Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT01660451
Status:
COMPLETED
Last Update Posted:
2024-07-17
First Post:
2012-08-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Open-label, Uncontrolled Phase II Trial of Intravenous PI3K Inhibitor BAY80-6946 in Patients With Relapsed, Indolent or Aggressive Non-Hodgkin's Lymphomas
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Chile', 'China', 'Colombia', 'Denmark', 'Japan', 'Luxembourg', 'Mexico', 'Peru']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000589253', 'term': 'copanlisib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayer.com', 'phone': '+1-888-8422937', 'title': 'Therapeutic Area Head', 'organization': 'Bayer'}, 'certainAgreement': {'otherDetails': 'Contract Partners (PI) shall provide to Bayer any proposed publication or oral presentation relating to the Study or the Results ("Publication") at least sixty (60) days prior to the intended submission or presentation of the Publication in order to allow Bayer to review it. If Bayer does not notify PI within forty-five (45) days of Bayer\'s receipt of the intended Publication, PI shall remind Bayer. If Bayer does not provide any comments within the sixty day period, PI shall be free to publish.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'After the first study intervention up to 35 days after the end of study intervention, Part A: approximately 6 years. Part B: approximately 9 years 7 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, Part A: approximately 6 years. Part B: approximately 9 years 7 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Part A: Indolent NHL/CLL', 'description': "Participants with indolent Non-Hodgkin's lymphoma/Chronic lymphocytic leukemia \\[iNHL/CLL\\] received copanlisib 0.8 milligram per kilogram (mg/kg), maximum 65 mg, intravenous (IV) infusion dosing over 1 hour in 100 milliliter (mL) normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.", 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 33, 'seriousNumAtRisk': 33, 'deathsNumAffected': 21, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': 'Part A: Aggressive NHL', 'description': "Participants with aggressive NHL (aNHL) received copanlisib 0.8 mg/kg, maximum 65 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.", 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 50, 'seriousNumAtRisk': 51, 'deathsNumAffected': 39, 'seriousNumAffected': 31}, {'id': 'EG002', 'title': 'Part B: Indolent NHL', 'description': 'Participants with indolent B-cell NHL received copanlisib 60 mg or 0.8 mg/kg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Revised Response Criteria for Malignant Lymphoma by Cheson et al., 2007, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.', 'otherNumAtRisk': 142, 'deathsNumAtRisk': 142, 'otherNumAffected': 138, 'seriousNumAtRisk': 142, 'deathsNumAffected': 75, 'seriousNumAffected': 81}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 21, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 43, 'numAffected': 27}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 16, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 25, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 117, 'numAffected': 40}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 30, 'numAffected': 21}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 16, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 21, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 65, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 39, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 98, 'numAffected': 51}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 17, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 22, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 45, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 24, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 25, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 20, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 41, 'numAffected': 36}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 17, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 22, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 54, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 10, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 22, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 16, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 13, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 45, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 13, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 42, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Eosinophil count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 15, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 19, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 16, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Weight decreased', 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'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 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0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Organising pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Dermatitis exfoliative generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Preoperative care', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Superficial vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objective Response Rate (ORR) Based on Independent Review-Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Indolent NHL/CLL', 'description': "Participants with indolent Non-Hodgkin's lymphoma/Chronic lymphocytic leukemia \\[iNHL/CLL\\] received copanlisib 0.8 milligram per kilogram (mg/kg), maximum 65 mg, intravenous (IV) infusion dosing over 1 hour in 100 milliliter (mL) normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study."}, {'id': 'OG001', 'title': 'Part A: Aggressive NHL', 'description': "Participants with aggressive NHL (aNHL) received copanlisib 0.8 mg/kg, maximum 65 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study."}], 'classes': [{'categories': [{'measurements': [{'value': '43.75', 'groupId': 'OG000', 'lowerLimit': '28.73', 'upperLimit': '59.68'}, {'value': '27.08', 'groupId': 'OG001', 'lowerLimit': '16.83', 'upperLimit': '39.57'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000'], 'paramType': 'Response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '45.45', 'ciLowerLimit': '30.49', 'ciUpperLimit': '61.06', 'pValueComment': '0.0001', 'groupDescription': 'Response rate was statistically compared by exact binomial test if higher than 5%.', 'statisticalMethod': 'Exact binomial test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0001', 'groupIds': ['OG001'], 'paramType': 'Response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '27.08', 'ciLowerLimit': '16.83', 'ciUpperLimit': '39.57', 'pValueComment': '0.0001', 'groupDescription': 'Response rate was statistically compared by exact binomial test if higher than 5%.', 'statisticalMethod': 'Exact binominal test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'P-value was based on the original patients in the aggressive arm (for the first 34 patients), not including the additional recruited patients.