Viewing Study NCT04083235

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Ignite Creation Date: 2025-12-24 @ 10:23 PM
Ignite Modification Date: 2026-01-22 @ 9:14 AM
Study NCT ID: NCT04083235
Status: COMPLETED
Last Update Posted: 2025-02-27
First Post: 2019-09-06
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Sweden']}, 'interventionBrowseModule': {'meshes': [{'id': 'C584112', 'term': 'irinotecan sucrosofate'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}, {'id': 'D000068196', 'term': 'Albumin-Bound Paclitaxel'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D000418', 'term': 'Albumins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical.trials@ipsen.com', 'phone': 'see email', 'title': 'Medical Director', 'organization': 'Ipsen Pharma'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to DCO date of 23 July 2022 (maximum of 893 days)', 'description': 'The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.', 'eventGroups': [{'id': 'EG000', 'title': 'NALIRIFOX', 'description': 'Participants were treated with irinotecan liposome injection 50 mg/m\\^2 followed by oxaliplatin 60 mg/m\\^2, followed by LV 400 mg/m\\^2 and then 5-FU 2400 mg/m\\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.', 'otherNumAtRisk': 370, 'deathsNumAtRisk': 370, 'otherNumAffected': 364, 'seriousNumAtRisk': 370, 'deathsNumAffected': 252, 'seriousNumAffected': 201}, {'id': 'EG001', 'title': 'Nab-paclitaxel+Gemcitabine', 'description': 'Participants were treated with nab-paclitaxel 125 mg/m\\^2 followed by gemcitabine 1000 mg/m\\^2 IV on Days 1, 8 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.', 'otherNumAtRisk': 379, 'deathsNumAtRisk': 379, 'otherNumAffected': 371, 'seriousNumAtRisk': 379, 'deathsNumAffected': 277, 'seriousNumAffected': 195}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 566, 'numAffected': 258}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 221, 'numAffected': 135}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 406, 'numAffected': 215}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 216, 'numAffected': 162}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 222, 'numAffected': 139}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 168, 'numAffected': 96}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 81, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 54, 'numAffected': 45}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 115, 'numAffected': 93}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 141, 'numAffected': 113}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 110, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 80, 'numAffected': 75}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 29, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 173, 'numAffected': 120}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 183, 'numAffected': 143}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 164, 'numAffected': 110}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 166, 'numAffected': 101}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 60, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 134, 'numAffected': 107}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 60, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 20, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 43, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 129, 'numAffected': 84}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 89, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 92, 'numAffected': 66}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 74, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 67, 'numAffected': 58}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 79, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 60, 'numAffected': 51}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 53, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 41, 'numAffected': 33}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 264, 'numAffected': 108}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 278, 'numAffected': 121}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 134, 'numAffected': 94}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 196, 'numAffected': 151}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 93, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 173, 'numAffected': 84}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 40, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 43, 'numAffected': 24}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 208, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 126, 'numAffected': 69}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 71, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 109, 'numAffected': 67}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 92, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 34, 'numAffected': 33}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 64, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 64, 'numAffected': 48}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 58, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 55, 'numAffected': 40}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 24, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 54, 'numAffected': 32}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 157, 'numAffected': 132}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 136, 'numAffected': 68}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 190, 'numAffected': 116}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 70, 'numAffected': 49}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 40, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 31, 'numAffected': 29}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 53, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 120, 'numAffected': 119}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 37, 'numAffected': 34}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 30, 'numAffected': 25}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 