 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG009', 'title': 'PF-03814735 50 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG010', 'title': 'PF-03814735 60 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05440', 'spread': 'NA', 'comment': 'Geometric CV % was not calculated for treatment groups with N \\<3.', 'groupId': 'OG000'}, {'value': '0.2330', 'spread': 'NA', 'comment': 'Geometric CV % was not calculated for treatment groups with N \\<3.', 'groupId': 'OG001'}, {'value': '0.3110', 'spread': 'NA', 'comment': 'Geometric CV % was not calculated for treatment groups with N \\<3.', 'groupId': 'OG002'}, {'value': '0.4521', 'spread': '27', 'groupId': 'OG003'}, {'value': '1.019', 'spread': '105', 'groupId': 'OG004'}, {'value': '1.061', 'spread': '86', 'groupId': 'OG005'}, {'value': '1.410', 'spread': '58', 'groupId': 'OG006'}, {'value': '0.4950', 'spread': 'NA', 'comment': 'Geometric CV % was not calculated for treatment groups with N \\<3.', 'groupId': 'OG007'}, {'value': '0.3901', 'spread': '271', 'groupId': 'OG008'}, {'value': '0.6636', 'spread': '178', 'groupId': 'OG009'}, {'value': '0.4217', 'spread': '61', 'groupId': 'OG010'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose', 'description': 'Cmin defined as the lowest serum concentration observed during the dosing interval.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis set'}, {'type': 'SECONDARY', 'title': 'Observed Serum Accumulation Ratio (Rac)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03814735 40 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG001', 'title': 'PF-03814735 50 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG002', 'title': 'PF-03814735 60 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.054', 'spread': '28', 'groupId': 'OG000'}, {'value': '1.503', 'spread': '44', 'groupId': 'OG001'}, {'value': '1.247', 'spread': '27', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Schedule B Day-5: pre-dose, 0.5, 1, 2, 4, 6, 10, 24, 32, 48, and 72 hours post-dose, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose', 'description': 'Rac was the ratio of Schedule B Cycle 1/Day 9 to Day -5 (Day 9 AUCτ to Day -5 AUCτ).', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis set. N=number of participants in the indicated population contributing to the mean.'}, {'type': 'SECONDARY', 'title': 'Terminal Half-life (t 1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03814735 5 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG001', 'title': 'PF-03814735 10 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG002', 'title': 'PF-03814735 20 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG003', 'title': 'PF-03814735 40 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG004', 'title': 'PF-03814735 60 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG005', 'title': 'PF-03814735 80 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG006', 'title': 'PF-03814735 100 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG007', 'title': 'PF-03814735 25 mg (Schedule B)', 'description': 'Participant was randomized to receive daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis. However, participant had reduced dose of 25 mg beginning on Cycle 1 Day 1 of treatment.'}, {'id': 'OG008', 'title': 'PF-03814735 40 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG009', 'title': 'PF-03814735 50 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG010', 'title': 'PF-03814735 60 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}], 'paramType': 'MEAN', 'timeFrame': 'Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose', 'description': 'Terminal half-life (serum decay half-life) is the time measured for the serum concentration to decrease by one half.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Half-life (t ½) was not reported for multiple-dose data since the 24-hour sampling period was not long enough to adequately characterize t ½.'}, {'type': 'SECONDARY', 'title': 'Urine Pharmacokinetics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03814735 80 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG001', 'title': 'PF-03814735 50 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose', 'description': 'Urine PK for quantification of unchanged PF-03814375 and any identified metabolites. 24-hour urine collection at 8-hour intervals after the morning dose (Schedule \\[Sch\\] A Day 4, Sch B Day 9; last sample collected just prior to the morning dose on Sch A Day 5 or Sch B Day 10 in the expanded maximum tolerated dose (MTD) cohort only (≥ 10 participants in Sch A 80 mg and Sch B 50 mg groups). The lower limit of quantification (LLOQ) was 1 nanogram per milliliter (ng/mL). Clinical specimens with concentrations below the LLOQ were to be reported as below the limited of quantification (BLQ) 1 ng/mL.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not summarized as the development of the compound was discontinued.'