Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2025-12-29 @ 9:04 PM
Study NCT ID:
NCT01337050
Status:
COMPLETED
Last Update Posted:
2015-10-28
First Post:
2011-04-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Asian Phase I Study Of PF-03446962
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, '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': "Designation of primary and secondary endpoints was based on study team's inputs, as the endpoints were not prioritized in the study protocol."}}, '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 non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'PF-03446962 4.5 mg/kg', 'description': 'PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.', 'otherNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PF-03446962 7.0 mg/kg', 'description': 'PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.', 'otherNumAtRisk': 13, 'otherNumAffected': 13, 'seriousNumAtRisk': 13, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'PF-03446962 10.0 mg/kg', 'description': 'PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.', 'otherNumAtRisk': 19, 'otherNumAffected': 19, 'seriousNumAtRisk': 19, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Anorectal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Injection site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Enteritis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pseudofolliculitis barbae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Eschar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Procedural site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Blood albumin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Periarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cancer pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Liver carcinoma ruptured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Tumour pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Monoplegia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nervous system disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Atonic urinary bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Azotaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nasal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Seborrhoeic dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Telangiectasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'seriousEvents': [{'term': 'Large intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Tolerated Dose (MTD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962', 'description': 'PF-03446962 4.5, 7.0 or 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 6', 'description': 'The MTD was defined as the highest dose of PF-03446962 associated with the occurrence of Dose Limiting Toxicities (DLTs) in at most 1 of 6 participants with the next higher dose having at least 2/3 or 2/6 participants experiencing DLTs (that is (i.e.) Maximum Administrated Dose). DLT is defined if the participants meets the following criteria during the first 6 weeks of treatment, possibly attributable to PF-03446962. Neutropenia grade 4 (less than \\[\\< \\])500/cubic millimeter \\[mm\\^ 3\\]) lasting for greater than equal to (\\>=) 8 days; Febrile Neutropenia \\>= Grade 3; Neutropenic Infection \\>= Grade 3; Grade 4 thrombocytopenia (\\<25,000/mm\\^3); Grade 3 thrombocytopenia (\\<50,000/mm\\^3) with active bleeding; Grade 3 or higher non-hematological toxicity.', 'unitOfMeasure': 'mg/kg', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all enrolled participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.'}, {'type': 'PRIMARY', 'title': 'Recommended Phase-2 Dose (RP2D)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962', 'description': 'PF-03446962 4.5, 7.0 or 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 28 days after last dose of study medication', 'description': 'RP2D was determined by a comprehensive assessments based on all the safety data, efficacy data, pharmacokinetics profile and biomarker data using blood and tumor samples.', 'unitOfMeasure': 'mg/kg', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all enrolled participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 4.5 mg/kg', 'description': 'PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'OG001', 'title': 'PF-03446962 7.0 mg/kg', 'description': 'PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'OG002', 'title': 'PF-03446962 10.0 mg/kg', 'description': 'PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 28 days after last dose', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. Treatment-emergent 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 pre-treatment state. AEs included both SAEs and non-serious adverse events (non-SAEs).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all enrolled participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 4.5 mg/kg', 'description': 'PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'OG001', 'title': 'PF-03446962 7.0 mg/kg', 'description': 'PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'OG002', 'title': 'PF-03446962 10.0 mg/kg', 'description': 'PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 28 days after last dose', 'description': 'Adverse event (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 1 (Mild Adverse Event), Grade 2 (Moderate Adverse Event), Grade 3 (Severe Adverse Event), Grade 4 (Life- Threatening or Disabling Adverse Event), Grade 5 (Death Related to Adverse Event).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all enrolled participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 4.5 mg/kg', 'description': 'PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'OG001', 'title': 'PF-03446962 7.0 mg/kg', 'description': 'PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'OG002', 'title': 'PF-03446962 10.0 mg/kg', 'description': 'PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 28 days after last dose', 'description': "An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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. AEs included both SAEs and non-serious adverse events (non-SAEs). Relatedness to study drug was assessed based on investigator's discretion.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all enrolled participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 4.5 mg/kg', 'description': 'PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'OG001', 'title': 'PF-03446962 7.0 mg/kg', 'description': 'PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'OG002', 'title': 'PF-03446962 10.0 mg/kg', 'description': 'PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}], 'classes': [{'title': 'Anemia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Hemoglobin increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocyte count increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Lymphopenia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophils (absolute)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Platelets', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'White Blood Cells (WBC)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Alanine aminotransferase (ALT)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Alkaline phosphatase', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Amylase', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Aspartate aminotransferase (AST)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Total bilirubin', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Hypercalcemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Hyperglycemia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'Hyperkalemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Hypernatremia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypoalbuminemia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Hypocalcemia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Hyponatremia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Hypophosphatemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Lipase', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Prothrombin time (PT)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'PT International Normalized Ratio(INR)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Urine