Ignite Creation Date:
2025-12-25 @ 1:13 AM
Ignite Modification Date:
2025-12-25 @ 11:23 PM
Study NCT ID:
NCT02444793
Status:
TERMINATED
Last Update Posted:
2019-02-27
First Post:
2015-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of PF-05082566 In Combination With Mogamulizumab In Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C577122', 'term': 'utomilumab'}, {'id': 'C549035', 'term': 'mogamulizumab'}]}}, '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': 'The study was terminated due to marginal efficacy and change in sponsor prioritization. No participants were enrolled in the dose-expansion portion.'}}, 'adverseEventsModule': {'timeFrame': 'Day 1 up to 60 days after last dose of study treatment', 'eventGroups': [{'id': 'EG000', 'title': 'PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'PF-05082566 100 mg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 3, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Erythema of eyelid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Temperature intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Genital herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Activated partial thromboplastin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vitamin B12 deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and 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{'term': 'Nasal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Respiratory tract congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Papule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rash erythematous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Skin exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Salmonellosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Dose Limiting Toxicities (DLT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG001', 'title': 'PF-05082566 100 mg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG002', 'title': 'PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG003', 'title': 'PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'First 2 Cycles (28 days in each cycle)', 'description': 'DLTs was defined as any of the following adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 at first 2 Cycles. Hematologic: (1) Grade 4 neutropenia lasting \\>7 days; (2) Febrile neutropenia, defined as absolute neutrophil count (ANC) \\<1000/mm3 with a single temperature of \\>38.3 degrees C (101 degrees F) or a sustained temperature of \\>=38 degrees C (100.4 degrees F) for more than 1 hour; (3) Grade \\>=3 neutropenic infection; (4) Grade \\>=3 thrombocytopenia with bleeding; (5) Grade 4 thrombocytopenia. Non-Hematologic: (1) Grade \\>=3 non laboratory toxicities (excluding infusion reactions), except those that had not been maximally treated (eg, nausea, vomiting, diarrhea); (2) Grade \\>=3 laboratory abnormalities (other than aspartate aminotransferase \\[AST\\]/alanine aminotransferase \\[ALT\\]) if: Medical intervention was required to treat the participant, or The abnormality led to hospitalization; (3) Grade 4 AST and ALT increase.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who were eligible for the study and received study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (All Causalities)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG001', 'title': 'PF-05082566 100 mg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG002', 'title': 'PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG003', 'title': 'PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 or 4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 up to 60 days after last dose of study treatment', 'description': 'An AE was any untoward medical occurrence in a participant administered a product or medical device without regard to possibility of causal relationship. Serious AEs (SAEs) were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions); resulted in congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. AEs were graded by the investigator according to NCI CTCAE version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). AEs included non-serious AEs and SAEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (PF-05082566 Related)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG001', 'title': 'PF-05082566 100 mg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG002', 'title': 'PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG003', 'title': 'PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 or 4 AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Grade 5 AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 up to 60 days after last dose of study treatment', 'description': 'An AE was any untoward medical occurrence in a participant administered a product or medical device has a causal relationship with PF-05082566. SAEs were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions); resulted in congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. AEs were graded by the investigator according to NCI CTCAE version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). AEs included non-serious AEs and SAEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (Mogamulizumab Related)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG001', 'title': 'PF-05082566 100 mg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG002', 'title': 'PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG003', 'title': 'PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 or 4 AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Grade 5 AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 up tp 60 days after last dose of study treatment', 'description': 'An AE was any untoward medical occurrence in a participant administered a product or medical device has a causal relationship with Mogamulizumab. SAEs were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions); resulted in congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. AEs were graded by the investigator according to NCI CTCAE version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). AEs included non-serious AEs and SAEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG001', 'title': 'PF-05082566 100 mg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG002', 'title': 'PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG003', 'title': 'PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}], 'classes': [{'title': 'Anemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hemoglobin increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Lymphocyte count increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Lymphopenia', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Neutrophils (absolute)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Platelets', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'White blood cells', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment', 'description': 'The hematology laboratory tests include: Anemia, Hemoglobin increased, Lymphocyte count increased, Lymphopenia, Neutrophils (absolute), Platelets, White blood cells.