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to the last patient has completed the 16 weeks of treatment', 'description': 'Objective response rate was defined as the proportion of participants with a best response rating of complete response (CR), unconfirmed complete response (CRu) or partial response (PR), based on the Report of an International Workshop to Standardize Response Criteria for non-Hodgkins Lymphomas, Cheson, 1999, as evaluated by the Independent Response Adjudication Committee (IRAC). For chronic lymphocytic leukemia (CLL) patients Hallek criteria (2008) were used and assessed by investigator.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol set included all patients treated with study drug and evaluated for ORR and had no major protocol deviation. (In Part A, for CLL patients, there was no independent assessment. Instead, the investigator assessment had been used.)'}, {'type': 'PRIMARY', 'title': 'ORR Based on Independent Review-Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Indolent NHL', 'description': 'Participants with indolent B-cell NHL received copanlisib 60 mg or 0.8 mg/kg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Revised Response Criteria for Malignant Lymphoma by Cheson et al., 2007, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.15', 'groupId': 'OG000', 'lowerLimit': '50.60', 'upperLimit': '67.32'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '59.15', 'ciLowerLimit': '50.60', 'ciUpperLimit': '67.32', 'pValueComment': '0.001', 'groupDescription': 'Response rate was statistically compared by exact binomial test if higher than 40%.', 'statisticalMethod': 'Exact binominal test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to the last patient has completed the 16 weeks of treatment', 'description': 'Objective response rate was defined as the proportion of participants with a best response rating of CR or PR, based on the International Working Group Revised response Criteria for Malignant Lymphoma, Cheson 2007.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all patients assigned to study treatment.'}, {'type': 'PRIMARY', 'title': 'ORR Based on Investigator Assessment-Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Indolent NHL/CLL', 'description': "Participants with indolent Non-Hodgkin's lymphoma/Chronic lymphocytic leukemia \\[iNHL/CLL\\] received copanlisib 0.8 milligram per kilogram (mg/kg), maximum 65 mg, intravenous (IV) infusion dosing over 1 hour in 100 milliliter (mL) normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study."}, {'id': 'OG001', 'title': 'Part A: Aggressive NHL', 'description': "Participants with aggressive NHL (aNHL) received copanlisib 0.8 mg/kg, maximum 65 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study."}], 'classes': [{'categories': [{'measurements': [{'value': '46.88', 'groupId': 'OG000', 'lowerLimit': '31.54', 'upperLimit': '62.66'}, {'value': '31.25', 'groupId': 'OG001', 'lowerLimit': '20.35', 'upperLimit': '43.97'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000'], 'paramType': 'Response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '46.88', 'ciLowerLimit': '31.54', 'ciUpperLimit': '62.66', 'pValueComment': '0.0001', 'groupDescription': 'Response rate was statistically compared by exact binomial test if higher than 5%.', 'statisticalMethod': 'Exact binominal test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0001', 'groupIds': ['OG001'], 'paramType': 'Response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '31.25', 'ciLowerLimit': '20.35', 'ciUpperLimit': '43.97', 'pValueComment': '0.0001', 'groupDescription': 'Response rate was statistically compared by exact binomial test if higher than 5%.', 'statisticalMethod': 'Exact binominal test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to the last patient has completed the 16 weeks of treatment', 'description': 'Objective response rate was defined as the proportion of participants with a best response rating of CR, CRu or PR, based on the Report of an International Workshop to Standardize Response Criteria for non-Hodgkins Lymphomas, Cheson, 1999. For CLL patients Hallek criteria (2008) were used and assessed by investigator.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol set included all patients treated with study drug and evaluated for ORR and had no major protocol deviation. Patients who were not evaluable for ORR and discontinued due to a drug-related toxicity, death / progression by clinical judgment before disease was re-evaluated and included.'}, {'type': 'PRIMARY', 'title': 'ORR Based on Investigator Assessment-Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Indolent NHL', 'description': 'Participants with indolent B-cell NHL received copanlisib 60 mg or 0.8 mg/kg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Revised Response Criteria for Malignant Lymphoma by Cheson et al., 2007, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.41', 'groupId': 'OG000', 'lowerLimit': '42.88', 'upperLimit': '59.87'}]}]}], 'analyses': [{'pValue': '0.0039', 'groupIds': ['OG000'], 'paramType': 'Response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '51.41', 'ciLowerLimit': '42.88', 'ciUpperLimit': '59.87', 'pValueComment': '0.01', 'groupDescription': 'Response rate was statistically compared by exact binomial test if higher than 40%.', 'statisticalMethod': 'Exact binominal test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to the last patient has completed the 16 weeks of treatment', 'description': 'Objective response rate was defined as the proportion of participants with a best response rating of CR or PR, based on the International Working Group Revised response Criteria for Malignant Lymphoma, Cheson 2007.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all patients assigned to study treatment.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) Based on Independent Review-Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Indolent NHL/CLL', 'description': "Participants with indolent Non-Hodgkin's lymphoma/Chronic lymphocytic leukemia \\[iNHL/CLL\\] received copanlisib 0.8 milligram per kilogram (mg/kg), maximum 65 mg, intravenous (IV) infusion dosing over 1 hour in 100 milliliter (mL) normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study."}, {'id': 'OG001', 'title': 'Part A: Aggressive NHL', 'description': "Participants with aggressive NHL (aNHL) received copanlisib 0.8 mg/kg, maximum 65 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study."}], 'classes': [{'categories': [{'measurements': [{'value': '322', 'comment': 'NA: Value cannot be estimated due to censored data', 'groupId': 'OG000', 'lowerLimit': '61', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA: Value cannot be estimated due to censored data', 'groupId': 'OG001', 'lowerLimit': '61', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to approximately 6 years', 'description': 'DOR was defined as the time from the date of the first observed tumor response of CR or PR (whichever was noted earlier) to first subsequent disease progression (either first progressive disease \\[PD\\], first clinical progression or first AE associated with clinical disease progression) or death caused by disease progression, if this death occurred before progression was documented. All deaths were considered as \'caused by disease progression\' except deaths with the reason "other" or "AE not related to disease progression. DOR was evaluated only for patients with at least one tumor response of CR, CRu, or PR. Some patients may have had no report of disease progression nor death caused by disease progression until the date of the LPLV. With regards to DOR, these patients were considered as right censored at the date of their last tumor assessment after first observed tumor response.