protein', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Hypoglycemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 28 days after last dose', 'description': 'Laboratory abnormalities were segregated into hematology, chemistry, coagulation and urinalysis test. It had been graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) into Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Life-threatening). Participants with abnormality of any of these grades are reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Serum Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 4.5 mg/kg', 'description': 'PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'OG001', 'title': 'PF-03446962 7.0 mg/kg', 'description': 'PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'OG002', 'title': 'PF-03446962 10.0 mg/kg', 'description': 'PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '89420', 'spread': '47', 'groupId': 'OG000'}, {'value': '121100', 'spread': '34', 'groupId': 'OG001'}, {'value': '169000', 'spread': '28', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Minimum Observed Serum Trough Concentration (Cmin)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 4.5 mg/kg', 'description': 'PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'OG001', 'title': 'PF-03446962 7.0 mg/kg', 'description': 'PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'OG002', 'title': 'PF-03446962 10.0 mg/kg', 'description': 'PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '6689', 'spread': '47', 'groupId': 'OG000'}, {'value': '14680', 'spread': '22', 'groupId': 'OG001'}, {'value': '22940', 'spread': '27', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 4.5 mg/kg', 'description': 'PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'OG001', 'title': 'PF-03446962 7.0 mg/kg', 'description': 'PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'OG002', 'title': 'PF-03446962 10.0 mg/kg', 'description': 'PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.74', 'spread': '47', 'groupId': 'OG000', 'lowerLimit': '0.983', 'upperLimit': '8.00'}, {'value': '2.00', 'spread': '22', 'groupId': 'OG001', 'lowerLimit': '0.900', 'upperLimit': '8.02'}, {'value': '1.50', 'spread': '27', 'groupId': 'OG002', 'lowerLimit': '0.950', 'upperLimit': '8.07'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1', 'unitOfMeasure': 'hours (hr)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to 28 Days [AUC (0-28)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 4.5 mg/kg', 'description': 'PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'OG001', 'title': 'PF-03446962 7.0 mg/kg', 'description': 'PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'OG002', 'title': 'PF-03446962 10.0 mg/kg', 'description': 'PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '12360000', 'spread': '36', 'groupId': 'OG000'}, {'value': '21980000', 'spread': '14', 'groupId': 'OG001'}, {'value': '30360000', 'spread': '22', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1', 'description': 'AUC (0-28)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-28).', 'unitOfMeasure': 'nanogram*hour per milliliter (ng*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 4.5 mg/kg', 'description': 'PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'OG001', 'title': 'PF-03446962 7.0 mg/kg', 'description': 'PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'OG002', 'title': 'PF-03446962 10.0 mg/kg', 'description': 'PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '12050000', 'spread': '39', 'groupId': 'OG000'}, {'value': '20500000', 'spread': '30', 'groupId': 'OG001'}, {'value': '26070000', 'spread': '62', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) for drug.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Systemic Clearance (CL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 4.5 mg/kg', 'description': 'PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'OG001', 'title': 'PF-03446962 7.0 mg/kg', 'description': 'PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'OG002', 'title': 'PF-03446962 10.0 mg/kg', 'description': 'PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01880', 'spread': '31', 'groupId': 'OG000'}, {'value': '0.01482', 'spread': '20', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not reported if less than 3 participants data was available, as planned.', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1', 'description': 'CL is a quantitative measure of the rate at which a drug substance is removed from the body.', 'unitOfMeasure': 'liter per hour (L/hr)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Volume of Distribution (Vd)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 4.5 mg/kg', 'description': 'PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'OG001', 'title': 'PF-03446962 7.0 mg/kg', 'description': 'PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'OG002', 'title': 'PF-03446962 10.0 mg/kg', 'description': 'PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.535', 'spread': '23', 'groupId': 'OG000'}, {'value': '6.556', 'spread': '23', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed if less than 3 participants were evaluable for the measure, as per planned analysis.', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1', '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.', 'unitOfMeasure': 'liter (L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Plasma Decay Half-Life (t1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 4.5 mg/kg', 'description': 'PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'OG001', 'title': 'PF-03446962 7.0 mg/kg', 'description': 'PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'OG002', 'title': 'PF-03446962 10.0 mg/kg', 'description': 'PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.58', 'spread': '2.2081', 'groupId': 'OG000'}, {'value': '14.16', 'spread': '1.7822', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed if less than 3 participants were evaluable for the measure, as per planned analysis.', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Soluble Proteins Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 4.5 mg/kg', 'description': 'PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'OG001', 'title': 'PF-03446962 7.0 mg/kg', 'description': 'PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'OG002', 'title': 'PF-03446962 10.0 mg/kg', 'description': 'PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}], 'classes': [{'title': 'VAM: Baseline (n=0,1,10)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not available as no participant was evaluable.', 'groupId': 'OG000'}, {'value': '5769662.5', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because only 1 participant was evaluable.', 'groupId': 'OG001'}, {'value': '4529407.4', 'spread': '2147607.09', 'groupId': 'OG002'}]}]}, {'title': 'VAM: Cycle1/Day1 0H(n=0,1,10)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not available as no participant was evaluable.', 'groupId': 'OG000'}, {'value': '5013301.1', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because only 1 participant was evaluable.', 'groupId': 'OG001'}, {'value': '4834240.9', 'spread': '4649500.22', 'groupId': 'OG002'}]}]}, {'title': 'VAM: Cycle1/Day1 6H (n=0,1,10)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not available as no participant was evaluable.', 'groupId': 'OG000'}, {'value': '6403610.0', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because only 1 participant was evaluable.', 'groupId': 'OG001'}, {'value': '5787177.6', 'spread': '4880400.90', 'groupId': 'OG002'}]}]}, {'title': 'VAM: Cycle1/Day22 (n=0,0,10)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not available as no participant was evaluable.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not available as no participant was evaluable.', 'groupId': 'OG001'}, {'value': '6388997.9', 'spread': '3326806.56', 'groupId': 'OG002'}]}]}, {'title': 'VAM: Cycle2/Day1 (n=0,0,8)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not available as no participant was evaluable.