Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2026-02-23 @ 11:34 AM
Study NCT ID:
NCT02436668
Status:
COMPLETED
Last Update Posted:
2020-12-30
First Post:
2015-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Ibrutinib vs Placebo, in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (RESOLVE)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C551803', 'term': 'ibrutinib'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gcole@pcyc.com', 'phone': '(408) 990-7340', 'title': 'George Cole', 'organization': 'Pharmacyclics, An AbbVie Company'}, 'certainAgreement': {'otherDetails': '1. Institution/Investigator will not publish without Sponsor prior review and approval\n2. Institution/Investigator will not publish until the earlier of (i) results of study are submitted for publication (ii) notification that submission of the multicenter results are no longer planned (iii) 18 months after study termination.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug up to 30 days after the last dose of study drug', 'description': 'There were 4 patient that was randomized but off study without any treatment. This patient had received baseline assessments and included in all efficacy analysis but was excluded from safety population, i.e. not at risk for AE assessment.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo (Plus Nab-paclitaxel and Gemcitabine)', 'description': 'Placebo daily in combination with:\n\nNab-paclitaxel and gemcitabine\n\nNab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion', 'otherNumAtRisk': 212, 'deathsNumAtRisk': 212, 'otherNumAffected': 211, 'seriousNumAtRisk': 212, 'deathsNumAffected': 188, 'seriousNumAffected': 127}, {'id': 'EG001', 'title': 'Ibrutinib (Plus Nab-paclitaxel and Gemcitabine)', 'description': 'Ibrutinib 560 mg (4 x 140 mg capsules) (or placebo) was administered orally once daily beginning on Day 1 of Cycle 1 of the treatment phase, with the first dose of ibrutinib given no more than 72 hours after randomization\n\nNab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion', 'otherNumAtRisk': 208, 'deathsNumAtRisk': 208, 'otherNumAffected': 208, 'seriousNumAtRisk': 208, 'deathsNumAffected': 189, 'seriousNumAffected': 112}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 309, 'numAffected': 95}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 289, 'numAffected': 90}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 208, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 221, 'numAffected': 75}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 328, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 139, 'numAffected': 68}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 61, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 19, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 20, 'numAffected': 17}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 240, 'numAffected': 109}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 357, 'numAffected': 147}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 242, 'numAffected': 107}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 228, 'numAffected': 116}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 184, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 169, 'numAffected': 85}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 96, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 91, 'numAffected': 68}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 99, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 94, 'numAffected': 63}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 40, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 64, 'numAffected': 38}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 28, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 50, 'numAffected': 36}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 26, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 38, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 35, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 30, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 283, 'numAffected': 93}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 311, 'numAffected': 100}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 181, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 150, 'numAffected': 85}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 170, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 149, 'numAffected': 78}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 143, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 97, 'numAffected': 60}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 29, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 36, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 21, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 24, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 25, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 23, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 33, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 19, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 61, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 26, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 42, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 16, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 48, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 19, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 34, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 12, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 129, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 135, 'numAffected': 85}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 32, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 37, 'numAffected': 25}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 28, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 24, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 16, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 58, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 36, 'numAffected': 28}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 38, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 31, 'numAffected': 25}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 30, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 20, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 31, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 24, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 153, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 171, 'numAffected': 69}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 42, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 79, 'numAffected': 27}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 24, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 25, 'numAffected': 21}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 22, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 22, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 33, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 24, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 28, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 33, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Neurotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 47, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 40, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Peripheral motor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 23, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 30, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 36, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 23, 'numAffected': 20}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 27, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 41, 'numAffected': 36}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 64, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 34, 'numAffected': 25}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 47, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 19, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 22, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 14, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 119, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 130, 'numAffected': 90}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 42, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 28, 'numAffected': 23}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Rash erythematous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 21, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 16, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 36, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 15, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 34, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 33, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}], 'seriousEvents': [{'term': 'Anaemia', 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'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Adenocarcinoma pancreas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Cancer pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Tumour pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, 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{'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Azotaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 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0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Pulmonary thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Tachypnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Arterial haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Jugular vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Guillain-Barre syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Ischaemic cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Peripheral sensorimotor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': "Wernicke's encephalopathy", 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Metabolic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibrutinib+Gemcitabine+Nab-paclitaxel', 'description': 'Ibrutinib daily in combination with:\n\nNab-paclitaxel and gemcitabine Ibrutinib was administered orally once daily at a starting dose of 560 mg. Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion.'}, {'id': 'OG001', 'title': 'Placebo+Gemcitabine+Nab-Paclitaxel', 'description': 'Placebo daily in combination with:\n\nNab-paclitaxel and gemcitabine Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '5.32', 'groupId': 'OG000', 'lowerLimit': '3.75', 'upperLimit': '5.49'}, {'value': '6.01', 'groupId': 'OG001', 'lowerLimit': '5.45', 'upperLimit': '7.16'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.525', 'ciLowerLimit': '1.241', 'ciUpperLimit': '1.873', 'pValueComment': 'P-value is from log-rank test stratified by the three randomization stratification factors \\[KPS (70-80 vs. 90-100), liver metastasis (present vs. absent), and age (≤65 vs. \\>65)\\].', 'groupDescription': 'The treatment effect was tested with an stratified log rank test. Hazard ratio is estimated using Cox regression model stratified by the three randomization stratification factors \\[KPS (70 80 vs. 90-100), liver metastasis (present vs. absent), and age (≤65 vs. \\>65)\\] and with treatment as the only covariate.