Viewing Study NCT00557856


Ignite Creation Date: 2025-12-24 @ 11:34 PM
Ignite Modification Date: 2026-01-02 @ 5:57 AM
Study NCT ID: NCT00557856
Status: COMPLETED
Last Update Posted: 2015-10-19
First Post: 2007-11-12
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: A First In Patient, Study Of Investigational Drug PF-03446962 In Patients With Advanced Solid Tumors
Sponsor:
Organization:

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C575087', 'term': 'ascrinvacumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Results for tumor vascular function adopting dynamic contrast enhanced-magnetic resonance imaging (DCE-MRI) was not reported as per change in planned analysis.'}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'PF-03446962', 'description': 'All participants who received PF-03446962 intravenous infusion (0.5 milligram/kilogram \\[mg/kg\\], 1 mg/kg, 2 mg, 3 mg/kg, 4.5 mg/kg, 6.75 mg/kg, 10 mg/kg, 15 mg/kg, 7 mg/kg), on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression or unacceptable toxicity.', 'otherNumAtRisk': 68, 'otherNumAffected': 68, 'seriousNumAtRisk': 68, 'seriousNumAffected': 24}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Eye discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Eyelid oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Mouth haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Subileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Pelvic mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Gallbladder disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Hypertransaminasaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Portal vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Rhinovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Periorbital haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Subcutaneous haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Ammonia increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Blood potassium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Breath sounds abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Heart rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Laboratory test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Gouty arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Scrotal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Testicular oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Swelling face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Telangiectasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Intra-abdominal haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Vasodilatation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Photopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Gastric haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Cytokine release syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Multiple allergies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Fungal oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Aspartate aminotransferase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Blood albumin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Blood calcium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Blood potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Blood sodium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Creatinine renal clearance decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Hypernatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Groin pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Muscle twitching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Renal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Jugular vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Condition aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Hepatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Blood albumin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Endometrial adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Tumour necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Tumour pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Respiratory disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Tolerated Dose (MTD): Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962', 'description': 'All participants who received PF-03446962 intravenous infusion (0.5 milligram/kilogram \\[mg/kg\\], 1 mg/kg, 2 mg, 3 mg/kg, 4.5 mg/kg, 6.75 mg/kg, 10 mg/kg, 15 mg/kg), on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 42 days after the start of each increased treatment dose', 'description': 'MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced DLT and at least 2 out of 3/6 participants in the next higher dose. DLT was defined as any of the following events occurring during the first 42 days of study drug: any grade greater than or equal to 3 hematologic and non-hematologic toxicity, all non-disease-related adverse events (AEs).', 'unitOfMeasure': 'milligram/kilogram (mg/kg)', 'reportingStatus': 'POSTED', 'populationDescription': 'The MTD analysis set included all participants who were enrolled in the dose escalation part of the study and received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Recommended Phase 2 Dose (RP2D): Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962', 'description': 'All participants who received PF-03446962 intravenous infusion (0.5 milligram/kilogram \\[mg/kg\\], 1 mg/kg, 2 mg, 3 mg/kg, 4.5 mg/kg, 6.75 mg/kg, 10 mg/kg, 15 mg/kg), on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 42 days after the start of each increased treatment dose', 'description': 'RP2D was defined as the lower dose level to MTD based on the safety profile.', 'unitOfMeasure': 'mg/kg', 'reportingStatus': 'POSTED', 'populationDescription': 'The MTD analysis set included all participants who were enrolled in the dose escalation part of the study and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (AEs): Part 1 and Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 0.5 mg/kg: Part 1', 'description': 'PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'PF-03446962 1 mg/kg', 'description': 'PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'PF-03446962 2 mg/kg : Part 1', 'description': 'PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'PF-03446962 3 mg/kg: Part 1', 'description': 'PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG004', 'title': 'PF-03446962 4.5 mg/kg: Part 1', 'description': 'PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'PF-03446962 6.75 mg/kg: Part 1', 'description': 'PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'PF-03446962 10 mg/kg: Part 1', 'description': 'PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG007', 'title': 'PF-03446962 15 mg/kg: Part 1', 'description': 'PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG008', 'title': 'PF-03446962 7 mg/kg: Part 2', 'description': 'PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}], 'classes': [{'title': 'All causalities', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}]}, {'title': 'Treatment-related', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '20', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 1 of Day 1 up to 28 days after the last dose of treatment', 'description': 'An all causality AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Treatment-related AEs was any untoward medical occurrence in participant that was attributed to study drug. Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all enrolled participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Severity: Part 1 and Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 0.5 mg/kg: Part 1', 'description': 'PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'PF-03446962 1 mg/kg: Part 1', 'description': 'PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'PF-03446962 2 mg/kg : Part 1', 'description': 'PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'PF-03446962 3 mg/kg: Part 1', 'description': 'PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG004', 'title': 'PF-03446962 4.5 mg/kg: Part 1', 'description': 'PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'PF-03446962 6.75 mg/kg: Part 1', 'description': 'PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'PF-03446962 10 mg/kg: Part 1', 'description': 'PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG007', 'title': 'PF-03446962 15 mg/kg: Part 1', 'description': 'PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG008', 'title': 'PF-03446962 7 mg/kg: Part 2', 'description': 'PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 1 of Day 1 up to 28 days after the last dose of treatment', 'description': 'AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity; Grade 0 (no change from normal); grade 1 (mild AE which did not cause any significant problem, no dose adjustment required); grade 2 (moderate AE which caused problem that did not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event); grade 3 (severe AE which caused problem that interfered significantly with usual activities or the clinical status, study drug stopped due to adverse event); grade 4 (life threatening AE) and grade 5 (death). Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all enrolled participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Seriousness: Part 1 and Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 0.5 mg/kg: Part 1', 'description': 'PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'PF-03446962 1 mg/kg: Part 1', 'description': 'PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'PF-03446962 2 mg/kg : Part 1', 'description': 'PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'PF-03446962 3 mg/kg: Part 1', 'description': 'PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG004', 'title': 'PF-03446962 4.5 mg/kg: Part 1', 'description': 'PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'PF-03446962 6.75 mg/kg: Part 1', 'description': 'PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'PF-03446962 10 mg/kg: Part 1', 'description': 'PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG007', 'title': 'PF-03446962 15 mg/kg: Part 1', 'description': 'PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG008', 'title': 'PF-03446962 7 mg/kg: Part 2', 'description': 'PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}], 'classes': [{'title': 'Non-Serious Adverse Events', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}]}, {'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 1 of Day 1 up to 28 days after the last dose of treatment', 'description': 'AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Seriousness of an AE was assessed as serious adverse event (SAE) and non-serious adverse event (non-SAE). An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Non-SAE included all AE minus SAE. Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all enrolled participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Time to Treatment-Emergent Adverse Events (AEs): Part 1 and Part 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'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 0.5 mg/kg: Part 1', 'description': 'PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'PF-03446962 1 mg/kg: Part 1', 'description': 'PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'PF-03446962 2 mg/kg : Part 1', 'description': 'PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'PF-03446962 3 mg/kg: Part 1', 'description': 'PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG004', 'title': 'PF-03446962 4.5 mg/kg: Part 1', 'description': 'PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'PF-03446962 6.75 mg/kg: Part 1', 'description': 'PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'PF-03446962 10 mg/kg: Part 1', 'description': 'PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG007', 'title': 'PF-03446962 15 mg/kg: Part 1', 'description': 'PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG008', 'title': 'PF-03446962 7 mg/kg: Part 2', 'description': 'PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}], 'timeFrame': 'Cycle 1 of Day 1 up to 28 days after the last dose of treatment', 'description': 'Total time from onset of adverse event till the event is resolved. Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for timing was reported in individual participant listing for every adverse event (AE) and mentioned for description of narrative of Serious AEs but was not statistically summarized for analysis on the entire safety population, as planned.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Abnormalities: Part 1 and Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 0.5 mg/kg: Part 1', 'description': 'PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'PF-03446962 1 mg/kg: Part 1', 'description': 'PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'PF-03446962 2 mg/kg : Part 1', 'description': 'PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'PF-03446962 3 mg/kg: Part 1', 'description': 'PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG004', 'title': 'PF-03446962 4.5 mg/kg: Part 1', 'description': 'PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'PF-03446962 6.75 mg/kg: Part 1', 'description': 'PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'PF-03446962 10 mg/kg: Part 1', 'description': 'PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG007', 'title': 'PF-03446962 15 mg/kg: Part 1', 'description': 'PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG008', 'title': 'PF-03446962 7 mg/kg: Part 2', 'description': 'PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}], 'classes': [{'title': 'Hemoglobin', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '20', 'groupId': 'OG008'}]}]}, {'title': 'Lymphocytes abs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}]}]}, {'title': 'Neutrophils abs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}]}, {'title': 'Platelets', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}]}]}, {'title': 'White blood cells', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}]}]}, {'title': 'Alanine Aminotransferase', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '18', 'groupId': 'OG008'}]}]}, {'title': 'Alkaline Phosphatase', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '20', 'groupId': 'OG008'}]}]}, {'title': 'Amylase', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}]}, {'title': 'Aspartate Aminotransferase', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '20', 'groupId': 'OG008'}]}]}, {'title': 'Bilirubin', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}]}]}, {'title': 'Creatinine', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}]}]}, {'title': 'Hypercalcemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Hyperglycemia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '23', 'groupId': 'OG008'}]}]}, {'title': 'Hyperkalemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}]}]}, {'title': 'Hypernatremia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Hypoalbuminemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}]}]}, {'title': 'Hypocalcemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}]}, {'title': 'Hypokalemia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}]}]}, {'title': 'Hyponatremia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '17', 'groupId': 'OG008'}]}]}, {'title': 'Hypophosphatemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}]}]}, {'title': 'Lipase', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}]}]}, {'title': 'Hypoglycemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 1 of Day 1 up to 28 days after the last dose of treatment', 'description': 'Laboratory tests included hematology (hemoglobin, lymphocytes absolute \\[abs\\], neutrophils abs, platelets, white blood cells) and chemistry (alanine aminotransferase, alkaline phosphatase, amylase, aspartate aminotransferase, bilirubin, creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypokalemia, hyponatremia, hypophosphatemia, lipase). Assays were based on National Cancer Institute \\[NCI\\] Common Terminology Criteria for AE (CTCAE) grading scale for AEs (grade 1 \\[mild AE: did not cause any significant problem, no dose adjustment required\\]; grade 2 \\[moderate AE: caused problem that did not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event\\]; grade 3 \\[severe AE: caused problem that interfered significantly with usual activities or the clinical status, study drug stopped due to adverse event\\] and grade 4 \\[life threatening AE\\]). Overall data of the 4 grades is reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all enrolled participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Objective Response: Part 1 and Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 0.5 mg/kg: Part 1', 'description': 'PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'PF-03446962 1 mg/kg: Part 1', 'description': 'PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'PF-03446962 2 mg/kg : Part 1', 'description': 'PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'PF-03446962 3 mg/kg: Part 1', 'description': 'PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG004', 'title': 'PF-03446962 4.5 mg/kg: Part 1', 'description': 'PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'PF-03446962 6.75 mg/kg: Part 1', 'description': 'PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'PF-03446962 10 mg/kg: Part 1', 'description': 'PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG007', 'title': 'PF-03446962 15 mg/kg: Part 1', 'description': 'PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG008', 'title': 'PF-03446962 7 mg/kg: Part 2', 'description': 'PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '45.