Viewing Study NCT02970318

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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-25 @ 5:02 AM

Ignite Modification Date: 2026-02-25 @ 7:08 PM

Study NCT ID: NCT02970318

Status: ACTIVE_NOT_RECRUITING

Last Update Posted: 2025-10-27

First Post: 2016-11-18

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Turkey (Türkiye)'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], 'ancestors': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000604908', 'term': 'acalabrutinib'}, {'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'C552946', 'term': 'idelalisib'}, {'id': 'D000069461', 'term': 'Bendamustine Hydrochloride'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '1-888-292-9613', 'title': 'Study Director', 'organization': 'Astrazeneca Clinical Trial'}, 'certainAgreement': {'otherDetails': 'Institution/Investigator will not publish or publicly present any study results without prior approval or prior to 12 months following completion of the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 54 months.', 'description': "Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug). For Arm B, adverse events are presented for Investigator's choice of IR/BR combined since the data were not reported separately for IR or BR.", 'eventGroups': [{'id': 'EG000', 'title': 'Arm A- Acala. 100 mg BID', 'description': 'Arm A- Acalabrutinib 100 mg BID', 'otherNumAtRisk': 154, 'deathsNumAtRisk': 155, 'otherNumAffected': 149, 'seriousNumAtRisk': 154, 'deathsNumAffected': 41, 'seriousNumAffected': 70}, {'id': 'EG001', 'title': 'Arm B: Investigator Choice (IR or BR)-Main Study Period', 'description': 'IR or BR data not presented separately similar to combined treatment arms approved for D8223C00009', 'otherNumAtRisk': 153, 'deathsNumAtRisk': 155, 'otherNumAffected': 145, 'seriousNumAtRisk': 153, 'deathsNumAffected': 33, 'seriousNumAffected': 86}, {'id': 'EG002', 'title': 'Arm B Cross Over', 'description': 'Arm B Investigator Choice Crossed Over to Acalabrutinib', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 73, 'seriousNumAtRisk': 80, 'deathsNumAffected': 20, 'seriousNumAffected': 31}], 'otherEvents': [{'term': 'Hyperleukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastric mucosa erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastric polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastric ulcer perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastrointestinal angiectasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastrointestinal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastrointestinal toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Immune thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastrointestinal tract mucosal pigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gingival pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Glossodynia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Haemorrhoids thrombosed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Immune-mediated enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Increased tendency to bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Lip haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Lip pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Mouth cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 27, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Noninfective sialoadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oesophageal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oral mucosal blistering', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oral mucosal eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Device related thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 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24.0'}, {'term': 'Ischaemic cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Laryngeal hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Organising pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Skin disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Toxic skin eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Iliac artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Peripheral venous disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 22, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free Survival (PFS) Per Independent Review Committee (IRC) Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Acalabrutinib Monotherapy', 'description': 'Acalabrutinib 100 mg orally twice a day'}, {'id': 'OG001', 'title': 'Arm B: Investigators Choice', 'description': 'Idelalisib+Rituximab or Bendamustine + Retuximab'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Kaplan-Meier Estimated Median PFS and 95% were not reached for Arm A.