}, {'type': 'SECONDARY', 'title': 'Summary of Tumor Metabolism Assessed by Positron Emission Tomography With F-18-fluorodeoxyglucose (FDG-PET)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03814735 80 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG001', 'title': 'PF-03814735 50 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Schedule A or Schedule B Day -7) and Schedule A Cycle 1/Day 3 or Day 4, Schedule B Cycle 1/Day 8 or 9', 'description': 'FTD-PET measured as standardized uptake volume (SUV) values corrected for lean body mass. Change from baseline categorized according to European Organization for Research and Treatment for Cancer (EORTC) criteria: Partial Metabolic Response (PMR): SUV value during treatment \\<75 percent (%) of baseline value; Progressive Metabolic Disease (PMD): SUV value during treatment \\>125% of baseline value; Stable Metabolic Disease (SMD): change in SUV value between PMR and PMD. Collected in the expanded MTD cohort only (≥ 10 participants in Sch A 80 mg and Sch B 50 mg groups).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not summarized as the development of the compound was discontinued.'}, {'type': 'SECONDARY', 'title': 'Target Modulation by Phosphohistone H3 (pH3) Expression in Tumor Tissue (IHC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03814735 80 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG001', 'title': 'PF-03814735 50 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}], 'paramType': 'MEAN', 'timeFrame': 'Schedule A Cycle 1 or Cycle 2 /Day 4 or Day 5, Schedule B Cycle 1/Day 9 or Day 10', 'description': 'pH3 expression is a method to enable the quantification of the proliferative potential of tumor cells. Post-dose tumor tissue sampling occurred after FDG-PET. Biopsies were not to be taken from lesions which were used for PET analysis and were to be taken between 1 and 6 hours after study drug administration. Collected in the expanded MTD cohort only (≥ 10 participants in Sch A 80 mg and Sch B 50 mg groups).', 'unitOfMeasure': 'percentage of cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not summarized as the development of the compound was discontinued.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Objective Tumor Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03814735 5 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG001', 'title': 'PF-03814735 10 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG002', 'title': 'PF-03814735 20 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG003', 'title': 'PF-03814735 40 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG004', 'title': 'PF-03814735 60 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG005', 'title': 'PF-03814735 80 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG006', 'title': 'PF-03814735 100 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG007', 'title': 'PF-03814735 40 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG008', 'title': 'PF-03814735 50 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG009', 'title': 'PF-03814735 60 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}], 'paramType': 'NUMBER', 'timeFrame': 'Every 2 cycles (each cycle=21 days) until disease progression or participant discontinuation; maximum follow-up was from baseline up to 12 cycles', 'description': 'Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not summarized as the development of the compound was discontinued.'}, {'type': 'SECONDARY', 'title': 'Time to Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03814735 5 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG001', 'title': 'PF-03814735 10 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG002', 'title': 'PF-03814735 20 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG003', 'title': 'PF-03814735 40 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG004', 'title': 'PF-03814735 60 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG005', 'title': 'PF-03814735 80 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG006', 'title': 'PF-03814735 100 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG007', 'title': 'PF-03814735 40 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG008', 'title': 'PF-03814735 50 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG009', 'title': 'PF-03814735 60 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, every 2 cycles (each cycle=21 days) until disease progression or participant discontinuation; maximum follow-up was from baseline up to 12 cycles', 'description': 'Time to Progression defined as the time from the date of enrollment to the date progressive disease first reported. If tumor progression data included more than 1 date, the first date was to be used. TTP = (first date of tumor progression - date of enrollment + 1). Progressive disease: ≥20% increase in sum LD of target lesions from smallest sum LD recorded since treatment start or appearance of ≥1 new lesions.', 'unitOfMeasure': 'months', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not summarized as the development of the compound was discontinued.'