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '45.1'}, {'value': '16.7', 'groupId': 'OG002', 'lowerLimit': '0.9', 'upperLimit': '58.2'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '63.2'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '52.7'}, {'value': '0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '31.2'}, {'value': '28.6', 'groupId': 'OG006', 'lowerLimit': '5.3', 'upperLimit': '65.9'}, {'value': '0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '39.3'}, {'value': '0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '11.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490', 'description': 'Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR defined as disappearance of all target lesions and non-target lesions. PR defined as \\>=30 % decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non-target lesions.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Response-evaluable set included all participants who received at least 1 dose of study drug with an adequate baseline tumor assessment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Disease Control: Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 7 mg/kg: Part 2', 'description': 'PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.2', 'groupId': 'OG000', 'lowerLimit': '14.6', 'upperLimit': '47.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490', 'description': 'Participants who achieved either a confirmed complete Response or confirmed partial response or a Stable disease lasting at least 12 weeks from the first dose was defined as achieving disease control. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR: disappearance of all target lesions and non-target lesions. PR: \\>=30 % decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD and stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as a reference the smallest sum of the LD according to RECIST associated to non-progressive disease response for non-target lesions. Percentage of participants achieving disease control was calculated out of the participants participating in the exploratory phase.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Response-evaluable set included all participants who started Cycle 1 with an adequate baseline tumor assessment.'}, {'type': 'SECONDARY', 'title': 'Time To Progression (TTP): Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 7 mg/kg: Part 2', 'description': 'PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '4.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490', 'description': 'Time in months from start of treatment to first documentation of objective tumor progression. TTP was calculated as (first event date or last known progression-free date minus the date of treatment plus 1) divided by 30.44. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \\[PD\\] per RECIST). PD: \\>=20% increase in the sum of the LD of the target lesions taking as a reference the smallest sum of the LD or the appearance of one or more new lesions and as unequivocal progression of existing non-target lesions, or the appearance of \\>=1 new lesions. TTP was calculated out of the participants participating in the exploratory phase.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least one dose of study drug.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Maximum Observed Serum Concentration (Cmax): Part 1 and Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 0.5 mg/kg: Part 1', 'description': 'PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'PF-03446962 1 mg/kg: Part 1', 'description': 'PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'PF-03446962 2 mg/kg : Part 1', 'description': 'PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'PF-03446962 3 mg/kg: Part 1', 'description': 'PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG004', 'title': 'PF-03446962 4.5 mg/kg: Part 1', 'description': 'PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'PF-03446962 6.75 mg/kg: Part 1', 'description': 'PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'PF-03446962 10 mg/kg: Part 1', 'description': 'PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG007', 'title': 'PF-03446962 15 mg/kg: Part 1', 'description': 'PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG008', 'title': 'PF-03446962 7 mg/kg: Part 2', 'description': 'PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '7210', 'spread': '2004.0', 'groupId': 'OG000'}, {'value': '18510', 'spread': '5623.4', 'groupId': 'OG001'}, {'value': '38090', 'spread': '20361', 'groupId': 'OG002'}, {'value': '62530', 'spread': '25484', 'groupId': 'OG003'}, {'value': '123700', 'spread': '49961', 'groupId': 'OG004'}, {'value': '140600', 'spread': '49562', 'groupId': 'OG005'}, {'value': '274500', 'spread': '102100', 'groupId': 'OG006'}, {'value': '304000', 'spread': '131350', 'groupId': 'OG007'}, {'value': '153100', 'spread': '60116', 'groupId': 'OG008'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)', 'unitOfMeasure': 'nanogram/milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Minimum Observed Serum Trough Concentration (Cmin): Part 1 and Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 0.5 mg/kg: Part 1', 'description': 'PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'PF-03446962 1 mg/kg: Part 1', 'description': 'PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'PF-03446962 2 mg/kg : Part 1', 'description': 'PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'PF-03446962 3 mg/kg: Part 1', 'description': 'PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG004', 'title': 'PF-03446962 4.5 mg/kg: Part 1', 'description': 'PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'PF-03446962 6.75 mg/kg: Part 1', 'description': 'PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'PF-03446962 10 mg/kg: Part 1', 'description': 'PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG007', 'title': 'PF-03446962 15 mg/kg: Part 1', 'description': 'PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG008', 'title': 'PF-03446962 7 mg/kg: Part 2', 'description': 'PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}], 'classes': [{'title': 'Cycle 2 Day 1 (n=3, 2, 6, 3, 4, 5, 5, 2, 15)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.', 'groupId': 'OG001'}, {'value': '1010', 'spread': '1377.1', 'groupId': 'OG002'}, {'value': '4473', 'spread': '1888.6', 'groupId': 'OG003'}, {'value': '8675', 'spread': '2203.0', 'groupId': 'OG004'}, {'value': '14820', 'spread': '4943.4', 'groupId': 'OG005'}, {'value': '33440', 'spread': '14738', 'groupId': 'OG006'}, {'value': '35450', 'spread': '1060.7', 'groupId': 'OG007'}, {'value': '17230', 'spread': '8815.0', 'groupId': 'OG008'}]}]}, {'title': 'Cycle 3 Day 1 (n=3, 2, 4, 3, 1, 4, 3, 1, 13)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.', 'groupId': 'OG000'}, {'value': '704.0', 'spread': '461.03', 'groupId': 'OG001'}, {'value': '9992', 'spread': '14932', 'groupId': 'OG002'}, {'value': '17070', 'spread': '5122.8', 'groupId': 'OG003'}, {'value': '4850', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG004'}, {'value': '45850', 'spread': '15660', 'groupId': 'OG005'}, {'value': '77530', 'spread': '31351', 'groupId': 'OG006'}, {'value': '69400', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG007'}, {'value': '40870', 'spread': '25784', 'groupId': 'OG008'}]}]}, {'title': 'Cycle 4 Day 1 (n=2, 2, 2, 3, 1, 4, 3, 1, 12)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.', 'groupId': 'OG000'}, {'value': '2000', 'spread': '353.55', 'groupId': 'OG001'}, {'value': '6715', 'spread': '2934.5', 'groupId': 'OG002'}, {'value': '22030', 'spread': '3931.1', 'groupId': 'OG003'}, {'value': '32700', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG004'}, {'value': '41880', 'spread': '3108.5', 'groupId': 'OG005'}, {'value': '93130', 'spread': '44384', 'groupId': 'OG006'}, {'value': '87100', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG007'}, {'value': '64960', 'spread': '35284', 'groupId': 'OG008'}]}]}, {'title': 'Cycle 5 Day 1 (n= 1, 0, 2, 3, 1, 3, 3, 1, 12)', 'categories': [{'measurements': [{'value': '588.0', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.', 'groupId': 'OG001'}, {'value': '11490', 'spread': '3691.1', 'groupId': 'OG002'}, {'value': '25930', 'spread': '5488.5', 'groupId': 'OG003'}, {'value': '42200', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG004'}, {'value': '51600', 'spread': '12065', 'groupId': 'OG005'}, {'value': '103300', 'spread': '56589', 'groupId': 'OG006'}, {'value': '98800', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG007'}, {'value': '76960', 'spread': '40711', 'groupId': 'OG008'}]}]}, {'title': 'Cycle 6 Day 1 (n=0, 2, 2, 1, 1, 1, 1, 0, 7)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.', 'groupId': 'OG001'}, {'value': '13470', 'spread': '6554.9', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.', 'groupId': 'OG003'}, {'value': '45000', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG004'}, {'value': '58070', 'spread': '8471.9', 'groupId': 'OG005'}, {'value': '44700', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.', 'groupId': 'OG007'}, {'value': '69250', 'spread': '52222', 'groupId': 'OG008'}]}]}, {'title': 'Cycle 7 Day 1 (n=0, 0, 2, 1, 1, 3, 1, 0, 7)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.', 'groupId': 'OG001'}, {'value': '11920', 'spread': '7749.9', 'groupId': 'OG002'}, {'value': '34200', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG003'}, {'value': '45000', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG004'}, {'value': '73670', 'spread': '24393', 'groupId': 'OG005'}, {'value': '44700', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.', 'groupId': 'OG007'}, {'value': '68100', 'spread': '56580', 'groupId': 'OG008'}]}]}, {'title': 'Cycle 8 Day 1 (n=0, 0, 2, 1, 1, 2, 1, 0, 5)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.', 'groupId': 'OG001'}, {'value': '10850', 'spread': '353.55', 'groupId': 'OG002'}, {'value': '43400', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG003'}, {'value': '45100', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG004'}, {'value': '76950', 'spread': '42497', 'groupId': 'OG005'}, {'value': '217000', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.', 'groupId': 'OG007'}, {'value': '99740', 'spread': '66263', 'groupId': 'OG008'}]}]}, {'title': 'Cycle 9 Day 1 (n=0, 0, 2, 1, 1, 2, 1, 0, 4)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.', 'groupId': 'OG001'}, {'value': '14150', 'spread': '1626.3', 'groupId': 'OG002'}, {'value': '47500', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG003'}, {'value': '55200', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG004'}, {'value': '55150', 'spread': '11526', 'groupId': 'OG005'}, {'value': '294000', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.', 'groupId': 'OG007'}, {'value': '85750', 'spread': '57225', 'groupId': 'OG008'}]}]}, {'title': 'Cycle 10 Day 1 (n=0, 0, 1, 1, 1, 2, 1, 0, 3)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.', 'groupId': 'OG001'}, {'value': '20100', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG002'}, {'value': '43200', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG003'}, {'value': '39000', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG004'}, {'value': '59050', 'spread': '16334', 'groupId': 'OG005'}, {'value': '190000', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.', 'groupId': 'OG007'}, {'value': '66620', 'spread': '50809', 'groupId': 'OG008'}]}]}, {'title': 'Cycle 11 Day 1 (n=0, 0, 0, 1, 1, 2, 1, 0, 3)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.', 'groupId': 'OG002'}, {'value': '44200', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG003'}, {'value': '40500', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG004'}, {'value': '55050', 'spread': '10677', 'groupId': 'OG005'}, {'value': '186000', 'spread': 'NA', 'comment': 'Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.', 'groupId': 'OG007'}, {'value': '103600', 'spread': '78883', 'groupId': 'OG008'}]}]}, {'title': 'Cycle 12 Day 1 (n=0, 0, 0, 0, 1, 2, 1, 0, 2)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.', 'groupId': 'OG003'}, {'value': '64500', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG004'}, {'value': '52100', 'spread': '7636.8', 'groupId': 'OG005'}, {'value': '222000', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed since no participants were evaluable for at this time point for the specific arm group.', 'groupId': 'OG007'}, {'value': '69200', 'spread': '71842', 'groupId': 'OG008'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hr (pre dose), 1 hr post-dose C1D1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to C12', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here "N" (Number of participants analyzed) signifies those who were evaluable for the measure and "n" signifies those participants who were evaluable at specific time-point.