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '16.5', 'groupId': 'OG001', 'lowerLimit': '14.0', 'upperLimit': '17.1'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.31', 'ciLowerLimit': '0.20', 'ciUpperLimit': '0.49', 'pValueComment': 'Stratified by randomization stratification factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).', 'estimateComment': 'Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'IRC assessments from randomization date until disease progression or death or IRC discontinuation on 15Jan2019 (as IA per this data cutoff showed crossing superiority boundary) whichever came first, up to 22 months of follow-up', 'description': 'To evaluate the efficacy of acalabrutinib monotherapy (Arm A) compared with idelalisib/rituximab or bendamustine/rituximab (Arm B) based on Independent Review Committee (IRC) assessment of progression-free survival (PFS) per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria (Hallek 2008) with incorporation of the clarification for treatment-related lymphocytosis (Cheson 2012) hereafter referred to as IWCLL 2008 criteria in subjects with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL). As planned and reported in the interim clinical study report (dated 17 July 2019), because the study did cross the boundary at interim analysis.\n\nIRC assessments were discontinued after the interim analysis. All IRC-related efficacy analyses in this clinical study report were based on the interim analysis data cutoff date of 15 January 2019. All other efficacy analyses were based on the final analysis data cutoff date of 03 September 2021.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population including all randomized participants'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS) Per Investigator Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Acalabrutinib Monotherapy', 'description': 'Acalabrutinib 100 mg orally twice a day'}, {'id': 'OG001', 'title': "Arm B: Investigator's Choice", 'description': 'Idelalisib+Rituximab or Bendamustine + Retuximab'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Kaplan-Meier Estimates for median PFS and upper 95% CI were not reached for Arm A.', 'groupId': 'OG000', 'lowerLimit': '45.8', 'upperLimit': 'NA'}, {'value': '16.8', 'groupId': 'OG001', 'lowerLimit': '14.1', 'upperLimit': '22.5'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.28', 'ciLowerLimit': '0.20', 'ciUpperLimit': '0.38', 'pValueComment': 'Stratified by randomization stratification factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).', 'estimateComment': 'Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization date to date of disease progression or death due to any cause or data cutoff date on 03Sep2021, whichever came first, regardless of use of subsequent anticancer therapy, until 53 months of follow-up.', 'description': 'PFS per investigator assessment based on the final analysis data cutoff date of 03 September 2021.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population including all randomized participants'}, {'type': 'SECONDARY', 'title': 'IRC-assessed Overall Response Rate (ORR) Per IWCLL 2008 Criteria Based on Data Cutoff 15 January 2019 From Interim Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Acalabrutinib Monotherapy', 'description': 'Acalabrutinib 100 mg orally twice a day'}, {'id': 'OG001', 'title': "Arm B: Investigator's Choice", 'description': 'Idelalisib+Rituximab or Bendamustine + Retuximab'}], 'classes': [{'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2248', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.8', 'ciLowerLimit': '-3.3', 'ciUpperLimit': '14.9', 'estimateComment': 'Risk difference (% Arm A - Arm B) based on Cochran-Mantel-Haenszel test with adjustment for randomization stratification factors as recorded in IXRS.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Based on Cochran-Mantel-Haenszel test with adjustment for randomization stratification factors as recorded in IXRS.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'IRC assessments from randomization date until disease progression or death or IRC discontinuation on 15Jan2019 (as IA per this data cutoff showed crossing superiority boundary) whichever came first, up to 22 months of follow-up', 'description': 'IRC-assessed overall response rate (ORR) including complete response (CR), CR with incomplete blood count recovery (CRi) nodular PR (nPR), and Partial Response (PR)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population including all randomized participants'}, {'type': 'SECONDARY', 'title': 'Investigator Assessed Overall Response Rate (ORR) Per IWCLL 2008 Criteria Based on Data Cutoff 03 September 2021', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Acalabrutinib Monotherapy', 'description': 'Acalabrutinib 100 mg orally twice a day'}, {'id': 'OG001', 'title': "Arm B: Investigator's Choice", 'description': 'Idelalisib+Rituximab or Bendamustine + Retuximab'}], 'classes': [{'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7340', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-9.6', 'ciUpperLimit': '7.0', 'estimateComment': 'Risk difference (% Arm A - Arm B) based on Cochran-Mantel-Haenszel test with adjustment for randomization stratification factors as recorded in IXRS.