}, {'type': 'SECONDARY', 'title': 'Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03814735 5 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG001', 'title': 'PF-03814735 10 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG002', 'title': 'PF-03814735 20 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG003', 'title': 'PF-03814735 40 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG004', 'title': 'PF-03814735 60 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG005', 'title': 'PF-03814735 80 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG006', 'title': 'PF-03814735 100 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG007', 'title': 'PF-03814735 40 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG008', 'title': 'PF-03814735 50 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG009', 'title': 'PF-03814735 60 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}], 'paramType': 'NUMBER', 'timeFrame': 'Every 2 cycles (each cycle=21 days) until disease progression or participant discontinuation; maximum follow-up was from baseline up to 12 cycles', 'description': 'Duration of responses based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.', 'unitOfMeasure': 'months', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not summarized as the development of the compound was discontinued.'}, {'type': 'SECONDARY', 'title': 'Germ Line Polymorphism of Candidate Genes Targeted by PF-03814735', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03814735 80 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG001', 'title': 'PF-03814735 50 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}], 'paramType': 'NUMBER', 'timeFrame': 'Schedule A Cycle 1 or Cycle 2 /Day 4 or Day 5, Schedule B Cycle 1/Day 9 or Day 10 (each cycle=21 days)', 'description': 'Percentage of germ line polymorphism cell expression in relation to clinical response. Responses include CR: disappearance of all target lesions; PR: ≥30% decrease in sum of LD of target lesions referencing baseline sum LD; Progressive disease: ≥20% increase in sum LD of target lesions from smallest sum LD recorded since Tx start or appearance of ≥1 new lesions; Stable disease: neither sufficient shrinkage to=PR nor sufficient increase to=PD during first 6 weeks after Tx start referencing smallest sum LD since Tx start.', 'unitOfMeasure': 'percentage of cells', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not summarized as the development of the compound was discontinued.'}, {'type': 'SECONDARY', 'title': 'Aurora Gene Somatic Mutations/Amplification and Pathway Genes in Tumor Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03814735 80 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'OG001', 'title': 'PF-03814735 50 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}], 'paramType': 'NUMBER', 'timeFrame': 'Schedule A Cycle 1 or Cycle 2 /Day 4 or Day 5, Schedule B Cycle 1/Day 9 or Day 10 (each cycle=21 days)', 'description': 'Percentage of aurora gene somatic mutations/amplification and pathway genes in relation to clinical response. Responses include CR: disappearance of all target lesions; PR: ≥30% decrease in sum of longest dimensions (LD) of target lesions referencing baseline sum LD; Progressive disease: ≥20% increase in sum LD of target lesions from smallest sum LD recorded since Tx start or appearance of ≥1 new lesions; Stable disease: neither sufficient shrinkage to=PR nor sufficient increase to=PD during first 6 weeks after Tx start referencing smallest sum LD since Tx start.', 'unitOfMeasure': 'percentage of cells', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not summarized as the development of the compound was discontinued.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PF-03814735 5 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'FG001', 'title': 'PF-03814735 10 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'FG002', 'title': 'PF-03814735 20 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'FG003', 'title': 'PF-03814735 40 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'FG004', 'title': 'PF-03814735 60 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'FG005', 'title': 'PF-03814735 80 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'FG006', 'title': 'PF-03814735 100 mg (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'FG007', 'title': 'PF-03814735 40 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'FG008', 'title': 'PF-03814735 50 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'FG009', 'title': 'PF-03814735 60 mg (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '15'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '16'}, {'groupId': 'FG009', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '15'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '16'}, {'groupId': 'FG009', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '2'}]}, {'type': 'Global deterioration of health status', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Objective progression or relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '13'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '12'}, {'groupId': 'FG009', 'numSubjects': '4'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '59 participants enrolled and 57 sequentially assigned to treatment in Schedule A or B of study treatment. Schedule A: starting dose was 5 milligrams per day (mg/day) and dose was escalated up to 100 mg/day. Schedule B: starting dose determined based on occurrence of dose limiting toxicities and maximum tolerated dose in Schedule A.