Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2026-01-05 @ 3:57 AM
Study NCT ID:
NCT04038359
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2019-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 2 Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Participants With Indolent Non-Hodgkin Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C586691', 'term': 'duvelisib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'obentur@securabio.com', 'phone': '1-702-254-0011', 'title': 'Ohad Bentur, MD, MHA, MSc', 'organization': 'Secura Bio, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 37 months', 'description': 'All reported safety data based upon All-treated Analysis Set: all participants who receive at least 1 dose of duvelisib.', 'eventGroups': [{'id': 'EG000', 'title': 'Duvelisib, Continuous and Intermittent Dosing', 'description': 'Duvelisib 25 mg BID continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on of each subsequent 4-week cycle.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 49, 'seriousNumAtRisk': 51, 'deathsNumAffected': 8, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'Duvelisib, Intermittent Dosing', 'description': 'Duvelisib 25 mg BID dosed 2 weeks on and 2 weeks off.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 50, 'seriousNumAtRisk': 51, 'deathsNumAffected': 7, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 17}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Spinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'seriousEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pylorospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Clavicle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Drug reaction with eosinophilia and systemic symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pelvic venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Response Rate (ORR) According to the 2007 Revised International Working Group (IWG) Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duvelisib, Continuous and Intermittent Dosing', 'description': 'Duvelisib 25 mg BID continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on of each subsequent 4-week cycle.'}, {'id': 'OG001', 'title': 'Duvelisib, Intermittent Dosing', 'description': 'Duvelisib 25 mg BID dosed 2 weeks on and 2 weeks off.'}], 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.3', 'groupId': 'OG000', 'lowerLimit': '50.4', 'upperLimit': '78.3'}, {'value': '52.9', 'groupId': 'OG001', 'lowerLimit': '38.5', 'upperLimit': '67.1'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.2', 'groupId': 'OG000', 'lowerLimit': '46.5', 'upperLimit': '76.2'}, {'value': '54.3', 'groupId': 'OG001', 'lowerLimit': '39.0', 'upperLimit': '69.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 months', 'description': 'ORR was defined as the percentage of participants achieving a complete response (CR) or partial response (PR) and assessed using the 2007 revised IWG criteria. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease and PR as the regression of measurable disease and no new sites.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Modified Intent-to-treat (mITT) analysis set: all participants who receive at least 1 dose of duvelisib. Per-protocol (PP) Analysis Set: all participants in the mITT analysis set who did not violate the protocol in a way that would significantly affect the study outcome. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duvelisib, Continuous and Intermittent Dosing', 'description': 'Duvelisib 25 mg BID continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on of each subsequent 4-week cycle.'}, {'id': 'OG001', 'title': 'Duvelisib, Intermittent Dosing', 'description': 'Duvelisib 25 mg BID dosed 2 weeks on and 2 weeks off.'}], 'classes': [{'title': '2007 Revised IWG Criteria', 'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000', 'lowerLimit': '8.5', 'upperLimit': '27.2'}, {'value': '23.0', 'groupId': 'OG001', 'lowerLimit': '12.5', 'upperLimit': '34.3'}]}]}, {'title': '2014 Lugano Criteria', 'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000', 'lowerLimit': '8.5', 'upperLimit': '27.2'}, {'value': '23.0', 'groupId': 'OG001', 'lowerLimit': '12.5', 'upperLimit': '34.