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Based on Cochran-Mantel-Haenszel test with adjustment for randomization stratification factors as recorded in IXRS.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Investigator assessments were done from randomization date until date of death or date of exit from study or data cut off date on 03Sep2021, whichever came first, up to 53 months of follow-up.', 'description': 'IRC-assessed overall response rate (ORR) including complete response (CR), CR with incomplete blood count recovery (CRi) nodular PR (nPR), and Partial Response (PR)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population including all randomized participants'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Acalabrutinib Monotherapy', 'description': 'Acalabrutinib 100 mg orally twice a day'}, {'id': 'OG001', 'title': "Arm B: Investigator's Choice", 'description': 'Idelalisib+Rituximab or Bendamustine + Retuximab'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Kaplan-Meier estimate for median OS and 95% CIs were not reached.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Kaplan-Meier estimate for median OS and 95% CIs were not reached.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0783', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.46', 'ciUpperLimit': '1.04', 'estimateComment': 'Cox proportional hazard analysis stratified (Arm A vs. Arm B) by factors recorded in IXRS data including presence of deletion 17 p (yes / no), ECOG (0-1/2), # of prior therapies (1-3/4+).', 'groupDescription': 'Analysis stratified by factors recorded in IXRS data including presence of deletion 17 p (yes / no), ECOG (0-1/2), # of prior therapies (1-3/4+).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Log-Rank Analysis stratified by factors recorded in IXRS data: presence of deletion 17 p (yes / no), ECOG (0-1/2), # of prior therapies (1-3/4+).'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization date to date of death due to any cause, or date of study discontinuation, or date of data cutoff on 03Sep2021, whichever came first until 54 months of follow-up.', 'description': 'Overall Survival (OS) was based on data cutoff date of 03Sep2021', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to treat (ITT) population including all randomized participants'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) Per Independent Review Committee (IRC) Assessment Based on 15 January 2019 Data Cutoff From Interim Analysis.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Acalabrutinib Monotherapy', 'description': 'Acalabrutinib 100 mg orally twice a day'}, {'id': 'OG001', 'title': "Arm B: Investigator's Choice", 'description': 'Idelalisib+Rituximab or Bendamustine + Retuximab'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Kaplan-Meier Estimate of median DOR and 95% CI were not reached.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '13.6', 'comment': 'Kaplan-Meier estimate of upper 95% CI for median DOR was not reached.', 'groupId': 'OG001', 'lowerLimit': '11.9', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.33', 'ciLowerLimit': '0.19', 'ciUpperLimit': '0.59', 'pValueComment': 'Log Rank Test stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).', 'estimateComment': 'Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'IRC assessments from randomization date until disease progression or death or IRC discontinuation on 15Jan2019 (as IA per this data cutoff showed crossing superiority boundary) whichever came first, up to 22 months of follow-up', 'description': 'Duration of Response (DOR) is defined as from the first documentation of CR, CRi, PR, or nPR to the earlier of the first documentation of disease progression or death from any cause.