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG001', 'title': 'PF-05082566 100 mg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG002', 'title': 'PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG003', 'title': 'PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}], 'classes': [{'title': 'ALT', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Alkaline phosphatase', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'AST', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Bilirubin (total)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Creatinine', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hypercalcemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hyperglycemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hyperkalemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hypermagnesemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hypernatremia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hypoalbuminemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hypocalcemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hypoglycemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hypokalemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hypomagnesemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hyponatremia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hypophosphatemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment', 'description': 'The chemistry laboratory tests included: Alanine aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Lactate Dehydrogenase, Sodium, Potassium, Magnesium, Total Calcium, Phosphorus or Phosphate, Total bilirubin, Creatinine or creatinine clearance, Albumin, Total proteins, Uric Acid, BUN or Urea, Immunoglobulin G, Glucose (fasted).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Significant Observations in Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG001', 'title': 'PF-05082566 100 mg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG002', 'title': 'PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG003', 'title': 'PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment', 'description': 'Blood pressure (BP) and pulse rate were recorded in supine or sitting position.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Significant Changes From Baseline in Physical Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG001', 'title': 'PF-05082566 100 mg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG002', 'title': 'PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG003', 'title': 'PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}], 'classes': [{'title': 'Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Cycle 2 Day 1; End of the treatment.', 'description': 'Physical examination included an examination of major body systems, including general, head, ears, eyes, nose, mouth, throat, neck, lungs, heart, abdomen, musculoskeletal, lymph nodes, neurological and external genitalia. Significant changes from baseline were reported in each category.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least 1 dose of study treatment. Number analyzed was the number of participants at the given category.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Shift to Grades 2, 3, 4 or 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG001', 'title': 'PF-05082566 100 mg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG002', 'title': 'PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG003', 'title': 'PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment', 'description': 'ECOG performance status was classified as 5 grades: 0 (Fully active, able to carry on all predisease performance without restriction); 1 (Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, ie, light house work, office work); 2 (Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours); 3 (Capable of only limited self care, confined to bed or chair more than 50% of waking hours); 4 (Completely disabled. Cannot carry on any self care. Totally confined to bed or chair); 5 (Death). On-study shifts to ECOG performance statuses of 2, 3, 4 or 5 were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Serum Concentration (Cmax) of PF-05082566-Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG001', 'title': 'PF-05082566 100 mg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG002', 'title': 'PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG003', 'title': 'PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.71', 'spread': 'NA', 'comment': 'fewer than 3 participants had reportable parameter values', 'groupId': 'OG000'}, {'value': '27.80', 'spread': 'NA', 'comment': 'fewer than 3 participants had reportable parameter values', 'groupId': 'OG001'}, {'value': '105.7', 'spread': 'NA', 'comment': 'fewer than 3 participants had reportable parameter values', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.', 'description': 'Maximum Observed Serum Concentration (Cmax) was observed directly from the data.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Dose Normalized Cmax of PF-05082566-Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG001', 'title': 'PF-05082566 100 mg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG002', 'title': 'PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG003', 'title': 'PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.61', 'spread': 'NA', 'comment': 'fewer than 3 participants had reportable parameter values', 'groupId': 'OG000'}, {'value': '25.60', 'spread': 'NA', 'comment': 'fewer than 3 participants had reportable parameter values', 'groupId': 'OG001'}, {'value': '21.13', 'spread': 'NA', 'comment': 'fewer than 3 participants had reportable parameter values', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.', 'description': 'Dose normalized Cmax was calculated by Cmax / Dose', 'unitOfMeasure': 'µg/mL/mg/kg', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Cmax of Mogamulizumab-Cycles 1 and 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG001', 'title': 'PF-05082566 100 mg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG002', 'title': 'PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG003', 'title': 'PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18.78', 'spread': '19', 'groupId': 'OG000'}, {'value': '19.73', 'spread': '32', 'groupId': 'OG001'}, {'value': '19.77', 'spread': '16', 'groupId': 'OG002'}, {'value': '19.82', 'spread': '19', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '31.05', 'spread': 'NA', 'comment': 'fewer than 3 participants had reportable parameter values', 'groupId': 'OG000'}, {'value': '31.90', 'spread': 'NA', 'comment': 'fewer than 3 participants had reportable parameter values', 'groupId': 'OG001'}, {'value': '32.62', 'spread': 'NA', 'comment': 'fewer than 3 participants had reportable parameter values', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22; Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15', 'description': 'Maximum Observed Serum Concentration (Cmax) was observed directly from the data.