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 2 years', 'description': 'PFS was defined as the time from first dose to first progressive disease (PD) or death (progression date/death date - treatment start date + 1) or, for participants without PD or documented death, as the time from first dose to censoring date (censoring date - treatment start date + 1). The 2007 revised IWG criteria defined PD as any new lesion or increase by ≥50% of previously involved sites from nadir. The 2014 Lugano criteria defined PD as a progressive metabolic response (according to positron emission tomography-computed tomography \\[PET-CT\\]) and progressive disease (according to computed tomography \\[CT\\]). Results reported as months.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Modified Intent-to-treat (mITT) analysis set: all participants who receive at least 1 dose of duvelisib. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'ORR At Specific Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duvelisib, Continuous and Intermittent Dosing', 'description': 'Duvelisib 25 mg BID continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on of each subsequent 4-week cycle.'}, {'id': 'OG001', 'title': 'Duvelisib, Intermittent Dosing', 'description': 'Duvelisib 25 mg BID dosed 2 weeks on and 2 weeks off.'}], 'classes': [{'title': '6 months: 2007 Revised IWG Criteria', 'categories': [{'measurements': [{'value': '63.3', 'groupId': 'OG000', 'lowerLimit': '48.3', 'upperLimit': '76.6'}, {'value': '49.0', 'groupId': 'OG001', 'lowerLimit': '34.8', 'upperLimit': '63.4'}]}]}, {'title': '12 months: 2007 Revised IWG Criteria', 'categories': [{'measurements': [{'value': '65.3', 'groupId': 'OG000', 'lowerLimit': '50.4', 'upperLimit': '78.3'}, {'value': '52.9', 'groupId': 'OG001', 'lowerLimit': '38.5', 'upperLimit': '67.1'}]}]}, {'title': '18 months: 2007 Revised IWG Criteria', 'categories': [{'measurements': [{'value': '65.3', 'groupId': 'OG000', 'lowerLimit': '50.4', 'upperLimit': '78.3'}, {'value': '52.9', 'groupId': 'OG001', 'lowerLimit': '38.5', 'upperLimit': '67.1'}]}]}, {'title': '24 months: 2007 Revised IWG Criteria', 'categories': [{'measurements': [{'value': '65.3', 'groupId': 'OG000', 'lowerLimit': '50.4', 'upperLimit': '78.3'}, {'value': '52.9', 'groupId': 'OG001', 'lowerLimit': '38.5', 'upperLimit': '67.1'}]}]}, {'title': '6 months: 2014 Lugano Criteria', 'categories': [{'measurements': [{'value': '63.3', 'groupId': 'OG000', 'lowerLimit': '48.3', 'upperLimit': '76.6'}, {'value': '47.1', 'groupId': 'OG001', 'lowerLimit': '32.9', 'upperLimit': '61.5'}]}]}, {'title': '12 months: 2014 Lugano Criteria', 'categories': [{'measurements': [{'value': '65.3', 'groupId': 'OG000', 'lowerLimit': '50.4', 'upperLimit': '78.3'}, {'value': '51.0', 'groupId': 'OG001', 'lowerLimit': '36.6', 'upperLimit': '65.2'}]}]}, {'title': '18 months: 2014 Lugano Criteria', 'categories': [{'measurements': [{'value': '65.3', 'groupId': 'OG000', 'lowerLimit': '50.4', 'upperLimit': '78.3'}, {'value': '51.0', 'groupId': 'OG001', 'lowerLimit': '36.6', 'upperLimit': '65.2'}]}]}, {'title': '24 months: 2014 Lugano Criteria', 'categories': [{'measurements': [{'value': '65.3', 'groupId': 'OG000', 'lowerLimit': '50.4', 'upperLimit': '78.3'}, {'value': '51.0', 'groupId': 'OG001', 'lowerLimit': '36.6', 'upperLimit': '65.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6, 12, 18, and 24 months after first dose of study intervention', 'description': 'ORR at 6, 12, 18, and 24 months after first dose of study intervention was defined as the percentage of participants achieving CR or PR at each timepoint and was assessed using both the 2007 revised IWG criteria and the 2014 Lugano criteria. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease and PR as the regression of measurable disease and no new sites. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT) and PR as partial metabolic response (according to PET-CT) and partial remission (according to CT). The response was cumulative for each timepoint; a participant was considered a responder if their first response occurred up to the end of that timepoint.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Modified Intent-to-treat (mITT) analysis set: all participants who receive at least 1 dose of duvelisib. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duvelisib, Continuous and Intermittent Dosing', 'description': 'Duvelisib 25 mg BID continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on of each subsequent 4-week cycle.'}, {'id': 'OG001', 'title': 'Duvelisib, Intermittent Dosing', 'description': 'Duvelisib 25 mg BID dosed 2 weeks on and 2 weeks off.'