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population including all randomized participants'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) Per Investigator Assessment Based on 03 September 2021 Data Cutoff', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Acalabrutinib Monotherapy', 'description': 'Acalabrutinib 100 mg orally twice a day'}, {'id': 'OG001', 'title': "Arm B: Investigator's Choice", 'description': 'Idelalisib+Rituximab or Bendamustine + Retuximab'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Kaplan-Meier estimate of median DOR and upper 95% CI were not reached.', 'groupId': 'OG000', 'lowerLimit': '41.5', 'upperLimit': 'NA'}, {'value': '18.3', 'groupId': 'OG001', 'lowerLimit': '11.9', 'upperLimit': '21.7'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.23', 'ciLowerLimit': '0.16', 'ciUpperLimit': '0.33', 'pValueComment': 'Log Rank Test stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).', 'estimateComment': 'Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Investigator assessments were done from randomization date until date of death or study discontinuation or data cutoff date on 03Sep2021, whichever came first up to 53 months of follow-up.', 'description': 'Duration of Response (DOR) is defined as from the first documentation of CR, CRi, PR, or nPR to the earlier of the first documentation of disease progression or death from any cause.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population including all randomized participants'}, {'type': 'SECONDARY', 'title': 'Time to Next Treatment (TTNT) Based on 03 September 2021 Data Cutoff', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Acalabrutinib Monotherapy', 'description': 'Acalabrutinib 100 mg orally twice a day'}, {'id': 'OG001', 'title': "Arm B: Investigator's Choice", 'description': 'Idelalisib+Rituximab or Bendamustine + Retuximab'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Kaplan-Meier estimate of median TTNT and upper 95% CI were not reached.', 'groupId': 'OG000', 'lowerLimit': '46.9', 'upperLimit': 'NA'}, {'value': '22.5', 'groupId': 'OG001', 'lowerLimit': '17.5', 'upperLimit': '25.9'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.29', 'ciLowerLimit': '0.21', 'ciUpperLimit': '0.40', 'pValueComment': 'Log Rank Test stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).', 'estimateComment': 'Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization date to start of non-protocol specified subsequent anticancer therapy for CLL or death due to any cause or study discontinuation or data cutoff date on 03Sep2021,, whichever came first up to 53 months of follow-up.', 'description': 'Time to Next Treatment (TTNT) is defined as the time from date of randomization to date of institution of non-protocol-specified treatment for CLL (or first dose date of acalabrutinib for Arm B subjects crossing over to receive acalabrutinib) or death due to any cause, whichever comes first.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population including all randomized participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A- Acala 100 mg BID- Overall Study Period', 'description': 'Arm A- Acalabrutinib 100 mg BID- Overall Study Period'}, {'id': 'FG001', 'title': 'Arm B: Investigator Choice (IR or BR)-Main Study Period', 'description': 'IR or BR data not presented separately similar to combined treatment arms approved for D8223C00009'}, {'id': 'FG002', 'title': 'Arm B- Inv Choice of IR Crossed Over to Arm A- Acala. 100 mg BID', 'description': 'Arm B- Investigator Choice of IR Crossed Over to Arm A- Acala. 100 mg BID'}, {'id': 'FG003', 'title': 'Arm B- Inv. Choice of BR Crossed Over to Arm A- Acala. 100 mg BID', 'description': 'Arm B- Investigator Choice of BR Crossed Over to Arm A- Acala. 100 mg BID'}], 'periods': [{'title': 'Overall for Arm A & Main for Arm B', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '155'}, {'groupId': 'FG001', 'numSubjects': '155'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Arm B Treatment= Idelalisib Plus Rituximab', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '119'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Arm B Treatment = Bendamustine Plus Rituximab', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Completed', 'comment': 'Completed study treatment at final DCO (03Sep2021)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'This subject received 1st dose of study drug on 11Nov2011, completed study treatment on 14MAR2019, never crossed over, and and died 11 months after completing study treatment on 15Feb2020.', 'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Completed', 'comment': 'Patients ongoing treatment at final DCO (03Sep2021)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'comment': 'Patients Ongoing Treatment + Patients Completed Study Treatment at Final DCO (03Sep2021)', 'achievements': [{'comment': 'All 99 subjects ongoing treatment at final DCO.', 'groupId': 'FG000', 'numSubjects': '99'}, {'comment': '26 subjects ongoing treatment + 1 subject completed study treatment and died 11 months after completing study treatment on 15Feb2020.', 'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '128'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Arm B Crossed Over to Arm A Acala 100 mg Monotherapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '80'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'ArmB: Inv.Choice Crossed Over to Acala', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': "N/A. Note: No