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Pre-dose Concentration During Multiple Dosing (Ctrough) of PF-05082566-Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG001', 'title': 'PF-05082566 100 mg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG002', 'title': 'PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG003', 'title': 'PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.300', 'spread': 'NA', 'comment': 'fewer than 3 participants had reportable parameter values', 'groupId': 'OG000'}, {'value': '1.160', 'spread': 'NA', 'comment': 'fewer than 3 participants had reportable parameter values', 'groupId': 'OG001'}, {'value': '3.464', 'spread': 'NA', 'comment': 'fewer than 3 participants had reportable parameter values', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.', 'description': 'Pre-dose Concentration during Multiple Dosing (Ctrough) was observed directly from data', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Ctrough of Mogamulizumab- Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG001', 'title': 'PF-05082566 100 mg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG002', 'title': 'PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG003', 'title': 'PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.45', 'spread': 'NA', 'comment': 'fewer than 3 participants had reportable parameter values', 'groupId': 'OG000'}, {'value': '9.040', 'spread': 'NA', 'comment': 'fewer than 3 participants had reportable parameter values', 'groupId': 'OG001'}, {'value': '15.99', 'spread': 'NA', 'comment': 'fewer than 3 participants had reportable parameter values', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15', 'description': 'Pre-dose Concentration during Multiple Dosing (Ctrough) was observed directly from data.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Time for Cmax (Tmax) of PF-05082566-Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG001', 'title': 'PF-05082566 100 mg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG002', 'title': 'PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG003', 'title': 'PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.02', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '2.03'}, {'value': '6.00', 'groupId': 'OG001', 'lowerLimit': '6.00', 'upperLimit': '6.00'}, {'value': '1.08', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '1.25'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.', 'description': 'Time for Cmax (Tmax) was observed directly from the data.', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Time of Last Measurable Concentration (Tlast) of PF-05082566-Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG001', 'title': 'PF-05082566 100 mg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG002', 'title': 'PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG003', 'title': 'PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '336', 'groupId': 'OG000', 'lowerLimit': '335', 'upperLimit': '336'}, {'value': '309', 'groupId': 'OG001', 'lowerLimit': '309', 'upperLimit': '309'}, {'value': '97.6', 'groupId': 'OG003', 'lowerLimit': '25.1', 'upperLimit': '170'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.', 'description': 'Time of last measurable concentration was observed directly from data.', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Tmax of Mogamulizumab-Cycles 1 and 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG001', 'title': 'PF-05082566 100 mg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG002', 'title': 'PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG003', 'title': 'PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.28', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '5.50'}, {'value': '1.30', 'groupId': 'OG001', 'lowerLimit': '1.10', 'upperLimit': '2.25'}, {'value': '1.24', 'groupId': 'OG002', 'lowerLimit': '1.15', 'upperLimit': '4.58'}, {'value': '1.03', 'groupId': 'OG003', 'lowerLimit': '0.917', 'upperLimit': '1.18'}]}]}, {'title': 'Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.5', 'groupId': 'OG000', 'lowerLimit': '4.52', 'upperLimit': '22.4'}, {'value': '1.05', 'groupId': 'OG001', 'lowerLimit': '1.05', 'upperLimit': '1.05'}, {'value': '1.05', 'groupId': 'OG003', 'lowerLimit': '1.02', 'upperLimit': '1.07'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22; Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15', 'description': 'Time for Cmax (Tmax) was observed directly from the data.', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Tlast of Mogamulizumab-Cycles 1 and 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG001', 'title': 'PF-05082566 100 mg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG002', 'title': 'PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG003', 'title': 'PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '166', 'groupId': 'OG000', 'lowerLimit': '164', 'upperLimit': '285'}, {'value': '166', 'groupId': 'OG001', 'lowerLimit': '163', 'upperLimit': '214'}, {'value': '143', 'groupId': 'OG002', 'lowerLimit': '22.4', 'upperLimit': '194'}, {'value': '166', 'groupId': 'OG003', 'lowerLimit': '166', 'upperLimit': '171'}]}]}, {'title': 'Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '335', 'groupId': 'OG000', 'lowerLimit': '334', 'upperLimit': '335'}, {'value': '308', 'groupId': 'OG001', 'lowerLimit': '308', 'upperLimit': '308'}, {'value': '107', 'groupId': 'OG003', 'lowerLimit': '45.2', 'upperLimit': '168'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22; Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15', 'description': 'Time of last measurable concentration was observed directly from the data.', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Area Under the Serum Concentration-time Profile From Time 0 to the Time of the Last Measurable Concentration (AUClast) of PF-05082566-Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG001', 'title': 'PF-05082566 100 mg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG002', 'title': 'PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG003', 'title': 'PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '1143', 'spread': 'NA', 'comment': 'fewer than 3 participants had reportable parameter values', 'groupId': 'OG000'}, {'value': '2700', 'spread': 'NA', 'comment': 'fewer than 3 participants had reportable parameter values', 'groupId': 'OG001'}, {'value': '3875', 'spread': 'NA', 'comment': 