}], 'classes': [{'title': '2007 Revised IWG Criteria', 'categories': [{'measurements': [{'value': '21.4', 'comment': 'Insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '13.7', 'upperLimit': 'NA'}, {'value': '32.2', 'comment': 'Insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': '17.5', 'upperLimit': 'NA'}]}]}, {'title': '2014 Lugano Criteria', 'categories': [{'measurements': [{'value': '21.4', 'comment': 'Insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '13.7', 'upperLimit': 'NA'}, {'value': '32.2', 'comment': 'Insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': '13.8', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 2 years', 'description': 'DOR was defined for participants with CR or PR as the time from the date of first documentation of response (CR or PR) to date of the first documentation of PD or death. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease, PR as the regression of measurable disease and no new sites, and PD as any new lesion or increase by ≥50% of previously involved sites from nadir. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT), PR as partial metabolic response (according to PET-CT) and partial remission (according to CT), and PD as a progressive metabolic response (according to PET-CT) and progressive disease (according to CT). Results are reported as months.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Modified Intent-to-treat (mITT) analysis set: all participants who receive at least 1 dose of duvelisib. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duvelisib, Continuous and Intermittent Dosing', 'description': 'Duvelisib 25 mg BID continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on of each subsequent 4-week cycle.'}, {'id': 'OG001', 'title': 'Duvelisib, Intermittent Dosing', 'description': 'Duvelisib 25 mg BID dosed 2 weeks on and 2 weeks off.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 2 years', 'description': 'OS was the time from first dose to death (death date - treatment start date + 1). Participants without documented death were censored at their last known alive date (last known alive date - treatment start date + 1). Results reported as months.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Modified Intent-to-treat (mITT) analysis set: all participants who receive at least 1 dose of duvelisib. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Lymph Node Response Rate (LNRR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duvelisib, Continuous and Intermittent Dosing', 'description': 'Duvelisib 25 mg BID continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on of each subsequent 4-week cycle.'}, {'id': 'OG001', 'title': 'Duvelisib, Intermittent Dosing', 'description': 'Duvelisib 25 mg BID dosed 2 weeks on and 2 weeks off.'}], 'classes': [{'categories': [{'measurements': [{'value': '64.3', 'groupId': 'OG000', 'lowerLimit': '48.0', 'upperLimit': '78.4'}, {'value': '60.9', 'groupId': 'OG001', 'lowerLimit': '45.4', 'upperLimit': '74.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '14 months', 'description': 'LNRR was calculated as the percentage of participants achieving ≥50% decrease in the sum of the product of the diameters of target lymph nodes. The confidence interval for LNRR was calculated only for participants who had at least 1 nodal target lesion, using the Clopper-Pearson exact method for binomial proportions. Participants whose target lesions were all extranodal were excluded from this analysis.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Modified Intent-to-treat (mITT) analysis set: all participants who receive at least 1 dose of duvelisib. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Time To First Response (TTFR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duvelisib, Continuous and Intermittent Dosing', 'description': 'Duvelisib 25 mg BID continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on of each subsequent 4-week cycle.'}, {'id': 'OG001', 'title': 'Duvelisib, Intermittent Dosing', 'description': 'Duvelisib 25 mg BID dosed 2 weeks on and 2 weeks off.'}], 'classes': [{'title': '2007 Revised IWG Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.30', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '12.9'}, {'value': '2.30', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '12.5'}]}]}, {'title': '2014 Lugano Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.30', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '12.9'}, {'value': '2.30', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '12.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 14 months', 'description': 'For participants with CR or PR, TTFR was defined as the time from first dose of study intervention to time of first CR or PR and was calculated as: the date of first CR or PR - randomization date + 1. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease and PR as the regression of measurable disease and no new sites. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT) and PR as partial metabolic response (according to PET-CT) and partial remission (according to CT). Results are reported as months.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "Modified Intent-to-treat (mITT) analysis set: all participants who receive at least 1 dose of duvelisib. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Time To Treatment Failure (TTF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duvelisib, Continuous and Intermittent Dosing', 'description': 'Duvelisib 25 mg BID continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on of each subsequent 4-week cycle.'}, {'id': 'OG001', 'title': 'Duvelisib, Intermittent Dosing', 'description': 'Duvelisib 25 mg BID dosed 2 weeks on and 2 weeks off.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000', 'lowerLimit': '6.2', 'upperLimit': '17.1'}, {'value': '14.3', 'groupId': 'OG001', 'lowerLimit': '8.0', 'upperLimit': '23.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 2 years', 'description': 'TTF was calculated as the time from first dose of study treatment to discontinuation for any reason (discontinuation date - treatment start date + 1). Participants who were still ongoing treatment at time of data cut were censored (last dose date - treatment start date + 1). Results reported as months.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Modified Intent-to-treat (mITT) analysis set: all participants who receive at least 1 dose of duvelisib. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'ORR According to 2014 Lugano Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duvelisib, Continuous and Intermittent Dosing', 'description': 'Duvelisib 25 mg BID continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on of each subsequent 4-week cycle.'}, {'id': 'OG001', 'title': 'Duvelisib, Intermittent Dosing', 'description': 'Duvelisib 25 mg BID dosed 2 weeks on and 2 weeks off.'}], 'classes': [{'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.3', 'groupId': 'OG000', 'lowerLimit': '50.4', 'upperLimit': '78.3'}, {'value': '51.0', 'groupId': 'OG001', 'lowerLimit': '36.6', 'upperLimit': '65.2'}]}]}, {'title': 'PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.2', 'groupId': 'OG000', 'lowerLimit': '46.5', 'upperLimit': '76.2'}, {'value': '52.2', 'groupId': 'OG001', 'lowerLimit': '36.9', 'upperLimit': '67.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 months', 'description': 'ORR was defined as the percentage of participants achieving a CR or PR and was assessed using the 2014 Lugano criteria. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT) and PR as partial metabolic response (according to PET-CT) and partial remission (according to CT).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Modified Intent-to-treat (mITT) analysis set: all participants who receive at least 1 dose of duvelisib. Per-protocol (PP) Analysis Set: all participants in the mITT analysis set who did not violate the protocol in a way that would significantly affect the study outcome. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Duvelisib, Continuous and Intermittent Dosing', 'description': 'Duvelisib 25 milligrams (mg) twice daily (BID) continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on of each subsequent 4-week cycle.'}, {'id': 'FG001', 'title': 'Duvelisib, Intermittent Dosing', 'description': 'Duvelisib 25 mg BID dosed 2 weeks on and 2 weeks off.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'Received At Least 1 Dose of Study Drug', 'comment': 'All-treated (AT) Analysis Set/Modified Intent-to-treat (mITT) Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Consent Withdrawn Prior to Receiving Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Participant Moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Duvelisib, Continuous and Intermittent Dosing', 'description': 'Duvelisib 25 mg BID continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on of each subsequent 4-week cycle.'}, {'id': 'BG001', 'title': 'Duvelisib, Intermittent Dosing', 'description': 'Duvelisib 25 mg BID dosed 2 weeks on and 2 weeks off.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.5', 'spread': '12.15', 'groupId': 'BG000'}, {'value': '63.9', 'spread': '11.40', 'groupId': 'BG001'}, {'value': '62.2', 'spread': '11.85', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', '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': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '23', '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': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All-Treated (AT) Analysis Set: All participants who receive at least 1 dose of duvelisib.