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not available as no participant was evaluable.', 'groupId': 'OG001'}, {'value': '8156950.3', 'spread': '8059603.45', 'groupId': 'OG002'}]}]}, {'title': 'VAM: Cycle3/Day1 (n=0,1,3)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not available as no participant was evaluable.', 'groupId': 'OG000'}, {'value': '3539105.4', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because only 1 participant was evaluable.', 'groupId': 'OG001'}, {'value': '6601473.2', 'spread': '3524102.00', 'groupId': 'OG002'}]}]}, {'title': 'VAM: End of Treatment (n=0,3,5)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not available as no participant was evaluable.', 'groupId': 'OG000'}, {'value': '10329091.1', 'spread': '1748797.03', 'groupId': 'OG001'}, {'value': '5648426.5', 'spread': '1095588.29', 'groupId': 'OG002'}]}]}, {'title': 'MCP-1: Baseline (n=4,13,19)', 'categories': [{'measurements': [{'value': '1049.6', 'spread': '202.58', 'groupId': 'OG000'}, {'value': '934.8', 'spread': '444.61', 'groupId': 'OG001'}, {'value': '1016.7', 'spread': '341.58', 'groupId': 'OG002'}]}]}, {'title': 'MCP-1: Cycle1/Day1 0H (n=4,13,19)', 'categories': [{'measurements': [{'value': '916.9', 'spread': '79.30', 'groupId': 'OG000'}, {'value': '911.2', 'spread': '233.53', 'groupId': 'OG001'}, {'value': '867.9', 'spread': '345.20', 'groupId': 'OG002'}]}]}, {'title': 'MCP-1: Cycle1/Day1 6H (n=4,13,19)', 'categories': [{'measurements': [{'value': '1246.8', 'spread': '453.48', 'groupId': 'OG000'}, {'value': '1774.5', 'spread': '1150.89', 'groupId': 'OG001'}, {'value': '2283.8', 'spread': '1462.53', 'groupId': 'OG002'}]}]}, {'title': 'MCP-1: Cycle1/Day22 (n=4,12,16)', 'categories': [{'measurements': [{'value': '932.2', 'spread': '241.45', 'groupId': 'OG000'}, {'value': '870.5', 'spread': '233.82', 'groupId': 'OG001'}, {'value': '1201.5', 'spread': '654.63', 'groupId': 'OG002'}]}]}, {'title': 'MCP-1: Cycle2/Day1 (n=3,12,14)', 'categories': [{'measurements': [{'value': '1202.9', 'spread': '208.51', 'groupId': 'OG000'}, {'value': '864.1', 'spread': '188.86', 'groupId': 'OG001'}, {'value': '1154.6', 'spread': '741.31', 'groupId': 'OG002'}]}]}, {'title': 'MCP-1: Cycle3/Day1 (n=2,8,5)', 'categories': [{'measurements': [{'value': '857.5', 'spread': '95.32', 'groupId': 'OG000'}, {'value': '916.8', 'spread': '288.98', 'groupId': 'OG001'}, {'value': '797.8', 'spread': '403.62', 'groupId': 'OG002'}]}]}, {'title': 'MCP-1: End of Treatment (n=4,7,11)', 'categories': [{'measurements': [{'value': '811.3', 'spread': '185.47', 'groupId': 'OG000'}, {'value': '1066.0', 'spread': '451.04', 'groupId': 'OG001'}, {'value': '1144.0', 'spread': '547.92', 'groupId': 'OG002'}]}]}, {'title': 'Angioprotein-2: Baseline (n=4,13,19)', 'categories': [{'measurements': [{'value': '358.7', 'spread': '183.72', 'groupId': 'OG000'}, {'value': '490.5', 'spread': '300.64', 'groupId': 'OG001'}, {'value': '730.1', 'spread': '800.18', 'groupId': 'OG002'}]}]}, {'title': 'Angioprotein-2: Cycle1/Day1 0H (n=4,13,19)', 'categories': [{'measurements': [{'value': '369.9', 'spread': '167.24', 'groupId': 'OG000'}, {'value': '439.2', 'spread': '190.70', 'groupId': 'OG001'}, {'value': '654.3', 'spread': '686.73', 'groupId': 'OG002'}]}]}, {'title': 'Angioprotein-2: Cycle1/Day1 6H (n=4,13,19)', 'categories': [{'measurements': [{'value': '282.1', 'spread': '130.38', 'groupId': 'OG000'}, {'value': '416.0', 'spread': '239.46', 'groupId': 'OG001'}, {'value': '792.7', 'spread': '813.77', 'groupId': 'OG002'}]}]}, {'title': 'Angioprotein-2: Cycle1/Day22 (n=4,12,16)', 'categories': [{'measurements': [{'value': '406.8', 'spread': '234.83', 'groupId': 'OG000'}, {'value': '503.4', 'spread': '242.67', 'groupId': 'OG001'}, {'value': '1282.8', 'spread': '1901.84', 'groupId': 'OG002'}]}]}, {'title': 'Angioprotein-2: Cycle2/Day1 (n=3,12,14)', 'categories': [{'measurements': [{'value': '269.5', 'spread': '122.91', 'groupId': 'OG000'}, {'value': '513.6', 'spread': '280.22', 'groupId': 'OG001'}, {'value': '752.2', 'spread': '568.44', 'groupId': 'OG002'}]}]}, {'title': 'Angioprotein-2: Cycle3/Day1 (n=2,8,5)', 'categories': [{'measurements': [{'value': '309.1', 'spread': '48.30', 'groupId': 'OG000'}, {'value': '510.8', 'spread': '256.27', 'groupId': 'OG001'}, {'value': '416.4', 'spread': '514.40', 'groupId': 'OG002'}]}]}, {'title': 'Angioprotein-2: End of Treatment (n=4,7,11)', 'categories': [{'measurements': [{'value': '288.6', 'spread': '154.63', 'groupId': 'OG000'}, {'value': '666.1', 'spread': '510.48', 'groupId': 'OG001'}, {'value': '1147.2', 'spread': '1452.48', 'groupId': 'OG002'}]}]}, {'title': 'ICAM-1: Baseline (n=0,1,10)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not available as no participant was evaluable.', 'groupId': 'OG000'}, {'value': '1277073.8', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because only 1 participant was evaluable.', 'groupId': 'OG001'}, {'value': '931954.7', 'spread': '1058110.51', 'groupId': 'OG002'}]}]}, {'title': 'ICAM-1: Cycle1/Day1 0H (n=0,1,10)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not available as no participant was evaluable.', 'groupId': 'OG000'}, {'value': '878849.0', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because only 1 participant was evaluable.', 'groupId': 'OG001'}, {'value': '844534.8', 'spread': '802742.55', 'groupId': 'OG002'}]}]}, {'title': 'ICAM-1: Cycle1/Day1 6H (n=0,1,10,)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not available as no participant was evaluable.', 'groupId': 'OG000'}, {'value': '806572.4', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because only 1 participant was evaluable.', 'groupId': 'OG001'}, {'value': '915166.4', 'spread': '923611.09', 'groupId': 'OG002'}]}]}, {'title': 'ICAM-1: Cycle1/Day22(n=0,0,10)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not available as no participant was evaluable.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not available as no participant was evaluable.', 'groupId': 'OG001'}, {'value': '1226089.9', 'spread': '1128415.32', 'groupId': 'OG002'}]}]}, {'title': 'ICAM-1: Cycle2/Day1 (n=0,0,8)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not available as no participant was evaluable.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not available as no participant was evaluable.', 'groupId': 'OG001'}, {'value': '827621.8', 'spread': '367125.98', 'groupId': 'OG002'}]}]}, {'title': 'ICAM-1: Cycle3/Day1 (n=0,1,3)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not available as no participant was evaluable.', 'groupId': 'OG000'}, {'value': '479439.4', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated because only 1 participant was evaluable.', 'groupId': 'OG001'}, {'value': '542607.5', 'spread': '150328.01', 'groupId': 'OG002'}]}]}, {'title': 'ICAM-1: End of Treatment (n=0,3,5)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not available as no participant was evaluable.', 'groupId': 'OG000'}, {'value': '1271075.6', 'spread': '515605.73', 'groupId': 'OG001'}, {'value': '1651061.8', 'spread': '2042387.17', 'groupId': 'OG002'}]}]}, {'title': 'SIAM-1: Baseline (n=4,12,9)', 'categories': [{'measurements': [{'value': '701303.4', 'spread': '294804.13', 'groupId': 'OG000'}, {'value': '466302.8', 'spread': '309842.34', 'groupId': 'OG001'}, {'value': '525958.2', 'spread': '113283.77', 'groupId': 'OG002'}]}]}, {'title': 'SIAM-1: Cycle1/Day1 0H (n=4,12,9)', 'categories': [{'measurements': [{'value': '623840.0', 'spread': '181192.64', 'groupId': 'OG000'}, {'value': '504021.3', 'spread': '256755.23', 'groupId': 'OG001'}, {'value': '532390.8', 'spread': '180640.87', 'groupId': 'OG002'}]}]}, {'title': 'SIAM-1: Cycle1/Day1 6H (n=4,12,9)', 'categories': [{'measurements': [{'value': '604163.5', 'spread': '214935.46', 'groupId': 'OG000'}, {'value': '411628.1', 'spread': '261009.28', 'groupId': 'OG001'}, {'value': '569359.0', 'spread': '201989.70', 'groupId': 'OG002'}]}]}, {'title': 'SIAM-1: Cycle1/Day22 (n=4,12,6)', 'categories': [{'measurements': [{'value': '668593.1', 'spread': '184915.57', 'groupId': 'OG000'}, {'value': '501742.8', 'spread': '320205.39', 'groupId': 'OG001'}, {'value': '622325.0', 'spread': '238791.57', 'groupId': 'OG002'}]}]}, {'title': 'SIAM-1: Cycle2/Day1 (n=3,12,6)', 'categories': [{'measurements': [{'value': '552736.5', 'spread': '184915.57', 'groupId': 'OG000'}, {'value': '501742.8', 'spread': '320205.39', 'groupId': 'OG001'}, {'value': '622325.0', 'spread': '238791.57', 