subjects stayed in Arm: Investigator's choice of IR/BR during cross-over period.", 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'Note: There were a total of 80 subjects in Arm B crossing over to Arm A shown under the last row of Main Study Period. Among them 63 were randomized to Arm B: IR and 17 were randomized to BR.', 'groupId': 'FG002', 'numSubjects': '63'}, {'comment': 'Note: There were a total of 80 subjects in Arm B crossing over to Arm A shown under the last row of Main Study Period. Among them 63 were randomized to Arm B: IR and 17 were randomized to BR.', 'groupId': 'FG003', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'comment': 'Ongoing Treatment at Final DCO (03Sep2021)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '42'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}], 'recruitmentDetails': "A Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator's Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia. A total of 310 subjects met the eligibility criteria and were randomized to the acalabrutinib arm (N = 155) and IR/BR arm (N = 155).\n\nAll but 3 subjects (1 randomized to acalabrutinib and 2 randomized to IR/BR) received study treatment.", 'preAssignmentDetails': '310 patients were enrolled in this study and agreed to move forward in participating in the trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '310', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A- Acala. 100 mg BID', 'description': 'Arm A- Acalabrutinib 100 mg BID'}, {'id': 'BG001', 'title': 'Arm B: Investigator Choice (IR or BR)-Main Study Period', 'description': 'IR or BR data not presented separately similar to combined treatment arms approved for D8223C00009'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age < 65 Years', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}]}, {'title': 'Age >=65 years', 'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '276', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '286', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'North America', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'New Zealand', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Europe', 'categories': [{'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '263', 'groupId': 'BG002'}]}]}, {'title': 'Taiwan, Province Of China', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Hong Kong', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Korea, Republic Of', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Singapore', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis was performed on Intent-to-Treat (ITT) population, which included all randomized participants grouped according to assigned treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-26', 'size': 2380857, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-09-02T02:50', 'hasProtocol': True}, {'date': '2019-03-06', 'size': 688953, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-09-02T01:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 310}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-24', 'studyFirstSubmitDate': '2016-11-18', 'resultsFirstSubmitDate': '2022-09-02', 'studyFirstSubmitQcDate': '2016-11-18', 'lastUpdatePostDateStruct': {'date': '2025-10-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2023-06-28', 'studyFirstPostDateStruct': {'date': '2016-11-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS) Per Independent Review Committee (IRC) Assessment', 'timeFrame': 'IRC assessments from randomization date until disease progression or death or IRC discontinuation on 15Jan2019 (as IA per this data cutoff showed crossing superiority boundary) whichever came first, up to 22 months of follow-up', 'description': 'To evaluate the efficacy of acalabrutinib monotherapy (Arm A) compared with idelalisib/rituximab or bendamustine/rituximab (Arm B) based on Independent Review Committee (IRC) assessment of progression-free survival (PFS) per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria (Hallek 2008) with incorporation of the clarification for treatment-related lymphocytosis (Cheson 2012) hereafter referred to as IWCLL 2008 criteria in subjects with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL). As planned and reported in the interim clinical study report (dated 17 July 2019), because the study did cross the boundary at interim analysis.\n\nIRC assessments were discontinued after the interim analysis. All IRC-related efficacy analyses in this clinical study report were based on the interim analysis data cutoff date of 15 January 2019. All other efficacy analyses were based on the final analysis data cutoff date of 03 September 2021.'