'fewer than 3 participants had reportable parameter values', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.', 'description': 'AUClast was area under the serum concentration-time profile from time 0 to the time of the last measurable concentration (Clast), which was measured by Linear/Log trapezoidal method.', 'unitOfMeasure': 'μg*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Dose Normalized AUClast of PF-05082566-Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG001', 'title': 'PF-05082566 100 mg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG002', 'title': 'PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG003', 'title': 'PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '952.5', 'spread': 'NA', 'comment': 'fewer than 3 participants had reportable parameter values', 'groupId': 'OG000'}, {'value': '2490', 'spread': 'NA', 'comment': 'fewer than 3 participants had reportable parameter values', 'groupId': 'OG001'}, {'value': '773.0', 'spread': 'NA', 'comment': 'fewer than 3 participants had reportable parameter values', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.', 'description': 'Dose normalized AUClast was calculated by AUClast / Dose', 'unitOfMeasure': 'µg•hr/mL/mg/kg', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'AUClast of Mogamulizumab-Cycles 1 and 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG001', 'title': 'PF-05082566 100 mg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG002', 'title': 'PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG003', 'title': 'PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2001', 'spread': '24', 'groupId': 'OG000'}, {'value': '2182', 'spread': '36', 'groupId': 'OG001'}, {'value': '1382', 'spread': '133', 'groupId': 'OG002'}, {'value': '2126', 'spread': '24', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6853', 'spread': 'NA', 'comment': 'fewer than 3 participants had reportable parameter values', 'groupId': 'OG000'}, {'value': '5870', 'spread': 'NA', 'comment': 'fewer than 3 participants had reportable parameter values', 'groupId': 'OG001'}, {'value': '2310', 'spread': 'NA', 'comment': 'fewer than 3 participants had reportable parameter values', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22; Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15', 'description': 'AUClast was area under the serum concentration-time profile from time 0 to the time of the last measurable concentration (Clast), which was measured by Linear/Log trapezoidal method.', 'unitOfMeasure': 'μg*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Area Under the Serum Concentration-time Profile From Time 0 to 168 Hours (AUC168) of Mogamulizumab-Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG001', 'title': 'PF-05082566 100 mg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG002', 'title': 'PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG003', 'title': 'PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '1945', 'spread': '25', 'groupId': 'OG000'}, {'value': '2124', 'spread': '33', 'groupId': 'OG001'}, {'value': '2353', 'spread': '14', 'groupId': 'OG002'}, {'value': '2123', 'spread': '24', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22', 'description': 'AUC168 was area under the serum concentration-time profile from time 0 to 168 hours post dose (Cycle 1 only where dosing was once a week), which was measured by Linear/Log trapezoidal method.', 'unitOfMeasure': 'μg*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Area Under the Serum Concentration-time Profile From Time 0 to Time Tau (AUCtau) of Mogamulizumab-Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG001', 'title': 'PF-05082566 100 mg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG002', 'title': 'PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG003', 'title': 'PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '6868', 'spread': 'NA', 'comment': 'fewer than 3 participants had reportable parameter values', 'groupId': 'OG000'}, {'value': '6160', 'spread': 'NA', 'comment': 'fewer than 3 participants had reportable parameter values', 'groupId': 'OG001'}, {'value': '6950', 'spread': 'NA', 'comment': 'fewer than 3 participants had reportable parameter values', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15', 'description': 'AUCtau was area under the serum concentration-time profile from time 0 to time tau, the dosing interval, where tau=336 hours', 'unitOfMeasure': 'μg*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Clearance (CL) of Mogamulizumab-Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG001', 'title': 'PF-05082566 100 mg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG002', 'title': 'PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG003', 'title': 'PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.146', 'spread': 'NA', 'comment': 'fewer than 3 participants had reportable parameter values', 'groupId': 'OG000'}, {'value': '0.162', 'spread': 'NA', 'comment': 'fewer than 3 participants had reportable parameter values', 'groupId': 'OG001'}, {'value': '0.144', 'spread': 'NA', 'comment': 'fewer than 3 participants had reportable parameter values', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15', 'description': 'Clearance (CL) was measured by Dose / AUCtau', 'unitOfMeasure': 'mL/hr/kg', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Anti-Drug Antibody (ADA) Titer for PF-05082566', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG001', 'title': 'PF-05082566 100 mg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG002', 'title': 'PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG003', 'title': 'PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.98', 'groupId': 'OG000', 'lowerLimit': '12.31', 'upperLimit': '16.31'}, {'value': '10.80', 'groupId': 'OG001', 'lowerLimit': '6.23', 'upperLimit': '10.92'}, {'value': '17.25', 'comment': 'Only 1 participant was positive for ADA', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '8.03', 'groupId': 'OG003', 'lowerLimit': '6.23', 'upperLimit': '9.82'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months', 'description': 'Serum samples were assayed for ADA using a validated analytical method.', 'unitOfMeasure': 'Titer', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed was determined as participants with treatment-induced ADA.'}, {'type': 'SECONDARY', 'title': 'Neutralizing Antibodies (NAb) Titers for PF-05082566', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG001', 'title': 'PF-05082566 100 mg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG002', 'title': 'PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG003', 'title': 'PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.80', 'groupId': 'OG000', 'lowerLimit': '1.56', 'upperLimit': '1.86'}, {'value': '1.30', 'groupId': 'OG001', 'lowerLimit': '1.30', 'upperLimit': '1.30'}, {'value': '2.64', 'comment': 'Only 1 participant was positive for NAb', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.30', 'comment': 'Only 1 participant was positive for NAb', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months', 'description': 'ADA positive samples were further analyzed for NAb using a validated assay.', 'unitOfMeasure': 'Titer', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed was determined as participants with treatment-induced NAb.'