49, 'numAffected': 43}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 43, 'numAffected': 31}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 34, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 29, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 33, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 21, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 32, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 20, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 26, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 22, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 20, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 25, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 44, 'numAffected': 40}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 37, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 24, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 19, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 20, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Neurotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 35, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 22, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 33, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 31, 'numAffected': 30}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 44, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 22, 'numAffected': 16}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 21, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 21, 'numAffected': 20}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 54, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 35, 'numAffected': 34}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 42, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 33, 'numAffected': 31}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 23, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 23, 'numAffected': 22}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 26, 'numAffected': 22}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 29, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 29, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 28, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 48, 'numAffected': 45}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 18, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 31, 'numAffected': 30}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 37, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 36, 'numAffected': 33}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 41, 'numAffected': 30}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 22, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 24, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 35, 'numAffected': 30}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 27, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 26, 'numAffected': 25}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 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'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Cardiac flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Exposure to SARS-CoV-2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Chest wall haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Pathological fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Tumour haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Peritumoural oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Tumour pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Penile vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Priapism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Retinal vein occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Thrombosis in device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 379, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '383', 'groupId': 'OG000'}, {'value': '387', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NALIRIFOX', 'description': 'Participants were treated with irinotecan liposome injection 50 mg/m\\^2 followed by oxaliplatin 60 mg/m\\^2, followed by LV 400 mg/m\\^2 and then 5-FU 2400 mg/m\\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.'}, {'id': 'OG001', 'title': 'Nab-paclitaxel+Gemcitabine', 'description': 'Participants were treated with nab-paclitaxel 125 mg/m\\^2 followed by gemcitabine 1000 mg/m\\^2 IV on Days 1, 8 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '12.1'}, {'value': '9.2', 'groupId': 'OG001', 'lowerLimit': '8.3', 'upperLimit': '10.6'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.70', 'ciUpperLimit': '0.99', 'estimateComment': 'The HR and 95% confidence interval (CI) was based on a stratified Cox proportional hazards regression model, stratified by baseline Eastern Cooperative Oncology Group (ECOG) performance status, region and liver metastases as per IWRS.', 'statisticalMethod': 'Stratified log-rank test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose, end of treatment (EoT) visit, then every 2 months thereafter up to DCO date of 23 July 2022 (maximum of 893 days)', 'description': 'The OS was defined as time from the date of randomization to the date of death due to any cause. Participants who did not have a date of death recorded at the time of the final analysis were censored at the last known time that the participant was alive. The median OS was measured using Kaplan-Meier technique.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all randomized participants to whom study treatment was assigned by randomization.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NALIRIFOX', 'description': 'Participants were treated with irinotecan liposome injection 50 mg/m\\^2 followed by oxaliplatin 60 mg/m\\^2, followed by LV 400 mg/m\\^2 and then 5-FU 2400 mg/m\\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.'