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Results at an overall median follow-up of 24.87 months', 'description': 'PFS is defined as the time from the date of randomization until disease progression per RECIST 1.1 criteria assessed by investigator, or death from any cause, whichever occurs first.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibrutinib+Gemcitabine+Nab-paclitaxel', 'description': 'Ibrutinib daily in combination with:\n\nNab-paclitaxel and gemcitabine Ibrutinib was administered orally once daily at a starting dose of 560 mg. Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion.'}, {'id': 'OG001', 'title': 'Placebo+Gemcitabine+Nab-Paclitaxel', 'description': 'Placebo daily in combination with:\n\nNab-paclitaxel and gemcitabine Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '9.69', 'groupId': 'OG000', 'lowerLimit': '8.57', 'upperLimit': '10.41'}, {'value': '10.78', 'groupId': 'OG001', 'lowerLimit': '8.94', 'upperLimit': '11.66'}]}]}], 'analyses': [{'pValue': '0.3225', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.109', 'ciLowerLimit': '0.903', 'ciUpperLimit': '1.363', 'groupDescription': 'The treatment effect was tested with an stratified log rank test. Hazard ratio is estimated using Cox regression model stratified by the three randomization stratification factors \\[KPS (70 80 vs. 90-100), liver metastasis (present vs. absent), and age (≤65 vs. \\>65)\\] and with treatment as the only covariate.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'P-value is based on log-rank test stratified by the three randomization stratification factors \\[KPS (70-80 vs. 90-100), liver metastasis (present vs. absent), and age (≤65 vs. \\>65)\\].'}], 'paramType': 'MEDIAN', 'timeFrame': 'Results at an overall median follow-up of 24.87 months', 'description': 'OS, is defined as the time from date of randomization until date of death from any cause.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib and Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+Gemcitabine+Nab-Paclitaxel', 'description': 'Placebo daily in combination with:\n\nNab-paclitaxel and gemcitabine Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion'}, {'id': 'OG001', 'title': 'Ibrutinib+Gemcitabine+Nab-paclitaxel', 'description': 'Ibrutinib daily in combination with:\n\nNab-paclitaxel and gemcitabine Ibrutinib was administered orally once daily at a starting dose of 560 mg. Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion.'}], 'classes': [{'title': 'Subjects with any TEAE >= Grade 3', 'categories': [{'measurements': [{'value': '86.8', 'groupId': 'OG000'}, {'value': '85.6', 'groupId': 'OG001'}]}]}, {'title': 'Subjects with ibrutinib/pbo-related TEAE >=Grade 3', 'categories': [{'measurements': [{'value': '55.7', 'groupId': 'OG000'}, {'value': '54.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Results at an overall median follow-up of 24.87 months', 'description': 'This is a measure of percentage of subjects with Treatment Emergent Adverse Events Grade 3 or above collected Up to 30 days after the last participating subject discontinues study drug.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included 420 subjects and was used for the analyses of all safety endpoints and included all subjects in the ITT population who received at least 1 dose of study drug (ibrutinib, placebo, nab-paclitaxel, or gemcitabine). The data sets analyzed are summarized in the following table.'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+Gemcitabine+Nab-Paclitaxel', 'description': 'Placebo daily in combination with:\n\nNab-paclitaxel and gemcitabine Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion'}, {'id': 'OG001', 'title': 'Ibrutinib+Gemcitabine+Nab-paclitaxel', 'description': 'Ibrutinib daily in combination with:\n\nNab-paclitaxel and gemcitabine Ibrutinib was administered orally once daily at a starting dose of 560 mg. Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.3', 'groupId': 'OG000', 'lowerLimit': '35.5', 'upperLimit': '49.2'}, {'value': '29.5', 'groupId': 'OG001', 'lowerLimit': '23.3', 'upperLimit': '36'}]}]}], 'analyses': [{'pValue': '0.0058', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.695', 'ciLowerLimit': '0.535', 'ciUpperLimit': '0.903', 'groupDescription': 'For rate ratio, numerator is Ibr+Gem/Abr arm and denominator is Pbo + Gem/Abr arm. P-value for rate ratio is based on Cochran-Mantel-Haenszel (CMH) test adjusted for the three randomization stratification factors. Two-sided 95% confidence interval for rate ratio is based on Mantel-Haenszel method.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Results at an overall median follow-up of 24.87 months', 'description': 'ORR is defined as the percentage of subjects who achieve a complete response or partial response, based on investigator assessment according to RECIST 1.1.', 'unitOfMeasure': 'percentage of Patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Benefit Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+Gemcitabine+Nab-Paclitaxel', 'description': 'Placebo daily in combination with:\n\nNab-paclitaxel and gemcitabine Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion'}, {'id': 'OG001', 'title': 'Ibrutinib+Gemcitabine+Nab-paclitaxel', 'description': 'Ibrutinib daily in combination with:\n\nNab-paclitaxel and gemcitabine Ibrutinib was administered orally once daily at a starting dose of 560 mg. Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion.\n\nI'}], 'classes': [{'title': 'Achieved a >=50% reduction in pain intensity', 'categories': [{'measurements': [{'value': '25.8', 'groupId': 'OG000'}, {'value': '27.5', 'groupId': 'OG001'}]}]}, {'title': '>=20-pt improvement in KPS (>=4 consecutive weeks)', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sustained weight gain (>=7% maintained >4 weeks', 'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000'}, {'value': '5.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Results at an overall median follow-up of 24.87 months', 'description': 'Subject achieved a ≥50% reduction in pain intensity (Memorial Pain Assessment Card \\[MPAC\\]) or analgesic consumption, or a 20-point or greater improvement in KPS for a period of at least 4 consecutive weeks, without showing any sustained worsening in other parameters.\n\nOR Subject was stable on all of the aforementioned parameters, and showed a marked, sustained weight gain (≥7% increase maintained for ≥4 weeks) not due to fluid accumulation (Burris 1997).', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinical benefit response rate was not analyzed due to incomplete data for the analgesic use. Data for subjects who "Achieved a \\>=50% reduction in pain intensity", "20-point or greater improvement in KPS (\\>=4 consecutive weeks)", "Sustained weight gain (\\>=7% increase maintained for \\>=4 weeks) not due to fluid accumulation"are reported.'}, {'type': 'SECONDARY', 'title': 'Carbohydrate Antigen 19-9 (CA19-9) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+Gemcitabine+Nab-Paclitaxel', 'description': 'Placebo daily in combination with:\n\nNab-paclitaxel and gemcitabine Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion'}, {'id': 'OG001', 'title': 'Ibrutinib+Gemcitabine+Nab-paclitaxel', 'description': 'Ibrutinib daily in combination with:\n\nNab-paclitaxel and gemcitabine Ibrutinib was administered orally once daily at a starting dose of 560 mg. Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '62.9', 'groupId': 'OG000', 'lowerLimit': '56.0', 'upperLimit': '69.4'}, {'value': '53.6', 'groupId': 'OG001', 'lowerLimit': '46.6', 'upperLimit': '60.4'}]}]}], 'analyses': [{'pValue': '0.0488', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.850', 'ciLowerLimit': '0.722', 'ciUpperLimit': '1.0', 'estimateComment': 'This 0.85 (0.722 to 1.0) with CI is referring to risk ratio not proportional/percentage of patients.', 'groupDescription': 'For rate ratio, numerator is Ibr+Gem/Abr arm and denominator is Pbo+Gem/Abr arm. P-value for rate ratio is based on Cochran-Mantel-Haenszel (CMH) test adjusted for the three randomization stratification factors. Two-sided 95% confidence interval for rate ratio is based on Mantel-Haenszel method.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Results at an overall median follow-up of 24.87 months', 'description': 'The CA19-9 response rate is defined as the percentage of subjects with a decline of 20%, 90%, and other thresholds considered clinically meaningful, from baseline. This is a percentage of patients with \\> or = 60% reduction from baseline.', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient-reported Outcome (PRO) by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+Gemcitabine+Nab-Paclitaxel', 'description': 'Placebo daily in combination with:\n\nNab-paclitaxel and gemcitabine Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion'}, {'id': 'OG001', 'title': 'Ibrutinib+Gemcitabine+Nab-paclitaxel', 'description': 'Ibrutinib daily in combination with:\n\nNab-paclitaxel and gemcitabine Ibrutinib was administered orally once daily at a starting dose of 560 mg. Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.14', 'groupId': 'OG000', 'lowerLimit': '4.86', 'upperLimit': '8.21'}, {'value': '4.21', 'groupId': 'OG001', 'lowerLimit': '2.86', 'upperLimit': '5.82'}]}]}], 'analyses': [{'pValue': '0.0782', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.265', 'ciLowerLimit': '0.975', 'ciUpperLimit': '1.642', 'pValueComment': 'P-value is from log-rank test stratified by the three randomization stratification factors.', 'groupDescription': '\\[1\\] Hazard ratio is based on a Cox proportional hazards model stratified by the three randomization stratification factors for time until definitive deterioration (TUDD1), a hazard ratio \\< 1 favors Ibr + Gem/Abr. TUDD1 is defined as the time interval between randomization and the first occurrence of a decrease in score by \\>= 10 points without any further improvement in score by \\>= 10 points or any further available QoL data due to dropout after deterioration.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Results at an overall median follow-up of 24.87 months', 'description': 'Unit is the month: TUDD1 - the time between random \\& 1st occurrence of a decrease in QLQ-C30 score ≥10 pts w/o improvement in QoL score of ≥10 points or any further QoL data due to deterioration. The proportion of subjects who met the "responder" criteria prior to subsequent anticancer therapy initiation. Response defined as achievement of a ≥50% reduction in MPAC visual analog scale which measures pain intensity or analgesic consumption, or a ≥20-point improvement from baseline in KPS sustained for a period of ≥ 4 consecutive weeks without showing any sustained worsening from baseline in any of the other parameters OR Subject stable on all parameters (pain and KPS), \\& showed a marked, sustained weight gain (≥7% increase from baseline maintained for ≥4 weeks) not due to fluid accumulation.