}, {'type': 'SECONDARY', 'title': 'Anti-Drug Antibody (ADA) Titers for Mogamulizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG001', 'title': 'PF-05082566 100 mg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG002', 'title': 'PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG003', 'title': 'PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '1024', 'comment': 'Only 1 participant was positive for ADA', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months', 'description': 'Serum samples were assayed for ADA using a validated analytical method.', 'unitOfMeasure': 'Titer', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed was determined as participants with treatment-induced ADA.'}, {'type': 'SECONDARY', 'title': 'Neutralizing Antibodies (NAb) Titers for Mogamulizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG001', 'title': 'PF-05082566 100 mg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG002', 'title': 'PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG003', 'title': 'PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}], 'timeFrame': 'Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months', 'description': 'ADA positive samples were further analyzed for NAb using a validated assay', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed was determined as participants with treatment-induced NAb.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Objective Response (OR) and Immune-related Objective Response (irOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG001', 'title': 'PF-05082566 100 mg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG002', 'title': 'PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'OG003', 'title': 'PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}], 'classes': [{'title': 'Objective Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'immune-related Objective Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Every 8 weeks up to 24 months', 'description': 'OR was defined as best overall response (BOR) of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. Immune-related OR (irOR) was defined as immune-related BOR (irBOR) of immune-related CR (irCR) and immune-related PR (irPR) according to immune-related RECIST. CR: Complete disappearance of all target lesions with the exception of nodal disease; PR: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all enrolled participants.'}, {'type': 'SECONDARY', 'title': 'Time to Response (TTR) and Immue-related Time to Response (irTTR)-Dose Expansion Portion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Expansion Cohort', 'description': 'Expansion cohorts of participants were to be enrolled to further study the safety, tolerability, PK/PD, and preliminary anti tumor activity for PF-05082566 in combination with mogamulizumab, as well as to study tumor associated biomarkers.'}], 'classes': [{'title': 'TTR'}, {'title': 'irTTR'}], 'timeFrame': 'Every 8 weeks up to 24 months', 'description': 'TTR was defined, for participants with an OR, as the time from the date of first dose of study treatment to the first documentation of OR (CR or PR), which was subsequently confirmed. irTTR was defined, for participants with an irOR, as the time from the first dose of study treatment to the first documentation of irOR (irCR or irPR) which was subsequently confirmed. CR: Complete disappearance of all target lesions with the exception of nodal disease; PR: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions.', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants were enrolled in the dose-expansion portion.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DR) and Immune-related DR (irDR) -Dose Expansion Portion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Expansion Cohort', 'description': 'Expansion cohorts of participants were to be enrolled to further study the safety, tolerability, PK/PD, and preliminary anti tumor activity for PF-05082566 in combination with mogamulizumab, as well as to study tumor associated biomarkers.'}], 'classes': [{'title': 'DR'}, {'title': 'irDR'}], 'timeFrame': 'Every 8 weeks from the first occurrence of CR or PR, until disease progression or death up to 24 months', 'description': 'DR was defined, for participants with an OR, as the time from first documentation of OR (CR or PR) to the date of first documentation of objective progression disease (PD) or death due to any cause. irDR was defined, for participants with an irOR, as the time from the first documentation of irOR (irCR or irPR) to the date of first documentation of immune-related PD (irPD) (which was subsequently confirmed) or death due to any cause. CR: Complete disappearance of all target lesions with the exception of nodal disease; PR: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions; PD: 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm.', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants were enrolled in the dose-expansion portion.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) and Immune-related PFS (irPFS) - Dose Expansion Portion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Expansion Cohort', 'description': 'Expansion cohorts of participants were to be enrolled to further study the safety, tolerability, PK/PD, and preliminary anti tumor activity for PF-05082566 in combination with mogamulizumab, as well as to study tumor associated biomarkers.'}], 'classes': [{'title': 'PFS'}, {'title': 'irPFS'}], 'timeFrame': 'Every 8 weeks up to 24 months', 'description': 'PFS was defined as the time from the date of first dose of study treatment to the date of the first documentation of PD or death due to any cause, whichever occurred first. irPFS was defined as the time from the first dose of study treatment to the date of first documentation of irPD (which was subsequently confirmed) or death due to any cause, whichever occurred first. PD:20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm.', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants were enrolled in the dose-expansion portion.