}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival (PFS) Per Investigator Assessment', 'timeFrame': 'From randomization date to date of disease progression or death due to any cause or data cutoff date on 03Sep2021, whichever came first, regardless of use of subsequent anticancer therapy, until 53 months of follow-up.', 'description': 'PFS per investigator assessment based on the final analysis data cutoff date of 03 September 2021.'}, {'measure': 'IRC-assessed Overall Response Rate (ORR) Per IWCLL 2008 Criteria Based on Data Cutoff 15 January 2019 From Interim Analysis', 'timeFrame': 'IRC assessments from randomization date until disease progression or death or IRC discontinuation on 15Jan2019 (as IA per this data cutoff showed crossing superiority boundary) whichever came first, up to 22 months of follow-up', 'description': 'IRC-assessed overall response rate (ORR) including complete response (CR), CR with incomplete blood count recovery (CRi) nodular PR (nPR), and Partial Response (PR)'}, {'measure': 'Investigator Assessed Overall Response Rate (ORR) Per IWCLL 2008 Criteria Based on Data Cutoff 03 September 2021', 'timeFrame': 'Investigator assessments were done from randomization date until date of death or date of exit from study or data cut off date on 03Sep2021, whichever came first, up to 53 months of follow-up.', 'description': 'IRC-assessed overall response rate (ORR) including complete response (CR), CR with incomplete blood count recovery (CRi) nodular PR (nPR), and Partial Response (PR)'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From randomization date to date of death due to any cause, or date of study discontinuation, or date of data cutoff on 03Sep2021, whichever came first until 54 months of follow-up.', 'description': 'Overall Survival (OS) was based on data cutoff date of 03Sep2021'}, {'measure': 'Duration of Response (DOR) Per Independent Review Committee (IRC) Assessment Based on 15 January 2019 Data Cutoff From Interim Analysis.', 'timeFrame': 'IRC assessments from randomization date until disease progression or death or IRC discontinuation on 15Jan2019 (as IA per this data cutoff showed crossing superiority boundary) whichever came first, up to 22 months of follow-up', 'description': 'Duration of Response (DOR) is defined as from the first documentation of CR, CRi, PR, or nPR to the earlier of the first documentation of disease progression or death from any cause.'}, {'measure': 'Duration of Response (DOR) Per Investigator Assessment Based on 03 September 2021 Data Cutoff', 'timeFrame': 'Investigator assessments were done from randomization date until date of death or study discontinuation or data cutoff date on 03Sep2021, whichever came first up to 53 months of follow-up.', 'description': 'Duration of Response (DOR) is defined as from the first documentation of CR, CRi, PR, or nPR to the earlier of the first documentation of disease progression or death from any cause.'}, {'measure': 'Time to Next Treatment (TTNT) Based on 03 September 2021 Data Cutoff', 'timeFrame': 'From randomization date to start of non-protocol specified subsequent anticancer therapy for CLL or death due to any cause or study discontinuation or data cutoff date on 03Sep2021,, whichever came first up to 53 months of follow-up.', 'description': 'Time to Next Treatment (TTNT) is defined as the time from date of randomization to date of institution of non-protocol-specified treatment for CLL (or first dose date of acalabrutinib for Arm B subjects crossing over to receive acalabrutinib) or death due to any cause, whichever comes first.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CLL', 'BTK', 'Bruton Tyrosine Kinase', 'acalabrutinib', 'ACP-196'], 'conditions': ['Chronic Lymphocytic Leukemia']}, 'referencesModule': {'references': [{'pmid': '33709202', 'type': 'DERIVED', 'citation': 'Eek D, Ivanescu C, Corredoira L, Meyers O, Cella D. Content validity and psychometric evaluation of the Functional Assessment of Chronic Illness Therapy-Fatigue scale in patients with chronic lymphocytic leukemia. J Patient Rep Outcomes. 2021 Mar 11;5(1):27. doi: 10.1186/s41687-021-00294-1.'}, {'pmid': '32459600', 'type': 'DERIVED', 'citation': 'Ghia P, Pluta A, Wach M, Lysak D, Kozak T, Simkovic M, Kaplan P, Kraychok I, Illes A, de la Serna J, Dolan S, Campbell P, Musuraca G, Jacob A, Avery E, Lee JH, Liang W, Patel P, Quah C, Jurczak W. ASCEND: Phase III, Randomized Trial of Acalabrutinib Versus Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia. J Clin Oncol. 2020 Sep 1;38(25):2849-2861. doi: 10.1200/JCO.19.03355. Epub 2020 May 27.'