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Venous Thromboembolic Events (VTE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+Gemcitabine+Nab-Paclitaxel', 'description': 'Placebo daily in combination with:\n\nNab-paclitaxel and gemcitabine Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion'}, {'id': 'OG001', 'title': 'Ibrutinib+Gemcitabine+Nab-paclitaxel', 'description': 'Ibrutinib daily in combination with:\n\nNab-paclitaxel and gemcitabine Ibrutinib was administered orally once daily at a starting dose of 560 mg. Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '15.8'}, {'value': '8.1', 'groupId': 'OG001', 'lowerLimit': '4.8', 'upperLimit': '12.6'}]}]}], 'analyses': [{'pValue': '0.3343', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For rate of VTEs, denominator is number of subjects in the Intent-to-Treat population and numerator is number of Intent-to-Treat subjects with at least one VTE observed any time on study. Confidence interval for rate of VTEs is based on Clopper-Pearson method.\n\n\\[1\\] P value is based on Chi-square test.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Results at an overall median follow-up of 24.87 months', 'description': 'The VTE rate is defined as percentage of subjects with Venous thromboembolic events (SMQ) per investigator assessment.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo+Gemcitabine+Nab-Paclitaxel', 'description': 'Placebo daily in combination with:\n\nNab-paclitaxel and gemcitabine\n\nNab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion'}, {'id': 'FG001', 'title': 'Ibrutinib+Gemcitabine+Nab-paclitaxel', 'description': 'Ibrutinib daily in combination with:\n\nNab-paclitaxel and gemcitabine\n\nIbrutinib was administered orally once daily at a starting dose of 560 mg.\n\nNab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '213'}, {'groupId': 'FG001', 'numSubjects': '211'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '212'}, {'groupId': 'FG001', 'numSubjects': '207'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'This study was conducted at 75 centers in the United States (US), European Union, and South Korea. The first subject enrolled 08 May 2015 and the last was enrolled on April 19, 2018.', 'preAssignmentDetails': 'There was a safety run-in of 6 patients; subsequently, 430 total patients were enrolled. Eligible subjects were required to have a confirmed diagnosis of Stage IV pancreatic adenocarcinoma within 6 weeks of randomization evaluable per RECIST 1.1 criteria with at least 1 measurable metastatic lesion. Key exclusion criteria included any previous cytotoxic chemotherapy for primary disease of pancreatic adenocarcinoma.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'BG000'}, {'value': '211', 'groupId': 'BG001'}, {'value': '424', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pbo+n-P/G', 'description': 'Placebo daily in combination with:\n\nNab-paclitaxel and gemcitabine\n\nNab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion.'}, {'id': 'BG001', 'title': 'Ibr+n-P/G', 'description': 'Ibrutinib daily in combination with:\n\nNab-paclitaxel and gemcitabine\n\nIbrutinib- orally once daily at a starting dose of 560 mg.\n\nNab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 were administered on Days 1, 8, and 15 of each 28-day cycle, each as a 30- to 40-minute intravenous infusion'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '237', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.0', 'groupId': 'BG000', 'lowerLimit': '32', 'upperLimit': '85'}, {'value': '64.0', 'groupId': 'BG001', 'lowerLimit': '32', 'upperLimit': '82'}, {'value': '64.0', 'groupId': 'BG002', 'lowerLimit': '32', 'upperLimit': '85'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '235', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '197', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '395', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-15', 'size': 450744, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-10-31T17:04', 'hasProtocol': False}, {'date': '2017-07-19', 'size': 1569883, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-10-31T17:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 430}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-07', 'studyFirstSubmitDate': '2015-05-04', 'resultsFirstSubmitDate': '2019-10-31', 'studyFirstSubmitQcDate': '2015-05-06', 'lastUpdatePostDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-20', 'studyFirstPostDateStruct': {'date': '2015-05-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Results at an overall median follow-up of 24.87 months', 'description': 'PFS is defined as the time from the date of randomization until disease progression per RECIST 1.1 criteria assessed by investigator, or death from any cause, whichever occurs first.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Results at an overall median follow-up of 24.87 months', 'description': 'OS, is defined as the time from date of randomization until date of death from any cause.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib and Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine.', 'timeFrame': 'Results at an overall median follow-up of 24.87 months', 'description': 'This is a measure of percentage of subjects with Treatment Emergent Adverse Events Grade 3 or above collected Up to 30 days after the last participating subject discontinues study drug.'