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PF-03814735 (Schedule A)', 'description': 'Participants received daily dosing of PF-03814735 of 5, 10, 20, 40, 60, 80, or 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'BG001', 'title': 'PF-03814735 (Schedule B)', 'description': 'Participants received daily dosing of PF-03814735 of 40, 50, or 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.6', 'spread': '9.0', 'groupId': 'BG000', 'lowerLimit': '44', 'upperLimit': '81'}, {'value': '58.2', 'spread': '10.2', 'groupId': 'BG001', 'lowerLimit': '28', 'upperLimit': '75'}, {'value': '61.2', 'spread': '9.8', 'groupId': 'BG002', 'lowerLimit': '28', 'upperLimit': '75'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-14', 'studyFirstSubmitDate': '2007-01-18', 'resultsFirstSubmitDate': '2012-03-21', 'studyFirstSubmitQcDate': '2007-01-18', 'lastUpdatePostDateStruct': {'date': '2012-06-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-05-07', 'studyFirstPostDateStruct': {'date': '2007-01-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With First Cycle Dose Limiting Toxicities (DLTs) Graded According to Common Terminology Criteria Adverse Events (CTCAE), Version 3', 'timeFrame': 'Day 1 up to Day 21 of first cycle', 'description': 'DLT defined as any of the following during the first cycle of treatment and attributable to PF-03814735: Grade (Gr) 4 neutropenia (absolute neutrophil count \\[ANC\\] \\<500 cells/mm\\^3) for \\>7 days or febrile neutropenia (ANC \\<1000/mm\\^3, fever ≥38 degrees Celsius; neutropenic infection (ANC \\<1000/mm\\^3); Gr 4 thrombocytopenia (platelets \\<25,000 cells/mm\\^3); ≥Gr 3 nausea, vomiting, or diarrhea, despite optimal antiemetic, anti-diarrheal support; ≥20% decrease in left ventricular ejection fraction compared to baseline; other non-hematological toxicity; any Gr ≥3 adverse event; or failure to recover.'}], 'secondaryOutcomes': [{'measure': 'Maximum Observed Serum Concentration (Cmax)', 'timeFrame': 'Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose'}, {'measure': 'Time for Maximum Observed Serum Concentration (Tmax)', 'timeFrame': 'Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose'}, {'measure': 'Area Under the Serum Concentration Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)', 'timeFrame': 'Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose', 'description': 'Area under the serum concentration time-curve from zero to the last measured concentration.'}, {'measure': 'Area Under the Serum Concentration Time Profile From Time 0 to Time Tau (τ), the Dosing Interval, Where τ = 24 Hours (AUCτ).', 'timeFrame': 'Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose'}, {'measure': 'Minimum Observed Serum Trough Concentration (Cmin)', 'timeFrame': 'Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose', 'description': 'Cmin defined as the lowest serum concentration observed during the dosing interval.'}, {'measure': 'Observed Serum Accumulation Ratio (Rac)', 'timeFrame': 'Schedule B Day-5: pre-dose, 0.5, 1, 2, 4, 6, 10, 24, 32, 48, and 72 hours post-dose, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose', 'description': 'Rac was the ratio of Schedule B Cycle 1/Day 9 to Day -5 (Day 9 AUCτ to Day -5 AUCτ).'}, {'measure': 'Terminal Half-life (t 1/2)', 'timeFrame': 'Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose', 'description': 'Terminal half-life (serum decay half-life) is the time measured for the serum concentration to decrease by one half.'}, {'measure': 'Urine Pharmacokinetics', 'timeFrame': 'Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose', 'description': 'Urine PK for quantification of unchanged PF-03814375 and any identified metabolites. 24-hour urine collection at 8-hour intervals after the morning dose (Schedule \\[Sch\\] A Day 4, Sch B Day 9; last sample collected just prior to the morning dose on Sch A Day 5 or Sch B Day 10 in the expanded maximum tolerated dose (MTD) cohort only (≥ 10 participants in Sch A 80 mg and Sch B 50 mg groups). The lower limit of quantification (LLOQ) was 1 nanogram per milliliter (ng/mL). Clinical specimens with concentrations below the LLOQ were to be reported as below the limited of quantification (BLQ) 1 ng/mL.'}, {'measure': 'Summary of Tumor Metabolism Assessed by Positron Emission Tomography With F-18-fluorodeoxyglucose (FDG-PET)', 'timeFrame': 'Baseline (Schedule A or Schedule B Day -7) and Schedule A Cycle 1/Day 3 or Day 4, Schedule B Cycle 1/Day 8 or 9', 'description': 'FTD-PET measured as standardized uptake volume (SUV) values corrected for lean body mass. Change from baseline categorized according to European Organization for Research and Treatment for Cancer (EORTC) criteria: Partial Metabolic Response (PMR): SUV value during treatment \\<75 percent (%) of baseline value; Progressive Metabolic Disease (PMD): SUV value during treatment \\>125% of baseline value; Stable Metabolic Disease (SMD): change in SUV value between PMR and PMD. Collected in the expanded MTD cohort only (≥ 10 participants in Sch A 80 mg and Sch B 50 mg groups).'}, {'measure': 'Target Modulation by Phosphohistone H3 (pH3) Expression in Tumor Tissue (IHC)', 'timeFrame': 'Schedule A Cycle 1 or Cycle 2 /Day 4 or Day 5, Schedule B Cycle 1/Day 9 or Day 10', 'description': 'pH3 expression is a method to enable the quantification of the proliferative potential of tumor cells. Post-dose tumor tissue sampling occurred after FDG-PET. Biopsies were not to be taken from lesions which were used for PET analysis and were to be taken between 1 and 6 hours after study drug administration. Collected in the expanded MTD cohort only (≥ 10 participants in Sch A 80 mg and Sch B 50 mg groups).'