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS included all patients with study drug administration that were evaluable for objective tumor response and had no major protocol deviation.\n\nDOR was only evaluated for patients with at least one tumor response of CR, Cru (only for Part A) or PR.'}, {'type': 'SECONDARY', 'title': 'DOR Based on Independent Review-Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Indolent NHL', 'description': 'Participants with indolent B-cell NHL received copanlisib 60 mg or 0.8 mg/kg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Revised Response Criteria for Malignant Lymphoma by Cheson et al., 2007, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000', 'lowerLimit': '9.2', 'upperLimit': '22.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to approximately 9 years 7 months', 'description': 'DOR was defined as the time from the date of the first observed tumor response of CR or PR (whichever was noted earlier) to first subsequent disease progression (either first progressive disease \\[PD\\], first clinical progression or first AE associated with clinical disease progression) or death caused by disease progression, if this death occurred before progression was documented. All deaths were considered as \'caused by disease progression\' except deaths with the reason "other" or "AE not related to disease progression. DOR was evaluated only for patients with at least one tumor response of CR, CRu, or PR. Some patients may have had no report of disease progression nor death caused by disease progression until the date of the LPLV. With regards to DOR, these patients were considered as right censored at the date of their last tumor assessment after first observed tumor response.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all patients assigned to study treatment. DOR was only evaluated for patients with at least one tumor response of CR, Cru (only for Part A) or PR.'}, {'type': 'SECONDARY', 'title': 'DOR Based on Investigator Assessment-Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Indolent NHL/CLL', 'description': "Participants with indolent Non-Hodgkin's lymphoma/Chronic lymphocytic leukemia \\[iNHL/CLL\\] received copanlisib 0.8 milligram per kilogram (mg/kg), maximum 65 mg, intravenous (IV) infusion dosing over 1 hour in 100 milliliter (mL) normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study."}, {'id': 'OG001', 'title': 'Part A: Aggressive NHL', 'description': "Participants with aggressive NHL (aNHL) received copanlisib 0.8 mg/kg, maximum 65 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study."}], 'classes': [{'categories': [{'measurements': [{'value': '189', 'groupId': 'OG000', 'lowerLimit': '56', 'upperLimit': '574'}, {'value': '190', 'comment': 'NA: Value cannot be estimated due to censored data', 'groupId': 'OG001', 'lowerLimit': '112', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to approximately 6 years', 'description': 'DOR was defined as the time from the date of the first observed tumor response of CR or PR (whichever was noted earlier) to first subsequent disease progression (either first progressive disease \\[PD\\], first clinical progression or first AE associated with clinical disease progression) or death caused by disease progression, if this death occurred before progression was documented. All deaths were considered as \'caused by disease progression\' except deaths with the reason "other" or "AE not related to disease progression. DOR was evaluated only for patients with at least one tumor response of CR, CRu, or PR. Some patients may have had no report of disease progression nor death caused by disease progression until the date of the LPLV. With regards to DOR, these patients were considered as right censored at the date of their last tumor assessment after first observed tumor response.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS included all patients with study drug administration that were evaluable for objective tumor response and had no major protocol deviation.\n\nDOR was only evaluated for patients with at least one tumor response of CR, Cru (only for Part A) or PR.'}, {'type': 'SECONDARY', 'title': 'DOR Based on Investigator Assessment-Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Indolent NHL', 'description': 'Participants with indolent B-cell NHL received copanlisib 60 mg or 0.8 mg/kg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Revised Response Criteria for Malignant Lymphoma by Cheson et al., 2007, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000', 'lowerLimit': '9.2', 'upperLimit': '16.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to approximately 9 years 7 months', 'description': 'DOR was defined as the time from the date of the first observed tumor response of CR or PR (whichever was noted earlier) to first subsequent disease progression (either first progressive disease \\[PD\\], first clinical progression or first AE associated with clinical disease progression) or death caused by disease progression, if this death occurred before progression was documented. All deaths were considered as \'caused by disease progression\' except deaths with the reason "other" or "AE not related to disease progression. DOR was evaluated only for patients with at least one tumor response of CR, CRu, or PR. Some patients may have had no report of disease progression nor death caused by disease progression until the date of the LPLV. With regards to DOR, these patients were considered as right censored at the date of their last tumor assessment after first observed tumor response.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all patients assigned to study treatment. DOR was only evaluated for patients with at least one tumor response of CR, Cru (only for Part A) or PR.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) Based on Independent Review-Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Indolent NHL/CLL', 'description': "Participants with indolent Non-Hodgkin's lymphoma/Chronic lymphocytic leukemia \\[iNHL/CLL\\] received copanlisib 0.8 milligram per kilogram (mg/kg), maximum 65 mg, intravenous (IV) infusion dosing over 1 hour in 100 milliliter (mL) normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study."}, {'id': 'OG001', 'title': 'Part A: Aggressive NHL', 'description': "Participants with aggressive NHL (aNHL) received copanlisib 0.8 mg/kg, maximum 65 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study."}], 'classes': [{'categories': [{'measurements': [{'value': '223', 'groupId': 'OG000', 'lowerLimit': '147', 'upperLimit': '546'}, {'value': '70', 'groupId': 'OG001', 'lowerLimit': '47', 'upperLimit': '115'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to approximately 6 years', 'description': 'PFS was defined as the time (in days) from the date of the first treatment to the date of first observed PD (radiological or clinical, or first AE associated with clinical PD, whichever was earlier) or death due to any cause (if death occurred before progression was documented).', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all patients assigned to study treatment.'