'groupId': 'OG002'}]}]}, {'title': 'SIAM-1: Cycle3/Day1 (n=2,7,2)', 'categories': [{'measurements': [{'value': '638075.4', 'spread': '127112.48', 'groupId': 'OG000'}, {'value': '598448.3', 'spread': '317579.77', 'groupId': 'OG001'}, {'value': '438595.7', 'spread': '166268.03', 'groupId': 'OG002'}]}]}, {'title': 'SIAM-1: End of Treatment (n=4,4,6)', 'categories': [{'measurements': [{'value': '628177.9', 'spread': '163803.34', 'groupId': 'OG000'}, {'value': '464669.7', 'spread': '174245.04', 'groupId': 'OG001'}, {'value': '719398.7', 'spread': '231843.95', 'groupId': 'OG002'}]}]}, {'title': 'SVAM-1: Baseline (n=4,12,9)', 'categories': [{'measurements': [{'value': '2135238.6', 'spread': '849420.75', 'groupId': 'OG000'}, {'value': '3651583.3', 'spread': '2216213.70', 'groupId': 'OG001'}, {'value': '2551024.9', 'spread': '595975.01', 'groupId': 'OG002'}]}]}, {'title': 'SVAM-1: Cycle1/Day1 0H (n=4,12,9)', 'categories': [{'measurements': [{'value': '2061387.9', 'spread': '858687.41', 'groupId': 'OG000'}, {'value': '3583328.2', 'spread': '1998977.25', 'groupId': 'OG001'}, {'value': '2620267.2', 'spread': '1001526.82', 'groupId': 'OG002'}]}]}, {'title': 'SVAM-1: Cycle1/Day1 6H (n=4,12,9)', 'categories': [{'measurements': [{'value': '2034173.6', 'spread': '756983.20', 'groupId': 'OG000'}, {'value': '3576192.6', 'spread': '2751678.60', 'groupId': 'OG001'}, {'value': '3071682.9', 'spread': '1447507.40', 'groupId': 'OG002'}]}]}, {'title': 'SVAM-1: Cycle1/Day22 (n=4,12,6)', 'categories': [{'measurements': [{'value': '2665272.7', 'spread': '1159532.95', 'groupId': 'OG000'}, {'value': '4276947.7', 'spread': '2862681.78', 'groupId': 'OG001'}, {'value': '3653830.7', 'spread': '1746452.25', 'groupId': 'OG002'}]}]}, {'title': 'SVAM-1: Cycle2/Day1 (n=3,12,6)', 'categories': [{'measurements': [{'value': '1892498.5', 'spread': '68777.63', 'groupId': 'OG000'}, {'value': '4628918.3', 'spread': '3257637.40', 'groupId': 'OG001'}, {'value': '3574717.1', 'spread': '1661302.68', 'groupId': 'OG002'}]}]}, {'title': 'SVAM-1: Cycle3/Day1 (n=2,7,2)', 'categories': [{'measurements': [{'value': '2117070.8', 'spread': '747786.71', 'groupId': 'OG000'}, {'value': '4755433.2', 'spread': '2598745.99', 'groupId': 'OG001'}, {'value': '2349177.5', 'spread': '638957.67', 'groupId': 'OG002'}]}]}, {'title': 'SVAM-1: End of Treatment (n=4,4,6)', 'categories': [{'measurements': [{'value': '3802384.0', 'spread': '2865638.01', 'groupId': 'OG000'}, {'value': '3318897.7', 'spread': '1948986.96', 'groupId': 'OG001'}, {'value': '3748602.8', 'spread': '1332529.49', 'groupId': 'OG002'}]}]}, {'title': 'VEGF-A: Baseline (n=4,13,19)', 'categories': [{'measurements': [{'value': '429.4', 'spread': '208.76', 'groupId': 'OG000'}, {'value': '889.8', 'spread': '1475.25', 'groupId': 'OG001'}, {'value': '463.4', 'spread': '425.39', 'groupId': 'OG002'}]}]}, {'title': 'VEGF-A: Cycle1/Day1 0H (n=4,13,19)', 'categories': [{'measurements': [{'value': '455.4', 'spread': '175.23', 'groupId': 'OG000'}, {'value': '595.3', 'spread': '628.14', 'groupId': 'OG001'}, {'value': '410.3', 'spread': '419.93', 'groupId': 'OG002'}]}]}, {'title': 'VEGF-A: Cycle1/Day1 6H (n=4,13,19)', 'categories': [{'measurements': [{'value': '438.6', 'spread': '210.06', 'groupId': 'OG000'}, {'value': '631.9', 'spread': '644.09', 'groupId': 'OG001'}, {'value': '460.5', 'spread': '344.90', 'groupId': 'OG002'}]}]}, {'title': 'VEGF-A: Cycle1/Day22 (n=4,12,16)', 'categories': [{'measurements': [{'value': '703.7', 'spread': '416.74', 'groupId': 'OG000'}, {'value': '462.8', 'spread': '381.85', 'groupId': 'OG001'}, {'value': '529.1', 'spread': '511.82', 'groupId': 'OG002'}]}]}, {'title': 'VEGF-A: Cycle2/Day1 (n=3,12,14)', 'categories': [{'measurements': [{'value': '941.0', 'spread': '415.59', 'groupId': 'OG000'}, {'value': '508.0', 'spread': '406.78', 'groupId': 'OG001'}, {'value': '524.7', 'spread': '541.09', 'groupId': 'OG002'}]}]}, {'title': 'VEGF-A: Cycle3/Day1 (n=2,8,5)', 'categories': [{'measurements': [{'value': '904.2', 'spread': '1051.75', 'groupId': 'OG000'}, {'value': '355.7', 'spread': '259.00', 'groupId': 'OG001'}, {'value': '373.5', 'spread': '124.19', 'groupId': 'OG002'}]}]}, {'title': 'VEGF-A: End of Treatment (n=4,7,11)', 'categories': [{'measurements': [{'value': '632.2', 'spread': '676.85', 'groupId': 'OG000'}, {'value': '491.6', 'spread': '329.84', 'groupId': 'OG001'}, {'value': '556.7', 'spread': '740.20', 'groupId': 'OG002'}]}]}, {'title': 'VEGF-C: Baseline (n=4,13,19)', 'categories': [{'measurements': [{'value': '110.6', 'spread': '64.88', 'groupId': 'OG000'}, {'value': '112.0', 'spread': '91.80', 'groupId': 'OG001'}, {'value': '139.9', 'spread': '92.74', 'groupId': 'OG002'}]}]}, {'title': 'VEGF-C: Cycle1/Day1 0H (n=4,13,19)', 'categories': [{'measurements': [{'value': '104.2', 'spread': '62.45', 'groupId': 'OG000'}, {'value': '98.2', 'spread': '101.48', 'groupId': 'OG001'}, {'value': '95.6', 'spread': '81.09', 'groupId': 'OG002'}]}]}, {'title': 'VEGF-C: Cycle1/Day1 6H (n=4,13,19)', 'categories': [{'measurements': [{'value': '81.8', 'spread': '52.85', 'groupId': 'OG000'}, {'value': '79.3', 'spread': '64.75', 'groupId': 'OG001'}, {'value': '104.2', 'spread': '91.99', 'groupId': 'OG002'}]}]}, {'title': 'VEGF-C: Cycle1/Day22 (n=4,12,16)', 'categories': [{'measurements': [{'value': '115.0', 'spread': '67.41', 'groupId': 'OG000'}, {'value': '94.2', 'spread': '90.41', 'groupId': 'OG001'}, {'value': '105.1', 'spread': '92.55', 'groupId': 'OG002'}]}]}, {'title': 'VEGF-C: Cycle2/Day1 (n=3,12,14)', 'categories': [{'measurements': [{'value': '91.6', 'spread': '61.06', 'groupId': 'OG000'}, {'value': '93.0', 'spread': '106.58', 'groupId': 'OG001'}, {'value': '93.7', 'spread': '96.83', 'groupId': 'OG002'}]}]}, {'title': 'VEGF-C: Cycle3/Day1 (n=2,8,5)', 'categories': [{'measurements': [{'value': '31.3', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '82.2', 'spread': '124.89', 'groupId': 'OG001'}, {'value': '128.3', 'spread': '116.64', 'groupId': 'OG002'}]}]}, {'title': 'VEGF-C: End of Treatment (n=4,7,11)', 'categories': [{'measurements': [{'value': '70.9', 'spread': '60.02', 'groupId': 'OG000'}, {'value': '93.3', 'spread': '111.24', 'groupId': 'OG001'}, {'value': '64.7', 'spread': '68.37', 'groupId': 'OG002'}]}]}, {'title': 'VEGF-D: Baseline (n=4,13,19)', 'categories': [{'measurements': [{'value': '988.6', 'spread': '208.49', 'groupId': 'OG000'}, {'value': '1349.5', 'spread': '1133.71', 'groupId': 'OG001'}, {'value': '1176.4', 'spread': '361.43', 'groupId': 'OG002'}]}]}, {'title': 'VEGF-D: Cycle1/Day1 0H (n=4,13,19)', 'categories': [{'measurements': [{'value': '941.6', 'spread': '114.91', 'groupId': 'OG000'}, {'value': '1323.1', 'spread': '962.53', 'groupId': 'OG001'}, {'value': '1059.7', 'spread': '365.10', 'groupId': 'OG002'}]}]}, {'title': 'VEGF-D: Cycle1/Day1 6H (n=4,13,19)', 'categories': [{'measurements': [{'value': '881.9', 'spread': '89.36', 'groupId': 'OG000'}, {'value': '1341.9', 'spread': '1154.09', 'groupId': 'OG001'}, {'value': '1160.3', 'spread': '389.49', 'groupId': 'OG002'}]}]}, {'title': 'VEGF-D: Cycle1/Day22 (n=4,12,16)', 'categories': [{'measurements': [{'value': '853.9', 'spread': '176.92', 'groupId': 'OG000'}, {'value': '1327.6', 'spread': '984.57', 'groupId': 'OG001'}, {'value': '1365.8', 'spread': '431.90', 'groupId': 'OG002'}]}]}, {'title': 'VEGF-D: Cycle2/Day1 (n=3,12,14)', 'categories': [{'measurements': [{'value': '836.2', 'spread': '161.42', 'groupId': 'OG000'}, {'value': '1430.0', 'spread': '1203.55', 'groupId': 'OG001'}, {'value': '1315.8', 'spread': '527.01', 'groupId': 'OG002'}]}]}, {'title': 'VEGF-D: Cycle3/Day1 (n=2,8,5)', 'categories': [{'measurements': [{'value': '995.7', 'spread': '263.82', 'groupId': 'OG000'}, {'value': '1445.3', 'spread': '1403.28', 'groupId': 'OG001'}, {'value': '995.2', 'spread': '443.14', 'groupId': 'OG002'}]}]}, {'title': 'VEGF-D: End of Treatment (n=4,7,11)', 'categories': [{'measurements': [{'value': '809.4', 'spread': '176.66', 'groupId': 'OG000'}, {'value': '1494.1', 'spread': '1000.50', 'groupId': 'OG001'}, {'value': '1420.1', 'spread': '402.57', 'groupId': 'OG002'}]}]}, {'title': 'SVEGF-REC 1: Baseline (n=4,13,19)', 'categories': [{'measurements': [{'value': '152.3', 'spread': '29.59', 'groupId': 'OG000'}, {'value': '162.3', 'spread': '60.10', 'groupId': 