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-19', 'size': 1014631, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-07-23T17:03', 'hasProtocol': True}, {'date': '2023-08-31', 'size': 3964926, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-07-23T17:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-04', 'studyFirstSubmitDate': '2019-07-10', 'resultsFirstSubmitDate': '2024-07-24', 'studyFirstSubmitQcDate': '2019-07-26', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-04', 'studyFirstPostDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response Rate (ORR) According to the 2007 Revised International Working Group (IWG) Criteria', 'timeFrame': 'Up to 14 months', 'description': 'ORR was defined as the percentage of participants achieving a complete response (CR) or partial response (PR) and assessed using the 2007 revised IWG criteria. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease and PR as the regression of measurable disease and no new sites.'}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'Up to 2 years', 'description': 'PFS was defined as the time from first dose to first progressive disease (PD) or death (progression date/death date - treatment start date + 1) or, for participants without PD or documented death, as the time from first dose to censoring date (censoring date - treatment start date + 1). The 2007 revised IWG criteria defined PD as any new lesion or increase by ≥50% of previously involved sites from nadir. The 2014 Lugano criteria defined PD as a progressive metabolic response (according to positron emission tomography-computed tomography \\[PET-CT\\]) and progressive disease (according to computed tomography \\[CT\\]). Results reported as months.'}, {'measure': 'ORR At Specific Timepoints', 'timeFrame': '6, 12, 18, and 24 months after first dose of study intervention', 'description': 'ORR at 6, 12, 18, and 24 months after first dose of study intervention was defined as the percentage of participants achieving CR or PR at each timepoint and was assessed using both the 2007 revised IWG criteria and the 2014 Lugano criteria. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease and PR as the regression of measurable disease and no new sites. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT) and PR as partial metabolic response (according to PET-CT) and partial remission (according to CT). The response was cumulative for each timepoint; a participant was considered a responder if their first response occurred up to the end of that timepoint.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to 2 years', 'description': 'DOR was defined for participants with CR or PR as the time from the date of first documentation of response (CR or PR) to date of the first documentation of PD or death. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease, PR as the regression of measurable disease and no new sites, and PD as any new lesion or increase by ≥50% of previously involved sites from nadir. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT), PR as partial metabolic response (according to PET-CT) and partial remission (according to CT), and PD as a progressive metabolic response (according to PET-CT) and progressive disease (according to CT). Results are reported as months.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 2 years', 'description': 'OS was the time from first dose to death (death date - treatment start date + 1). Participants without documented death were censored at their last known alive date (last known alive date - treatment start date + 1). Results reported as months.'}, {'measure': 'Lymph Node Response Rate (LNRR)', 'timeFrame': '14 months', 'description': 'LNRR was calculated as the percentage of participants achieving ≥50% decrease in the sum of the product of the diameters of target lymph nodes. The confidence interval for LNRR was calculated only for participants who had at least 1 nodal target lesion, using the Clopper-Pearson exact method for binomial proportions. Participants whose target lesions were all extranodal were excluded from this analysis.'}, {'measure': 'Time To First Response (TTFR)', 'timeFrame': 'Up to 14 months', 'description': 'For participants with CR or PR, TTFR was defined as the time from first dose of study intervention to time of first CR or PR and was calculated as: the date of first CR or PR - randomization date + 1. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease and PR as the regression of measurable disease and no new sites. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT) and PR as partial metabolic response (according to PET-CT) and partial remission (according to CT). Results are reported as months.'}, {'measure': 'Time To Treatment Failure (TTF)', 'timeFrame': 'Up to 2 years', 'description': 'TTF was calculated as the time from first dose of study treatment to discontinuation for any reason (discontinuation date - treatment start date + 1). Participants who were still ongoing treatment at time of data cut were censored (last dose date - treatment start date + 1). Results reported as months.'}, {'measure': 'ORR According to 2014 Lugano Criteria', 'timeFrame': 'Up to 14 months', 'description': 'ORR was defined as the percentage of participants achieving a CR or PR and was assessed using the 2014 Lugano criteria. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT) and PR as partial metabolic response (according to PET-CT) and partial remission (according to CT).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PI3K Inhibitor'], 'conditions': ['Indolent Non-Hodgkin Lymphoma']}, 'descriptionModule': {'briefSummary': 'This study examined the effects of predefined 2-week duvelisib dose holidays on tumor responses and safety/tolerability.', 'detailedDescription': 'This was a Phase 2, randomized, open-label, 2-arm study designed to evaluate the efficacy and safety of prescribed drug holidays of duvelisib treatment in participants with relapsed or refractory (R/R) indolent non-Hodgkin lymphoma (iNHL) who have received at least 1 prior systemic therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group performance status ≤ 2\n* Histologically confirmed diagnosis of iNHL (subtypes include follicular lymphoma \\[FL\\] Grades 1 to 3a), marginal zone lymphoma (splenic, nodal, or extranodal), or small lymphocytic lymphoma\n* Must have received 1 prior systemic regimen for iNHL\n* Must have documented radiologic evidence of disease progression, at least 1 bi-dimensionally measurable lesion ≥ 1.5 centimeters (which has not been previously irradiated), according to 2007 revised International Working Group criteria, and be a candidate for a subsequent line of therapy.\n* Must have adequate organ function defined by the following laboratory parameters:\n\n * Absolute neutrophil count ≥ 1.0 × 10\\^9/liter (L)\n * Platelet count ≥ 75 × 10\\^9/L\n * Hemoglobin ≥ 8 grams/deciliter\n * Estimated creatinine clearance ≥ 60 milliliters/minute, as determined by the Cockcroft-Gault method\n * Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (exception: participants with Gilbert's Syndrome may have a bilirubin \\> 1.5 × ULN)\n * Aspartate transaminase/serum glutamic-oxaloacetic transaminase and alanine aminotransferase/serum pyruvic transaminase ≤ 3.0 × ULN\n\nExclusion Criteria:\n\n* Anticancer treatment, major surgery, or use of any investigational drug within 28 days before the start of study intervention; palliative radiation therapy is allowed if \\> 7 days before planned first dose of study interventions, and any toxicity is Grade ≤ 1\n* Clinical or histological evidence of transformation to a more aggressive subtype of lymphoma or grade 3b FL or Richters' transformation or chronic lymphocytic leukemia\n* Prior allogeneic hematopoietic stem cell transplant; prior treatment with a PI3K inhibitor\n* History of drug-induced colitis or pneumonitis; tuberculosis treatment ≤ 2 years prior to randomization; administration of a live or live attenuated vaccine within 6 weeks of randomization\n* Ongoing treatment with chronic immunosuppressants or systemic steroids or treatment for systemic bacterial, fungal, or viral infection\n* Active cytomegalovirus or Epstein-Barr virus infection\n* Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus, or herpes zoster at screening\n* Concurrent administration of medications or foods that are strong inhibitors or inducers of cytochrome P450 3A. No prior use within 2 weeks before the start of study intervention.\n* Baseline QT interval corrected with Fridericia's method \\> 500 milliseconds\n* Concurrent active malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix, bladder cancer, or prostate cancer not requiring treatment. Participants with previous malignancies are eligible if they have been disease-free for 2 years or more.\n* Unstable or severe uncontrolled medical condition that would, in the Investigator's judgment, increase the participant's risk to participating in this study."