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-03446962: Part 1 and Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 0.5 mg/kg: Part 1', 'description': 'PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'PF-03446962 1 mg/kg: Part 1', 'description': 'PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'PF-03446962 2 mg/kg : Part 1', 'description': 'PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'PF-03446962 3 mg/kg: Part 1', 'description': 'PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG004', 'title': 'PF-03446962 4.5 mg/kg: Part 1', 'description': 'PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'PF-03446962 6.75 mg/kg: Part 1', 'description': 'PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'PF-03446962 10 mg/kg: Part 1', 'description': 'PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG007', 'title': 'PF-03446962 15 mg/kg: Part 1', 'description': 'PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG008', 'title': 'PF-03446962 7 mg/kg: Part 2', 'description': 'PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.50', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '2.00'}, {'value': '1.58', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '2.00'}, {'value': '1.75', 'groupId': 'OG002', 'lowerLimit': '0.917', 'upperLimit': '2.50'}, {'value': '1.50', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '2.00'}, {'value': '1.99', 'groupId': 'OG004', 'lowerLimit': '1.00', 'upperLimit': '3.75'}, {'value': '1.75', 'groupId': 'OG005', 'lowerLimit': '1.17', 'upperLimit': '5.00'}, {'value': '1.50', 'groupId': 'OG006', 'lowerLimit': '0.517', 'upperLimit': '5.00'}, {'value': '3.34', 'groupId': 'OG007', 'lowerLimit': '1.00', 'upperLimit': '24.0'}, {'value': '1.77', 'groupId': 'OG008', 'lowerLimit': '0.900', 'upperLimit': '215'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here "N" (Number of participants analyzed) signifies those who were evaluable for the measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Area Under the Curve From Time Zero to Day 28 [AUC (0-28)]: Part 1 and Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 0.5 mg/kg: Part 1', 'description': 'PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'PF-03446962 1 mg/kg: Part 1', 'description': 'PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'PF-03446962 2 mg/kg : Part 1', 'description': 'PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'PF-03446962 3 mg/kg: Part 1', 'description': 'PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG004', 'title': 'PF-03446962 4.5 mg/kg: Part 1', 'description': 'PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'PF-03446962 6.75 mg/kg: Part 1', 'description': 'PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'PF-03446962 10 mg/kg: Part 1', 'description': 'PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG007', 'title': 'PF-03446962 15 mg/kg: Part 1', 'description': 'PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG008', 'title': 'PF-03446962 7 mg/kg: Part 2', 'description': 'PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '490000', 'spread': '132220', 'groupId': 'OG000'}, {'value': '1752000', 'spread': '436440', 'groupId': 'OG001'}, {'value': '3281000', 'spread': '1817700', 'groupId': 'OG002'}, {'value': '8247000', 'spread': '2657400', 'groupId': 'OG003'}, {'value': '15070000', 'spread': '1447700', 'groupId': 'OG004'}, {'value': '22890000', 'spread': '7372200', 'groupId': 'OG005'}, {'value': '45750000', 'spread': '15972000', 'groupId': 'OG006'}, {'value': '52660000', 'spread': '29315000', 'groupId': 'OG007'}, {'value': '22890000', 'spread': '10395000', 'groupId': 'OG008'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)', 'description': 'AUC (0-28) = Area under the plasma concentration versus time curve from time zero (pre-dose) to Day 28 (0-28).', 'unitOfMeasure': 'nanogram*hour/milliliter (ng*hr/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here "N" (Number of participants analyzed) signifies those who were evaluable for the measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast): Part 1 and Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 0.5 mg/kg: Part 1', 'description': 'PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'PF-03446962 1 mg/kg: Part 1', 'description': 'PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'PF-03446962 2 mg/kg : Part 1', 'description': 'PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'PF-03446962 3 mg/kg: Part 1', 'description': 'PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG004', 'title': 'PF-03446962 4.5 mg/kg: Part 1', 'description': 'PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'PF-03446962 6.75 mg/kg: Part 1', 'description': 'PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'PF-03446962 10 mg/kg: Part 1', 'description': 'PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG007', 'title': 'PF-03446962 15 mg/kg: Part 1', 'description': 'PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG008', 'title': 'PF-03446962 7 mg/kg: Part 2', 'description': 'PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '471400', 'spread': '124340', 'groupId': 'OG000'}, {'value': '1683000', 'spread': '435490', 'groupId': 'OG001'}, {'value': '3273000', 'spread': '1819200', 'groupId': 'OG002'}, {'value': '8247000', 'spread': '2657400', 'groupId': 'OG003'}, {'value': '15690000', 'spread': '2965800', 'groupId': 'OG004'}, {'value': '21380000', 'spread': '7823700', 'groupId': 'OG005'}, {'value': '44110000', 'spread': '15577000', 'groupId': 'OG006'}, {'value': '51160000', 'spread': '21718000', 'groupId': 'OG007'}, {'value': '22850000', 'spread': '10504000', 'groupId': 'OG008'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here "N" (Number of participants analyzed) signifies those who were evaluable for the measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Systemic Clearance(CL): Part 1 and Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 0.5 mg/kg: Part 1', 'description': 'PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'PF-03446962 1 mg/kg: Part 1', 'description': 'PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'PF-03446962 2 mg/kg : Part 1', 'description': 'PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'PF-03446962 3 mg/kg: Part 1', 'description': 'PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG004', 'title': 'PF-03446962 4.5 mg/kg: Part 1', 'description': 'PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'PF-03446962 6.75 mg/kg: Part 1', 'description': 'PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'PF-03446962 10 mg/kg: Part 1', 'description': 'PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG007', 'title': 'PF-03446962 15 mg/kg: Part 1', 'description': 'PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG008', 'title': 'PF-03446962 7 mg/kg: Part 2', 'description': 'PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.07675', 'spread': '0.02318', 'groupId': 'OG000'}, {'value': '0.03469', 'spread': '0.00866', 'groupId': 'OG001'}, {'value': '0.04198', 'spread': '0.03927', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not summarized since only 1 participant had reportable value, as per planned analysis.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not summarized since only 2 participants had reportable value, as per planned analysis.', 'groupId': 'OG004'}, {'value': '0.01861', 'spread': '0.00225', 'groupId': 'OG005'}, {'value': '0.01668', 'spread': '0.00482', 'groupId': 'OG006'}, {'value': '0.01169', 'spread': '0.01288', 'groupId': 'OG007'}, {'value': '0.01921', 'spread': '0.00507', 'groupId': 'OG008'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)', 'description': 'CL is a quantitative measure of the rate at which a drug substance is removed from the body. As per planned analysis, CL was summarized if at least 3 participants had reportable value.', 'unitOfMeasure': 'liter/hour (L/hr)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here "N" (Number of participants analyzed) signifies those who were evaluable for the measure.'}, {'type': 'SECONDARY', 'title': 'Volume of Distribution: Part 1 and Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 0.5 mg/kg: Part 1', 'description': 'PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'PF-03446962 1 mg/kg: Part 1', 'description': 'PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'PF-03446962 2 mg/kg : Part 1', 'description': 'PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'PF-03446962 3 mg/kg: Part 1', 'description': 'PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG004', 'title': 'PF-03446962 4.5 mg/kg: Part 1', 'description': 'PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'PF-03446962 6.75 mg/kg: Part 1', 'description': 'PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'PF-03446962 10 mg/kg: Part 1', 'description': 'PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG007', 'title': 'PF-03446962 15 mg/kg: Part 1', 'description': 'PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG008', 'title': 'PF-03446962 7 mg/kg: Part 2', 'description': 'PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.350', 'spread': '1.1399', 'groupId': 'OG000'}, {'value': '5.770', 'spread': '1.1850', 'groupId': 'OG001'}, {'value': '7.421', 'spread': '2.8525', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not summarized since only 1 participant had reportable value, as per planned analysis.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not summarized since only 2 participants had reportable value, as per planned analysis.', 'groupId': 'OG004'}, {'value': '6.718', 'spread': '1.2400', 'groupId': 'OG005'}, {'value': '5.373', 'spread': '0.85541', 'groupId': 'OG006'}, {'value': '6.675', 'spread': '2.4858', 'groupId': 'OG007'}, {'value': '6.110', 'spread': '1.6303', 'groupId': 'OG008'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. As per planned analysis, volume of distribution was summarized if at least 3 participants had reportable value.', 'unitOfMeasure': 'liter (L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here "N" (Number of participants analyzed) signifies those who were evaluable for the measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Plasma Decay Half-Life (t1/2): Part 1 and Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 0.5 mg/kg: Part 1', 'description': 'PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'PF-03446962 1 mg/kg: Part 1', 'description': 'PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'PF-03446962 2 mg/kg : Part 1', 'description': 'PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'PF-03446962 3 mg/kg: Part 1', 'description': 'PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG004', 'title': 'PF-03446962 4.5 mg/kg: Part 1', 'description': 'PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'PF-03446962 6.75 mg/kg: Part 1', 'description': 'PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'PF-03446962 10 mg/kg: Part 1', 'description': 'PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG007', 'title': 'PF-03446962 15 mg/kg: Part 1', 'description': 'PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG008', 'title': 'PF-03446962 7 mg/kg: Part 2', 'description': 'PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.678', 'spread': '1.0622', 'groupId': 'OG000'}, {'value': '5.588', 'spread': '2.3790', 'groupId': 'OG001'}, {'value': '7.360', 'spread': '4.5596', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not summarized since only 1 participant had reportable value, as per planned analysis.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not summarized since only 2 participants had reportable value, as per planned analysis.', 'groupId': 'OG004'}, {'value': '11.90', 'spread': '0.88882', 'groupId': 'OG005'}, {'value': '10.22', 'spread': '2.3394', 'groupId': 'OG006'}, {'value': '17.77', 'spread': '5.6589', 'groupId': 'OG007'}, {'value': '9.616', 'spread': '2.3870', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. As per planned analysis, t1/2 was summarized if at least 3 participants had reportable value.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here "N" (Number of participants analyzed) signifies those who were evaluable for the measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Human Anti - Human Antibody (HAHA) Concentration: Part 1 and Part 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'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 0.5 mg/kg: Part 1', 'description': 'PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'PF-03446962 1 mg/kg: Part 1', 'description': 'PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'PF-03446962 2 mg/kg : Part 1', 'description': 'PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'PF-03446962 3 mg/kg: Part 1', 'description': 'PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG004', 'title': 'PF-03446962 4.5 mg/kg: Part 1', 'description': 'PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'PF-03446962 6.75 mg/kg: Part 1', 'description': 'PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'PF-03446962 10 mg/kg: Part 1', 'description': 'PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG007', 'title': 'PF-03446962 15 mg/kg: Part 1', 'description': 'PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG008', 'title': 'PF-03446962 7 mg/kg: Part 2', 'description': 'PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}], 'timeFrame': 'Baseline up to 3 months after last dose', 'description': 'HAHA concentration was analyzed in blood samples for the evaluation of immunogenicity of PF-03446962. HAHA concentration was reported for samples above lower limit of quantification (\\>=4.32).', 'reportingStatus': 'POSTED', 'populationDescription': 'Statistical Data was not statistically summarized as majority of participants had concentration below the limit of quantification.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Soluble Protein Biomarker [Angiopoietin-2 (Ang-2), Bone Morphogenetic Protein-9 (BMP-9), Chemokine (C-C Motif) Ligand 2 (CCL2)]: Part 1 and Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 0.5 mg/kg: Part 1', 'description': 'PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'PF-03446962 1 mg/kg: Part 1', 'description': 'PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'PF-03446962 2 mg/kg : Part 1', 'description': 'PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'PF-03446962 3 mg/kg: Part 1', 'description': 'PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG004', 'title': 'PF-03446962 4.5 mg/kg: Part 1', 'description': 'PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'PF-03446962 6.75 mg/kg: Part 1', 'description': 'PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'PF-03446962 10 mg/kg: Part 1', 'description': 'PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG007', 'title': 'PF-03446962 15 mg/kg: Part 1', 'description': 'PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG008', 'title': 'PF-03446962 7 mg/kg: Part 2', 'description': 'PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}], 'classes': [{'title': 'Baseline: Ang-2 (n=5, 5, 6, 3, 4, 8, 7, 6, 24)', 'categories': [{'measurements': [{'value': '280.9', 'spread': '107.01', 'groupId': 'OG000'}, {'value': '245.2', 'spread': '85.36', 'groupId': 'OG001'}, {'value': '405.3', 'spread': '171.82', 'groupId': 'OG002'}, {'value': '233.8', 'spread': '47.89', 'groupId': 'OG003'}, {'value': '554.3', 'spread': '404.80', 'groupId': 'OG004'}, {'value': '629.7', 'spread': '265.33', 'groupId': 'OG005'}, {'value': '566.3', 'spread': '617.76', 'groupId': 'OG006'}, {'value': '600.5', 'spread': '469.09', 'groupId': 'OG007'}, {'value': '1497.4', 'spread': '881.71', 'groupId': 'OG008'}]}]}, {'title': 'C1D16H: Ang-2 (n=4, 3, 6, 3, 4, 8, 7, 6, 24)', 'categories': [{'measurements': [{'value': '357.7', 'spread': '87.87', 'groupId': 'OG000'}, {'value': '326.0', 'spread': '122.58', 'groupId': 'OG001'}, {'value': '410.2', 'spread': '170.55', 'groupId': 'OG002'}, {'value': '266.3', 'spread': '28.31', 'groupId': 'OG003'}, {'value': '580.3', 'spread': '485.49', 'groupId': 'OG004'}, {'value': '558.0', 'spread': '249.90', 'groupId': 'OG005'}, {'value': '498.4', 'spread': '508.76', 'groupId': 'OG006'}, {'value': '548.1', 'spread': '324.70', 'groupId': 'OG007'}, {'value': '1509.6', 'spread': '813.06', 'groupId': 'OG008'}]}]}, {'title': 'C1D22: Ang-2 (n=4, 5, 6, 3, 4, 6, 7, 5, 20)', 'categories': [{'measurements': [{'value': '297.0', 'spread': '146.98', 'groupId': 'OG000'}, {'value': '429.8', 'spread': '202.03', 'groupId': 'OG001'}, {'value': '489.7', 'spread': '235.28', 'groupId': 'OG002'}, {'value': '248.0', 'spread': '84.73', 'groupId': 'OG003'}, {'value': '725.2', 'spread': '654.99', 'groupId': 'OG004'}, {'value': '491.8', 'spread': '236.61', 'groupId': 'OG005'}, {'value': '613.0', 'spread': '627.25', 'groupId': 'OG006'}, {'value': '400.0', 'spread': '198.85', 'groupId': 'OG007'}, {'value': '1651.4', 'spread': '894.33', 'groupId': 'OG008'}]}]}, {'title': 'C2D1: Ang-2 (n=3, 2, 6, 3, 4, 5, 5, 2, 20)', 'categories': [{'measurements': [{'value': '304.4', 'spread': '126.39', 'groupId': 'OG000'}, {'value': '312.4', 'spread': '195.37', 'groupId': 'OG001'}, {'value': '501.2', 'spread': '194.40', 'groupId': 'OG002'}, {'value': '205.7', 'spread': '48.10', 'groupId': 'OG003'}, {'value': '637.5', 'spread': '535.52', 'groupId': 