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'FG001', 'title': 'PF-05082566 100 mg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'FG002', 'title': 'PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'FG003', 'title': 'PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Objective progression or relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'BG001', 'title': 'PF-05082566 100 mg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'BG002', 'title': 'PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'BG003', 'title': 'PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.5', 'spread': '4.9', 'groupId': 'BG000'}, {'value': '66.2', 'spread': '8.6', 'groupId': 'BG001'}, {'value': '67.8', 'spread': '4.0', 'groupId': 'BG002'}, {'value': '62.7', 'spread': '8.7', 'groupId': 'BG003'}, {'value': '63.9', 'spread': '6.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}, {'title': 'Black', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Included all enrolled participants who received at least 1 dose of study treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-02-04', 'size': 7111860, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-09-24T08:53', 'hasProtocol': True}, {'date': '2017-09-21', 'size': 3792275, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-09-24T08:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'whyStopped': 'The study was terminated due to marginal efficacy and change in sponsor prioritization. The combination had a manageable safety profile.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-13', 'studyFirstSubmitDate': '2015-05-12', 'resultsFirstSubmitDate': '2018-09-26', 'studyFirstSubmitQcDate': '2015-05-12', 'lastUpdatePostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-09-26', 'studyFirstPostDateStruct': {'date': '2015-05-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Dose Limiting Toxicities (DLT)', 'timeFrame': 'First 2 Cycles (28 days in each cycle)', 'description': 'DLTs was defined as any of the following adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 at first 2 Cycles. Hematologic: (1) Grade 4 neutropenia lasting \\>7 days; (2) Febrile neutropenia, defined as absolute neutrophil count (ANC) \\<1000/mm3 with a single temperature of \\>38.3 degrees C (101 degrees F) or a sustained temperature of \\>=38 degrees C (100.4 degrees F) for more than 1 hour; (3) Grade \\>=3 neutropenic infection; (4) Grade \\>=3 thrombocytopenia with bleeding; (5) Grade 4 thrombocytopenia. Non-Hematologic: (1) Grade \\>=3 non laboratory toxicities (excluding infusion reactions), except those that had not been maximally treated (eg, nausea, vomiting, diarrhea); (2) Grade \\>=3 laboratory abnormalities (other than aspartate aminotransferase \\[AST\\]/alanine aminotransferase \\[ALT\\]) if: Medical intervention was required to treat the participant, or The abnormality led to hospitalization; (3) Grade 4 AST and ALT increase.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Adverse Events (All Causalities)', 'timeFrame': 'Day 1 up to 60 days after last dose of study treatment', 'description': 'An AE was any untoward medical occurrence in a participant administered a product or medical device without regard to possibility of causal relationship. Serious AEs (SAEs) were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions); resulted in congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. AEs were graded by the investigator according to NCI CTCAE version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). AEs included non-serious AEs and SAEs.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (PF-05082566 Related)', 'timeFrame': 'Day 1 up to 60 days after last dose of study treatment', 'description': 'An AE was any untoward medical occurrence in a participant administered a product or medical device has a causal relationship with PF-05082566. SAEs were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions); resulted in congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. AEs were graded by the investigator according to NCI CTCAE version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). AEs included non-serious AEs and SAEs.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (Mogamulizumab Related)', 'timeFrame': 'Day 1 up tp 60 days after last dose of study treatment', 'description': 'An AE was any untoward medical occurrence in a participant administered a product or medical device has a causal relationship with Mogamulizumab. SAEs were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions); resulted in congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. AEs were graded by the investigator according to NCI CTCAE version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). AEs included non-serious AEs and SAEs.'}, {'measure': 'Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4', 'timeFrame': 'Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment', 'description': 'The hematology laboratory tests include: Anemia, Hemoglobin increased, Lymphocyte count increased, Lymphopenia, Neutrophils (absolute), Platelets, White blood cells.'}, {'measure': 'Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4', 'timeFrame': 'Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment', 'description': 'The chemistry laboratory tests included: Alanine aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Lactate Dehydrogenase, Sodium, Potassium, Magnesium, Total Calcium, Phosphorus or Phosphate, Total bilirubin, Creatinine or creatinine clearance, Albumin, Total proteins, Uric Acid, BUN or Urea, Immunoglobulin G, Glucose (fasted).'}, {'measure': 'Number of Participants With Clinical Significant Observations in Vital Signs', 'timeFrame': 'Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment', 'description': 'Blood pressure (BP) and pulse rate were recorded in supine or sitting position.'}, {'measure': 'Number of Participants With Significant Changes From Baseline in Physical Examination', 'timeFrame': 'Cycle 2 Day 1; End of the treatment.', 'description': 'Physical examination included an examination of major body systems, including general, head, ears, eyes, nose, mouth, throat, neck, lungs, heart, abdomen, musculoskeletal, lymph nodes, neurological and external genitalia. Significant changes from baseline were reported in each category.'}, {'measure': 'Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Shift to Grades 2, 3, 4 or 5', 'timeFrame': 'Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment', 'description': 'ECOG performance status was classified as 5 grades: 0 (Fully active, able to carry on all predisease performance without restriction); 1 (Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, ie, light house work, office work); 2 (Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours); 3 (Capable of only limited self care, confined to bed or chair more than 50% of waking hours); 4 (Completely disabled. Cannot carry on any self care. Totally confined to bed or chair); 5 (Death). On-study shifts to ECOG performance statuses of 2, 3, 4 or 5 were reported.'