}, {'type': 'SECONDARY', 'title': 'PFS Based on Independent Review-Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Indolent NHL', 'description': 'Participants with indolent B-cell NHL received copanlisib 60 mg or 0.8 mg/kg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Revised Response Criteria for Malignant Lymphoma by Cheson et al., 2007, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.3', 'groupId': 'OG000', 'lowerLimit': '8.1', 'upperLimit': '17.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to approximately 9 years 7 months', 'description': 'PFS was defined as the time (in days) from the date of the first treatment to the date of first observed PD (radiological or clinical, or first AE associated with clinical PD, whichever was earlier) or death due to any cause (if death occurred before progression was documented).', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all patients assigned to study treatment.'}, {'type': 'SECONDARY', 'title': 'PFS Based on Investigator Assessment-Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Indolent NHL/CLL', 'description': "Participants with indolent Non-Hodgkin's lymphoma/Chronic lymphocytic leukemia \\[iNHL/CLL\\] received copanlisib 0.8 milligram per kilogram (mg/kg), maximum 65 mg, intravenous (IV) infusion dosing over 1 hour in 100 milliliter (mL) normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study."}, {'id': 'OG001', 'title': 'Part A: Aggressive NHL', 'description': "Participants with aggressive NHL (aNHL) received copanlisib 0.8 mg/kg, maximum 65 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study."}], 'classes': [{'categories': [{'measurements': [{'value': '224', 'groupId': 'OG000', 'lowerLimit': '172', 'upperLimit': '419'}, {'value': '70', 'groupId': 'OG001', 'lowerLimit': '47', 'upperLimit': '115'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to approximately 6 years', 'description': 'PFS was defined as the time (in days) from the date of the first treatment to the date of first observed PD (radiological or clinical, or first AE associated with clinical PD, whichever was earlier) or death due to any cause (if death occurred before progression was documented).', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all patients assigned to study treatment.'}, {'type': 'SECONDARY', 'title': 'PFS Based on Investigator Assessment-Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Indolent NHL', 'description': 'Participants with indolent B-cell NHL received copanlisib 60 mg or 0.8 mg/kg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Revised Response Criteria for Malignant Lymphoma by Cheson et al., 2007, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '12.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to approximately 9 years 7 months', 'description': 'PFS was defined as the time (in days) from the date of the first treatment to the date of first observed PD (radiological or clinical, or first AE associated with clinical PD, whichever was earlier) or death due to any cause (if death occurred before progression was documented).', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all patients assigned to study treatment.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)-Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Indolent NHL/CLL', 'description': "Participants with indolent Non-Hodgkin's lymphoma/Chronic lymphocytic leukemia \\[iNHL/CLL\\] received copanlisib 0.8 milligram per kilogram (mg/kg), maximum 65 mg, intravenous (IV) infusion dosing over 1 hour in 100 milliliter (mL) normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study."}, {'id': 'OG001', 'title': 'Part A: Aggressive NHL', 'description': "Participants with aggressive NHL (aNHL) received copanlisib 0.8 mg/kg, maximum 65 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study."}], 'classes': [{'categories': [{'measurements': [{'value': '657', 'comment': 'NA: Value cannot be estimated due to censored data', 'groupId': 'OG000', 'lowerLimit': '391', 'upperLimit': 'NA'}, {'value': '211', 'groupId': 'OG001', 'lowerLimit': '140', 'upperLimit': '399'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to approximately 6 years', 'description': 'OS was defined as the time (in days) from the date of first administration of study treatment to death due to any cause. Patients who were alive at the date of the LPLV were censored at the minimum of the date of LPLV and the last available date of evidence that the patient was still alive.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all patients assigned to study treatment.'}, {'type': 'SECONDARY', 'title': 'OS-Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Indolent NHL', 'description': 'Participants with indolent B-cell NHL received copanlisib 60 mg or 0.8 mg/kg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Revised Response Criteria for Malignant Lymphoma by Cheson et al., 2007, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.1', 'comment': 'NA: Value cannot be estimated due to censored data', 'groupId': 'OG000', 'lowerLimit': '36.5', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to approximately 9 years 7 months', 'description': 'OS was defined as the time (in days) from the date of first administration of study treatment to death due to any cause. OS was defined as the time (in days) from the date of first administration of study treatment to death due to any cause. Patients who were alive at the date of the LPLV were censored at the minimum of the date of LPLV and the last available date of evidence that the patient was still alive.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all patients assigned to study treatment.'}, {'type': 'SECONDARY', 'title': 'Functional Assessment of Cancer Therapy - Lymphoma Lymphoma Subscale (FACT-Lym LymS) at Week 16 - Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Indolent NHL', 'description': 'Participants with indolent B-cell NHL received copanlisib 60 mg or 0.8 mg/kg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Revised Response Criteria for Malignant Lymphoma by Cheson et al., 2007, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.50', 'groupId': 'OG000', 'lowerLimit': '40.50', 'upperLimit': '52.00'}]}]}, {'title': 'Value at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '49.00', 'groupId': 'OG000', 'lowerLimit': '42.00', 'upperLimit': '54.00'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Hodges-Lehmann-estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.5', 'ciUpperLimit': '2.5', 'groupDescription': 'Hodges-Lehmann-estimate was used to calculate change to Week 16 and 95% confidence interval.