'OG004'}, {'value': '445.3', 'spread': '231.91', 'groupId': 'OG005'}, {'value': '557.9', 'spread': '575.66', 'groupId': 'OG006'}, {'value': '338.1', 'spread': '84.57', 'groupId': 'OG007'}, {'value': '1473.5', 'spread': '690.55', 'groupId': 'OG008'}]}]}, {'title': 'C3D1: Ang-2 (n=3, 2, 4, 3, 1, 4, 3, 1, 12)', 'categories': [{'measurements': [{'value': '309.1', 'spread': '133.43', 'groupId': 'OG000'}, {'value': '338.1', 'spread': '235.11', 'groupId': 'OG001'}, {'value': '417.6', 'spread': '192.35', 'groupId': 'OG002'}, {'value': '258.3', 'spread': '57.44', 'groupId': 'OG003'}, {'value': '501.3', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG004'}, {'value': '510.0', 'spread': '305.51', 'groupId': 'OG005'}, {'value': '254.5', 'spread': '44.89', 'groupId': 'OG006'}, {'value': '586.8', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG007'}, {'value': '1539.3', 'spread': '1036.24', 'groupId': 'OG008'}]}]}, {'title': 'EOT: Ang-2 (n=5, 5, 2, 3, 4, 4, 5, 5, 17)', 'categories': [{'measurements': [{'value': '507.2', 'spread': '375.16', 'groupId': 'OG000'}, {'value': '355.6', 'spread': '166.32', 'groupId': 'OG001'}, {'value': '439.5', 'spread': '292.25', 'groupId': 'OG002'}, {'value': '346.7', 'spread': '57.94', 'groupId': 'OG003'}, {'value': '775.6', 'spread': '618.41', 'groupId': 'OG004'}, {'value': '499.8', 'spread': '368.96', 'groupId': 'OG005'}, {'value': '974.9', 'spread': '1014.67', 'groupId': 'OG006'}, {'value': '737.9', 'spread': '572.30', 'groupId': 'OG007'}, {'value': '2791.2', 'spread': '3637.55', 'groupId': 'OG008'}]}]}, {'title': 'Baseline: BMP-9 (n=5, 5, 6, 3, 4, 8, 7, 6, 24)', 'categories': [{'measurements': [{'value': '41.7', 'spread': '44.60', 'groupId': 'OG000'}, {'value': '18.3', 'spread': '6.92', 'groupId': 'OG001'}, {'value': '67.2', 'spread': '114.87', 'groupId': 'OG002'}, {'value': '18.4', 'spread': '11.54', 'groupId': 'OG003'}, {'value': '68.2', 'spread': '79.58', 'groupId': 'OG004'}, {'value': '262.0', 'spread': '669.08', 'groupId': 'OG005'}, {'value': '48.9', 'spread': '23.13', 'groupId': 'OG006'}, {'value': '29.0', 'spread': '11.38', 'groupId': 'OG007'}, {'value': '47.6', 'spread': '50.88', 'groupId': 'OG008'}]}]}, {'title': 'C1D16H: BMP-9 (n=4, 3, 6, 2, 4, 7, 7, 6, 23)', 'categories': [{'measurements': [{'value': '55.3', 'spread': '66.60', 'groupId': 'OG000'}, {'value': '19.5', 'spread': '10.38', 'groupId': 'OG001'}, {'value': '56.4', 'spread': '104.06', 'groupId': 'OG002'}, {'value': '20.9', 'spread': '10.39', 'groupId': 'OG003'}, {'value': '54.1', 'spread': '58.18', 'groupId': 'OG004'}, {'value': '273.3', 'spread': '658.58', 'groupId': 'OG005'}, {'value': '35.6', 'spread': '25.63', 'groupId': 'OG006'}, {'value': '14.0', 'spread': '5.99', 'groupId': 'OG007'}, {'value': '45.0', 'spread': '48.97', 'groupId': 'OG008'}]}]}, {'title': 'C1D22: BMP-9 (n=4, 5, 6, 2, 4, 5, 7, 5, 19)', 'categories': [{'measurements': [{'value': '45.7', 'spread': '51.45', 'groupId': 'OG000'}, {'value': '16.7', 'spread': '7.57', 'groupId': 'OG001'}, {'value': '60.5', 'spread': '121.98', 'groupId': 'OG002'}, {'value': '17.1', 'spread': '9.90', 'groupId': 'OG003'}, {'value': '35.7', 'spread': '36.66', 'groupId': 'OG004'}, {'value': '394.0', 'spread': '852.68', 'groupId': 'OG005'}, {'value': '33.0', 'spread': '20.44', 'groupId': 'OG006'}, {'value': '22.0', 'spread': '12.27', 'groupId': 'OG007'}, {'value': '39.2', 'spread': '40.88', 'groupId': 'OG008'}]}]}, {'title': 'C2D1: BMP-9 (n=3, 2, 6, 2, 4, 4, 5, 2, 20)', 'categories': [{'measurements': [{'value': '47.5', 'spread': '52.77', 'groupId': 'OG000'}, {'value': '23.9', 'spread': '0.49', 'groupId': 'OG001'}, {'value': '54.7', 'spread': '112.92', 'groupId': 'OG002'}, {'value': '18.2', 'spread': '0.28', 'groupId': 'OG003'}, {'value': '58.9', 'spread': '85.35', 'groupId': 'OG004'}, {'value': '391.7', 'spread': '755.57', 'groupId': 'OG005'}, {'value': '26.5', 'spread': '16.89', 'groupId': 'OG006'}, {'value': '12.2', 'spread': '4.88', 'groupId': 'OG007'}, {'value': '40.0', 'spread': '51.36', 'groupId': 'OG008'}]}]}, {'title': 'C3D1: BMP-9 (n=2, 2, 4, 2, 1, 3, 3, 1, 12)', 'categories': [{'measurements': [{'value': '80.4', 'spread': '86.41', 'groupId': 'OG000'}, {'value': '21.3', 'spread': '2.76', 'groupId': 'OG001'}, {'value': '99.4', 'spread': '176.84', 'groupId': 'OG002'}, {'value': '18.8', 'spread': '0.00', 'groupId': 'OG003'}, {'value': '10.8', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG004'}, {'value': '933.3', 'spread': '1593.69', 'groupId': 'OG005'}, {'value': '32.2', 'spread': '13.14', 'groupId': 'OG006'}, {'value': '16.6', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG007'}, {'value': '40.8', 'spread': '36.65', 'groupId': 'OG008'}]}]}, {'title': 'EOT: BMP-9 (n=5, 5, 2, 2, 4, 4, 5, 5, 17)', 'categories': [{'measurements': [{'value': '53.2', 'spread': '70.27', 'groupId': 'OG000'}, {'value': '15.5', 'spread': '5.86', 'groupId': 'OG001'}, {'value': '156.4', 'spread': '179.39', 'groupId': 'OG002'}, {'value': '16.5', 'spread': '2.33', 'groupId': 'OG003'}, {'value': '75.5', 'spread': '94.07', 'groupId': 'OG004'}, {'value': '246.1', 'spread': '460.69', 'groupId': 'OG005'}, {'value': '44.0', 'spread': '35.00', 'groupId': 'OG006'}, {'value': '17.1', 'spread': '7.69', 'groupId': 'OG007'}, {'value': '33.8', 'spread': '27.55', 'groupId': 'OG008'}]}]}, {'title': 'Baseline: CCL2 (n=5, 5, 6, 3, 4, 8, 7, 6, 24)', 'categories': [{'measurements': [{'value': '1048.4', 'spread': '259.96', 'groupId': 'OG000'}, {'value': '897.1', 'spread': '414.25', 'groupId': 'OG001'}, {'value': '1296.3', 'spread': '629.37', 'groupId': 'OG002'}, {'value': '1179.8', 'spread': '597.43', 'groupId': 'OG003'}, {'value': '858.5', 'spread': '697.41', 'groupId': 'OG004'}, {'value': '1648.5', 'spread': '744.80', 'groupId': 'OG005'}, {'value': '1798.7', 'spread': '1374.40', 'groupId': 'OG006'}, {'value': '2659.5', 'spread': '1356.79', 'groupId': 'OG007'}, {'value': '1743.1', 'spread': '1267.52', 'groupId': 'OG008'}]}]}, {'title': 'C1D16H: CCL2 (n=4, 3, 6, 3, 4, 8, 7, 6, 24)', 'categories': [{'measurements': [{'value': '1413.1', 'spread': '451.52', 'groupId': 'OG000'}, {'value': '868.2', 'spread': '348.23', 'groupId': 'OG001'}, {'value': '1019.8', 'spread': '222.52', 'groupId': 'OG002'}, {'value': '845.5', 'spread': '309.44', 'groupId': 'OG003'}, {'value': '746.4', 'spread': '330.31', 'groupId': 'OG004'}, {'value': '910.1', 'spread': '297.10', 'groupId': 'OG005'}, {'value': '1176.7', 'spread': '198.86', 'groupId': 'OG006'}, {'value': '1253.9', 'spread': '353.28', 'groupId': 'OG007'}, {'value': '887.7', 'spread': '411.38', 'groupId': 'OG008'}]}]}, {'title': 'C1D22: CCL2 (n=4, 5, 6, 3, 4, 6, 7, 5, 20)', 'categories': [{'measurements': [{'value': '1300.7', 'spread': '519.44', 'groupId': 'OG000'}, {'value': '882.1', 'spread': '300.21', 'groupId': 'OG001'}, {'value': '1065.6', 'spread': '491.41', 'groupId': 'OG002'}, {'value': '898.4', 'spread': '144.11', 'groupId': 'OG003'}, {'value': '801.0', 'spread': '432.10', 'groupId': 'OG004'}, {'value': '896.0', 'spread': '365.37', 'groupId': 'OG005'}, {'value': '1146.9', 'spread': '400.30', 'groupId': 'OG006'}, {'value': '1061.8', 'spread': '469.42', 'groupId': 'OG007'}, {'value': '846.5', 'spread': '524.84', 'groupId': 'OG008'}]}]}, {'title': 'C2D1: CCL2 (n=3, 2, 6, 3, 4, 5, 5, 2, 20)', 'categories': [{'measurements': [{'value': '1466.4', 'spread': '510.75', 'groupId': 'OG000'}, {'value': '1156.6', 'spread': '493.42', 'groupId': 'OG001'}, {'value': '1091.0', 'spread': '317.65', 'groupId': 'OG002'}, {'value': '777.6', 'spread': '220.42', 'groupId': 'OG003'}, {'value': '692.5', 'spread': '216.16', 'groupId': 'OG004'}, {'value': '1206.5', 'spread': '443.00', 'groupId': 'OG005'}, {'value': '858.6', 'spread': '165.26', 'groupId': 'OG006'}, {'value': '1060.8', 'spread': '577.85', 'groupId': 'OG007'}, {'value': '801.9', 'spread': '338.56', 'groupId': 'OG008'}]}]}, {'title': 'C3D1: CCL2 (n=3, 2, 4, 3, 1, 4, 3, 1, 12)', 'categories': [{'measurements': [{'value': '1413.8', 'spread': '651.34', 'groupId': 'OG000'}, {'value': '933.3', 'spread': '259.79', 'groupId': 'OG001'}, {'value': '951.0', 'spread': '418.52', 'groupId': 'OG002'}, {'value': '793.2', 'spread': '180.32', 'groupId': 'OG003'}, {'value': '735.7', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG004'}, {'value': '818.3', 'spread': '422.89', 'groupId': 'OG005'}, {'value': '909.9', 'spread': '278.50', 'groupId': 'OG006'}, {'value': '617.1', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG007'}, {'value': '791.3', 'spread': '364.58', 'groupId': 'OG008'}]}]}, {'title': 'EOT: CCL2 (n=5, 5, 2, 3, 4, 4, 5, 5, 17)', 'categories': [{'measurements': [{'value': '1132.1', 'spread': '202.68', 'groupId': 'OG000'}, {'value': '898.5', 'spread': '270.19', 'groupId': 'OG001'}, {'value': '729.7', 'spread': '242.18', 'groupId': 'OG002'}, {'value': '645.4', 'spread': '94.59', 'groupId': 'OG003'}, {'value': '699.6', 'spread': '372.50', 'groupId': 'OG004'}, {'value': '1190.4', 'spread': '675.67', 'groupId': 'OG005'}, {'value': '1176.2', 'spread': '699.03', 'groupId': 'OG006'}, {'value': '1179.9', 'spread': '370.44', 'groupId': 'OG007'}, {'value': '743.7', 'spread': '314.64', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)', 'description': 'Plasma concentrations of soluble proteins (Ang-2, BMP-9, C-C motif) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity.', 'unitOfMeasure': 'picogram/milliliter (pg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Soluble protein biomarker analysis set included all participants who received at least one dose of study drug with a baseline (pre-dose C1D1) or screening biomarker result, and at least one on-treatment biomarker result for at least one biomarker. "n" signifies those participants who were evaluable at specific time-point.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Soluble Protein Biomarker [Cluster of Differentiation 106 (CD106), Cluster of Differentiation 54 (CD54), Endoglin]: Part 1 and Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 0.5 mg/kg: Part 1', 'description': 'PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'PF-03446962 1 mg/kg: Part 1', 'description': 'PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'PF-03446962 2 mg/kg : Part 1', 'description': 'PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'PF-03446962 3 mg/kg: Part 1', 'description': 'PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG004', 'title': 'PF-03446962 4.5 mg/kg: Part 1', 'description': 'PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'PF-03446962 6.75 mg/kg: Part 1', 'description': 'PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'PF-03446962 10 mg/kg: Part 1', 'description': 'PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG007', 'title': 'PF-03446962 15 mg/kg: Part 1', 'description': 'PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG008', 'title': 'PF-03446962 7 mg/kg: Part 2', 'description': 'PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}], 'classes': [{'title': 'Baseline: CD106 (n= 5, 5, 6, 3, 4, 8, 7, 6, 24)', 'categories': [{'measurements': [{'value': '1426995', 'spread': '59227.1', 'groupId': 'OG000'}, {'value': '1977059', 'spread': '278968', 'groupId': 'OG001'}, {'value': '2103430', 'spread': '918193', 'groupId': 'OG002'}, {'value': '1550000', 'spread': '637320', 'groupId': 'OG003'}, {'value': '2317802', 'spread': '1217870', 'groupId': 'OG004'}, {'value': '2537306', 'spread': '1097384', 'groupId': 'OG005'}, {'value': '1994549', 'spread': '1151754', 'groupId': 'OG006'}, {'value': '2380621', 'spread': '1221978', 'groupId': 'OG007'}, {'value': '4618397', 'spread': '2077485', 'groupId': 'OG008'}]}]}, {'title': 'C1D16H: CD106 (n= 4, 3, 6, 3, 4, 8, 7, 6, 24)', 'categories': [{'measurements': [{'value': '1553640', 'spread': '248023', 'groupId': 'OG000'}, {'value': '1751998', 'spread': '131286', 'groupId': 'OG001'}, {'value': '1997949', 'spread': '699820', 'groupId': 'OG002'}, {'value': '1409035', 'spread': '308143', 'groupId': 'OG003'}, {'value': '2058998', 'spread': '1253058', 'groupId': 'OG004'}, {'value': '2121253', 'spread': '675955', 'groupId': 'OG005'}, {'value': '1825721', 'spread': '1290987', 'groupId': 'OG006'}, {'value': '2105192', 'spread': '1365510', 'groupId': 'OG007'}, {'value': '4441245', 'spread': '2178832', 'groupId': 'OG008'}]}]}, {'title': 'C1D22: CD106 (n= 4, 5, 6, 3, 4, 6, 7, 5, 20)', 'categories': [{'measurements': [{'value': '1531678', 'spread': '249394', 'groupId': 'OG000'}, {'value': '2134392', 'spread': '357871', 'groupId': 'OG001'}, {'value': '2251447', 'spread': '517132', 'groupId': 'OG002'}, {'value': '1370676', 'spread': '329573', 'groupId': 'OG003'}, {'value': '2817598', 'spread': '2026342', 'groupId': 'OG004'}, {'value': '2762433', 'spread': '1722911', 'groupId': 'OG005'}, {'value': '2701837', 'spread': '1710834', 'groupId': 'OG006'}, {'value': '2456276', 'spread': '1404983', 'groupId': 'OG007'}, {'value': '5453614', 'spread': '2116043', 'groupId': 'OG008'}]}]}, {'title': 'C2D1: CD106 (n= 3, 2, 6, 3, 4, 5, 5, 2, 20)', 'categories': [{'measurements': [{'value': '1577290', 'spread': '378509', 'groupId': 'OG000'}, {'value': '1799035', 'spread': '695018', 'groupId': 'OG001'}, {'value': '2229424', 'spread': '469152', 'groupId': 'OG002'}, {'value': '1269574', 'spread': '366430', 'groupId': 'OG003'}, {'value': '2370883', 'spread': '1278663', 'groupId': 'OG004'}, {'value': '2542120', 'spread': '2147151', 'groupId': 'OG005'}, {'value': '1676349', 'spread': '691658', 'groupId': 'OG006'}, {'value': '3247890', 'spread': '1683551', 'groupId': 'OG007'}, {'value': '5217619', 'spread': '2747474', 'groupId': 'OG008'}]}]}, {'title': 'C3D1: CD106 (n= 3, 2, 4, 3, 1, 4, 3, 1, 12)', 'categories': [{'measurements': [{'value': '1508775', 'spread': '201658', 'groupId': 'OG000'}, {'value': '1994588', 'spread': '266837', 'groupId': 'OG001'}, {'value': '2465890', 'spread': '1070226', 'groupId': 'OG002'}, {'value': '1892928', 'spread': '571192', 'groupId': 'OG003'}, {'value': '2162501', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG004'}, {'value': '3009982', 'spread': '2128505', 'groupId': 'OG005'}, {'value': '1380137', 'spread': '234263', 'groupId': 'OG006'}, {'value': '4814239', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG007'}, {'value': '4482748', 'spread': '2376204', 'groupId': 'OG008'}]}]}, {'title': 'EOT: CD106 (n= 5, 5, 2, 3, 4, 4, 5, 5, 17)', 'categories': [{'measurements': [{'value': '2097201', 'spread': '582243', 'groupId': 'OG000'}, {'value': '1782709', 'spread': '473363', 'groupId': 'OG001'}, {'value': '3480129', 'spread': '1753142', 'groupId': 'OG002'}, {'value': '1600889', 'spread': '484412', 'groupId': 'OG003'}, {'value': '3004218', 'spread': '2225879', 'groupId': 'OG004'}, {'value': '2169361', 'spread': '755936', 'groupId': 'OG005'}, {'value': '3869570', 'spread': '2242247', 'groupId': 'OG006'}, {'value': '2600730', 'spread': '1098325', 'groupId': 'OG007'}, {'value': '6321592', 'spread': '2385497', 'groupId': 'OG008'}]}]}, {'title': 'Baseline: CD54 (n= 5, 5, 6, 3, 4, 8, 7, 6, 24)', 'categories': [{'measurements': [{'value': '456653', 'spread': '100191', 'groupId': 'OG000'}, {'value': '592276', 'spread': '164098', 'groupId': 'OG001'}, {'value': '598761', 'spread': '333166', 'groupId': 'OG002'}, {'value': '703255', 'spread': '486462', 'groupId': 'OG003'}, {'value': '590523', 'spread': '144561', 'groupId': 'OG004'}, {'value': '567736', 'spread': '306989', 'groupId': 'OG005'}, {'value': '627494', 'spread': '279501', 'groupId': 'OG006'}, {'value': '554785', 'spread': '201270', 'groupId': 'OG007'}, {'value': '925590', 'spread': '408338', 'groupId': 'OG008'}]}]}, {'title': 'C1D16H: CD54 (n= 4, 3, 6, 3, 4, 8, 7, 6, 24)', 'categories': [{'measurements': [{'value': '458194', 'spread': '64789.1', 'groupId': 'OG000'}, {'value': '512402', 'spread': '81155.7', 'groupId': 'OG001'}, {'value': '624061', 'spread': '233499', 'groupId': 'OG002'}, {'value': '450887', 'spread': '168300', 'groupId': 'OG003'}, {'value': '538807', 'spread': '172168', 'groupId': 'OG004'}, {'value': '548456', 'spread': '201218', 