}, {'id': 'OG001', 'title': 'Nab-paclitaxel+Gemcitabine', 'description': 'Participants were treated with nab-paclitaxel 125 mg/m\\^2 followed by gemcitabine 1000 mg/m\\^2 IV on Days 1, 8 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '7.7'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '5.3', 'upperLimit': '5.8'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.58', 'ciUpperLimit': '0.83', 'estimateComment': 'The HR and 95% CI was based on a stratified Cox proportional hazards regression model, stratified by baseline ECOG performance status, region and liver metastases as per IWRS.', 'statisticalMethod': 'Stratified log-rank test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose until EoT visit (maximum of 893 days)', 'description': 'PFS was defined as the time from the date of randomization to the first documented disease progression using response evaluation criteria in solid tumors (RECIST) Version 1.1 as per Investigator assessment or death due to any cause. The median PFS was measured using Kaplan-Meier technique.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all randomized participants to whom study treatment was assigned by randomization. Only participants with PFS event are reported.'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '383', 'groupId': 'OG000'}, {'value': '387', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NALIRIFOX', 'description': 'Participants were treated with irinotecan liposome injection 50 mg/m\\^2 followed by oxaliplatin 60 mg/m\\^2, followed by LV 400 mg/m\\^2 and then 5-FU 2400 mg/m\\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.'}, {'id': 'OG001', 'title': 'Nab-paclitaxel+Gemcitabine', 'description': 'Participants were treated with nab-paclitaxel 125 mg/m\\^2 followed by gemcitabine 1000 mg/m\\^2 IV on Days 1, 8 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.8', 'groupId': 'OG000', 'lowerLimit': '36.8', 'upperLimit': '46.9'}, {'value': '36.2', 'groupId': 'OG001', 'lowerLimit': '31.4', 'upperLimit': '41.2'}]}]}], 'analyses': [{'pValue': '0.11', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.26', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.69', 'estimateComment': 'OR, 95% CI and p-value were obtained from the Cochran-Mantel-Haenszel test adjusting by baseline ECOG performance status, region and liver metastases as per IWRS.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose until EoT visit, (maximum of 893 days)', 'description': 'The ORR was defined as the percentage of participants with a best overall response (BOR) characterized as either a complete response (CR) or partial response (PR) per RECIST Version 1.1. BOR was defined as the best response as recorded from randomization until documented objective disease progression using RECIST Version 1.1. As per RECIST version 1.1, CR is disappearance of all target lesions; PR is \\>=30% decrease in the sum of the longest diameter of target lesions; and overall response = CR + PR. The ORR was calculated using Clopper-Pearson method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all randomized participants to whom study treatment was assigned by randomization.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NALIRIFOX', 'description': 'Participants were treated with irinotecan liposome injection 50 milligram per square meter (mg/m\\^2) followed by oxaliplatin 60 mg/m\\^2, followed by leucovorin (LV) 400 mg/m\\^2 and then 5-fluorouracil (FU) 2400 mg/m\\^2 intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.'}, {'id': 'FG001', 'title': 'Nab-paclitaxel+Gemcitabine', 'description': 'Participants were treated with nab-paclitaxel 125 mg/m\\^2 followed by gemcitabine 1000 mg/m\\^2 IV on Days 1, 8 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '383'}, {'groupId': 'FG001', 'numSubjects': '387'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '370'}, {'groupId': 'FG001', 'numSubjects': '379'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '77'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '324'}, {'groupId': 'FG001', 'numSubjects': '310'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '252'}, {'groupId': 'FG001', 'numSubjects': '277'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Does not meet entry criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Did not receive treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Ongoing at the time of DCO', 'reasons': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'This Phase 3, open-label study was conducted in participants with metastatic adenocarcinoma of the pancreas at 187 investigational sites in 18 countries (Australia, Brazil, Canada, Israel, Republic of Korea, United States, Austria, Belgium, Czechia, France, Germany, Greece, Hungary, Italy, Portugal, Spain, United Kingdom, and Russia). First participant was recruited on 11 February 2020 and data cut-off (DCO) date was 23 July 2022.', 'preAssignmentDetails': 'This study consisted of a screening period (up to 28 days), treatment period (28-day cycles of treatment until radiologically determined disease progression per response evaluation criteria in solid tumors \\[RECIST 1.1\\]), unacceptable study medication related toxicity or withdrawal from study treatment followed by survival follow-up (until death or study closure, whichever occurred first). A total of 770 participants were randomized in 1:1 ratio using an interactive web response system (IWRS).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '383', 'groupId': 'BG000'}, {'value': '387', 'groupId': 'BG001'}, {'value': '770', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'NALIRIFOX', 'description': 'Participants were treated with irinotecan liposome injection 50 mg/m\\^2 followed by oxaliplatin 60 mg/m\\^2, followed by LV 400 mg/m\\^2 and then 5-FU 2400 mg/m\\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.'