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to week 16', 'description': 'HRQoL assessment was used to describe development of patients with copanlisib by using FACT-Lym questionnaire assessment tool. It contains 42 items (questions) covering HRQoL, common lymphoma symptoms and treatment side-effects. The FACT - General (FACT-G) questionnaire contains 27 items covering 4 core HRQoL subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 items) (FACT-Lym LymS), addressing issues typically experienced by lymphoma patients. Some of the issues covered include pain, itching, night sweats, trouble sleeping, fatigue and trouble concentrating. FACT-Lym also asks patients about lumps and swelling, fevers, infections, weight, appetite, emotional stability and treatment. Score range for the FACT-Lym LymS was 0 - 60, higher score represent less symptoms. Here in below table "n" signifies evaluable participants for the respective category.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all patients assigned to study treatment. The analysis was performed by using last observation carried forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Total Score at Week 16 - Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Indolent NHL', 'description': 'Participants with indolent B-cell NHL received copanlisib 60 mg or 0.8 mg/kg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Revised Response Criteria for Malignant Lymphoma by Cheson et al., 2007, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '127.50', 'groupId': 'OG000', 'lowerLimit': '113.75', 'upperLimit': '145.75'}]}]}, {'title': 'Value at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '130.83', 'groupId': 'OG000', 'lowerLimit': '113.33', 'upperLimit': '146.50'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Hodges-Lehmann-estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.50', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '3.2', 'groupDescription': 'Hodges-Lehmann-estimate was used to calculate change to Week 16 and 95% confidence interval.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to week 16', 'description': 'HRQoL assessment was used to describe development of patients with copanlisib by using FACT-Lym questionnaire assessment tool. It contains 42 items (questions) covering HRQoL, common lymphoma symptoms and treatment side-effects. The FACT - General (FACT-G) questionnaire contains 27 items covering 4 core HRQoL subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 items) (FACT-Lym LymS), addressing issues typically experienced by lymphoma patients. Some of the issues covered include pain, itching, night sweats, trouble sleeping, fatigue and trouble concentrating. FACT-Lym also asks patients about lumps and swelling, fevers, infections, weight, appetite, emotional stability and treatment. FACT-Lym total score range was 0-168, higher score indicates better HRQoL. Here, in the below table "n" signifies evaluable participants for the respective category.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all patients assigned to study treatment. The analysis was performed by using last LOCF method.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A: Indolent NHL/CLL', 'description': "Participants with indolent Non-Hodgkin's lymphoma/Chronic lymphocytic leukemia \\[iNHL/CLL\\] received copanlisib 0.8 milligram per kilogram (mg/kg), maximum 65 mg, intravenous (IV) infusion dosing over 1 hour in 100 milliliter (mL) normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study."}, {'id': 'FG001', 'title': 'Part A: Aggressive NHL', 'description': "Participants with aggressive NHL (aNHL) received copanlisib 0.8 mg/kg, maximum 65 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study."}, {'id': 'FG002', 'title': 'Part B: Indolent NHL', 'description': 'Participants with indolent B-cell NHL received copanlisib 60 mg or 0.8 mg/kg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Revised Response Criteria for Malignant Lymphoma by Cheson et al., 2007, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '142'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '142'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'AE not associated with clinical disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '40'}]}, {'type': 'AE associated with clinical disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'Trial closure.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Switching to other therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Progressive disease - clinical progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Progressive disease - radiological progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '50'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Part A-Study enrolled participants from 41 study centers in 10 countries, between 19 NOV 2012 (first participant first visit \\[FPFV\\]) and 13 AUG 2018 (last participant last visit \\[LPLV\\]). Part B-Study enrolled participants from 81 study centers in 24 countries, between 04 NOV 2013 (FPFV) and 18 MAY 2023 (LPLV),', 'preAssignmentDetails': 'Part A: Overall 125 participants were screened, of them 41 were screened but never assigned to treatment. Total 84 were assigned to treatment. Part B: Overall 213 participants were screened, of them 70 were screened but never assigned to treatment. Total 143 were assigned to treatment, of them 1 was suspected as fraudulent and excluded from analysis sets. Therefore 142 participants were evaluable.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}, {'value': '226', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A: Indolent NHL/CLL', 'description': "Participants with indolent Non-Hodgkin's lymphoma/Chronic lymphocytic leukemia \\[iNHL/CLL\\] received copanlisib 0.8 milligram per kilogram (mg/kg), maximum 65 mg, intravenous (IV) infusion dosing over 1 hour in 100 milliliter (mL) normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study."}, {'id': 'BG001', 'title': 'Part A: Aggressive NHL', 'description': "Participants with aggressive NHL (aNHL) received copanlisib 0.8 mg/kg, maximum 65 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study."}, {'id': 'BG002', 'title': 'Part B: Indolent NHL', 'description': 'Participants with indolent B-cell NHL received copanlisib 60 mg or 0.8 mg/kg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Revised Response Criteria for Malignant Lymphoma by Cheson et al., 2007, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18 to 90 years', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}, {'value': '226', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '111', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}, {'value': '181', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '185', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set (FAS) included all participants assigned to study treatment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 227}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-25', 'studyFirstSubmitDate': '2012-08-06', 'resultsFirstSubmitDate': '2017-10-13', 'studyFirstSubmitQcDate': '2012-08-06', 'lastUpdatePostDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-12-08', 'studyFirstPostDateStruct': {'date': '2012-08-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR) Based on Independent Review-Part A', 'timeFrame': 'Baseline up to the last patient has completed the 16 weeks of treatment', 'description': 'Objective response rate was defined as the proportion of participants with a best response rating of complete response (CR), unconfirmed complete response (CRu) or partial response (PR), based on the Report of an International Workshop to Standardize Response Criteria for non-Hodgkins Lymphomas, Cheson, 1999, as evaluated by the Independent Response Adjudication Committee (IRAC). For chronic lymphocytic leukemia (CLL) patients Hallek criteria (2008) were used and assessed by investigator.'