'groupId': 'OG005'}, {'value': '603467', 'spread': '311056', 'groupId': 'OG006'}, {'value': '517460', 'spread': '251249', 'groupId': 'OG007'}, {'value': '1053926', 'spread': '491420', 'groupId': 'OG008'}]}]}, {'title': 'C1D22: CD54 (n= 4, 5, 6, 3, 4, 6, 7, 5, 20)', 'categories': [{'measurements': [{'value': '428766', 'spread': '80302.4', 'groupId': 'OG000'}, {'value': '585405', 'spread': '46397.3', 'groupId': 'OG001'}, {'value': '578775', 'spread': '246897', 'groupId': 'OG002'}, {'value': '356495', 'spread': '54530.0', 'groupId': 'OG003'}, {'value': '565451', 'spread': '196841', 'groupId': 'OG004'}, {'value': '612504', 'spread': '370207', 'groupId': 'OG005'}, {'value': '939357', 'spread': '706017', 'groupId': 'OG006'}, {'value': '604023', 'spread': '291355', 'groupId': 'OG007'}, {'value': '1173444', 'spread': '546999', 'groupId': 'OG008'}]}]}, {'title': 'C2D1: CD54 (n= 3, 2, 6, 3, 4, 5, 5, 2, 20)', 'categories': [{'measurements': [{'value': '433203', 'spread': '90282.8', 'groupId': 'OG000'}, {'value': '841543', 'spread': '568591', 'groupId': 'OG001'}, {'value': '585420', 'spread': '308551', 'groupId': 'OG002'}, {'value': '375141', 'spread': '32483.6', 'groupId': 'OG003'}, {'value': '628011', 'spread': '242437', 'groupId': 'OG004'}, {'value': '575469', 'spread': '392901', 'groupId': 'OG005'}, {'value': '641992', 'spread': '351793', 'groupId': 'OG006'}, {'value': '727099', 'spread': '302728', 'groupId': 'OG007'}, {'value': '980791', 'spread': '354159', 'groupId': 'OG008'}]}]}, {'title': 'C3D1: CD54 (n= 3, 2, 4, 3, 1, 4, 3, 1, 12)', 'categories': [{'measurements': [{'value': '495252', 'spread': '112929', 'groupId': 'OG000'}, {'value': '566407', 'spread': '160088', 'groupId': 'OG001'}, {'value': '646360', 'spread': '390594', 'groupId': 'OG002'}, {'value': '474589', 'spread': '70371.2', 'groupId': 'OG003'}, {'value': '605375', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG004'}, {'value': '664537', 'spread': '533228', 'groupId': 'OG005'}, {'value': '414291', 'spread': '147170', 'groupId': 'OG006'}, {'value': '890980', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG007'}, {'value': '969068', 'spread': '433245', 'groupId': 'OG008'}]}]}, {'title': 'EOT: CD54 (n= 5, 5, 2, 3, 4, 4, 5, 5, 17)', 'categories': [{'measurements': [{'value': '535193', 'spread': '116435', 'groupId': 'OG000'}, {'value': '504828', 'spread': '53486.9', 'groupId': 'OG001'}, {'value': '1022507', 'spread': '841417', 'groupId': 'OG002'}, {'value': '483216', 'spread': '158483', 'groupId': 'OG003'}, {'value': '600281', 'spread': '94835.6', 'groupId': 'OG004'}, {'value': '537001', 'spread': '171132', 'groupId': 'OG005'}, {'value': '1096693', 'spread': '941040', 'groupId': 'OG006'}, {'value': '569412', 'spread': '121592', 'groupId': 'OG007'}, {'value': '1108796', 'spread': '416355', 'groupId': 'OG008'}]}]}, {'title': 'Baseline: Endoglin (n= 5, 5, 6, 3, 4, 8, 7, 6, 24)', 'categories': [{'measurements': [{'value': '24345.9', 'spread': '1067.46', 'groupId': 'OG000'}, {'value': '28133.0', 'spread': '5202.28', 'groupId': 'OG001'}, {'value': '22355.2', 'spread': '5984.52', 'groupId': 'OG002'}, {'value': '30265.3', 'spread': '2727.69', 'groupId': 'OG003'}, {'value': '26342.4', 'spread': '2922.41', 'groupId': 'OG004'}, {'value': '24864.6', 'spread': '3830.51', 'groupId': 'OG005'}, {'value': '26313.7', 'spread': '6449.03', 'groupId': 'OG006'}, {'value': '25599.5', 'spread': '7530.00', 'groupId': 'OG007'}, {'value': '32680.3', 'spread': '6820.09', 'groupId': 'OG008'}]}]}, {'title': 'C1D16H: Endoglin (n= 4, 3, 6, 3, 4, 8, 7, 6, 24)', 'categories': [{'measurements': [{'value': '24961.0', 'spread': '2310.44', 'groupId': 'OG000'}, {'value': '24983.9', 'spread': '5489.16', 'groupId': 'OG001'}, {'value': '21789.5', 'spread': '3978.18', 'groupId': 'OG002'}, {'value': '31365.1', 'spread': '3547.94', 'groupId': 'OG003'}, {'value': '25209.2', 'spread': '3357.89', 'groupId': 'OG004'}, {'value': '24336.6', 'spread': '3196.96', 'groupId': 'OG005'}, {'value': '25110.6', 'spread': '8066.23', 'groupId': 'OG006'}, {'value': '26774.1', 'spread': '11443.0', 'groupId': 'OG007'}, {'value': '33976.7', 'spread': '9156.44', 'groupId': 'OG008'}]}]}, {'title': 'C1D22: Endoglin (n= 4, 5, 6, 3, 4, 6, 7, 5, 20)', 'categories': [{'measurements': [{'value': '25412.5', 'spread': '2910.37', 'groupId': 'OG000'}, {'value': '30123.0', 'spread': '2225.81', 'groupId': 'OG001'}, {'value': '27615.3', 'spread': '9426.55', 'groupId': 'OG002'}, {'value': '32203.6', 'spread': '5574.70', 'groupId': 'OG003'}, {'value': '26231.6', 'spread': '3899.05', 'groupId': 'OG004'}, {'value': '29895.0', 'spread': '2248.59', 'groupId': 'OG005'}, {'value': '33397.7', 'spread': '13366.3', 'groupId': 'OG006'}, {'value': '24970.6', 'spread': '7020.96', 'groupId': 'OG007'}, {'value': '36010.7', 'spread': '7362.59', 'groupId': 'OG008'}]}]}, {'title': 'C2D1: Endoglin (n= 3, 2, 6, 3, 4, 5, 5, 2, 20)', 'categories': [{'measurements': [{'value': '22204.3', 'spread': '1736.96', 'groupId': 'OG000'}, {'value': '32984.2', 'spread': '691.27', 'groupId': 'OG001'}, {'value': '23247.5', 'spread': '5843.99', 'groupId': 'OG002'}, {'value': '27246.9', 'spread': '4925.02', 'groupId': 'OG003'}, {'value': '28478.7', 'spread': '5527.04', 'groupId': 'OG004'}, {'value': '24736.3', 'spread': '5716.80', 'groupId': 'OG005'}, {'value': '27295.5', 'spread': '8538.87', 'groupId': 'OG006'}, {'value': '27813.5', 'spread': '15243.7', 'groupId': 'OG007'}, {'value': '37263.6', 'spread': '9744.94', 'groupId': 'OG008'}]}]}, {'title': 'C3D1: Endoglin (n= 3, 2, 4, 3, 1, 4, 3, 1, 12)', 'categories': [{'measurements': [{'value': '24503.9', 'spread': '3500.18', 'groupId': 'OG000'}, {'value': '29688.2', 'spread': '2138.72', 'groupId': 'OG001'}, {'value': '24944.4', 'spread': '2436.94', 'groupId': 'OG002'}, {'value': '31266.8', 'spread': '3466.76', 'groupId': 'OG003'}, {'value': '22233.2', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG004'}, {'value': '24395.8', 'spread': '2414.67', 'groupId': 'OG005'}, {'value': '24540.0', 'spread': '4547.98', 'groupId': 'OG006'}, {'value': '33259.2', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG007'}, {'value': '35347.9', 'spread': '6702.15', 'groupId': 'OG008'}]}]}, {'title': 'EOT: Endoglin (n= 5, 5, 2, 3, 4, 4, 5, 5, 17)', 'categories': [{'measurements': [{'value': '28268.0', 'spread': '7727.06', 'groupId': 'OG000'}, {'value': '26852.1', 'spread': '6037.41', 'groupId': 'OG001'}, {'value': '23453.9', 'spread': '3631.56', 'groupId': 'OG002'}, {'value': '28064.5', 'spread': '4097.50', 'groupId': 'OG003'}, {'value': '28094.3', 'spread': '1554.41', 'groupId': 'OG004'}, {'value': '29350.8', 'spread': '2213.84', 'groupId': 'OG005'}, {'value': '38234.3', 'spread': '16532.0', 'groupId': 'OG006'}, {'value': '26855.9', 'spread': '4711.30', 'groupId': 'OG007'}, {'value': '35726.0', 'spread': '8159.01', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)', 'description': 'Plasma concentrations of soluble proteins (CD106, CD54 and Endoglin) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity.', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Soluble protein biomarker analysis set included all participants who received at least one dose of study drug with a baseline (pre-dose C1D1) or screening biomarker result, and at least one on-treatment biomarker result for at least one biomarker. "n" signifies those participants who were evaluable at specific time-point.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Soluble Protein Biomarker [Placental Growth Factor (PLGF), Transforming Growth Beta 1 (TGFB1), Vascular Endothelial Growth Factor A (VEGF-A)]: Part 1 and Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 0.5 mg/kg: Part 1', 'description': 'PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'PF-03446962 1 mg/kg: Part 1', 'description': 'PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'PF-03446962 2 mg/kg : Part 1', 'description': 'PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'PF-03446962 3 mg/kg: Part 1', 'description': 'PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG004', 'title': 'PF-03446962 4.5 mg/kg: Part 1', 'description': 'PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'PF-03446962 6.75 mg/kg: Part 1', 'description': 'PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'PF-03446962 10 mg/kg: Part 1', 'description': 'PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG007', 'title': 'PF-03446962 15 mg/kg: Part 1', 'description': 'PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG008', 'title': 'PF-03446962 7 mg/kg: Part 2', 'description': 'PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}], 'classes': [{'title': 'Baseline: PLGF (n=4, 3, 5, 3, 2, 7, 6, 5, 21)', 'categories': [{'measurements': [{'value': '9.1', 'spread': '5.69', 'groupId': 'OG000'}, {'value': '9.3', 'spread': '2.06', 'groupId': 'OG001'}, {'value': '14.7', 'spread': '4.30', 'groupId': 'OG002'}, {'value': '6.4', 'spread': '2.50', 'groupId': 'OG003'}, {'value': '10.6', 'spread': '1.98', 'groupId': 'OG004'}, {'value': '13.4', 'spread': '5.86', 'groupId': 'OG005'}, {'value': '17.2', 'spread': '9.83', 'groupId': 'OG006'}, {'value': '22.3', 'spread': '19.56', 'groupId': 'OG007'}, {'value': '13.4', 'spread': '5.27', 'groupId': 'OG008'}]}]}, {'title': 'C1D16H: PLGF (n=4, 3, 5, 3, 2, 7, 6, 5, 22)', 'categories': [{'measurements': [{'value': '8.4', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '3.09', 'groupId': 'OG001'}, {'value': '12.4', 'spread': '2.94', 'groupId': 'OG002'}, {'value': '6.4', 'spread': '3.04', 'groupId': 'OG003'}, {'value': '8.4', 'spread': '1.91', 'groupId': 'OG004'}, {'value': '8.7', 'spread': '2.84', 'groupId': 'OG005'}, {'value': '22.0', 'spread': '25.07', 'groupId': 'OG006'}, {'value': '15.0', 'spread': '11.95', 'groupId': 'OG007'}, {'value': '8.9', 'spread': '3.66', 'groupId': 'OG008'}]}]}, {'title': 'C1D22: PLGF (n=4, 5, 6, 2, 3, 6, 6, 4, 18)', 'categories': [{'measurements': [{'value': '11.3', 'spread': '6.94', 'groupId': 'OG000'}, {'value': '9.6', 'spread': '3.98', 'groupId': 'OG001'}, {'value': '9.5', 'spread': '2.48', 'groupId': 'OG002'}, {'value': '6.4', 'spread': '0.85', 'groupId': 'OG003'}, {'value': '6.6', 'spread': '3.01', 'groupId': 'OG004'}, {'value': '6.8', 'spread': '2.19', 'groupId': 'OG005'}, {'value': '13.6', 'spread': '9.77', 'groupId': 'OG006'}, {'value': '8.5', 'spread': '1.89', 'groupId': 'OG007'}, {'value': '8.4', 'spread': '3.28', 'groupId': 'OG008'}]}]}, {'title': 'C2D1: PLGF (n=3, 2, 6, 1, 3, 4, 3, 2, 18)', 'categories': [{'measurements': [{'value': '9.4', 'spread': '4.81', 'groupId': 'OG000'}, {'value': '7.6', 'spread': '0.49', 'groupId': 'OG001'}, {'value': '9.8', 'spread': '3.55', 'groupId': 'OG002'}, {'value': '11.0', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG003'}, {'value': '7.3', 'spread': '3.00', 'groupId': 'OG004'}, {'value': '9.7', 'spread': '5.09', 'groupId': 'OG005'}, {'value': '16.5', 'spread': '13.95', 'groupId': 'OG006'}, {'value': '7.1', 'spread': '1.91', 'groupId': 'OG007'}, {'value': '8.3', 'spread': '2.39', 'groupId': 'OG008'}]}]}, {'title': 'C3D1: PLGF (n=3, 2, 3, 1, 1, 4, 2, 1, 10)', 'categories': [{'measurements': [{'value': '11.0', 'spread': '3.87', 'groupId': 'OG000'}, {'value': '15.2', 'spread': '5.66', 'groupId': 'OG001'}, {'value': '9.9', 'spread': '4.37', 'groupId': 'OG002'}, {'value': '7.5', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG003'}, {'value': '11.9', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG004'}, {'value': '7.1', 'spread': '2.05', 'groupId': 'OG005'}, {'value': '8.9', 'spread': '3.54', 'groupId': 'OG006'}, {'value': '7.0', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG007'}, {'value': '6.9', 'spread': '1.92', 'groupId': 'OG008'}]}]}, {'title': 'EOT: PLGF (n=5, 4, 2, 2, 2, 3, 2, 4, 14)', 'categories': [{'measurements': [{'value': '11.8', 'spread': '3.15', 'groupId': 'OG000'}, {'value': '8.3', 'spread': '3.20', 'groupId': 'OG001'}, {'value': '8.7', 'spread': '0.64', 'groupId': 'OG002'}, {'value': '8.6', 'spread': '1.34', 'groupId': 'OG003'}, {'value': '6.8', 'spread': '3.39', 'groupId': 'OG004'}, {'value': '9.1', 'spread': '2.29', 'groupId': 'OG005'}, {'value': '20.1', 'spread': '12.45', 'groupId': 'OG006'}, {'value': '19.9', 'spread': '20.49', 'groupId': 'OG007'}, {'value': '7.8', 'spread': '3.30', 'groupId': 'OG008'}]}]}, {'title': 'Baseline: TGFb1 (n=5, 5, 6, 3, 4, 8, 7, 6, 24)', 'categories': [{'measurements': [{'value': '192856', 'spread': '167465', 'groupId': 'OG000'}, {'value': '58530.3', 'spread': '70338.7', 'groupId': 'OG001'}, {'value': '188182', 'spread': '199702', 'groupId': 'OG002'}, {'value': '322573', 'spread': '249585', 'groupId': 'OG003'}, {'value': '174960', 'spread': '171958', 'groupId': 'OG004'}, {'value': '236277', 'spread': '108993', 'groupId': 'OG005'}, {'value': '190445', 'spread': '113478', 'groupId': 'OG006'}, {'value': '184332', 'spread': '59292.8', 'groupId': 'OG007'}, {'value': '72635.0', 'spread': '69063.0', 'groupId': 'OG008'}]}]}, {'title': 'C1D16H: TGFb1 (n=4, 3, 6, 3, 4, 8, 7, 6, 24)', 'categories': [{'measurements': [{'value': '185701', 'spread': '107677', 'groupId': 'OG000'}, {'value': '203200', 'spread': '158543', 'groupId': 'OG001'}, {'value': '225230', 'spread': '129870', 'groupId': 'OG002'}, {'value': '269437', 'spread': '225974', 'groupId': 'OG003'}, {'value': '297119', 'spread': '87426.7', 'groupId': 'OG004'}, {'value': '265679', 'spread': '89033.4', 'groupId': 'OG005'}, {'value': '311792', 'spread': '104827', 'groupId': 'OG006'}, {'value': '282944', 'spread': '196959', 'groupId': 'OG007'}, {'value': '66293.0', 'spread': '47427.2', 'groupId': 'OG008'}]}]}, {'title': 'C1D22: TGFb1 (n=4, 5, 6, 3, 4, 6, 7, 5, 20)', 'categories': [{'measurements': [{'value': '160128', 'spread': '119814', 'groupId': 'OG000'}, {'value': '328947', 'spread': '271795', 'groupId': 'OG001'}, {'value': '272123', 'spread': '162239', 'groupId': 'OG002'}, {'value': '307758', 'spread': '206598', 'groupId': 'OG003'}, {'value': '298611', 'spread': '178683', 'groupId': 'OG004'}, {'value': '234304', 'spread': '146086', 'groupId': 'OG005'}, {'value': '212425', 'spread': '106195', 'groupId': 'OG006'}, {'value': '340151', 'spread': '232305', 'groupId': 'OG007'}, {'value': '65483.2', 'spread': '35965.8', 'groupId': 'OG008'}]}]}, {'title': 'C2D1: TGFb1 (n=3, 2, 6, 3, 4, 5, 5, 2, 20)', 'categories': [{'measurements': [{'value': '216478', 'spread': '33849.2', 'groupId': 'OG000'}, {'value': '162468', 'spread': '63111.4', 'groupId': 'OG001'}, {'value': '182580', 'spread': '112201', 'groupId': 'OG002'}, {'value': '213943', 'spread': '64818.6', 'groupId': 'OG003'}, {'value': '302708', 'spread': '213685', 'groupId': 'OG004'}, {'value': '258286', 'spread': '88746.3', 'groupId': 'OG005'}, {'value': '230125', 'spread': '174311', 'groupId': 'OG006'}, {'value': '156793', 'spread': '108469', 'groupId': 'OG007'}, {'value': '65275.6', 'spread': '48954.3', 'groupId': 'OG008'}]}]}, {'title': 'C3D1: TGFb1 (n=3, 2, 4, 3, 1, 4, 3, 1, 12)', 'categories': [{'measurements': [{'value': '387504', 'spread': '211630', 'groupId': 'OG000'}, {'value': '327375', 'spread': '208226', 'groupId': 'OG001'}, {'value': '281413', 'spread': '181027', 'groupId': 'OG002'}, {'value': '191820', 'spread': '123461', 'groupId': 'OG003'}, {'value': '238304', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG004'}, {'value': '326939', 'spread': '184808', 'groupId': 'OG005'}, {'value': '295378', 'spread': '133164', 'groupId': 'OG006'}, {'value': '62172.4', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG007'}, {'value': '73118.3', 'spread': '49778.0', 'groupId': 'OG008'}]}]}, {'title': 'EOT: TGFb1 (n=5, 5, 2, 3, 4, 4, 5, 5, 17)', 'categories': [{'measurements': [{'value': '172056', 'spread': '100831', 'groupId': 'OG000'}, {'value': '279062', 'spread': '214205', 'groupId': 'OG001'}, {'value': '203631', 'spread': '254400', 'groupId': 'OG002'}, {'value': '292165', 'spread': '163750', 'groupId': 'OG003'}, {'value': '250882', 'spread': '165972', 'groupId': 'OG004'}, {'value': '336973', 