}], 'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=ACE-CL-309&attachmentIdentifier=4d2fac79-d899-4138-8657-0bb2b540784b&fileName=ace-cl-309-csp-amend-8-redact.pdf&versionIdentifier=', 'label': 'Redacted CSP'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=ACE-CL-309&attachmentIdentifier=5ba8b7a4-ac40-4f7a-b333-9c025218e080&fileName=ace-cl-309-sap-ed-3-redact.pdf&versionIdentifier=', 'label': 'Redacted SAP'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=ACE-CL-309&attachmentIdentifier=aa63aaa7-e136-4da4-89c9-2ad21beb4457&fileName=ace-cl-309-Study_Synopsis-redact.pdf&versionIdentifier=', 'label': 'Redacted CSR synopsis'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the efficacy of acalabrutinib compared with rituximab in combination with idelalisib or bendamustine in previously treated subjects with chronic lymphocytic leukemia (CLL).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Men and women ≥ 18 years of age.\n2. ECOG performance status of 0 to 2.\n3. Diagnosis of CLL that meets published diagnostic criteria (Hallek 2008):\n\n 1. Monoclonal B-cells (either kappa or lambda light chain restricted) that are clonally co-expressing ≥ 1 B-cell marker (CD19, CD20, or CD23) and CD5.\n 2. Prolymphocytes may comprise ≤ 55% of blood lymphocytes.\n 3. Presence of ≥ 5 x 10\\^9 B lymphocytes/L (5000/μL) in the peripheral blood (at any point since initial diagnosis).\n4. Must have documented CD20-positive CLL.\n5. Active disease meeting ≥ 1 of the following IWCLL 2008 criteria for requiring treatment:\n\n 1. Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia (hemoglobin \\< 10 g/dL) and/or thrombocytopenia (platelets \\< 100,000/μL).\n 2. Massive (i.e., ≥ 6 cm below the left costal margin), progressive, or symptomatic splenomegaly.\n 3. Massive nodes (i.e., ≥ 10 cm in the longest diameter), progressive, or symptomatic lymphadenopathy.\n 4. Progressive lymphocytosis with an increase of \\> 50% over a 2-month period or a LDT of \\< 6 months. LDT may be obtained by linear regression extrapolation of ALC obtained at intervals of 2 weeks over an observation period of 2 to 3 months. In subjects with initial blood lymphocyte counts of \\< 30 x 10\\^9/L (30,000/μL), LDT should not be used as a single parameter to define indication for treatment. In addition, factors contributing to lymphocytosis or lymphadenopathy other than CLL (e.g., infections) should be excluded.\n 5. Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy.\n 6. Constitutional symptoms documented in the subject's chart with supportive objective measures, as appropriate, defined as ≥ 1 of the following disease-related symptoms or signs:\n\n i. Unintentional weight loss ≥ 10% within the previous 6 months before screening.\n\n ii. Significant fatigue (ECOG performance score 2; inability to work or perform usual activities).\n\n iii. Fevers higher than 100.5°F or 38.0°C for ≥ 2 weeks before screening without evidence of infection.\n\n iv. Night sweats for \\> 1 month before screening without evidence of infection.\n6. Meet the following laboratory parameters:\n\n 1. ANC ≥ 750 cells/μL (0.75 x 10\\^9/L), or ≥ 500 cells/μL (0.50 x 10\\^9/L) in subjects with documented bone marrow involvement, and independent of growth factor support 7 days before assessment.\n 2. Platelet count ≥ 50,000 cells/μL (50 x 10\\^9/L), or ≥ 30,000 cells/μL (30 x 10\\^9/L) in subjects with documented bone marrow involvement, and without transfusion support 7 days before assessment. Subjects with transfusion-dependent thrombocytopenia are excluded. If an Investigator has chosen bendamustine/rituximab as the Arm B treatment, platelets must be ≥ 75,000 cells/μL (75 x 10\\^9/L).\n 3. Serum AST and ALT ≤ 2.0 x ULN.\n 4. Total bilirubin ≤ 1.5 x ULN.\n 5. Estimated creatinine clearance of ≥ 30 mL/min, calculated using the formula of Cockcroft and Gault \\[(140-Age) • Mass (kg)/(72 • creatinine mg/dL); multiply by 0.85 if female\\].\n7. Must have received ≥ 1 prior systemic therapies for CLL. Note: Single-agent steroids or localized radiation are not considered a prior line of therapy. If a single-agent anti-CD20 antibody was previously administered, subjects must have received ≥ 2 doses.\n8. Women who are sexually active and can bear children must agree to use highly effective forms of contraception while on the study and for 2 days after the last dose of acalabrutinib, 90 days after the last dose of idelalisib, 6 months after the last dose of bendamustine, or 12 months after the last dose of rituximab, whichever is longer. Highly effective forms of contraception are defined in Section 9.2.5.\n9. Men who are sexually active and can beget children must agree to use highly effective forms of contraception during the study and for 90 days after the last dose of idelalisib, 6 months after the last dose of bendamustine, or 12 months after the last dose of rituximab, whichever is longer. Highly effective forms of contraception are defined in Section 9.2.5.\n10. Men must agree to refrain from sperm donation during the study and for 90 days after the last dose of idelalisib, 6 months after the last dose of bendamustine, or 12 months after the last dose of rituximab, whichever is longer.