}, {'id': 'BG001', 'title': 'Nab-paclitaxel+Gemcitabine', 'description': 'Participants were treated with nab-paclitaxel 125 mg/m\\^2 followed by gemcitabine 1000 mg/m\\^2 IV on Days 1, 8 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.8', 'spread': '9.71', 'groupId': 'BG000'}, {'value': '64.0', 'spread': '8.34', 'groupId': 'BG001'}, {'value': '63.4', 'spread': '9.06', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '179', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '336', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '204', 'groupId': 'BG000'}, {'value': '230', 'groupId': 'BG001'}, {'value': '434', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '305', 'groupId': 'BG000'}, {'value': '328', 'groupId': 'BG001'}, {'value': '633', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '315', 'groupId': 'BG000'}, {'value': '324', 'groupId': 'BG001'}, {'value': '639', 'groupId': 'BG002'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Multiple', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Intent-to-Treat (ITT) population consisted of all randomized participants to whom study treatment was assigned by randomization.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-19', 'size': 4115219, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-04-11T09:41', 'hasProtocol': True}, {'date': '2022-09-20', 'size': 6013982, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-02-14T20:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 770}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'dispFirstSubmitDate': '2023-07-18', 'completionDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-26', 'studyFirstSubmitDate': '2019-09-06', 'resultsFirstSubmitDate': '2024-02-15', 'studyFirstSubmitQcDate': '2019-09-06', 'dispFirstPostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-15', 'studyFirstPostDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose, end of treatment (EoT) visit, then every 2 months thereafter up to DCO date of 23 July 2022 (maximum of 893 days)', 'description': 'The OS was defined as time from the date of randomization to the date of death due to any cause. Participants who did not have a date of death recorded at the time of the final analysis were censored at the last known time that the participant was alive. The median OS was measured using Kaplan-Meier technique.'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose until EoT visit (maximum of 893 days)', 'description': 'PFS was defined as the time from the date of randomization to the first documented disease progression using response evaluation criteria in solid tumors (RECIST) Version 1.1 as per Investigator assessment or death due to any cause. The median PFS was measured using Kaplan-Meier technique.'}, {'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose until EoT visit, (maximum of 893 days)', 'description': 'The ORR was defined as the percentage of participants with a best overall response (BOR) characterized as either a complete response (CR) or partial response (PR) per RECIST Version 1.1. BOR was defined as the best response as recorded from randomization until documented objective disease progression using RECIST Version 1.1. As per RECIST version 1.1, CR is disappearance of all target lesions; PR is \\>=30% decrease in the sum of the longest diameter of target lesions; and overall response = CR + PR. The ORR was calculated using Clopper-Pearson method.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Adenocarcinoma of the Pancreas']}, 'referencesModule': {'references': [{'pmid': '37708904', 'type': 'DERIVED', 'citation': "Wainberg ZA, Melisi D, Macarulla T, Pazo Cid R, Chandana SR, De La Fouchardiere C, Dean A, Kiss I, Lee WJ, Goetze TO, Van Cutsem E, Paulson AS, Bekaii-Saab T, Pant S, Hubner RA, Xiao Z, Chen H, Benzaghou F, O'Reilly EM. NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): a randomised, open-label, phase 3 trial. Lancet. 2023 Oct 7;402(10409):1272-1281. doi: 10.1016/S0140-6736(23)01366-1. Epub 2023 Sep 11."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to look at the efficacy and safety of Irinotecan liposome injection in combination with other approved drugs used for cancer therapy, namely 5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to nab-paclitaxel + gemcitabine treatment in improving the overall survival of patients not previously treated for metastatic pancreatic cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological or cytologically confirmed adenocarcinoma of the pancreas that has not been previously treated in the metastatic setting.\n* Initial diagnosis of metastatic disease must have occurred ≤6 weeks prior to screening.\n* Subject has one or more metastatic lesions measurable by computed tomography (CT) scan (or magnetic resonance imaging (MRI), if the subject is allergic to CT contrast media) according to RECIST Version 1.1 criteria.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Subject has adequate biological parameters as demonstrated by the following blood counts:(a) Absolute neutrophil count (ANC) ≥2000/mm3 without the use of hemopoietic growth factors within the last 7 days prior to randomisation (b) Platelet count ≥100,000/mm3 (c) Haemoglobin (Hgb) ≥9 g/dL obtained ≤14 days prior to randomisation.\n* Adequate hepatic function as evidenced by: (a) Serum total bilirubin ≤1.5x ULN (biliary drainage is allowed for biliary obstruction), and (b) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5x upper limit of normal (ULN) (≤5x ULN is acceptable if liver metastases are present).\n* Adequate renal function as evidenced by creatinine clearance ≥30 mL/min.\n* Adequate coagulation studies (obtained ≤14 days prior to randomisation) as demonstrated by prothrombin time and partial thromboplastin time within normal limits (≤1.5xULN ).\n\nExclusion Criteria:\n\n* Prior treatment of pancreatic cancer in the metastatic setting with surgery, radiotherapy, chemotherapy or investigational therapy\n* Prior treatment of pancreatic adenocarcinoma with chemotherapy in the adjuvant setting, except those where at least 12 months have elapsed since completion of the last dose and no persistent treatment-related toxicities are present.\n* Subject has only localised advanced disease.\n* Documented serum albumin \\<3 g/dL\n* Known history of central nervous system (CNS) metastases.