'spread': '225077', 'groupId': 'OG005'}, {'value': '183926', 'spread': '163333', 'groupId': 'OG006'}, {'value': '486629', 'spread': '381351', 'groupId': 'OG007'}, {'value': '95074.9', 'spread': '92796.5', 'groupId': 'OG008'}]}]}, {'title': 'Baseline: VEGF-A (n=4, 5, 6, 3, 3, 8, 7, 6, 24)', 'categories': [{'measurements': [{'value': '907.5', 'spread': '479.21', 'groupId': 'OG000'}, {'value': '222.3', 'spread': '201.48', 'groupId': 'OG001'}, {'value': '452.5', 'spread': '328.65', 'groupId': 'OG002'}, {'value': '522.2', 'spread': '512.23', 'groupId': 'OG003'}, {'value': '669.4', 'spread': '608.96', 'groupId': 'OG004'}, {'value': '437.7', 'spread': '268.81', 'groupId': 'OG005'}, {'value': '538.9', 'spread': '421.35', 'groupId': 'OG006'}, {'value': '634.6', 'spread': '874.12', 'groupId': 'OG007'}, {'value': '613.5', 'spread': '984.96', 'groupId': 'OG008'}]}]}, {'title': 'C1D16H: VEGF-A (n=4, 3, 6, 3, 4, 8, 7, 6, 24)', 'categories': [{'measurements': [{'value': '988.3', 'spread': '646.26', 'groupId': 'OG000'}, {'value': '476.4', 'spread': '155.58', 'groupId': 'OG001'}, {'value': '788.6', 'spread': '578.29', 'groupId': 'OG002'}, {'value': '592.6', 'spread': '684.51', 'groupId': 'OG003'}, {'value': '587.5', 'spread': '437.86', 'groupId': 'OG004'}, {'value': '542.3', 'spread': '400.82', 'groupId': 'OG005'}, {'value': '648.7', 'spread': '482.00', 'groupId': 'OG006'}, {'value': '671.6', 'spread': '997.74', 'groupId': 'OG007'}, {'value': '671.1', 'spread': '998.34', 'groupId': 'OG008'}]}]}, {'title': 'C1D22: VEGF-A (n=4, 5, 6, 3, 4, 6, 7, 4, 20)', 'categories': [{'measurements': [{'value': '564.3', 'spread': '212.89', 'groupId': 'OG000'}, {'value': '772.5', 'spread': '466.51', 'groupId': 'OG001'}, {'value': '786.5', 'spread': '650.76', 'groupId': 'OG002'}, {'value': '748.0', 'spread': '527.71', 'groupId': 'OG003'}, {'value': '479.2', 'spread': '359.29', 'groupId': 'OG004'}, {'value': '617.6', 'spread': '481.63', 'groupId': 'OG005'}, {'value': '656.6', 'spread': '579.52', 'groupId': 'OG006'}, {'value': '1432.7', 'spread': '1566.42', 'groupId': 'OG007'}, {'value': '1078.9', 'spread': '1095.02', 'groupId': 'OG008'}]}]}, {'title': 'C2D1: VEGF-A (n=3, 2, 6, 3, 4, 5, 5, 2, 20)', 'categories': [{'measurements': [{'value': '623.7', 'spread': '330.44', 'groupId': 'OG000'}, {'value': '321.7', 'spread': '401.42', 'groupId': 'OG001'}, {'value': '608.8', 'spread': '789.07', 'groupId': 'OG002'}, {'value': '671.0', 'spread': '349.68', 'groupId': 'OG003'}, {'value': '600.0', 'spread': '529.40', 'groupId': 'OG004'}, {'value': '653.6', 'spread': '339.01', 'groupId': 'OG005'}, {'value': '754.8', 'spread': '683.82', 'groupId': 'OG006'}, {'value': '1904.2', 'spread': '2559.16', 'groupId': 'OG007'}, {'value': '1064.3', 'spread': '2200.07', 'groupId': 'OG008'}]}]}, {'title': 'C3D1: VEGF-A (n=3, 2, 4, 3, 1, 4, 3, 1, 12)', 'categories': [{'measurements': [{'value': '1106.9', 'spread': '374.74', 'groupId': 'OG000'}, {'value': '378.6', 'spread': '427.52', 'groupId': 'OG001'}, {'value': '633.0', 'spread': '332.78', 'groupId': 'OG002'}, {'value': '526.5', 'spread': '324.46', 'groupId': 'OG003'}, {'value': '710.1', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG004'}, {'value': '621.1', 'spread': '409.65', 'groupId': 'OG005'}, {'value': '980.7', 'spread': '656.43', 'groupId': 'OG006'}, {'value': '76.4', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG007'}, {'value': '641.8', 'spread': '651.66', 'groupId': 'OG008'}]}]}, {'title': 'EOT: VEGF-A (n=5, 5, 2, 3, 4, 4, 5, 5, 17)', 'categories': [{'measurements': [{'value': '991.3', 'spread': '606.54', 'groupId': 'OG000'}, {'value': '700.2', 'spread': '406.16', 'groupId': 'OG001'}, {'value': '231.6', 'spread': '187.74', 'groupId': 'OG002'}, {'value': '579.8', 'spread': '205.68', 'groupId': 'OG003'}, {'value': '511.0', 'spread': '496.32', 'groupId': 'OG004'}, {'value': '804.5', 'spread': '577.55', 'groupId': 'OG005'}, {'value': '1195.4', 'spread': '1390.00', 'groupId': 'OG006'}, {'value': '871.9', 'spread': '1068.86', 'groupId': 'OG007'}, {'value': '802.5', 'spread': '880.22', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)', 'description': 'Plasma concentrations of soluble proteins (PLGF, TGFB1, VEGF-A) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity.', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Soluble protein biomarker analysis set included all participants who received at least one dose of study drug with a baseline (pre-dose C1D1) or screening biomarker result, and at least one on-treatment biomarker result for at least one biomarker. "n" signifies those participants who were evaluable at specific time-point.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Soluble Protein Biomarker [Vascular Endothelial Growth Factor C (VEGF-C), Vascular Endothelial Growth Factor-d (VEGF-d), Vascular Endothelial Growth Factor Receptor Type 1 (VEGFR1)]: Part 1 and Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 0.5 mg/kg: Part 1', 'description': 'PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'PF-03446962 1 mg/kg: Part 1', 'description': 'PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'PF-03446962 2 mg/kg : Part 1', 'description': 'PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'PF-03446962 3 mg/kg: Part 1', 'description': 'PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG004', 'title': 'PF-03446962 4.5 mg/kg: Part 1', 'description': 'PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'PF-03446962 6.75 mg/kg: Part 1', 'description': 'PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'PF-03446962 10 mg/kg: Part 1', 'description': 'PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG007', 'title': 'PF-03446962 15 mg/kg: Part 1', 'description': 'PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG008', 'title': 'PF-03446962 7 mg/kg: Part 2', 'description': 'PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}], 'classes': [{'title': 'Baseline: VEGF-C (n= 3, 1, 3, 2, 2, 4, 4, 4, 15)', 'categories': [{'measurements': [{'value': '157.8', 'spread': '47.72', 'groupId': 'OG000'}, {'value': '129.4', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG001'}, {'value': '80.8', 'spread': '26.11', 'groupId': 'OG002'}, {'value': '130.1', 'spread': '74.10', 'groupId': 'OG003'}, {'value': '200.7', 'spread': '55.58', 'groupId': 'OG004'}, {'value': '86.1', 'spread': '25.17', 'groupId': 'OG005'}, {'value': '85.5', 'spread': '23.49', 'groupId': 'OG006'}, {'value': '195.3', 'spread': '164.87', 'groupId': 'OG007'}, {'value': '123.1', 'spread': '59.79', 'groupId': 'OG008'}]}]}, {'title': 'C1D16H: VEGF-C (n= 2, 2, 4, 2, 2, 5, 5, 4, 13)', 'categories': [{'measurements': [{'value': '128.2', 'spread': '82.17', 'groupId': 'OG000'}, {'value': '41.8', 'spread': '7.71', 'groupId': 'OG001'}, {'value': '102.2', 'spread': '27.40', 'groupId': 'OG002'}, {'value': '146.0', 'spread': '129.90', 'groupId': 'OG003'}, {'value': '151.4', 'spread': '67.03', 'groupId': 'OG004'}, {'value': '116.9', 'spread': '62.28', 'groupId': 'OG005'}, {'value': '80.4', 'spread': '24.55', 'groupId': 'OG006'}, {'value': '120.2', 'spread': '63.80', 'groupId': 'OG007'}, {'value': '144.2', 'spread': '40.73', 'groupId': 'OG008'}]}]}, {'title': 'C1D22: VEGF-C (n= 3, 5, 4, 2, 2, 4, 4, 4, 12)', 'categories': [{'measurements': [{'value': '86.7', 'spread': '58.88', 'groupId': 'OG000'}, {'value': '85.7', 'spread': '40.52', 'groupId': 'OG001'}, {'value': '129.1', 'spread': '129.05', 'groupId': 'OG002'}, {'value': '82.3', 'spread': '45.18', 'groupId': 'OG003'}, {'value': '187.6', 'spread': '8.84', 'groupId': 'OG004'}, {'value': '103.8', 'spread': '45.97', 'groupId': 'OG005'}, {'value': '130.9', 'spread': '78.92', 'groupId': 'OG006'}, {'value': '193.8', 'spread': '42.02', 'groupId': 'OG007'}, {'value': '154.1', 'spread': '85.63', 'groupId': 'OG008'}]}]}, {'title': 'C2D1: VEGF-C (n= 2, 1, 2, 1, 2, 4, 4, 1, 11)', 'categories': [{'measurements': [{'value': '82.0', 'spread': '56.92', 'groupId': 'OG000'}, {'value': '102.8', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG001'}, {'value': '73.0', 'spread': '27.37', 'groupId': 'OG002'}, {'value': '75.5', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG003'}, {'value': '195.5', 'spread': '22.56', 'groupId': 'OG004'}, {'value': '78.1', 'spread': '24.17', 'groupId': 'OG005'}, {'value': '92.7', 'spread': '60.15', 'groupId': 'OG006'}, {'value': '209.0', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG007'}, {'value': '201.4', 'spread': '91.96', 'groupId': 'OG008'}]}]}, {'title': 'C3D1: VEGF-C (n= 2, 1, 2, 0, 1, 3, 1, 0, 8)', 'categories': [{'measurements': [{'value': '217.8', 'spread': '175.08', 'groupId': 'OG000'}, {'value': '139.8', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG001'}, {'value': '100.2', 'spread': '64.49', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not reported since no participant was evaluable for this arm group', 'groupId': 'OG003'}, {'value': '72.5', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG004'}, {'value': '93.6', 'spread': '38.86', 'groupId': 'OG005'}, {'value': '90.5', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not reported since no participant was evaluable for this arm group', 'groupId': 'OG007'}, {'value': '190.5', 'spread': '71.75', 'groupId': 'OG008'}]}]}, {'title': 'EOT: VEGF-C (n= 5, 4, 0, 1, 2, 3, 4, 5, 10)', 'categories': [{'measurements': [{'value': '140.0', 'spread': '102.64', 'groupId': 'OG000'}, {'value': '110.1', 'spread': '55.86', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not reported since no participant was evaluable for this arm group', 'groupId': 'OG002'}, {'value': '60.1', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG003'}, {'value': '146.8', 'spread': '108.75', 'groupId': 'OG004'}, {'value': '131.8', 'spread': '21.49', 'groupId': 'OG005'}, {'value': '138.0', 'spread': '112.15', 'groupId': 'OG006'}, {'value': '114.9', 'spread': '43.61', 'groupId': 'OG007'}, {'value': '186.1', 'spread': '91.79', 'groupId': 'OG008'}]}]}, {'title': 'Baseline: VEGF-d (n= 5, 5, 6, 3, 4, 8, 7, 6, 24)', 'categories': [{'measurements': [{'value': '1482.0', 'spread': '661.38', 'groupId': 'OG000'}, {'value': '2365.6', 'spread': '2277.70', 'groupId': 'OG001'}, {'value': '1694.0', 'spread': '1200.02', 'groupId': 'OG002'}, {'value': '1393.9', 'spread': '371.40', 'groupId': 'OG003'}, {'value': '2073.3', 'spread': '1258.05', 'groupId': 'OG004'}, {'value': '2421.0', 'spread': '2415.95', 'groupId': 'OG005'}, {'value': '1282.9', 'spread': '308.22', 'groupId': 'OG006'}, {'value': '1144.6', 'spread': '214.88', 'groupId': 'OG007'}, {'value': '2127.8', 'spread': '1620.79', 'groupId': 'OG008'}]}]}, {'title': 'C1D16H: VEGF-d (n= 4, 3, 6, 3, 4, 8, 7, 6, 24)', 'categories': [{'measurements': [{'value': '1521.1', 'spread': '863.10', 'groupId': 'OG000'}, {'value': '1554.8', 'spread': '968.88', 'groupId': 'OG001'}, {'value': '1862.7', 'spread': '1422.39', 'groupId': 'OG002'}, {'value': '1453.6', 'spread': '469.17', 'groupId': 'OG003'}, {'value': '1400.7', 'spread': '634.61', 'groupId': 'OG004'}, {'value': '2638.6', 'spread': '3254.13', 'groupId': 'OG005'}, {'value': '1487.3', 'spread': '654.83', 'groupId': 'OG006'}, {'value': '1031.1', 'spread': '285.11', 'groupId': 'OG007'}, {'value': '2142.8', 'spread': '1494.28', 'groupId': 'OG008'}]}]}, {'title': 'C1D22: VEGF-d (n= 4, 5, 6, 3, 4, 6, 7, 5, 19)', 'categories': [{'measurements': [{'value': '896.2', 'spread': '257.64', 'groupId': 'OG000'}, {'value': '1544.2', 'spread': '952.69', 'groupId': 'OG001'}, {'value': '1627.6', 'spread': '1133.17', 'groupId': 'OG002'}, {'value': '1376.2', 'spread': '468.11', 'groupId': 'OG003'}, {'value': '1916.3', 'spread': '1499.55', 'groupId': 'OG004'}, {'value': '2831.2', 'spread': '3980.28', 'groupId': 'OG005'}, {'value': '1634.0', 'spread': '741.59', 'groupId': 'OG006'}, {'value': '1191.6', 'spread': '407.20', 'groupId': 'OG007'}, {'value': '2375.2', 'spread': '1506.25', 'groupId': 'OG008'}]}]}, {'title': 'C2D1: VEGF-d (n= 3, 2, 6, 3, 4, 5, 5, 2, 20)', 'categories': [{'measurements': [{'value': '1276.2', 'spread': '830.02', 'groupId': 'OG000'}, {'value': '1787.2', 'spread': '1467.67', 'groupId': 'OG001'}, {'value': '1873.7', 'spread': '1363.68', 'groupId': 'OG002'}, {'value': '1359.8', 'spread': '590.91', 'groupId': 'OG003'}, {'value': '2277.6', 'spread': '2283.70', 'groupId': 'OG004'}, {'value': '2557.3', 'spread': '3427.60', 'groupId': 'OG005'}, {'value': '1333.5', 'spread': '404.55', 'groupId': 'OG006'}, {'value': '1025.5', 'spread': '132.44', 'groupId': 'OG007'}, {'value': '1957.2', 'spread': '963.83', 'groupId': 'OG008'}]}]}, {'title': 'C3D1: VEGF-d (n= 3, 2, 4, 3, 1, 4, 3, 1, 12)', 'categories': [{'measurements': [{'value': '1259.9', 'spread': '763.65', 'groupId': 'OG000'}, {'value': '1826.2', 'spread': '1660.36', 'groupId': 'OG001'}, {'value': '1954.2', 'spread': '1737.30', 'groupId': 'OG002'}, {'value': '1300.9', 'spread': '623.64', 'groupId': 'OG003'}, {'value': '1584.0', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG004'}, {'value': '3876.5', 'spread': '5419.26', 'groupId': 'OG005'}, {'value': '1100.3', 'spread': '395.55', 'groupId': 'OG006'}, {'value': '1470.1', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG007'}, {'value': '2094.4', 'spread': '837.78', 'groupId': 'OG008'}]}]}, {'title': 'EOT: VEGF-d (n= 5, 5, 2, 3, 4, 4, 5, 5, 17)', 'categories': [{'measurements': [{'value': '1259.0', 'spread': '640.63', 'groupId': 'OG000'}, {'value': '1463.6', 'spread': '813.87', 'groupId': 'OG001'}, {'value': '2218.0', 'spread': '2141.83', 'groupId': 'OG002'}, {'value': '1289.9', 'spread': '633.94', 'groupId': 'OG003'}, {'value': '2181.2', 'spread': '1622.16', 'groupId': 'OG004'}, {'value': '2079.0', 'spread': '1987.67', 'groupId': 'OG005'}, {'value': '1464.0', 'spread': '959.39', 'groupId': 'OG006'}, {'value': '1093.7', 'spread': '308.36', 'groupId': 'OG007'}, {'value': '2011.1', 'spread': '988.62', 'groupId': 'OG008'}]}]}, {'title': 'Baseline: VEGFR1 (n= 5, 5, 6, 3, 4, 7, 7, 6, 23)', 'categories': [{'measurements': [{'value': '1377.6', 'spread': '2854.50', 'groupId': 'OG000'}, {'value': '216.1', 'spread': '302.01', 'groupId': 'OG001'}, {'value': '118.1', 'spread': '65.01', 'groupId': 'OG002'}, {'value': '75.3', 'spread': '20.82', 'groupId': 'OG003'}, {'value': '262.3', 'spread': '261.24', 'groupId': 'OG004'}, {'value': '77.5', 'spread': '39.81', 'groupId': 'OG005'}, {'value': '219.5', 'spread': '195.62', 'groupId': 'OG006'}, {'value': '200.4', 'spread': '119.61', 'groupId': 'OG007'}, {'value': '243.6', 'spread': '128.59', 'groupId': 'OG008'}]}]}, {'title': 'C1D16H: VEGFR1 (n= 4, 3, 6, 3, 4, 8, 6, 6, 23)', 'categories': [{'measurements': [{'value': '98.6', 'spread': '45.70', 'groupId': 'OG000'}, {'value': '230.0', 'spread': '262.82', 'groupId': 'OG001'}, {'value': '200.2', 'spread': '241.23', 'groupId': 'OG002'}, {'value': '258.4', 'spread': '336.53', 'groupId': 'OG003'}, {'value': '656.3', 'spread': '1160.02', 'groupId': 'OG004'}, {'value': '79.6', 'spread': '62.56', 'groupId': 'OG005'}, {'value': '362.6', 'spread': '525.74', 'groupId': 'OG006'}, {'value': '134.8', 'spread': '83.44', 'groupId': 'OG007'}, {'value': '251.7', 'spread': '306.54', 'groupId': 'OG008'}]}]}, {'title': 'C1D22: VEGFR1 (n= 4, 5, 6, 3, 3, 5, 7, 4, 20)', 'categories': [{'measurements': [{'value': '102.1', 'spread': '40.47', 'groupId': 'OG000'}, {'value': '325.0', 'spread': '545.00', 'groupId': 'OG001'}, {'value': '181.8', 'spread': '207.89', 'groupId': 'OG002'}, {'value': '79.2', 'spread': '27.82', 'groupId': 'OG003'}, {'value': '377.0', 'spread': '372.66', 'groupId': 'OG004'}, {'value': '77.8', 'spread': '30.55', 'groupId': 'OG005'}, {'value': '127.9', 'spread': '91.93', 'groupId': 'OG006'}, {'value': '149.3', 'spread': '95.67', 'groupId': 'OG007'}, {'value': '187.6', 'spread': '80.10', 'groupId': 'OG008'}]}]}, {'title': 'C2D1: VEGFR1 (n= 3, 1, 6, 3, 4, 5, 5, 2, 20)', 'categories': [{'measurements': [{'value': '63.0', 'spread': '24.69', 'groupId': 'OG000'}, {'value': '1556.8', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG001'}, {'value': '464.1', 'spread': '611.85', 'groupId': 'OG002'}, {'value': '81.9', 'spread': '37.78', 'groupId': 'OG003'}, {'value': '215.9', 'spread': '236.35', 'groupId': 'OG004'}, {'value': '56.4', 'spread': '22.50', 'groupId': 'OG005'}, {'value': '179.1', 'spread': '153.00', 'groupId': 'OG006'}, {'value': '164.5', 'spread': '89.31', 'groupId': 'OG007'}, {'value': '656.5', 'spread': '2066.54', 'groupId': 'OG008'}]}]}, {'title': 'C3D1: VEGFR1 (n= 3, 2, 4, 3, 1, 4, 2, 1, 12)', 'categories': [{'measurements': [{'value': '97.7', 'spread': '45.58', 'groupId': 'OG000'}, {'value': '2659.5', 'spread': '3611.41', 'groupId': 'OG001'}, {'value': '109.5', 'spread': '34.95', 'groupId': 'OG002'}, {'value': '244.4', 'spread': '304.26', 'groupId': 'OG003'}, {'value': '386.2', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG004'}, {'value': '50.3', 'spread': '26.44', 'groupId': 'OG005'}, {'value': '388.4', 'spread': '351.79', 'groupId': 'OG006'}, {'value': '283.3', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG007'}, {'value': '236.1', 'spread': '245.35', 'groupId': 'OG008'}]}]}, {'title': 'EOT: VEGFR1 (n= 5, 5, 2, 2, 4, 4, 4, 5, 17)', 'categories': [{'measurements': [{'value': '125.2', 'spread': '57.71', 'groupId': 'OG000'}, {'value': '316.4', 'spread': '561.02', 'groupId': 'OG001'}, {'value': '412.9', 'spread': '389.40', 'groupId': 'OG002'}, {'value': '209.0', 'spread': '148.00', 'groupId': 'OG003'}, {'value': '173.1', 'spread': '110.45', 'groupId': 'OG004'}, {'value': '118.9', 'spread': '22.12', 'groupId': 'OG005'}, {'value': '365.3', 'spread': '267.06', 'groupId': 'OG006'}, {'value': '175.3', 'spread': '138.87', 'groupId': 'OG007'}, {'value': '242.4', 'spread': '140.35', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)', 'description': 'Plasma concentrations of soluble proteins (VEGF-C, VEGF-d, VEGFR1) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity.', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Soluble protein biomarker analysis set included all participants who received at least one dose of study drug with a baseline (pre-dose C1D1) or screening biomarker result, and at least one on-treatment biomarker result for at least one biomarker. "n" signifies those participants who were evaluable at specific time-point.