}, {'measure': 'ORR Based on Independent Review-Part B', 'timeFrame': 'Baseline up to the last patient has completed the 16 weeks of treatment', 'description': 'Objective response rate was defined as the proportion of participants with a best response rating of CR or PR, based on the International Working Group Revised response Criteria for Malignant Lymphoma, Cheson 2007.'}, {'measure': 'ORR Based on Investigator Assessment-Part A', 'timeFrame': 'Baseline up to the last patient has completed the 16 weeks of treatment', 'description': 'Objective response rate was defined as the proportion of participants with a best response rating of CR, CRu or PR, based on the Report of an International Workshop to Standardize Response Criteria for non-Hodgkins Lymphomas, Cheson, 1999. For CLL patients Hallek criteria (2008) were used and assessed by investigator.'}, {'measure': 'ORR Based on Investigator Assessment-Part B', 'timeFrame': 'Baseline up to the last patient has completed the 16 weeks of treatment', 'description': 'Objective response rate was defined as the proportion of participants with a best response rating of CR or PR, based on the International Working Group Revised response Criteria for Malignant Lymphoma, Cheson 2007.'}], 'secondaryOutcomes': [{'measure': 'Duration of Response (DOR) Based on Independent Review-Part A', 'timeFrame': 'Baseline up to approximately 6 years', 'description': 'DOR was defined as the time from the date of the first observed tumor response of CR or PR (whichever was noted earlier) to first subsequent disease progression (either first progressive disease \\[PD\\], first clinical progression or first AE associated with clinical disease progression) or death caused by disease progression, if this death occurred before progression was documented. All deaths were considered as \'caused by disease progression\' except deaths with the reason "other" or "AE not related to disease progression. DOR was evaluated only for patients with at least one tumor response of CR, CRu, or PR. Some patients may have had no report of disease progression nor death caused by disease progression until the date of the LPLV. With regards to DOR, these patients were considered as right censored at the date of their last tumor assessment after first observed tumor response.'}, {'measure': 'DOR Based on Independent Review-Part B', 'timeFrame': 'Baseline up to approximately 9 years 7 months', 'description': 'DOR was defined as the time from the date of the first observed tumor response of CR or PR (whichever was noted earlier) to first subsequent disease progression (either first progressive disease \\[PD\\], first clinical progression or first AE associated with clinical disease progression) or death caused by disease progression, if this death occurred before progression was documented. All deaths were considered as \'caused by disease progression\' except deaths with the reason "other" or "AE not related to disease progression. DOR was evaluated only for patients with at least one tumor response of CR, CRu, or PR. Some patients may have had no report of disease progression nor death caused by disease progression until the date of the LPLV. With regards to DOR, these patients were considered as right censored at the date of their last tumor assessment after first observed tumor response.'}, {'measure': 'DOR Based on Investigator Assessment-Part A', 'timeFrame': 'Baseline up to approximately 6 years', 'description': 'DOR was defined as the time from the date of the first observed tumor response of CR or PR (whichever was noted earlier) to first subsequent disease progression (either first progressive disease \\[PD\\], first clinical progression or first AE associated with clinical disease progression) or death caused by disease progression, if this death occurred before progression was documented. All deaths were considered as \'caused by disease progression\' except deaths with the reason "other" or "AE not related to disease progression. DOR was evaluated only for patients with at least one tumor response of CR, CRu, or PR. Some patients may have had no report of disease progression nor death caused by disease progression until the date of the LPLV. With regards to DOR, these patients were considered as right censored at the date of their last tumor assessment after first observed tumor response.'}, {'measure': 'DOR Based on Investigator Assessment-Part B', 'timeFrame': 'Baseline up to approximately 9 years 7 months', 'description': 'DOR was defined as the time from the date of the first observed tumor response of CR or PR (whichever was noted earlier) to first subsequent disease progression (either first progressive disease \\[PD\\], first clinical progression or first AE associated with clinical disease progression) or death caused by disease progression, if this death occurred before progression was documented. All deaths were considered as \'caused by disease progression\' except deaths with the reason "other" or "AE not related to disease progression. DOR was evaluated only for patients with at least one tumor response of CR, CRu, or PR. Some patients may have had no report of disease progression nor death caused by disease progression until the date of the LPLV. With regards to DOR, these patients were considered as right censored at the date of their last tumor assessment after first observed tumor response.'}, {'measure': 'Progression Free Survival (PFS) Based on Independent Review-Part A', 'timeFrame': 'Baseline up to approximately 6 years', 'description': 'PFS was defined as the time (in days) from the date of the first treatment to the date of first observed PD (radiological or clinical, or first AE associated with clinical PD, whichever was earlier) or death due to any cause (if death occurred before progression was documented).'}, {'measure': 'PFS Based on Independent Review-Part B', 'timeFrame': 'Baseline up to approximately 9 years 7 months', 'description': 'PFS was defined as the time (in days) from the date of the first treatment to the date of first observed PD (radiological or clinical, or first AE associated with clinical PD, whichever was earlier) or death due to any cause (if death occurred before progression was documented).'}, {'measure': 'PFS Based on Investigator Assessment-Part A', 'timeFrame': 'Baseline up to approximately 6 years', 'description': 'PFS was defined as the time (in days) from the date of the first treatment to the date of first observed PD (radiological or clinical, or first AE associated with clinical PD, whichever was earlier) or death due to any cause (if death occurred before progression was documented).'}, {'measure': 'PFS Based on Investigator Assessment-Part B', 'timeFrame': 'Baseline up to approximately 9 years 7 months', 'description': 'PFS was defined as the time (in days) from the date of the first treatment to the date of first observed PD (radiological or clinical, or first AE associated with clinical PD, whichever was earlier) or death due to any cause (if death occurred before progression was documented).'