'OG001'}, {'value': '228.5', 'spread': '88.14', 'groupId': 'OG002'}]}]}, {'title': 'SVEGF-REC 1: Cycle1/Day1 0H (n=4,13,19)', 'categories': [{'measurements': [{'value': '114.0', 'spread': '51.72', 'groupId': 'OG000'}, {'value': '1397.1', 'spread': '4204.03', 'groupId': 'OG001'}, {'value': '3196.4', 'spread': '10603.61', 'groupId': 'OG002'}]}]}, {'title': 'SVEGF-REC 1: Cycle1/Day1 6H (n=4,13,19)', 'categories': [{'measurements': [{'value': '116.9', 'spread': '16.94', 'groupId': 'OG000'}, {'value': '177.1', 'spread': '81.20', 'groupId': 'OG001'}, {'value': '255.2', 'spread': '95.68', 'groupId': 'OG002'}]}]}, {'title': 'SVEGF-REC 1: Cycle1/Day22 (n=4,12,16)', 'categories': [{'measurements': [{'value': '132.0', 'spread': '39.82', 'groupId': 'OG000'}, {'value': '170.9', 'spread': '93.07', 'groupId': 'OG001'}, {'value': '299.4', 'spread': '138.60', 'groupId': 'OG002'}]}]}, {'title': 'SVEGF-REC 1: Cycle2/Day1 (n=3,12,14)', 'categories': [{'measurements': [{'value': '447.4', 'spread': '467.46', 'groupId': 'OG000'}, {'value': '222.5', 'spread': '142.78', 'groupId': 'OG001'}, {'value': '261.0', 'spread': '115.68', 'groupId': 'OG002'}]}]}, {'title': 'SVEGF-REC 1: Cycle3/Day1 (n=2,8,5)', 'categories': [{'measurements': [{'value': '103.8', 'spread': '29.27', 'groupId': 'OG000'}, {'value': '155.5', 'spread': '80.26', 'groupId': 'OG001'}, {'value': '192.5', 'spread': '82.80', 'groupId': 'OG002'}]}]}, {'title': 'SVEGF-REC 1: End of Treatment (n=4,7,11)', 'categories': [{'measurements': [{'value': '113.7', 'spread': '33.47', 'groupId': 'OG000'}, {'value': '234.2', 'spread': '172.30', 'groupId': 'OG001'}, {'value': '276.8', 'spread': '227.19', 'groupId': 'OG002'}]}]}, {'title': 'SVEGF-REC 2: Baseline (n=4,13,19)', 'categories': [{'measurements': [{'value': '7436.6', 'spread': '1857.86', 'groupId': 'OG000'}, {'value': '6888.7', 'spread': '2231.62', 'groupId': 'OG001'}, {'value': '8440.8', 'spread': '2437.27', 'groupId': 'OG002'}]}]}, {'title': 'SVEGF-REC 2: Cycle1/Day1 0H (n=4,13,19)', 'categories': [{'measurements': [{'value': '7914.2', 'spread': '2988.27', 'groupId': 'OG000'}, {'value': '7026.7', 'spread': '2025.46', 'groupId': 'OG001'}, {'value': '7741.2', 'spread': '2133.30', 'groupId': 'OG002'}]}]}, {'title': 'SVEGF-REC 2: Cycle1/Day1 6H (n=4,13,19)', 'categories': [{'measurements': [{'value': '7870.7', 'spread': '3373.09', 'groupId': 'OG000'}, {'value': '6586.3', 'spread': '2081.36', 'groupId': 'OG001'}, {'value': '8378.4', 'spread': '1904.55', 'groupId': 'OG002'}]}]}, {'title': 'SVEGF-REC 2: Cycle1/Day22 (n=4,12,16)', 'categories': [{'measurements': [{'value': '7235.8', 'spread': '2807.65', 'groupId': 'OG000'}, {'value': '7069.1', 'spread': '2453.67', 'groupId': 'OG001'}, {'value': '8493.1', 'spread': '1844.69', 'groupId': 'OG002'}]}]}, {'title': 'SVEGF-REC 2: Cycle2/Day1 (n=3,12,14)', 'categories': [{'measurements': [{'value': '7597.3', 'spread': '3168.18', 'groupId': 'OG000'}, {'value': '7245.4', 'spread': '2560.56', 'groupId': 'OG001'}, {'value': '7965.4', 'spread': '2421.06', 'groupId': 'OG002'}]}]}, {'title': 'SVEGF-REC 2: Cycle3/Day1 (n=2,8,5)', 'categories': [{'measurements': [{'value': '8516.8', 'spread': '3960.15', 'groupId': 'OG000'}, {'value': '6827.8', 'spread': '2613.39', 'groupId': 'OG001'}, {'value': '8193.9', 'spread': '2074.23', 'groupId': 'OG002'}]}]}, {'title': 'SVEGF-REC 2: End of Treatment (n=4,7,11)', 'categories': [{'measurements': [{'value': '6714.4', 'spread': '2171.59', 'groupId': 'OG000'}, {'value': '6908.6', 'spread': '2872.56', 'groupId': 'OG001'}, {'value': '8963.3', 'spread': '1366.42', 'groupId': 'OG002'}]}]}, {'title': 'SVEGF-REC 3: Baseline (n=4,13,19)', 'categories': [{'measurements': [{'value': '456712.6', 'spread': '63869.92', 'groupId': 'OG000'}, {'value': '332957.5', 'spread': '114561.87', 'groupId': 'OG001'}, {'value': '434940.1', 'spread': '109510.31', 'groupId': 'OG002'}]}]}, {'title': 'SVEGF-REC 3: Cycle1/Day1 0H (n=4,13,19)', 'categories': [{'measurements': [{'value': '406786.4', 'spread': '11524.53', 'groupId': 'OG000'}, {'value': '355960.5', 'spread': '132035.48', 'groupId': 'OG001'}, {'value': '407148.7', 'spread': '92393.49', 'groupId': 'OG002'}]}]}, {'title': 'SVEGF-REC 3: Cycle1/Day1 6H (n=4,13,19)', 'categories': [{'measurements': [{'value': '395896.6', 'spread': '61076.24', 'groupId': 'OG000'}, {'value': '336962.5', 'spread': '141091.61', 'groupId': 'OG001'}, {'value': '416266.6', 'spread': '90886.33', 'groupId': 'OG002'}]}]}, {'title': 'SVEGF-REC 3: Cycle1/Day22 (n=4,12,16)', 'categories': [{'measurements': [{'value': '374514.7', 'spread': '33518.13', 'groupId': 'OG000'}, {'value': '310883.6', 'spread': '87289.24', 'groupId': 'OG001'}, {'value': '454274.1', 'spread': '141305.28', 'groupId': 'OG002'}]}]}, {'title': 'SVEGF-REC 3: Cycle2/Day1 (n=3,12,14)', 'categories': [{'measurements': [{'value': '405961.9', 'spread': '34525.64', 'groupId': 'OG000'}, {'value': '317659.8', 'spread': '79198.45', 'groupId': 'OG001'}, {'value': '450339.2', 'spread': '162644.43', 'groupId': 'OG002'}]}]}, {'title': 'SVEGF-REC 3: Cycle3/Day1 (n=2,8,5)', 'categories': [{'measurements': [{'value': '421505.5', 'spread': '23124.80', 'groupId': 'OG000'}, {'value': '289021.4', 'spread': '73419.94', 'groupId': 'OG001'}, {'value': '311026.0', 'spread': '93213.81', 'groupId': 'OG002'}]}]}, {'title': 'SVEGF-REC 3: End of Treatment (n=4,7,11)', 'categories': [{'measurements': [{'value': '345569.6', 'spread': '19964.62', 'groupId': 'OG000'}, {'value': '307319.1', 'spread': '99790.00', 'groupId': 'OG001'}, {'value': '434549.1', 'spread': '95476.81', 'groupId': 'OG002'}]}]}, {'title': 'BMP-9: Baseline (n=4,13,19)', 'categories': [{'measurements': [{'value': '8.3', 'spread': '4.77', 'groupId': 'OG000'}, {'value': '64.5', 'spread': '155.34', 'groupId': 'OG001'}, {'value': '24.8', 'spread': '18.39', 'groupId': 'OG002'}]}]}, {'title': 'BMP-9: Cycle1/Day1 0H (n=4,13,19)', 'categories': [{'measurements': [{'value': '7.4', 'spread': '5.00', 'groupId': 'OG000'}, {'value': '47.3', 'spread': '114.00', 'groupId': 'OG001'}, {'value': '22.0', 'spread': '12.61', 'groupId': 'OG002'}]}]}, {'title': 'BMP-9: Cycle1/Day1 6H (n=4,13,19)', 'categories': [{'measurements': [{'value': '16.7', 'spread': '8.95', 'groupId': 'OG000'}, {'value': '58.6', 'spread': '130.87', 'groupId': 'OG001'}, {'value': '33.4', 'spread': '15.93', 'groupId': 'OG002'}]}]}, {'title': 'BMP-9: Cycle1/Day22 (n=4,12,16)', 'categories': [{'measurements': [{'value': '8.9', 'spread': '6.39', 'groupId': 'OG000'}, {'value': '49.8', 'spread': '121.48', 'groupId': 'OG001'}, {'value': '25.7', 'spread': '12.26', 'groupId': 'OG002'}]}]}, {'title': 'BMP-9: Cycle2/Day1 (n=3,12,14)', 'categories': [{'measurements': [{'value': '8.1', 'spread': '5.01', 'groupId': 'OG000'}, {'value': '61.5', 'spread': '158.39', 'groupId': 'OG001'}, {'value': '24.7', 'spread': '12.58', 'groupId': 'OG002'}]}]}, {'title': 'BMP-9: Cycle3/Day1 (n=2,8,5)', 'categories': [{'measurements': [{'value': '16.5', 'spread': '16.33', 'groupId': 'OG000'}, {'value': '84.8', 'spread': '194.91', 'groupId': 'OG001'}, {'value': '25.2', 'spread': '10.90', 'groupId': 'OG002'}]}]}, {'title': 'BMP-9: End of Treatment (n=4,7,11)', 'categories': [{'measurements': [{'value': '11.2', 'spread': '6.09', 'groupId': 'OG000'}, {'value': '123.3', 'spread': '259.17', 'groupId': 'OG001'}, {'value': '47.0', 'spread': '70.74', 'groupId': 'OG002'}]}]}, {'title': 'Endoglin: Baseline (n=4,13,19)', 'categories': [{'measurements': [{'value': '22292.9', 'spread': '7065.67', 'groupId': 'OG000'}, {'value': '26312.5', 'spread': '8345.99', 'groupId': 'OG001'}, {'value': '31096.0', 'spread': '7553.99', 'groupId': 'OG002'}]}]}, {'title': 'Endoglin: Cycle1/Day1 0H (n=4,13,19)', 'categories': [{'measurements': [{'value': '21148.2', 'spread': '4493.48', 'groupId': 'OG000'}, {'value': '26514.1', 'spread': '4171.10', 'groupId': 'OG001'}, {'value': '29437.1', 'spread': '8796.80', 'groupId': 'OG002'}]}]}, {'title': 'Endoglin: Cycle1/Day1 6H (n=4,13,19)', 'categories': [{'measurements': [{'value': '20252.9', 'spread': '3093.23', 'groupId': 'OG000'}, {'value': '24385.0', 'spread': '7947.74', 'groupId': 'OG001'}, {'value': '29898.7', 'spread': '7743.02', 'groupId': 'OG002'}]}]}, {'title': 'Endoglin: Cycle1/Day22 (n=4,12,16)', 'categories': [{'measurements': [{'value': '20304.6', 