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Soluble Protein Biomarker [Vascular Endothelial Growth Factor Receptor Type 2 (VEGFR2), Vascular Endothelial Growth Factor Receptor Type 3 (VEGFR3)]: Part 1 and Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 0.5 mg/kg: Part 1', 'description': 'PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'PF-03446962 1 mg/kg: Part 1', 'description': 'PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'PF-03446962 2 mg/kg : Part 1', 'description': 'PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'PF-03446962 3 mg/kg: Part 1', 'description': 'PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG004', 'title': 'PF-03446962 4.5 mg/kg: Part 1', 'description': 'PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'PF-03446962 6.75 mg/kg: Part 1', 'description': 'PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'PF-03446962 10 mg/kg: Part 1', 'description': 'PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG007', 'title': 'PF-03446962 15 mg/kg: Part 1', 'description': 'PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG008', 'title': 'PF-03446962 7 mg/kg: Part 2', 'description': 'PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}], 'classes': [{'title': 'Baseline: VEGFR2 (n= 5, 5, 6, 3, 4, 8, 7, 6, 24)', 'categories': [{'measurements': [{'value': '8414.2', 'spread': '3145.86', 'groupId': 'OG000'}, {'value': '8281.8', 'spread': '4500.81', 'groupId': 'OG001'}, {'value': '8834.8', 'spread': '1749.43', 'groupId': 'OG002'}, {'value': '10475.6', 'spread': '862.91', 'groupId': 'OG003'}, {'value': '9536.4', 'spread': '2527.39', 'groupId': 'OG004'}, {'value': '7526.1', 'spread': '1910.18', 'groupId': 'OG005'}, {'value': '7712.5', 'spread': '2738.41', 'groupId': 'OG006'}, {'value': '8934.9', 'spread': '1266.00', 'groupId': 'OG007'}, {'value': '6495.9', 'spread': '2172.45', 'groupId': 'OG008'}]}]}, {'title': 'C1D16H: VEGFR2 (n= 4, 3, 6, 3, 4, 8, 7, 6, 24)', 'categories': [{'measurements': [{'value': '7989.8', 'spread': '3208.34', 'groupId': 'OG000'}, {'value': '7069.9', 'spread': '5395.12', 'groupId': 'OG001'}, {'value': '9884.4', 'spread': '3258.50', 'groupId': 'OG002'}, {'value': '10980.4', 'spread': '1881.48', 'groupId': 'OG003'}, {'value': '7707.1', 'spread': '2003.97', 'groupId': 'OG004'}, {'value': '7902.7', 'spread': '2606.45', 'groupId': 'OG005'}, {'value': '7500.6', 'spread': '2409.88', 'groupId': 'OG006'}, {'value': '8827.1', 'spread': '1458.20', 'groupId': 'OG007'}, {'value': '6708.1', 'spread': '2314.78', 'groupId': 'OG008'}]}]}, {'title': 'C1D22: VEGFR2 (n= 4, 5, 6, 3, 4, 6, 7, 5, 20)', 'categories': [{'measurements': [{'value': '8310.6', 'spread': '4171.13', 'groupId': 'OG000'}, {'value': '9672.8', 'spread': '4841.31', 'groupId': 'OG001'}, {'value': '9057.3', 'spread': '1614.38', 'groupId': 'OG002'}, {'value': '10248.0', 'spread': '1886.86', 'groupId': 'OG003'}, {'value': '8057.2', 'spread': '1948.44', 'groupId': 'OG004'}, {'value': '8912.0', 'spread': '2327.17', 'groupId': 'OG005'}, {'value': '9230.3', 'spread': '4272.69', 'groupId': 'OG006'}, {'value': '9572.0', 'spread': '2736.01', 'groupId': 'OG007'}, {'value': '7147.6', 'spread': '2735.63', 'groupId': 'OG008'}]}]}, {'title': 'C2D1: VEGFR2 (n= 3, 2, 6, 3, 4, 5, 5, 2, 20)', 'categories': [{'measurements': [{'value': '6699.4', 'spread': '3398.50', 'groupId': 'OG000'}, {'value': '9896.8', 'spread': '1626.91', 'groupId': 'OG001'}, {'value': '9191.5', 'spread': '2061.89', 'groupId': 'OG002'}, {'value': '9354.7', 'spread': '2102.62', 'groupId': 'OG003'}, {'value': '6621.2', 'spread': '1637.27', 'groupId': 'OG004'}, {'value': '8016.8', 'spread': '1689.68', 'groupId': 'OG005'}, {'value': '7727.3', 'spread': '3137.81', 'groupId': 'OG006'}, {'value': '8567.2', 'spread': '222.95', 'groupId': 'OG007'}, {'value': '7468.4', 'spread': '2757.65', 'groupId': 'OG008'}]}]}, {'title': 'C3D1: VEGFR2 (n= 3, 2, 4, 3, 1, 4, 3, 1, 12)', 'categories': [{'measurements': [{'value': '8780.4', 'spread': '4855.85', 'groupId': 'OG000'}, {'value': '9372.8', 'spread': '1111.71', 'groupId': 'OG001'}, {'value': '9736.1', 'spread': '1396.40', 'groupId': 'OG002'}, {'value': '9988.4', 'spread': '1704.87', 'groupId': 'OG003'}, {'value': '7180.0', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG004'}, {'value': '9289.2', 'spread': '2003.70', 'groupId': 'OG005'}, {'value': '9784.5', 'spread': '2193.47', 'groupId': 'OG006'}, {'value': '9632.8', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG007'}, {'value': '7087.9', 'spread': '2430.45', 'groupId': 'OG008'}]}]}, {'title': 'EOT: VEGFR2 (n= 5, 5, 2, 3, 4, 4, 5, 5, 17)', 'categories': [{'measurements': [{'value': '9541.6', 'spread': '3903.58', 'groupId': 'OG000'}, {'value': '8297.5', 'spread': '4291.01', 'groupId': 'OG001'}, {'value': '7490.4', 'spread': '5124.26', 'groupId': 'OG002'}, {'value': '11521.7', 'spread': '1822.45', 'groupId': 'OG003'}, {'value': '8151.8', 'spread': '2508.61', 'groupId': 'OG004'}, {'value': '10018.0', 'spread': '2860.16', 'groupId': 'OG005'}, {'value': '7771.7', 'spread': '3593.10', 'groupId': 'OG006'}, {'value': '9357.8', 'spread': '2845.47', 'groupId': 'OG007'}, {'value': '8151.0', 'spread': '2254.12', 'groupId': 'OG008'}]}]}, {'title': 'Baseline: VEGFR3 (n= 5, 5, 6, 3, 4, 8, 7, 6, 24)', 'categories': [{'measurements': [{'value': '421297', 'spread': '89735.8', 'groupId': 'OG000'}, {'value': '396991', 'spread': '111696', 'groupId': 'OG001'}, {'value': '340605', 'spread': '106111', 'groupId': 'OG002'}, {'value': '282449', 'spread': '52144.0', 'groupId': 'OG003'}, {'value': '336510', 'spread': '183465', 'groupId': 'OG004'}, {'value': '402326', 'spread': '127490', 'groupId': 'OG005'}, {'value': '377133', 'spread': '109330', 'groupId': 'OG006'}, {'value': '409280', 'spread': '166548', 'groupId': 'OG007'}, {'value': '423268', 'spread': '152555', 'groupId': 'OG008'}]}]}, {'title': 'C1D16H: VEGFR3 (n= 4, 3, 6, 3, 4, 8, 7, 6, 24)', 'categories': [{'measurements': [{'value': '403555', 'spread': '118261', 'groupId': 'OG000'}, {'value': '417915', 'spread': '101370', 'groupId': 'OG001'}, {'value': '376867', 'spread': '146099', 'groupId': 'OG002'}, {'value': '282590', 'spread': '58032.4', 'groupId': 'OG003'}, {'value': '301990', 'spread': '114920', 'groupId': 'OG004'}, {'value': '371861', 'spread': '130334', 'groupId': 'OG005'}, {'value': '361958', 'spread': '106007', 'groupId': 'OG006'}, {'value': '375385', 'spread': '89006.0', 'groupId': 'OG007'}, {'value': '427567', 'spread': '133307', 'groupId': 'OG008'}]}]}, {'title': 'C1D22: VEGFR3 (n= 4, 5, 6, 3, 4, 6, 7, 5, 20)', 'categories': [{'measurements': [{'value': '418199', 'spread': '135460', 'groupId': 'OG000'}, {'value': '413223', 'spread': '111775', 'groupId': 'OG001'}, {'value': '482016', 'spread': '227736', 'groupId': 'OG002'}, {'value': '278094', 'spread': '29688.1', 'groupId': 'OG003'}, {'value': '335397', 'spread': '159853', 'groupId': 'OG004'}, {'value': '405426', 'spread': '135402', 'groupId': 'OG005'}, {'value': '384832', 'spread': '157842', 'groupId': 'OG006'}, {'value': '367493', 'spread': '104354', 'groupId': 'OG007'}, {'value': '439596', 'spread': '117856', 'groupId': 'OG008'}]}]}, {'title': 'C2D1: VEGFR3 (n= 3, 2, 6, 3, 4, 5, 5, 2, 20)', 'categories': [{'measurements': [{'value': '456367', 'spread': '205119', 'groupId': 'OG000'}, {'value': '283799', 'spread': '30962.7', 'groupId': 'OG001'}, {'value': '483165', 'spread': '166891', 'groupId': 'OG002'}, {'value': '299955', 'spread': '42094.9', 'groupId': 'OG003'}, {'value': '326823', 'spread': '171815', 'groupId': 'OG004'}, {'value': '403432', 'spread': '164005', 'groupId': 'OG005'}, {'value': '326291', 'spread': '81142.0', 'groupId': 'OG006'}, {'value': '330917', 'spread': '3323.61', 'groupId': 'OG007'}, {'value': '436507', 'spread': '130015', 'groupId': 'OG008'}]}]}, {'title': 'C3D1: VEGFR3 (n= 3, 2, 4, 3, 1, 4, 3, 1, 12)', 'categories': [{'measurements': [{'value': '486756', 'spread': '156161', 'groupId': 'OG000'}, {'value': '335446', 'spread': '688.51', 'groupId': 'OG001'}, {'value': '380689', 'spread': '189516', 'groupId': 'OG002'}, {'value': '272982', 'spread': '12015.1', 'groupId': 'OG003'}, {'value': '563837', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG004'}, {'value': '356012', 'spread': '127436', 'groupId': 'OG005'}, {'value': '301489', 'spread': '85606.4', 'groupId': 'OG006'}, {'value': '309162', 'spread': 'NA', 'comment': 'Standard deviation was not reported since only 1 participant was evaluable for this arm group.', 'groupId': 'OG007'}, {'value': '401286', 'spread': '120518', 'groupId': 'OG008'}]}]}, {'title': 'EOT: VEGFR3 (n= 5, 5, 2, 3, 4, 4, 5, 5, 17)', 'categories': [{'measurements': [{'value': '456664', 'spread': '83808.5', 'groupId': 'OG000'}, {'value': '358829', 'spread': '70878.1', 'groupId': 'OG001'}, {'value': '396443', 'spread': '324477', 'groupId': 'OG002'}, {'value': '306684', 'spread': '72478.1', 'groupId': 'OG003'}, {'value': '319223', 'spread': '117705', 'groupId': 'OG004'}, {'value': '419244', 'spread': '54326.1', 'groupId': 'OG005'}, {'value': '446291', 'spread': '293311', 'groupId': 'OG006'}, {'value': '440490', 'spread': '118906', 'groupId': 'OG007'}, {'value': '457457', 'spread': '144474', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)', 'description': 'Plasma concentrations of soluble proteins (VEGFR2, VEGFR3) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity.', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Soluble Protein Biomarker Analysis Set included all participants who received at least one dose of study drug with a baseline (pre-dose C1D1) or screening biomarker result, and at least one on-treatment biomarker result for at least one biomarker. "n" signifies those participants who were evaluable at specific time-point.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Circulating Endothelial Cells (CEC)and Circulating Endothelial Progenitors (CEP): Part 1 and Part 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'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 0.5 mg/kg: Part 1', 'description': 'PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'PF-03446962 1 mg/kg: Part 1', 'description': 'PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'PF-03446962 2 mg/kg : Part 1', 'description': 'PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'PF-03446962 3 mg/kg: Part 1', 'description': 'PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG004', 'title': 'PF-03446962 4.5 mg/kg: Part 1', 'description': 'PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'PF-03446962 6.75 mg/kg: Part 1', 'description': 'PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'PF-03446962 10 mg/kg: Part 1', 'description': 'PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG007', 'title': 'PF-03446962 15 mg/kg: Part 1', 'description': 'PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'OG008', 'title': 'PF-03446962 7 mg/kg: Part 2', 'description': 'PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}], 'timeFrame': 'Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)', 'description': 'Circulating endothelial cells (CECs) are noninvasive marker of vascular damage, remodeling, and dysfunction. Blood samples for the assessment of CECs and circulating CEPs were collected to analyze effects of therapy on the number, viability/apoptotic state, and/or target activity/expression in CECs. Circulating Cells were classified as CEPs if cluster differentiation 133 positive cells (CD133+) were detected.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was reported in individual participant listings but not statistically summarized due to statistical constraints.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PF-03446962 0.5 mg/kg: Part 1', 'description': 'PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'FG001', 'title': 'PF-03446962 1 mg/kg: Part 1', 'description': 'PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'FG002', 'title': 'PF-03446962 2 mg/kg : Part 1', 'description': 'PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'FG003', 'title': 'PF-03446962 3 mg/kg: Part 1', 'description': 'PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'FG004', 'title': 'PF-03446962 4.5 mg/kg: Part 1', 'description': 'PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'FG005', 'title': 'PF-03446962 6.75 mg/kg: Part 1', 'description': 'PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'FG006', 'title': 'PF-03446962 10 mg/kg: Part 1', 'description': 'PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'FG007', 'title': 'PF-03446962 15 mg/kg: Part 1', 'description': 'PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}, {'id': 'FG008', 'title': 'PF-03446962 7 mg/kg: Part 2', 'description': 'PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.'}], 'periods': [{'title': 'Part 1: Dose Escalation Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'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'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'objective progression or relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'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': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'global deterioration of health status', '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': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'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'}]}]}, {'title': 'Part 2: Exploratory Phase', 'milestones': [{'type': 'STARTED', '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': '24'}]}, {'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'}]}, {'type': 'NOT 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': '24'}]}], 'dropWithdraws': [{'type': 'objective progression or relapse', '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': '15'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}]}, {'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': '4'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}]}, {'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': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '2'}]}, {'type': 'global deterioration of health status', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'PF-03446962', 'description': 'All participants who received PF-03446962 intravenous infusion (0.5 milligram/kilogram \\[mg/kg\\], 1 mg/kg, 2 mg, 3 mg/kg, 4.5 mg/kg, 6.75 mg/kg, 10 mg/kg, 15 mg/kg, 7 mg/kg), on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression or unacceptable toxicity.