}, {'measure': 'Overall Survival (OS)-Part A', 'timeFrame': 'Baseline up to approximately 6 years', 'description': 'OS was defined as the time (in days) from the date of first administration of study treatment to death due to any cause. Patients who were alive at the date of the LPLV were censored at the minimum of the date of LPLV and the last available date of evidence that the patient was still alive.'}, {'measure': 'OS-Part B', 'timeFrame': 'Baseline up to approximately 9 years 7 months', 'description': 'OS was defined as the time (in days) from the date of first administration of study treatment to death due to any cause. OS was defined as the time (in days) from the date of first administration of study treatment to death due to any cause. Patients who were alive at the date of the LPLV were censored at the minimum of the date of LPLV and the last available date of evidence that the patient was still alive.'}, {'measure': 'Functional Assessment of Cancer Therapy - Lymphoma Lymphoma Subscale (FACT-Lym LymS) at Week 16 - Part B', 'timeFrame': 'Baseline up to week 16', 'description': 'HRQoL assessment was used to describe development of patients with copanlisib by using FACT-Lym questionnaire assessment tool. It contains 42 items (questions) covering HRQoL, common lymphoma symptoms and treatment side-effects. The FACT - General (FACT-G) questionnaire contains 27 items covering 4 core HRQoL subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 items) (FACT-Lym LymS), addressing issues typically experienced by lymphoma patients. Some of the issues covered include pain, itching, night sweats, trouble sleeping, fatigue and trouble concentrating. FACT-Lym also asks patients about lumps and swelling, fevers, infections, weight, appetite, emotional stability and treatment. Score range for the FACT-Lym LymS was 0 - 60, higher score represent less symptoms. Here in below table "n" signifies evaluable participants for the respective category.'}, {'measure': 'Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Total Score at Week 16 - Part B', 'timeFrame': 'Baseline up to week 16', 'description': 'HRQoL assessment was used to describe development of patients with copanlisib by using FACT-Lym questionnaire assessment tool. It contains 42 items (questions) covering HRQoL, common lymphoma symptoms and treatment side-effects. The FACT - General (FACT-G) questionnaire contains 27 items covering 4 core HRQoL subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 items) (FACT-Lym LymS), addressing issues typically experienced by lymphoma patients. Some of the issues covered include pain, itching, night sweats, trouble sleeping, fatigue and trouble concentrating. FACT-Lym also asks patients about lumps and swelling, fevers, infections, weight, appetite, emotional stability and treatment. FACT-Lym total score range was 0-168, higher score indicates better HRQoL. Here, in the below table "n" signifies evaluable participants for the respective category.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Clinical trial, phase II', 'Phosphatidylinositol 3-Kinase', "Class I, Non-Hodgkin's lymphoma"], 'conditions': ['Lymphoma, Non-Hodgkin']}, 'referencesModule': {'references': [{'pmid': '28633365', 'type': 'RESULT', 'citation': 'Dreyling M, Morschhauser F, Bouabdallah K, Bron D, Cunningham D, Assouline SE, Verhoef G, Linton K, Thieblemont C, Vitolo U, Hiemeyer F, Giurescu M, Garcia-Vargas J, Gorbatchevsky I, Liu L, Koechert K, Pena C, Neves M, Childs BH, Zinzani PL. Phase II study of copanlisib, a PI3K inhibitor, in relapsed or refractory, indolent or aggressive lymphoma. Ann Oncol. 2017 Sep 1;28(9):2169-2178. doi: 10.1093/annonc/mdx289.'}, {'pmid': '38226495', 'type': 'DERIVED', 'citation': 'Morcos PN, Moss J, Veasy J, Hiemeyer F, Childs BH, Garmann D. Model-Based Benefit/Risk Analysis for the Copanlisib Intermittent Dosing Regimen. Clin Pharmacol Ther. 2024 May;115(5):1092-1104. doi: 10.1002/cpt.3173. Epub 2024 Jan 16.'}, {'pmid': '33560394', 'type': 'DERIVED', 'citation': 'Panayiotidis P, Follows GA, Mollica L, Nagler A, Ozcan M, Santoro A, Stevens D, Trevarthen D, Hiemeyer F, Garcia-Vargas J, Childs BH, Zinzani PL, Dreyling M. Efficacy and safety of copanlisib in patients with relapsed or refractory marginal zone lymphoma. Blood Adv. 2021 Feb 9;5(3):823-828. doi: 10.1182/bloodadvances.2020002910.'}], 'seeAlsoLinks': [{'url': 'https://clinicaltrials.bayer.com/study/16349', 'label': "Click here to find further information and, after study completion, the study results according to Bayer's transparency standards."}, {'url': 'http://www.clinicaltrialsregister.eu/', 'label': 'Click here to find information about studies related to Bayer Healthcare products conducted in Europe'}]}, 'descriptionModule': {'briefSummary': "The objective of the study (part A) is to evaluate the efficacy and safety of BAY80-6946 in patients with indolent or aggressive Non-Hodgkin's Lymphoma, who have progressed after standard therapy. 30 patients will be enrolled to both indolent and aggressive disease group. The objective of the study part B (CHRONOS-1) is to evaluate the efficacy and safety of BAY80-6946 in patients with relapsed/refractory follicular lymphoma. 120 patients will be enrolled in the part B of the study. Further objectives are to evaluate the pharmacokinetics and biomarkers. Quality of life will be a further objective of part B of the study.\n\nIn a cohort of 20 patients (enrolled both in part A and B) an ECG substudy will be performed to assess the potential for cardiac toxicity and QT/QTc interval prolongation of BAY80-6946.\n\nAfter an up to 28-day screening period, eligible patients will start treatment with BAY80-6946 at a dose of 0.8 mg/kg (Part A) and at a dose of 60 mg (Part B).\n\nTreatment will be continued until disease has progressed or until another criterion is met for withdrawal from study. An end-of-treatment visit will be performed within 7 days after discontinuation of study treatment. Thirty to 35 days after last study drug administration, a safety followup visit will be performed for the collection of adverse events (AEs) and concomitant medication data. Patients will be contacted quarterly to determine overall survival status up to 4 years after last patient completed treatment. Patients who discontinue study drug for reasons other than disease progression will enter the Active Assessment Follow-up period. The end of study notification to Health Authorities will be based on the completion of the collection of survival data.\n\nThe efficacy is measured by the decrease in tumor size. Tumor assessments will be done at Screening, every 8 weeks during Year 1, every 12 weeks during Year 2, and every 6 months during Year 3. Blood samples will be collected for pharmacokinetic analysis. Archival tumor tissue and blood samples will be collected for biomarker analysis (mandatory) and for central pathology review (part B), fresh biopsy tissue will also be collected if available."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indolent NHL:\n\n * Histologically confirmed diagnosis of follicular lymphoma (FL) grades 1, 2 or 3a, marginal zone lymphoma (including nodal or splenic marginal zone B-cell lymphoma and mucosa-associated lymphoid tissue \\[MALT\\] lymphoma), lymphoplasmacytic lymphoma/Waldenström macroglobulinemia, chronic lymphocytic leukemia (CLL).