\n* Clinically significant gastrointestinal disorder\n* History of any second malignancy in the last 2 years\n* Concurrent illnesses that would be a relative contraindication to trial participation\n* Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1\n* Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma\n* Known low or absent dihydropyrimidine dehydrogenase (DPD) activity'}, 'identificationModule': {'nctId': 'NCT04083235', 'acronym': 'NAPOLI 3', 'briefTitle': 'A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ipsen'}, 'officialTitle': 'An Open-label, Randomised, Multicentre, Phase III Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Leucovorin Versus Nab-paclitaxel Plus Gemcitabine in Subjects Who Have Not Previously Received Chemotherapy for Metastatic Adenocarcinoma of the Pancreas', 'orgStudyIdInfo': {'id': 'D-US-60010-001'}, 'secondaryIdInfos': [{'id': '2018-003585-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Irinotecan liposome injection + Oxaliplatin + 5-FU/LV', 'description': 'Irinotecan liposome injection, oxaliplatin, 5 FU/LV, will be administered on Days 1 and 15 of each 28-day cycle (until progression or unacceptable toxicity).', 'interventionNames': ['Drug: Irinotecan Liposomal Injection', 'Drug: Oxaliplatin', 'Drug: 5Fluorouracil', 'Drug: Leucovorin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nab-paclitaxel + Gemcitabine', 'description': 'Nab-paclitaxel and gemcitabine will be administered on Days 1, 8 and 15 of each 28-day cycle (until progression or unacceptable toxicity).', 'interventionNames': ['Drug: Nab-paclitaxel', 'Drug: Gemcitabine']}], 'interventions': [{'name': 'Irinotecan Liposomal Injection', 'type': 'DRUG', 'otherNames': ['Onivyde®', 'Nal-IRI'], 'description': 'Irinotecan liposome injection is irinotecan in the form of the sucrosofate salt, encapsulated in liposomes for i.v. infusion. It is supplied in sterile, single-use vials containing 10 mL of irinotecan liposome injection at a concentration of 4.3 mg/mL free base equivalent (FBE).', 'armGroupLabels': ['Irinotecan liposome injection + Oxaliplatin + 5-FU/LV']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'otherNames': ['Eloxatin®'], 'description': 'Oxaliplatin injection, USP is supplied in single-dose vials containing 50 mg, 100 mg or 200 mg of oxaliplatin as a sterile, preservative-free, aqueous solution at a concentration of 5 mg/mL.', 'armGroupLabels': ['Irinotecan liposome injection + Oxaliplatin + 5-FU/LV']}, {'name': '5Fluorouracil', 'type': 'DRUG', 'otherNames': ['Adrucil®', 'flurouracil', '5-FU'], 'description': 'Fluorouracil injection, USP is a colorless to faint yellow, aqueous, sterile, nonpyrogenic injectable solution available in 50 mL and 100 mL pharmacy bulk package. Each mL contains 50 mg fluorouracil in water for injection, USP.', 'armGroupLabels': ['Irinotecan liposome injection + Oxaliplatin + 5-FU/LV']}, {'name': 'Leucovorin', 'type': 'DRUG', 'otherNames': ['Folinic Acid'], 'description': 'Leucovorin Calcium for Injection is supplied in vials ranging from 50-500 mg and available as an injectable solution or lyophilized powder for reconstitution.', 'armGroupLabels': ['Irinotecan liposome injection + Oxaliplatin + 5-FU/LV']}, {'name': 'Nab-paclitaxel', 'type': 'DRUG', 'otherNames': ['Abraxane®'], 'description': 'Nab-paclitaxel is a lyophilised powder containing 100 or 250 mg of paclitaxel formulated as albumin-bound particles in single-use vials for re-constitution. Each mL of the reconstituted formulation will contain 5 mg/mL paclitaxel.', 'armGroupLabels': ['Nab-paclitaxel + Gemcitabine']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'otherNames': ['Gemzar®'], 'description': 'Gemcitabine for injection is a lyophilised powder for solution for infusion, with each single use vial containing 200 mg, 1 g or 2 g of gemcitabine.', 'armGroupLabels': ['Nab-paclitaxel + Gemcitabine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner Health- MD Anderson Cancer Center', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic - Scottsdale', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Comprehensive Blood And Cancer Center', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '92627', 'city': 'Costa Mesa', 'state': 'California', 'country': 'United States', 'facility': 'University of California- Irvine Health Cancer Cente', 'geoPoint': {'lat': 33.64113, 'lon': -117.91867}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope National Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Los Angeles (UCLA)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92835', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'St. Jude Hospital Yorba Linda dba St. Joseph Heritage Healthcare', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California - Irvine Medical Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '90277', 'city': 'Redondo Beach', 'state': 'California', 'country': 'United States', 'facility': 'Torrance Memorial Physician Network Cancer Care', 'geoPoint': {'lat': 33.84918, 'lon': -118.38841}}, {'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Health Sacramento', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '90602', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'Presbyterian Intercommunity Hospital (PIH)', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '80909', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'UC Health Memorial Hospital', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Cancer Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Mount Sinai Medical Center of Florida, Inc.', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '34236', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists - Fort Myers', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '32308', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists - Panhandle', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists - St. Petersburg', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists - East', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60540', 'city': 'Elmhurst', 'state': 'Illinois', 'country': 'United States', 'facility': 'Edward Hospital - Elmhurst', 'geoPoint': {'lat': 41.89947, 'lon': -87.94034}}, {'zip': '61443', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois CancerCare - 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