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.3', 'spread': '11.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population included all enrolled participants who received at least one dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-27', 'studyFirstSubmitDate': '2007-11-12', 'resultsFirstSubmitDate': '2015-07-16', 'studyFirstSubmitQcDate': '2007-11-12', 'lastUpdatePostDateStruct': {'date': '2015-10-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-07-16', 'studyFirstPostDateStruct': {'date': '2007-11-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Maximum Observed Serum Concentration (Cmax): Part 1 and Part 2', 'timeFrame': '0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)'}, {'measure': 'Minimum Observed Serum Trough Concentration (Cmin): Part 1 and Part 2', 'timeFrame': '0 hr (pre dose), 1 hr post-dose C1D1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to C12'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-03446962: Part 1 and Part 2', 'timeFrame': '0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)'}, {'measure': 'Area Under the Curve From Time Zero to Day 28 [AUC (0-28)]: Part 1 and Part 2', 'timeFrame': '0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)', 'description': 'AUC (0-28) = Area under the plasma concentration versus time curve from time zero (pre-dose) to Day 28 (0-28).'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast): Part 1 and Part 2', 'timeFrame': '0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).'}, {'measure': 'Systemic Clearance(CL): Part 1 and Part 2', 'timeFrame': '0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)', 'description': 'CL is a quantitative measure of the rate at which a drug substance is removed from the body. As per planned analysis, CL was summarized if at least 3 participants had reportable value.'}, {'measure': 'Plasma Decay Half-Life (t1/2): Part 1 and Part 2', 'timeFrame': '0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. As per planned analysis, t1/2 was summarized if at least 3 participants had reportable value.'}, {'measure': 'Human Anti - Human Antibody (HAHA) Concentration: Part 1 and Part 2', 'timeFrame': 'Baseline up to 3 months after last dose', 'description': 'HAHA concentration was analyzed in blood samples for the evaluation of immunogenicity of PF-03446962. HAHA concentration was reported for samples above lower limit of quantification (\\>=4.32).'}, {'measure': 'Soluble Protein Biomarker [Angiopoietin-2 (Ang-2), Bone Morphogenetic Protein-9 (BMP-9), Chemokine (C-C Motif) Ligand 2 (CCL2)]: Part 1 and Part 2', 'timeFrame': 'Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)', 'description': 'Plasma concentrations of soluble proteins (Ang-2, BMP-9, C-C motif) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity.'}, {'measure': 'Soluble Protein Biomarker [Cluster of Differentiation 106 (CD106), Cluster of Differentiation 54 (CD54), Endoglin]: Part 1 and Part 2', 'timeFrame': 'Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)', 'description': 'Plasma concentrations of soluble proteins (CD106, CD54 and Endoglin) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity.'}, {'measure': 'Soluble Protein Biomarker [Placental Growth Factor (PLGF), Transforming Growth Beta 1 (TGFB1), Vascular Endothelial Growth Factor A (VEGF-A)]: Part 1 and Part 2', 'timeFrame': 'Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)', 'description': 'Plasma concentrations of soluble proteins (PLGF, TGFB1, VEGF-A) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity.'}, {'measure': 'Soluble Protein Biomarker [Vascular Endothelial Growth Factor C (VEGF-C), Vascular Endothelial Growth Factor-d (VEGF-d), Vascular Endothelial Growth Factor Receptor Type 1 (VEGFR1)]: Part 1 and Part 2', 'timeFrame': 'Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)', 'description': 'Plasma concentrations of soluble proteins (VEGF-C, VEGF-d, VEGFR1) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity.'}, {'measure': 'Soluble Protein Biomarker [Vascular Endothelial Growth Factor Receptor Type 2 (VEGFR2), Vascular Endothelial Growth Factor Receptor Type 3 (VEGFR3)]: Part 1 and Part 2', 'timeFrame': 'Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)', 'description': 'Plasma concentrations of soluble proteins (VEGFR2, VEGFR3) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity.'}, {'measure': 'Circulating Endothelial Cells (CEC)and Circulating Endothelial Progenitors (CEP): Part 1 and Part 2', 'timeFrame': 'Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)', 'description': 'Circulating endothelial cells (CECs) are noninvasive marker of vascular damage, remodeling, and dysfunction. Blood samples for the assessment of CECs and circulating CEPs were collected to analyze effects of therapy on the number, viability/apoptotic state, and/or target activity/expression in CECs. Circulating Cells were classified as CEPs if cluster differentiation 133 positive cells (CD133+) were detected.'}], 'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose (MTD): Part 1', 'timeFrame': 'Baseline up to 42 days after the start of each increased treatment dose', 'description': 'MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced DLT and at least 2 out of 3/6 participants in the next higher dose. DLT was defined as any of the following events occurring during the first 42 days of study drug: any grade greater than or equal to 3 hematologic and non-hematologic toxicity, all non-disease-related adverse events (AEs).'}, {'measure': 'Recommended Phase 2 Dose (RP2D): Part 1', 'timeFrame': 'Baseline up to 42 days after the start of each increased treatment dose', 'description': 'RP2D was defined as the lower dose level to MTD based on the safety profile.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs): Part 1 and Part 2', 'timeFrame': 'Cycle 1 of Day 1 up to 28 days after the last dose of treatment', 'description': 'An all causality AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Treatment-related AEs was any untoward medical occurrence in participant that was attributed to study drug. Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Severity: Part 1 and Part 2', 'timeFrame': 'Cycle 1 of Day 1 up to 28 days after the last dose of treatment', 'description': 'AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity; Grade 0 (no change from normal); grade 1 (mild AE which did not cause any significant problem, no dose adjustment required); grade 2 (moderate AE which caused problem that did not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event); grade 3 (severe AE which caused problem that interfered significantly with usual activities or the clinical status, study drug stopped due to adverse event); grade 4 (life threatening AE) and grade 5 (death). Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Seriousness: Part 1 and Part 2', 'timeFrame': 'Cycle 1 of Day 1 up to 28 days after the last dose of treatment', 'description': 'AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Seriousness of an AE was assessed as serious adverse event (SAE) and non-serious adverse event (non-SAE). An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Non-SAE included all AE minus SAE. Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.'}, {'measure': 'Time to Treatment-Emergent Adverse Events (AEs): Part 1 and Part 2', 'timeFrame': 'Cycle 1 of Day 1 up to 28 days after the last dose of treatment', 'description': 'Total time from onset of adverse event till the event is resolved. Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.'}, {'measure': 'Number of Participants With Laboratory Abnormalities: Part 1 and Part 2', 'timeFrame': 'Cycle 1 of Day 1 up to 28 days after the last dose of treatment', 'description': 'Laboratory tests included hematology (hemoglobin, lymphocytes absolute \\[abs\\], neutrophils abs, platelets, white blood cells) and chemistry (alanine aminotransferase, alkaline phosphatase, amylase, aspartate aminotransferase, bilirubin, creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypokalemia, hyponatremia, hypophosphatemia, lipase). Assays were based on National Cancer Institute \\[NCI\\] Common Terminology Criteria for AE (CTCAE) grading scale for AEs (grade 1 \\[mild AE: did not cause any significant problem, no dose adjustment required\\]; grade 2 \\[moderate AE: caused problem that did not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event\\]; grade 3 \\[severe AE: caused problem that interfered significantly with usual activities or the clinical status, study drug stopped due to adverse event\\] and grade 4 \\[life threatening AE\\]). Overall data of the 4 grades is reported.'}, {'measure': 'Percentage of Participants With Objective Response: Part 1 and Part 2', 'timeFrame': 'Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490', 'description': 'Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR defined as disappearance of all target lesions and non-target lesions. PR defined as \\>=30 % decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non-target lesions.'}, {'measure': 'Percentage of Participants With Disease Control: Part 2', 'timeFrame': 'Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490', 'description': 'Participants who achieved either a confirmed complete Response or confirmed partial response or a Stable disease lasting at least 12 weeks from the first dose was defined as achieving disease control. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR: disappearance of all target lesions and non-target lesions. PR: \\>=30 % decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD and stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as a reference the smallest sum of the LD according to RECIST associated to non-progressive disease response for non-target lesions. Percentage of participants achieving disease control was calculated out of the participants participating in the exploratory phase.'}, {'measure': 'Time To Progression (TTP): Part 2', 'timeFrame': 'Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490', 'description': 'Time in months from start of treatment to first documentation of objective tumor progression. TTP was calculated as (first event date or last known progression-free date minus the date of treatment plus 1) divided by 30.44. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \\[PD\\] per RECIST). PD: \\>=20% increase in the sum of the LD of the target lesions taking as a reference the smallest sum of the LD or the appearance of one or more new lesions and as unequivocal progression of existing non-target lesions, or the appearance of \\>=1 new lesions. TTP was calculated out of the participants participating in the exploratory phase.'}, {'measure': 'Volume of Distribution: Part 1 and Part 2', 'timeFrame': '0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. As per planned analysis, volume of distribution was summarized if at least 3 participants had reportable value.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Solid Tumors Transforming Growth Factor Beta Activin Receptor-like Kinase 1'], 'conditions': ['Advanced Solid Tumors']}, 'referencesModule': {'references': [{'pmid': '27329247', 'type': 'DERIVED', 'citation': 'Simonelli M, Zucali P, Santoro A, Thomas MB, de Braud FG, Borghaei H, Berlin J, Denlinger CS, Noberasco C, Rimassa L, Kim TY, English PA, Abbattista A, Gallo Stampino C, Carpentieri M, Williams JA. Phase I study of PF-03446962, a fully human monoclonal antibody against activin receptor-like kinase-1, in patients with hepatocellular carcinoma. Ann Oncol. 2016 Sep;27(9):1782-7. doi: 10.1093/annonc/mdw240. Epub 2016 Jun 20.'}, {'pmid': '26655846', 'type': 'DERIVED', 'citation': 'Goff LW, Cohen RB, Berlin JD, de Braud FG, Lyshchik A, Noberasco C, Bertolini F, Carpentieri M, Stampino CG, Abbattista A, Wang E, Borghaei H. A Phase I Study of the Anti-Activin Receptor-Like Kinase 1 (ALK-1) Monoclonal Antibody PF-03446962 in Patients with Advanced Solid Tumors. Clin Cancer Res. 2016 May 1;22(9):2146-54. doi: 10.1158/1078-0432.CCR-15-1622. Epub 2015 Dec 11.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8471001&StudyName=A%20First%20In%20Patient%2C%20Study%20Of%20Investigational%20Drug%20PF-03446962%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 test the safety and effectiveness of PF-03446962 when given as a single agent. Tumors require new blood vessels to support their ability to grow and to spread (metastasize). New treatments aimed at preventing these blood vessels have the ability to improve the clinical management of cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced measurable or non-measurable solid tumors\n* Adequate bone marrow function\n* Adequate liver function\n* Adequate renal function\n* Be able and willing to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures\n\nExclusion Criteria:\n\n* Chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of first dose of study medication\n* Active bleeding disorder, including gastrointestinal bleeding, as evidenced by hematemesis, hemoptysis or melena in the past 6 months\n* Any of the following within the 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus; or any other active thromboembolic event\n* QTc prolongation defined as QTc \\>450 msec\n* Patients with known brain metastasis\n* Patients with peritoneal carcinosis at risk of bleeding\n* Major surgical procedure within 4 weeks of treatment\n* Pregnancy or breastfeeding'}, 'identificationModule': {'nctId': 'NCT00557856', 'briefTitle': 'A First In Patient, Study Of Investigational Drug PF-03446962 In Patients With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1 Pharmacokinetic And Pharmacodynamic Study Of Pf-03446962 In Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'A8471001'}, 'secondaryIdInfos': [{'id': '2007-001422-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: PF-03446962']}], 'interventions': [{'name': 'PF-03446962', 'type': 'DRUG', 'description': 'To determine the maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of PF-03446962 administered in patients with advanced solid tumors.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina, Hollings Cancer Center', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '37212-3505', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '20133', 'city': 'Milan', 'country': 'Italy', 'facility': 'S.C Diagnostica Radiologica 2', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20133', 'city': 'Milan', 'country': 'Italy', 'facility': 'S.C. Chirurgia Generale Indirizzo Oncologico 1 (epato-gastro-pancreatica)', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20133', 'city': 'Milan', 'country': 'Italy', 'facility': 'S.C. Medicina Oncologica I, Fondazione IRCCS Istituto Nazionale Tumori', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20141', 'city': 'Milan', 'country': 'Italy', 'facility': 'Dipartimento di Medicina', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20089', 'city': 'Rozzano (MI)', 'country': 'Italy', 'facility': 'UO di Oncologia ed Ematologia, Istituto Clinico Humanitas-Humanitas Cancer Center', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital / Department of Internal Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}