'spread': '3085.27', 'groupId': 'OG000'}, {'value': '28106.4', 'spread': '6786.70', 'groupId': 'OG001'}, {'value': '39570.2', 'spread': '11857.18', 'groupId': 'OG002'}]}]}, {'title': 'Endoglin: Cycle2/Day1 (n=3,12,14)', 'categories': [{'measurements': [{'value': '18974.4', 'spread': '2212.35', 'groupId': 'OG000'}, {'value': '29533.7', 'spread': '8065.27', 'groupId': 'OG001'}, {'value': '35585.1', 'spread': '8558.35', 'groupId': 'OG002'}]}]}, {'title': 'Endoglin: Cycle3/Day1 (n=2,8,5)', 'categories': [{'measurements': [{'value': '20441.2', 'spread': '5168.88', 'groupId': 'OG000'}, {'value': '28063.4', 'spread': '6794.28', 'groupId': 'OG001'}, {'value': '33439.4', 'spread': '7464.88', 'groupId': 'OG002'}]}]}, {'title': 'Endoglin: End of Treatment (n=4,7,11)', 'categories': [{'measurements': [{'value': '21756.8', 'spread': '5825.18', 'groupId': 'OG000'}, {'value': '31653.3', 'spread': '9829.63', 'groupId': 'OG001'}, {'value': '33159.2', 'spread': '10674.69', 'groupId': 'OG002'}]}]}, {'title': 'TGF-Beta1: Baseline (n=4,13,19)', 'categories': [{'measurements': [{'value': '439154.4', 'spread': '194384.01', 'groupId': 'OG000'}, {'value': '288057.2', 'spread': '95964.14', 'groupId': 'OG001'}, {'value': '264779.6', 'spread': '245081.23', 'groupId': 'OG002'}]}]}, {'title': 'TGF-Beta1: Cycle1/Day1 0H (n=4,13,19)', 'categories': [{'measurements': [{'value': '420293.6', 'spread': '154286.55', 'groupId': 'OG000'}, {'value': '228313.8', 'spread': '101963.47', 'groupId': 'OG001'}, {'value': '187730.4', 'spread': '173444.62', 'groupId': 'OG002'}]}]}, {'title': 'TGF-Beta1: Cycle1/Day1 6H (n=4,13,19)', 'categories': [{'measurements': [{'value': '361727.2', 'spread': '195371.45', 'groupId': 'OG000'}, {'value': '240430.8', 'spread': '97194.19', 'groupId': 'OG001'}, {'value': '194814.7', 'spread': '173849.07', 'groupId': 'OG002'}]}]}, {'title': 'TGF-Beta1: Cycle1/Day22 (n=4,12,16)', 'categories': [{'measurements': [{'value': '322848.7', 'spread': '122214.82', 'groupId': 'OG000'}, {'value': '248764.0', 'spread': '105171.95', 'groupId': 'OG001'}, {'value': '169310.4', 'spread': '187249.43', 'groupId': 'OG002'}]}]}, {'title': 'TGF-Beta1: Cycle2/Day1 (n=3,12,14)', 'categories': [{'measurements': [{'value': '485627.2', 'spread': '145104.03', 'groupId': 'OG000'}, {'value': '253554.9', 'spread': '97795.74', 'groupId': 'OG001'}, {'value': '214255.5', 'spread': '269963.90', 'groupId': 'OG002'}]}]}, {'title': 'TGF-Beta1: Cycle3/Day1 (n=2,8,5)', 'categories': [{'measurements': [{'value': '355810.5', 'spread': '308789.78', 'groupId': 'OG000'}, {'value': '231920.2', 'spread': '128882.61', 'groupId': 'OG001'}, {'value': '280515.6', 'spread': '270982.35', 'groupId': 'OG002'}]}]}, {'title': 'TGF-Beta1: End of Treatment (n=4,7,11)', 'categories': [{'measurements': [{'value': '292378.4', 'spread': '154058.94', 'groupId': 'OG000'}, {'value': '235871.6', 'spread': '129631.54', 'groupId': 'OG001'}, {'value': '249663.6', 'spread': '300797.29', 'groupId': 'OG002'}]}]}, {'title': 'PGF: Baseline (n=4,13,19)', 'categories': [{'measurements': [{'value': '15.6', 'spread': '16.56', 'groupId': 'OG000'}, {'value': '10.7', 'spread': '4.03', 'groupId': 'OG001'}, {'value': '9.6', 'spread': '4.80', 'groupId': 'OG002'}]}]}, {'title': 'PGF: Cycle1/Day1 0H (n=4,13,19)', 'categories': [{'measurements': [{'value': '15.3', 'spread': '13.03', 'groupId': 'OG000'}, {'value': '12.7', 'spread': '4.67', 'groupId': 'OG001'}, {'value': '9.5', 'spread': '4.40', 'groupId': 'OG002'}]}]}, {'title': 'PGF: Cycle1/Day1 6H (n=4,13,19)', 'categories': [{'measurements': [{'value': '15.7', 'spread': '9.90', 'groupId': 'OG000'}, {'value': '14.8', 'spread': '7.35', 'groupId': 'OG001'}, {'value': '14.8', 'spread': '7.29', 'groupId': 'OG002'}]}]}, {'title': 'PGF: Cycle1/Day22 (n=4,12,16)', 'categories': [{'measurements': [{'value': '14.5', 'spread': '8.19', 'groupId': 'OG000'}, {'value': '9.6', 'spread': '3.28', 'groupId': 'OG001'}, {'value': '9.9', 'spread': '6.58', 'groupId': 'OG002'}]}]}, {'title': 'PGF:Cycle2/Day1 (n=3,12,14)', 'categories': [{'measurements': [{'value': '9.9', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '3.77', 'groupId': 'OG001'}, {'value': '9.2', 'spread': '5.15', 'groupId': 'OG002'}]}]}, {'title': 'PGF: Cycle3/Day1 (n=2,8,5)', 'categories': [{'measurements': [{'value': '7.2', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '2.60', 'groupId': 'OG001'}, {'value': '6.9', 'spread': '1.87', 'groupId': 'OG002'}]}]}, {'title': 'PGF: End of Treatment (n=4,7,11)', 'categories': [{'measurements': [{'value': '10.3', 'spread': '8.28', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '2.43', 'groupId': 'OG001'}, {'value': '8.6', 'spread': '5.15', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1, 0 hour (H), 6 H Cycle 1 Day 1, Day 22 of Cycle 1, Day 1 Cycle 2, Day 1 Cycle 3 and end of treatment (up to cycle 30)', 'description': 'Soluble proteins related to Activin Receptor-Like Kinase 1 (ALK-1) signaling and angiogenesis signaling including Vascular adhesion molecule (VAM), Monocyte chemotactic protein 1 (MCP-1), Angiopoietin 2, Tear intercellular adhesive molecule 1 (ICAM-1), Soluble intracellular adhesion molecule 1 (SIAM-1), Soluble vascular adhesion molecule 1 (SVAM-1), Vascular endothelial growth factor A (VEGF-A), Vascular endothelial growth factor C (VEGF-C), Vascular endothelial growth factor D (VEGF-D), Soluble vascular endothelial growth factor- Receptor 1 (REC 1) (SVEGF-REC 1), Soluble vascular endothelial growth factor- REC 2 (SVEGF-REC 2), Soluble vascular endothelial growth factor- REC 3 (SVEGF-REC 3), Bone morphogenetic protein-9 (BMP-9), Endoglin, Transforming growth factor- beta 1 (TGF- Beta 1), Placental growth factor (PGF) was evaluated.', 'unitOfMeasure': 'picogram per milliliter (pg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Biomarker analysis population included all enrolled and treated participants with baseline and on-treatment biomarker sample analyzed. Here "n"= participants who were evaluable for specified biomarker at given time point for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Human Anti-Human Antibody (HAHA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 4.5 mg/kg', 'description': 'PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'OG001', 'title': 'PF-03446962 7.0 mg/kg', 'description': 'PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'OG002', 'title': 'PF-03446962 10.0 mg/kg', 'description': 'PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'groupId': 'OG000'}, {'value': '1', 'spread': '2147607.09', 'groupId': 'OG001'}, {'value': '3', 'spread': '2071432.82', 'groupId': 'OG002'}]}]}, {'title': 'Post-Dose', 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'groupId': 'OG000'}, {'value': '0', 'spread': '4649500.22', 'groupId': 'OG001'}, {'value': '0', 'spread': '4411233.60', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Post-dose (Day 1 of every Cycle up to 28 days after last dose) up to Cycle 30', 'description': 'HAHA analysis was performed using validated, sensitive and specific chemiluminescence enzyme-linked immunosorbent assay (ELISA) methodology.