}, {'measure': 'Maximum Observed Serum Concentration (Cmax) of PF-05082566-Cycle 5', 'timeFrame': 'Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.', 'description': 'Maximum Observed Serum Concentration (Cmax) was observed directly from the data.'}, {'measure': 'Dose Normalized Cmax of PF-05082566-Cycle 5', 'timeFrame': 'Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.', 'description': 'Dose normalized Cmax was calculated by Cmax / Dose'}, {'measure': 'Cmax of Mogamulizumab-Cycles 1 and 5', 'timeFrame': 'Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22; Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15', 'description': 'Maximum Observed Serum Concentration (Cmax) was observed directly from the data.'}, {'measure': 'Pre-dose Concentration During Multiple Dosing (Ctrough) of PF-05082566-Cycle 5', 'timeFrame': 'Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.', 'description': 'Pre-dose Concentration during Multiple Dosing (Ctrough) was observed directly from data'}, {'measure': 'Ctrough of Mogamulizumab- Cycle 5', 'timeFrame': 'Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15', 'description': 'Pre-dose Concentration during Multiple Dosing (Ctrough) was observed directly from data.'}, {'measure': 'Time for Cmax (Tmax) of PF-05082566-Cycle 5', 'timeFrame': 'Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.', 'description': 'Time for Cmax (Tmax) was observed directly from the data.'}, {'measure': 'Time of Last Measurable Concentration (Tlast) of PF-05082566-Cycle 5', 'timeFrame': 'Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.', 'description': 'Time of last measurable concentration was observed directly from data.'}, {'measure': 'Tmax of Mogamulizumab-Cycles 1 and 5', 'timeFrame': 'Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22; Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15', 'description': 'Time for Cmax (Tmax) was observed directly from the data.'}, {'measure': 'Tlast of Mogamulizumab-Cycles 1 and 5', 'timeFrame': 'Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22; Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15', 'description': 'Time of last measurable concentration was observed directly from the data.'}, {'measure': 'Area Under the Serum Concentration-time Profile From Time 0 to the Time of the Last Measurable Concentration (AUClast) of PF-05082566-Cycle 5', 'timeFrame': 'Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.', 'description': 'AUClast was area under the serum concentration-time profile from time 0 to the time of the last measurable concentration (Clast), which was measured by Linear/Log trapezoidal method.'}, {'measure': 'Dose Normalized AUClast of PF-05082566-Cycle 5', 'timeFrame': 'Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.', 'description': 'Dose normalized AUClast was calculated by AUClast / Dose'}, {'measure': 'AUClast of Mogamulizumab-Cycles 1 and 5', 'timeFrame': 'Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22; Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15', 'description': 'AUClast was area under the serum concentration-time profile from time 0 to the time of the last measurable concentration (Clast), which was measured by Linear/Log trapezoidal method.'}, {'measure': 'Area Under the Serum Concentration-time Profile From Time 0 to 168 Hours (AUC168) of Mogamulizumab-Cycle 1', 'timeFrame': 'Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22', 'description': 'AUC168 was area under the serum concentration-time profile from time 0 to 168 hours post dose (Cycle 1 only where dosing was once a week), which was measured by Linear/Log trapezoidal method.'}, {'measure': 'Area Under the Serum Concentration-time Profile From Time 0 to Time Tau (AUCtau) of Mogamulizumab-Cycle 5', 'timeFrame': 'Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15', 'description': 'AUCtau was area under the serum concentration-time profile from time 0 to time tau, the dosing interval, where tau=336 hours'}, {'measure': 'Clearance (CL) of Mogamulizumab-Cycle 5', 'timeFrame': 'Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15', 'description': 'Clearance (CL) was measured by Dose / AUCtau'}, {'measure': 'Anti-Drug Antibody (ADA) Titer for PF-05082566', 'timeFrame': 'Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months', 'description': 'Serum samples were assayed for ADA using a validated analytical method.'}, {'measure': 'Neutralizing Antibodies (NAb) Titers for PF-05082566', 'timeFrame': 'Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months', 'description': 'ADA positive samples were further analyzed for NAb using a validated assay.'}, {'measure': 'Anti-Drug Antibody (ADA) Titers for Mogamulizumab', 'timeFrame': 'Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months', 'description': 'Serum samples were assayed for ADA using a validated analytical method.'}, {'measure': 'Neutralizing Antibodies (NAb) Titers for Mogamulizumab', 'timeFrame': 'Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months', 'description': 'ADA positive samples were further analyzed for NAb using a validated assay'}, {'measure': 'Number of Participants With Objective Response (OR) and Immune-related Objective Response (irOR)', 'timeFrame': 'Every 8 weeks up to 24 months', 'description': 'OR was defined as best overall response (BOR) of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. Immune-related OR (irOR) was defined as immune-related BOR (irBOR) of immune-related CR (irCR) and immune-related PR (irPR) according to immune-related RECIST. CR: Complete disappearance of all target lesions with the exception of nodal disease; PR: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions.'}, {'measure': 'Time to Response (TTR) and Immue-related Time to Response (irTTR)-Dose Expansion Portion', 'timeFrame': 'Every 8 weeks up to 24 months', 'description': 'TTR was defined, for participants with an OR, as the time from the date of first dose of study treatment to the first documentation of OR (CR or PR), which was subsequently confirmed. irTTR was defined, for participants with an irOR, as the time from the first dose of study treatment to the first documentation of irOR (irCR or irPR) which was subsequently confirmed. CR: Complete disappearance of all target lesions with the exception of nodal disease; PR: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions.'}, {'measure': 'Duration of Response (DR) and Immune-related DR (irDR) -Dose Expansion Portion', 'timeFrame': 'Every 8 weeks from the first occurrence of CR or PR, until disease progression or death up to 24 months', 'description': 'DR was defined, for participants with an OR, as the time from first documentation of OR (CR or PR) to the date of first documentation of objective progression disease (PD) or death due to any cause. irDR was defined, for participants with an irOR, as the time from the first documentation of irOR (irCR or irPR) to the date of first documentation of immune-related PD (irPD) (which was subsequently confirmed) or death due to any cause. CR: Complete disappearance of all target lesions with the exception of nodal disease; PR: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions; PD: 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm.'