}, {'measure': 'Number of Participants With Objective Tumor Response', 'timeFrame': 'Every 2 cycles (each cycle=21 days) until disease progression or participant discontinuation; maximum follow-up was from baseline up to 12 cycles', 'description': 'Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.'}, {'measure': 'Time to Progression', 'timeFrame': 'Baseline, every 2 cycles (each cycle=21 days) until disease progression or participant discontinuation; maximum follow-up was from baseline up to 12 cycles', 'description': 'Time to Progression defined as the time from the date of enrollment to the date progressive disease first reported. If tumor progression data included more than 1 date, the first date was to be used. TTP = (first date of tumor progression - date of enrollment + 1). Progressive disease: ≥20% increase in sum LD of target lesions from smallest sum LD recorded since treatment start or appearance of ≥1 new lesions.'}, {'measure': 'Duration of Response', 'timeFrame': 'Every 2 cycles (each cycle=21 days) until disease progression or participant discontinuation; maximum follow-up was from baseline up to 12 cycles', 'description': 'Duration of responses based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.'}, {'measure': 'Germ Line Polymorphism of Candidate Genes Targeted by PF-03814735', 'timeFrame': 'Schedule A Cycle 1 or Cycle 2 /Day 4 or Day 5, Schedule B Cycle 1/Day 9 or Day 10 (each cycle=21 days)', 'description': 'Percentage of germ line polymorphism cell expression in relation to clinical response. Responses include CR: disappearance of all target lesions; PR: ≥30% decrease in sum of LD of target lesions referencing baseline sum LD; Progressive disease: ≥20% increase in sum LD of target lesions from smallest sum LD recorded since Tx start or appearance of ≥1 new lesions; Stable disease: neither sufficient shrinkage to=PR nor sufficient increase to=PD during first 6 weeks after Tx start referencing smallest sum LD since Tx start.'}, {'measure': 'Aurora Gene Somatic Mutations/Amplification and Pathway Genes in Tumor Tissue', 'timeFrame': 'Schedule A Cycle 1 or Cycle 2 /Day 4 or Day 5, Schedule B Cycle 1/Day 9 or Day 10 (each cycle=21 days)', 'description': 'Percentage of aurora gene somatic mutations/amplification and pathway genes in relation to clinical response. Responses include CR: disappearance of all target lesions; PR: ≥30% decrease in sum of longest dimensions (LD) of target lesions referencing baseline sum LD; Progressive disease: ≥20% increase in sum LD of target lesions from smallest sum LD recorded since Tx start or appearance of ≥1 new lesions; Stable disease: neither sufficient shrinkage to=PR nor sufficient increase to=PD during first 6 weeks after Tx start referencing smallest sum LD since Tx start.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Solid Tumors']}, 'referencesModule': {'references': [{'pmid': '21852114', 'type': 'DERIVED', 'citation': 'Schoffski P, Jones SF, Dumez H, Infante JR, Van Mieghem E, Fowst C, Gerletti P, Xu H, Jakubczak JL, English PA, Pierce KJ, Burris HA. Phase I, open-label, multicentre, dose-escalation, pharmacokinetic and pharmacodynamic trial of the oral aurora kinase inhibitor PF-03814735 in advanced solid tumours. Eur J Cancer. 2011 Oct;47(15):2256-64. doi: 10.1016/j.ejca.2011.07.008. Epub 2011 Aug 16.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9491001&StudyName=Phase%201%20Study%20Of%20Aurora%20Kinase%20Inhibitor%20PF-03814735%20In%20Patients%20With%20Advanced%20Solid%20Tumors', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the maximum tolerated dose and recommended phase 2 dose of PF-03814735 administered orally as single agent in patients with advanced solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Metastatic solid tumor resistant to standard therapy or for which no standard therapy is available\n* Adequate bone marrow, liver and kidney function\n\nExclusion Criteria:\n\n* Brain metastases that are symptomatic and/or require treatment with steroids and/or anticonvulsants, or brain metastases that have been treated within 3 months prior to study start\n* Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident in the previous 6 months'}, 'identificationModule': {'nctId': 'NCT00424632', 'briefTitle': 'Phase 1 Study Of Aurora Kinase Inhibitor PF-03814735 In Patients With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1, Open Label, Multi-Center, Accelerated Dose-Escalation, Pharmacokinetic And Pharmacodynamic Trial Of The Oral Single Agent Aurora Kinase Inhibitor PF-03814735 In Patients With Advanced Solid Tumors For Whom No Standard Therapy Is Available', 'orgStudyIdInfo': {'id': 'A9491001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single arm dose escalation', 'interventionNames': ['Drug: PF-03814735']}], 'interventions': [{'name': 'PF-03814735', 'type': 'DRUG', 'description': '1, 5, and 25 mg gelatin capsules administered orally once a day from day 1 to day 5, or from day 1 to day 10 every 3 weeks until disease progression or unacceptable toxicity.', 'armGroupLabels': ['Single arm dose escalation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}