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all enrolled participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Best Overall Response (BOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 4.5 mg/kg', 'description': 'PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'OG001', 'title': 'PF-03446962 7.0 mg/kg', 'description': 'PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'OG002', 'title': 'PF-03446962 10.0 mg/kg', 'description': 'PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}], 'classes': [{'title': 'CR', 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'groupId': 'OG000'}, {'value': '0', 'spread': '2147607.09', 'groupId': 'OG001'}, {'value': '0', 'spread': '2071432.82', 'groupId': 'OG002'}]}]}, {'title': 'PR', 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'groupId': 'OG000'}, {'value': '0', 'spread': '4649500.22', 'groupId': 'OG001'}, {'value': '0', 'spread': '4411233.60', 'groupId': 'OG002'}]}]}, {'title': 'SD', 'categories': [{'measurements': [{'value': '1', 'spread': 'NA', 'groupId': 'OG000'}, {'value': '4', 'spread': '8059603.45', 'groupId': 'OG001'}, {'value': '4', 'spread': '8059603.45', 'groupId': 'OG002'}]}]}, {'title': 'PD', 'categories': [{'measurements': [{'value': '2', 'spread': 'NA', 'groupId': 'OG000'}, {'value': '7', 'spread': '3524102.00', 'groupId': 'OG001'}, {'value': '13', 'spread': '3259456.10', 'groupId': 'OG002'}]}]}, {'title': 'Symptomatic Deterioration', 'categories': [{'measurements': [{'value': '0', 'spread': '1748797.03', 'groupId': 'OG000'}, {'value': '0', 'spread': '1095588.29', 'groupId': 'OG001'}, {'value': '1', 'spread': '2725448.88', 'groupId': 'OG002'}]}]}, {'title': 'Early Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Indeterminate', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, thereafter every 6 weeks up to end of treatment (up to Cycle 30)', 'description': "Number of participants with best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST); Complete response (CR): disappearance of all lesions, Pathological lymph nodes' reduction in short axis (SA) to less than (\\<)10 millimeter (mm); Partial response (PR): greater than equal to (\\>=) 30% decrease in sum of longest dimensions (LD) of Target Lesions (TL) taking reference baseline sum LD; Progressive disease (PD):\\>=20% (\\>= 5 mm increase) increase sum of LD of TL taking as a reference smallest sum of LD recorded since treatment start, appearance of \\>=1 new lesions, unequivocal progression of existing non-TL, or appearance of \\>=1 new lesion; Stable disease (SD): insufficient shrinkage to qualify for PR, insufficient increase to qualify for PD taking reference smallest sum of the LD since treatment start. Confirmed response=that persist at least 4 weeks after initial documentation.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Response evaluable population included all enrolled participants with measurable disease who received at least 1 dose of PF-03446962 and had an adequate baseline tumor assessment. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Benefit Response (CBR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 4.5 mg/kg', 'description': 'PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'OG001', 'title': 'PF-03446962 7.0 mg/kg', 'description': 'PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'OG002', 'title': 'PF-03446962 10.0 mg/kg', 'description': 'PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, thereafter every 6 weeks up to end of treatment (up to Cycle 30)', 'description': "Number of participant with clinical benefit response (CBR): CBR was defined as CR, PR, SD \\>12 weeks, SD\\<12weeks or PD according to RECIST criteria; Complete response (CR): disappearance of all lesions, Pathological lymph nodes' reduction in short axis (SA) to \\<10 mm; Partial response (PR): \\>=30% decrease in sum of longest dimensions (LD) of Target Lesions (TL) taking reference baseline sum LD; Progressive disease (PD):\\>=20% (\\>= 5 mm increase) increase sum of LD of TL taking as a reference smallest sum of LD recorded since treatment start, appearance of \\>=1 new lesions, unequivocal progression of existing non-TL, or appearance of \\>=1 new lesion; Stable disease (SD): insufficient shrinkage to qualify for PR, insufficient increase to qualify for PD taking reference smallest sum of the LD since treatment start.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Response evaluable population included all enrolled participants with measurable disease who received at least 1 dose of PF-03446962 and had an adequate baseline tumor assessment. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03446962 4.5 mg/kg', 'description': 'PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'OG001', 'title': 'PF-03446962 7.0 mg/kg', 'description': 'PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'OG002', 'title': 'PF-03446962 10.0 mg/kg', 'description': 'PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': 'NA', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '2.9'}, {'value': '1.8', 'spread': '2147607.09', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '5.6'}, {'value': '1.3', 'spread': '2071432.82', 'groupId': 'OG002', 'lowerLimit': '1.2', 'upperLimit': '1.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, thereafter every 6 weeks up to end of treatment (up to Cycle 30)', 'description': 'PFS was defined as the time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. PFS calculated as (Months) = (first event date minus randomization or the first dose date plus 1) divided by 30.44). PFS was calculated using the median, and 95% Confidence Intervals (CIs) and Progressive disease (PD):\\>=20% (\\>= 5 mm increase) increase sum of LD of TL taking as a reference smallest sum of LD recorded since treatment start, appearance of \\>=1 new lesions, unequivocal progression of existing non-TL, or appearance of \\>=1 new lesion.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Response evaluable population included all enrolled participants with measurable disease who received at least 1 dose of PF-03446962 and had an adequate baseline tumor assessment. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PF-03446962 4.5 mg/kg', 'description': 'PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'FG001', 'title': 'PF-03446962 7.0 mg/kg', 'description': 'PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'FG002', 'title': 'PF-03446962 10.0 mg/kg', 'description': 'PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Participants refused further follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'PF-03446962 4.5 mg/kg', 'description': 'PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'BG001', 'title': 'PF-03446962 7.0 mg/kg', 'description': 'PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'BG002', 'title': 'PF-03446962 10.0 mg/kg', 'description': 'PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.0', 'spread': '10.9', 'groupId': 'BG000'}, {'value': '56.5', 'spread': '12.4', 'groupId': 'BG001'}, {'value': '57.7', 'spread': '13.1', 'groupId': 'BG002'}, {'value': '57.4', 'spread': '12.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set included all enrolled participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-06', 'studyFirstSubmitDate': '2011-04-06', 'resultsFirstSubmitDate': '2015-07-16', 'studyFirstSubmitQcDate': '2011-04-15', 'lastUpdatePostDateStruct': {'date': '2015-10-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-08-13', 'studyFirstPostDateStruct': {'date': '2011-04-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose (MTD)', 'timeFrame': 'Baseline up to Week 6', 'description': 'The MTD was defined as the highest dose of PF-03446962 associated with the occurrence of Dose Limiting Toxicities (DLTs) in at most 1 of 6 participants with the next higher dose having at least 2/3 or 2/6 participants experiencing DLTs (that is (i.e.) Maximum Administrated Dose). DLT is defined if the participants meets the following criteria during the first 6 weeks of treatment, possibly attributable to PF-03446962. Neutropenia grade 4 (less than \\[\\< \\])500/cubic millimeter \\[mm\\^ 3\\]) lasting for greater than equal to (\\>=) 8 days; Febrile Neutropenia \\>= Grade 3; Neutropenic Infection \\>= Grade 3; Grade 4 thrombocytopenia (\\<25,000/mm\\^3); Grade 3 thrombocytopenia (\\<50,000/mm\\^3) with active bleeding; Grade 3 or higher non-hematological toxicity.'}, {'measure': 'Recommended Phase-2 Dose (RP2D)', 'timeFrame': 'Baseline up to 28 days after last dose of study medication', 'description': 'RP2D was determined by a comprehensive assessments based on all the safety data, efficacy data, pharmacokinetics profile and biomarker data using blood and tumor samples.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline up to 28 days after last dose', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. Treatment-emergent 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 pre-treatment state. AEs included both SAEs and non-serious adverse events (non-SAEs).'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Severity', 'timeFrame': 'Baseline up to 28 days after last dose', 'description': 'Adverse event (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 1 (Mild Adverse Event), Grade 2 (Moderate Adverse Event), Grade 3 (Severe Adverse Event), Grade 4 (Life- Threatening or Disabling Adverse Event), Grade 5 (Death Related to Adverse Event).'