\n * Relapsed after ≥ 2 prior chemotherapy- or immunotherapy-based regimens for indolent NHL, or refractory to 2 prior chemotherapy and/ or immunotherapy-based regimens.\n* Aggressive NHL:\n\n * Histologically confirmed diagnosis of grade 3b follicular lymphoma (FL), transformed indolent lymphoma, diffuse large B-cell lymphoma (DLBCL), mediastinal large B-cell lymphoma, mantle cell lymphoma (MCL), peripheral T-cell lymphoma unspecified, or anaplastic large cell lymphoma primary systemic type, or angioimmunoblastic T cell lymphoma.\n * Relapsed after ≥ 2 prior chemotherapy regimens, including the following: First-line treatment with standard anthracycline-containing regimen (e.g., cyclophosphamide, doxorubicin, vincristine, and prednisone or equivalent). At least 1 additional combination chemotherapy regimen. Patients relapsed after or refractory to first prior chemotherapy- and/or immunotherapy-based regimen for aggressive NHL and not eligible for high-dose regimen followed by transplant. High-dose chemotherapy, or chemoradiotherapy with autologous stem cell transplantation is considered 1 regimen. Patients with CD20 expressing neoplastic cells must have received prior rituximab, if available.\n * Patients with transformed indolent lymphoma must have received at least 2 prior chemotherapy- and/or immunotherapy-based regimens\n * Consent to provide fresh tumor tissue during screening\n* Indolent B-cell NHL lymphoma (study part B):\n\n * Histologically confirmed diagnosis of indolent B-cell NHL, with histological subtype limited to the following:\n\n * Follicular lymphoma (FL) grade 1-2-3a\n * Small lymphocytic lymphoma (SLL) with absolute lymphocyte count \\< 5 x 109/L at the time of diagnosis and at study entry\n * Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM)\n * Marginal zone lymphoma (MZL) (splenic, nodal, or extranodal)\n * Relapsed or refractory after ≥ 2 prior lines of therapy (refractory defined as not responding to a standard regimen or progressing within 6 months of the last course of a standard regimen). Patients must have received Rituximab and alkylating agents.\n* For all patients:\n\n * Male or female patients \\> 18 years of age\n * ECOG performance status ≤ 2 (ECOG: Eastern Cooperative Oncology Group)\n * Life expectancy of at least 3 months\n * Adequate bone marrow, liver and renal function as assessed within 7 days before starting study treatment\n * Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (LLN) for the Institution\n * Availability of archival tumor tissue\n\nExclusion Criteria:\n\n* Uncontrolled hypertension (blood pressure ≥ 150/90 mmHg despite optimal medical management)\n* Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event ≥ CTCAE Grade 3 within 4 weeks of start of study medication (CTCAE: Common Terminology Criteria for Adverse Events).\n* History or concurrent condition of interstitial lung disease\n* Unresolved toxicity higher than CTCAE grade 1 (NCI-CTC version 4.0) attributed to any prior therapy/procedure excluding alopecia. (NCI: National Cancer Institute)\n* Prior treatment with PI3K inhibitors\n* Systemic corticosteroid therapy (ongoing)\n* Hepatitis B or C. All subjects must be screened for hepatitis B and C up to 28 days prior to study drug start using the hepatitis virus panel laboratorial routine. Subjects positive for HBsAg or HBcAb will be eligible if they are negative for HBV-DNA; subjects positive for HCV IgG will be eligible if they are negative for HCV RNA.\n* For Part B:\n\n * Histologically confirmed diagnosis of follicular lymphoma grade 3b or transformed disease and chronic lymphocytic leukemia (CLL)\n * History or concurrent condition of interstitial lung disease or severely impaired pulmonary function\n* Excluded medical conditions:\n\n * Previous or concurrent cancer that is distinct in primary site or histology from indolent B-cell NHL within 5 years prior to treatment start EXCEPT for curatively treated cervical cancer in situ, nonmelanoma skin cancer and superficial bladder tumors \\[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)\\].\n * Hepatitis B or C. All subjects must be screened for hepatitis B and C up to 28 days prior to study drug start using the hepatitis virus panel laboratorial routine. Subjects positive for HBsAg or HBcAb will be eligible if they are negative for HBV-DNA; subjects positive for HCV IgG will be eligible if they are negative for HCV-RNA.\n * Type I or II diabetes mellitus with HbA1c \\> 8.5% or fasting plasma glucose \\> 160 mg/dL at screening.\n * Previous or concurrent cancer that is distinct in primary site or histology from indolent B-cell NHL within 5 years prior to treatment start EXCEPT for curatively treated cervical cancer in situ, nonmelanoma skin cancer and superficial bladder tumors \\[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)\\].'}, 'identificationModule': {'nctId': 'NCT01660451', 'briefTitle': "Open-label, Uncontrolled Phase II Trial of Intravenous PI3K Inhibitor BAY80-6946 in Patients With Relapsed, Indolent or Aggressive Non-Hodgkin's Lymphomas", 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': "Open-label, Uncontrolled Phase II Trial of Intravenous PI3K Inhibitor BAY80-6946 in Patients With Relapsed, Indolent or Aggressive Non-Hodgkin's Lymphomas", 'orgStudyIdInfo': {'id': '16349'}, 'secondaryIdInfos': [{'id': '2012-002602-52', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Copanlisib (indolent NHL)', 'description': 'Part A: Participants in this arm will be patients with indolent NHL.', 'interventionNames': ['Drug: Copanlisib (Aliqopa, BAY80-6946)']}, {'type': 'EXPERIMENTAL', 'label': 'Copanlisib (aggressive NHL)', 'description': 'Part A: Participants in this arm will be patients with aggressive NHL.', 'interventionNames': ['Drug: Copanlisib (Aliqopa, BAY80-6946)']}, {'type': 'EXPERIMENTAL', 'label': 'Copanlisib (indolent B-cell NHL)', 'description': 'Part B: Participants in this arm will be patients with indolent B-cell NHL.', 'interventionNames': ['Drug: Copanlisib (Aliqopa, BAY80-6946)']}], 'interventions': [{'name': 'Copanlisib (Aliqopa, BAY80-6946)', 'type': 'DRUG', 'description': 'BAY 80-6946 is administered in a normal saline solution, 100 mL, intravenously over 1h. No intravenous glucose preparations should be administered on the days of infusion. Dosing is weekly for the first 3 weeks (on Days 1, 8, and 15) of a 28-day cycle, followed by a 1-week break (i.e., no infusion on Day 22).\n\nPart A: The individual dose will be 0.8 mg/kg (max. 65 mg) per infusion from Cycle 1 on. The maximum dose of 65 mg should never be exceeded.\n\nPart B: The individual dose will be 60 mg per infusion from Cycle 1 on.', 'armGroupLabels': ['Copanlisib (aggressive NHL)', 'Copanlisib (indolent B-cell NHL)', 'Copanlisib (indolent NHL)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35213', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '90801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '80528', 'city': 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This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.\n\nInterested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}