}, 'identificationModule': {'nctId': 'NCT04038359', 'acronym': 'TEMPO', 'briefTitle': 'A Phase 2 Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Participants With Indolent Non-Hodgkin Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'SecuraBio'}, 'officialTitle': 'A Phase 2, Randomized, Open-label, 2-Arm Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Subjects With Indolent Non-Hodgkin Lymphoma (iNHL)', 'orgStudyIdInfo': {'id': 'VS-0145-229'}, 'secondaryIdInfos': [{'id': '2019-001381-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Duvelisib, Continuous and Intermittent Dosing', 'description': 'Duvelisib 25 milligrams (mg) twice daily (BID) continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on for each subsequent 4-week cycle.', 'interventionNames': ['Drug: Duvelisib']}, {'type': 'EXPERIMENTAL', 'label': 'Duvelisib, Intermittent Dosing', 'description': 'Duvelisib 25 mg BID dosed 2 weeks on and 2 weeks off.', 'interventionNames': ['Drug: Duvelisib']}], 'interventions': [{'name': 'Duvelisib', 'type': 'DRUG', 'otherNames': ['Copiktra', 'VS-0145', 'IPI-145'], 'description': 'Phosphoinositide 3-kinase (PI3K) inhibitor', 'armGroupLabels': ['Duvelisib, Continuous and Intermittent Dosing', 'Duvelisib, Intermittent Dosing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists - Fort Myers', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '34461', 'city': 'Lecanto', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists & Research Institute - Lecanto', 'geoPoint': {'lat': 28.85165, 'lon': -82.4876}}, {'zip': '32763', 'city': 'Orange City', 'state': 'Florida', 'country': 'United States', 'facility': 'Mid-Florida Cancer Centers', 'geoPoint': {'lat': 28.94888, 'lon': -81.29867}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Robert H. Lurie Comprehensive Cancer Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '89169', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Comprehensive Cancer Centers of Nevada', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Oncology', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '500 05', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'FN Hradec Kralove', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '128 08', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Vseobecna fakultni nemocnice v Praze', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '53127', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Universitaetsklinikum Bonn AöR', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '47014', 'city': 'Meldola', 'state': 'Forli', 'country': 'Italy', 'facility': 'Oncology Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori', 'geoPoint': {'lat': 44.12775, 'lon': 12.0626}}, {'zip': '20141', 'city': 'Milan', 'country': 'Italy', 'facility': 'IEO - Istituto Europeo di Oncologia, IRCCS', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '42123', 'city': 'Reggio Emilia', 'country': 'Italy', 'facility': 'AUSL di Reggio Emilia IRCCS, Arcispedale Santa Maria Nuova di Reggio Emilia', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}, {'zip': '05100', 'city': 'Terni', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Santa Maria di Terni', 'geoPoint': {'lat': 42.56335, 'lon': 12.64329}}, {'zip': '21100', 'city': 'Varese', 'country': 'Italy', 'facility': 'Ospedale di Circolo, PO Varese, AO Ospedale di Circolo e Fondazione Macchi', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}, {'zip': '76-200', 'city': 'Słupsk', 'state': 'Pomeranian Voivodeship', 'country': 'Poland', 'facility': 'Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.', 'geoPoint': {'lat': 54.46405, 'lon': 17.02872}}, {'zip': '40-519', 'city': 'Katowice', 'country': 'Poland', 'facility': 'Pratia Onkologia Katowice', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '60-185', 'city': 'Skórzewo', 'country': 'Poland', 'facility': 'Centrum Medyczne Pratia Poznan', 'geoPoint': {'lat': 53.03629, 'lon': 17.81889}}, {'zip': '108814', 'city': 'Moscow', 'country': 'Russia', 'facility': 'State Budgetary Healthcare Institution of Moscow City Moscow Multidisciplinary Clinical Center "Kommunarka" of the Department of Healthcare of Moscow City', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '125284', 'city': 'Moscow', 'country': 'Russia', 'facility': 'City Clinical Hospital n.a. Botkin', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '197022', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'First Saint-Petersburg State Medical University n.a. I.P. 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