}, {'measure': 'Overall Response Rate', 'timeFrame': 'Results at an overall median follow-up of 24.87 months', 'description': 'ORR is defined as the percentage of subjects who achieve a complete response or partial response, based on investigator assessment according to RECIST 1.1.'}, {'measure': 'Clinical Benefit Response', 'timeFrame': 'Results at an overall median follow-up of 24.87 months', 'description': 'Subject achieved a ≥50% reduction in pain intensity (Memorial Pain Assessment Card \\[MPAC\\]) or analgesic consumption, or a 20-point or greater improvement in KPS for a period of at least 4 consecutive weeks, without showing any sustained worsening in other parameters.\n\nOR Subject was stable on all of the aforementioned parameters, and showed a marked, sustained weight gain (≥7% increase maintained for ≥4 weeks) not due to fluid accumulation (Burris 1997).'}, {'measure': 'Carbohydrate Antigen 19-9 (CA19-9) Response', 'timeFrame': 'Results at an overall median follow-up of 24.87 months', 'description': 'The CA19-9 response rate is defined as the percentage of subjects with a decline of 20%, 90%, and other thresholds considered clinically meaningful, from baseline. This is a percentage of patients with \\> or = 60% reduction from baseline.'}, {'measure': 'Patient-reported Outcome (PRO) by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30).', 'timeFrame': 'Results at an overall median follow-up of 24.87 months', 'description': 'Unit is the month: TUDD1 - the time between random \\& 1st occurrence of a decrease in QLQ-C30 score ≥10 pts w/o improvement in QoL score of ≥10 points or any further QoL data due to deterioration. The proportion of subjects who met the "responder" criteria prior to subsequent anticancer therapy initiation. Response defined as achievement of a ≥50% reduction in MPAC visual analog scale which measures pain intensity or analgesic consumption, or a ≥20-point improvement from baseline in KPS sustained for a period of ≥ 4 consecutive weeks without showing any sustained worsening from baseline in any of the other parameters OR Subject stable on all parameters (pain and KPS), \\& showed a marked, sustained weight gain (≥7% increase from baseline maintained for ≥4 weeks) not due to fluid accumulation.'}, {'measure': 'Rate of Venous Thromboembolic Events (VTE)', 'timeFrame': 'Results at an overall median follow-up of 24.87 months', 'description': 'The VTE rate is defined as percentage of subjects with Venous thromboembolic events (SMQ) per investigator assessment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Pancreatic Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'This is a phase 3 study to evaluate the efficacy of ibrutinib in combination with nab-paclitaxel and gemcitabine for the first line treatment of patients with metastatic pancreatic adenocarcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma.\n2. Stage IV disease diagnosed within 6 weeks of randomization\n3. Adequate hematologic function:\n\n * Absolute neutrophil count (ANC) ≥1.5 x 109/L\n * Platelet count ≥100 x 109/L\n * Hemoglobin ≥9 g/dL\n4. Adequate hepatic and renal function defined as:\n\n * AST and/or ALT ≤5.0 x upper limit of normal (ULN) if liver metastases, or ≤3 x ULN without liver metastases\n * Alkaline phosphatase \\<3.0 x ULN or ≤5.0 x ULN if liver or bone metastases present\n * Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin, such as hemolysis)\n * Estimated Creatinine Clearance ≥30 mL/min\n5. PT/INR \\<1.5 x ULN and PTT (aPTT) \\<1.5 x ULN\n6. KPS ≥70.\n7. Eastern Cooperative Oncology Group (ECOG) 0-1\n\nExclusion Criteria:\n\n1. Prior therapies: BTK inhibitor, radiotherapy, radiotherapy in the adjuvant setting, or cytotoxic chemotherapy for primary disease of pancreatic adenocarcinoma.\n2. Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma\n3. Known brain or leptomeningeal disease (CT or MRI scan of the brain required only in case of clinical suspicion of central nervous system involvement).\n4. Major surgery within 4 weeks of first dose of study drug.\n5. History of stroke or intracranial hemorrhage within 6 months prior to enrollment.\n6. Treatment with a strong cytochrome P450 (CYP) 3A inhibitor."}, 'identificationModule': {'nctId': 'NCT02436668', 'briefTitle': 'Study of Ibrutinib vs Placebo, in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (RESOLVE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pharmacyclics LLC.'}, 'officialTitle': "A Randomized, Multicenter, Double-blind, Placebo-controlled, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib in Combination With Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma", 'orgStudyIdInfo': {'id': 'PCYC-1137-CA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ibrutinib', 'description': 'Ibrutinib daily in combination with:\n\nNab-paclitaxel and gemcitabine', 'interventionNames': ['Drug: Ibrutinib', 'Drug: Gemcitabine', 'Drug: Nab-paclitaxel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo daily in combination with:\n\nNab-paclitaxel and gemcitabine', 'interventionNames': ['Drug: Gemcitabine', 'Drug: Nab-paclitaxel']}], 'interventions': [{'name': 'Ibrutinib', 'type': 'DRUG', 'otherNames': ['IMBRUVICA®'], 'armGroupLabels': ['Ibrutinib']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'armGroupLabels': ['Ibrutinib', 'Placebo']}, {'name': 'Nab-paclitaxel', 'type': 'DRUG', 'armGroupLabels': ['Ibrutinib', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35805', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Oncology Specialties, PC; 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