}, {'measure': 'Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline up to 28 days after last dose', 'description': "An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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. AEs included both SAEs and non-serious adverse events (non-SAEs). Relatedness to study drug was assessed based on investigator's discretion."}, {'measure': 'Number of Participants With Laboratory Abnormalities', 'timeFrame': 'Baseline up to 28 days after last dose', 'description': 'Laboratory abnormalities were segregated into hematology, chemistry, coagulation and urinalysis test. It had been graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) into Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Life-threatening). Participants with abnormality of any of these grades are reported.'}, {'measure': 'Maximum Observed Serum Concentration (Cmax)', 'timeFrame': '0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1'}, {'measure': 'Minimum Observed Serum Trough Concentration (Cmin)', 'timeFrame': '0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', 'timeFrame': '0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1'}, {'measure': 'Area Under the Curve From Time Zero to 28 Days [AUC (0-28)]', 'timeFrame': '0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1', 'description': 'AUC (0-28)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-28).'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)', 'timeFrame': '0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) for drug.'}, {'measure': 'Systemic Clearance (CL)', 'timeFrame': '0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1', 'description': 'CL is a quantitative measure of the rate at which a drug substance is removed from the body.'}, {'measure': 'Volume of Distribution (Vd)', 'timeFrame': '0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1', '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.'}, {'measure': 'Plasma Decay Half-Life (t1/2)', 'timeFrame': '0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.'}, {'measure': 'Soluble Proteins Level', 'timeFrame': 'Baseline, Day 1, 0 hour (H), 6 H Cycle 1 Day 1, Day 22 of Cycle 1, Day 1 Cycle 2, Day 1 Cycle 3 and end of treatment (up to cycle 30)', 'description': 'Soluble proteins related to Activin Receptor-Like Kinase 1 (ALK-1) signaling and angiogenesis signaling including Vascular adhesion molecule (VAM), Monocyte chemotactic protein 1 (MCP-1), Angiopoietin 2, Tear intercellular adhesive molecule 1 (ICAM-1), Soluble intracellular adhesion molecule 1 (SIAM-1), Soluble vascular adhesion molecule 1 (SVAM-1), Vascular endothelial growth factor A (VEGF-A), Vascular endothelial growth factor C (VEGF-C), Vascular endothelial growth factor D (VEGF-D), Soluble vascular endothelial growth factor- Receptor 1 (REC 1) (SVEGF-REC 1), Soluble vascular endothelial growth factor- REC 2 (SVEGF-REC 2), Soluble vascular endothelial growth factor- REC 3 (SVEGF-REC 3), Bone morphogenetic protein-9 (BMP-9), Endoglin, Transforming growth factor- beta 1 (TGF- Beta 1), Placental growth factor (PGF) was evaluated.'}, {'measure': 'Number of Participants With Human Anti-Human Antibody (HAHA)', 'timeFrame': 'Baseline, Post-dose (Day 1 of every Cycle up to 28 days after last dose) up to Cycle 30', 'description': 'HAHA analysis was performed using validated, sensitive and specific chemiluminescence enzyme-linked immunosorbent assay (ELISA) methodology.'}, {'measure': 'Number of Participants With Best Overall Response (BOR)', 'timeFrame': 'Baseline, thereafter every 6 weeks up to end of treatment (up to Cycle 30)', 'description': "Number of participants with best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST); Complete response (CR): disappearance of all lesions, Pathological lymph nodes' reduction in short axis (SA) to less than (\\<)10 millimeter (mm); Partial response (PR): greater than equal to (\\>=) 30% decrease in sum of longest dimensions (LD) of Target Lesions (TL) taking reference baseline sum LD; Progressive disease (PD):\\>=20% (\\>= 5 mm increase) increase sum of LD of TL taking as a reference smallest sum of LD recorded since treatment start, appearance of \\>=1 new lesions, unequivocal progression of existing non-TL, or appearance of \\>=1 new lesion; Stable disease (SD): insufficient shrinkage to qualify for PR, insufficient increase to qualify for PD taking reference smallest sum of the LD since treatment start. Confirmed response=that persist at least 4 weeks after initial documentation."}, {'measure': 'Number of Participants With Clinical Benefit Response (CBR)', 'timeFrame': 'Baseline, thereafter every 6 weeks up to end of treatment (up to Cycle 30)', 'description': "Number of participant with clinical benefit response (CBR): CBR was defined as CR, PR, SD \\>12 weeks, SD\\<12weeks or PD according to RECIST criteria; Complete response (CR): disappearance of all lesions, Pathological lymph nodes' reduction in short axis (SA) to \\<10 mm; Partial response (PR): \\>=30% decrease in sum of longest dimensions (LD) of Target Lesions (TL) taking reference baseline sum LD; Progressive disease (PD):\\>=20% (\\>= 5 mm increase) increase sum of LD of TL taking as a reference smallest sum of LD recorded since treatment start, appearance of \\>=1 new lesions, unequivocal progression of existing non-TL, or appearance of \\>=1 new lesion; Stable disease (SD): insufficient shrinkage to qualify for PR, insufficient increase to qualify for PD taking reference smallest sum of the LD since treatment start."}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Baseline, thereafter every 6 weeks up to end of treatment (up to Cycle 30)', 'description': 'PFS was defined as the time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. PFS calculated as (Months) = (first event date minus randomization or the first dose date plus 1) divided by 30.44). PFS was calculated using the median, and 95% Confidence Intervals (CIs) and Progressive disease (PD):\\>=20% (\\>= 5 mm increase) increase sum of LD of TL taking as a reference smallest sum of LD recorded since treatment start, appearance of \\>=1 new lesions, unequivocal progression of existing non-TL, or appearance of \\>=1 new lesion.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hepatocellular Carcinoma', 'Advanced/Metastatic solid tumors'], 'conditions': ['Neoplasms']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8471004&StudyName=Asian%20Phase%20I%20Study%20Of%20PF-03446962', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is an Asian Phase 1, multi center, open label, single arm study of PF 03446962 with dose escalation and designed to define the Maximum Tolerated Dose \\[MTD\\] and the Recommended Phase 2 Dose \\[RP2D\\].'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of stomach cancer\n* advanced/metastasis solid tumor refractory or intolerant to established therapy\n* adequate blood chemistry, blood counts and kidney/liver function\n* willing to participate to study requirements and sign an informed consent document\n\nExclusion Criteria:\n\n* Chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of first dose of study medication\n* excessive toxicities related to prior therapies\n* pregnant or breastfeeding patients'}, 'identificationModule': {'nctId': 'NCT01337050', 'briefTitle': 'Asian Phase I Study Of PF-03446962', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase I Pharmacokinetic And Pharmacodynamic Study Of Pf-03446962 In Asian Patient With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'A8471004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'PF-03446962', 'interventionNames': ['Drug: PF-03446962']}], 'interventions': [{'name': 'PF-03446962', 'type': 'DRUG', 'description': 'PF 03446962 given by a 1 hour IV infusion. Each patient will initially receive the first dose on Cycle 1 Day 1 with a 28 day observation period. Cycle 2 will start on Day 29. The dosing interval will be 14 days for Cycle 2 and subsequent cycles.', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '277-8577', 'city': 'Kashiwa', 'state': 'Chiba', 'country': 'Japan', 'facility': 'National Cancer Center Hospital East', 'geoPoint': {'lat': 35.86224, 'lon': 139.97732}}, {'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'}}}}