}, {'measure': 'Progression Free Survival (PFS) and Immune-related PFS (irPFS) - Dose Expansion Portion', 'timeFrame': 'Every 8 weeks up to 24 months', 'description': 'PFS was defined as the time from the date of first dose of study treatment to the date of the first documentation of PD or death due to any cause, whichever occurred first. irPFS was defined as the time from the first dose of study treatment to the date of first documentation of irPD (which was subsequently confirmed) or death due to any cause, whichever occurred first. PD:20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Advanced/Metastatic Solid Tumors']}, 'referencesModule': {'references': [{'pmid': '31801624', 'type': 'DERIVED', 'citation': 'Cohen EEW, Pishvaian MJ, Shepard DR, Wang D, Weiss J, Johnson ML, Chung CH, Chen Y, Huang B, Davis CB, Toffalorio F, Thall A, Powell SF. A phase Ib study of utomilumab (PF-05082566) in combination with mogamulizumab in patients with advanced solid tumors. J Immunother Cancer. 2019 Dec 4;7(1):342. doi: 10.1186/s40425-019-0815-6.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1641004&StudyName=A%20Phase%201b%20Study%20Of%20Pf-05082566%20In%20Combination%20With%20Mogamulizumab%20%28kw-0761%29%20In%20Patients%20With%20Advanced%20Solid%20Tumors', 'label': 'To obtain contact information for a study center near you, click here.'}, {'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1641004&StudyName=A+Phase+1b+Study+Of+Pf-05082566+In+Combination+With+Mogamulizumab+%28kw-0761%29+In+Patients+With+Advanced+Solid+Tumors', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study is a Phase 1b, open label, multi center, multi-dose trial designed to estimate the maximum tolerated dose (MTD) and select the recommended dose for phase 2 (RP2D) investigations of PF- 05082566 in combination with KW-0761 (mogamulizumab) in patients with advanced solid tumors. Once the MTD of PF-05082566 administered in combination with KW-0761 is estimated (dose finding), one or more expansion cohorts of patients with selected advanced solid tumors (dose-expansion ) will be enrolled to further characterize the combination in term of safety profile, anti tumor activity, pharmacokinetics, pharmacodynamics and biomarkers modulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy. Dose Finding Cohorts: Tumor types will be limited to CRC, SCCHN, squamous NSCLC, bladder, or ovarian carcinomas which have progressed on standard therapy, or for which no standard therapy is available.\n* Measurable disease by RECIST version 1.1.\n* For Expansion Cohorts only: patients must have tumor accessible for biopsies (core needle biopsy or excision preferred).\n* Age 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate bone marrow, renal and liver function.\n* Serum/urine pregnancy test (for females of childbearing potential) negative at screening and before the patient will receive the study treatment.\n* Male and female patients of childbearing potential and at risk for pregnancy must agree to use two (2) highly effective methods of contraception throughout the study and for 60 days after the last dose of assigned study treatment.\n\nExclusion Criteria:\n\n* Active central nervous system primary or secondary malignancies, active seizure disorder, spinal cord compression, or carcinomatous meningitis.\n* Therapeutic or experimental monoclonal antibodies in last 60 days prior registration.\n* Systemic anticancer therapy or major surgery within 28 days prior to registration. In absence of toxicity from prior systemic anticancer therapy, 5 half-lives since completion of prior systemic anticancer therapy is allowed.\n* Systemic steroids, any other form of immunosuppressive therapy or radiation therapy within 14 days prior to registration.\n* Live vaccine within 30 days prior to registration.\n* Severe hypersensitivity reaction to treatment with another monoclonal antibody, known or suspected hypersensitivity to study drugs or any component of their formulation.\n* History of autoimmune disease or known inflammatory bowel disease.\n* Uncontrolled hypertension (blood pressure \\>150/100 mmHg despite optimal medical therapy) or any of the following within 12 months prior to registration: myocardial infarction, congenital long QT syndrome, torsade de points, arrhythmias, right bundle branch block and left anterior hemiblock uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, ongoing NCICTCAE Grade 2 cardiac dysrhythmias, atrial fibrillation or QTcF interval \\>470 msec.'}, 'identificationModule': {'nctId': 'NCT02444793', 'briefTitle': 'A Study of PF-05082566 In Combination With Mogamulizumab In Patients With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 1B STUDY OF PF-05082566 IN COMBINATION WITH MOGAMULIZUMAB (KW-0761) IN PATIENTS WITH ADVANCED SOLID TUMORS', 'orgStudyIdInfo': {'id': 'B1641004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-05082566 + KW-0761', 'description': 'During Parts 1 \\& 2 Mogamulizumab and PF-05082566 will be administered at appropriate intervals. Part 1: PF-05082566 dose escalation; increased doses of PF-05082566 IV are administered with mogamulizumab IV. Part 2: patients will be treated with the maximum tolerated dose established in Phase 1 for the combination.', 'interventionNames': ['Drug: PF-05082566', 'Drug: KW-0761']}], 'interventions': [{'name': 'PF-05082566', 'type': 'DRUG', 'description': 'Part 1: PF-05082566 dose escalation; Increased doses of PF-05082566 IV are administered at appropriate intervals. Part 2: MTD of PF-05082566 IV established in Part 1 is administered.', 'armGroupLabels': ['PF-05082566 + KW-0761']}, {'name': 'KW-0761', 'type': 'DRUG', 'otherNames': ['KW-0761= Mogamulizumab or POTELIGEO®'], 'description': 'Part 1: KW-0761 IV administered at appropriate intervals. Part 2: KW-0761 IV administered at appropriate intervals at the MTD dose for the combination.', 'armGroupLabels': ['PF-05082566 + KW-0761']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037-0845', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UC San Diego Moores Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UC San Diego Medical Center - La Jolla(Thornton Hospital)', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University Of California / San Diego Moores Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego Moores Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'UC San Diego Medical Center - 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