\n11. Willing and able to participate in all required evaluations and procedures in this study protocol, including swallowing capsules without difficulty.\n12. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations).\n\nExclusion Criteria:\n\n1. Known CNS lymphoma or leukemia.\n2. Known prolymphocytic leukemia or history of, or currently suspected, Richter's syndrome.\n3. Uncontrolled AIHA or ITP defined as declining hemoglobin or platelet count secondary to autoimmune destruction within the screening period or requirement for high doses of steroids (\\> 20 mg daily of prednisone or equivalent).\n4. Prior exposure to a BCL-2 inhibitor (e.g., venetoclax/ABT-199) or a BCR inhibitor (e.g., BTK inhibitors or PI3K inhibitors). Prior bendamustine is allowed if Investigator's choice for treatment in Arm B is idelalisib with rituximab. Bendamustine retreatment is allowed if the prior response to bendamustine lasted \\> 24 months.\n5. Received any chemotherapy, external beam radiation therapy, anticancer antibodies, or investigational drug within 30 days before first dose of study drug.\n6. Corticosteroid use \\> 20 mg daily prednisone equivalent within 1 week before first dose of study drug, except as indicated for other medical conditions such as inhaled steroid for asthma, topical steroid use, or as premedication for administration of study drug or contrast. For example, subjects requiring steroids at daily doses \\> 20 mg prednisone equivalent systemic exposure daily, or those who are administered steroids for leukemia control or white blood cell count lowering are excluded.\n7. Prior radio- or toxin-conjugated antibody therapy.\n8. Prior allogeneic stem cell transplant or prior autologous transplant within 6 months of first dose of study drug(s) or presence of graft-vs-host disease or receiving treatment for graft-vs-host disease.\n9. Major surgical procedure within 30 days of first dose of study drug. Note: If a subject had major surgery, they must have recovered adequately from any toxicity and/or complications from the intervention before the first dose of study drug.\n10. History of prior malignancy except for the following:\n\n 1. Malignancy treated with curative intent and with no evidence of active disease present for more than 2 years before screening and felt to be at low risk for recurrence by treating physician.\n 2. Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled nonmelanomatous skin cancer.\n 3. Adequately treated carcinoma in situ without current evidence of disease.\n11. Significant cardiovascular disease such as uncontrolled or untreated symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or QTc \\> 480 msec (calculated using Fridericia's formula: QT/RR\\^0.33) at screening. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study.\n12. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach, or extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.\n13. Received a live virus vaccination within 28 days of first dose of study drug.\n14. Known history of infection with HIV or any uncontrolled active systemic infection (e.g., bacterial, viral, or fungal). For study sites in Germany: active infection with human immunodeficiency virus (seropositivity for HIV-1 or HIV-2 antibodies, and if positive, reactivity against the HIV-specific p24 antigen).\n15. Active CMV infection (active viremia as evidenced by positive polymerase chain reaction \\[PCR\\] result for CMV DNA).\n16. Serologic status reflecting active hepatitis B or C infection.\n\n 1. Subjects who are anti-HBc positive and who are surface antigen negative will need to have a negative PCR result before randomization. Those who are HbsAg-positive or hepatitis B PCR positive will be excluded.\n 2. Subjects who are hepatitis C antibody positive will need to have a negative PCR result before randomization. Those who are hepatitis C PCR positive will be excluded.\n17. Ongoing, drug-induced liver injury, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension.\n18. History of or ongoing drug-induced pneumonitis.\n19. History of serious allergic reactions including anaphylaxis and toxic epidermal necrolysis.\n20. History of stroke or intracranial hemorrhage within 6 months before first dose of study drug.\n21. History of bleeding diathesis (e.g., hemophilia, von Willebrand disease).\n22. Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon) within 7 days of first dose of study drug.\n23. Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening.\n24. Requires treatment with a strong CYP3A inhibitor/inducer.\n25. Requires treatment with proton-pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving proton-pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment to this study.\n26. Breast feeding or pregnant.\n27. Concurrent participation in another therapeutic clinical trial.\n28. Prothrombin time/INR or aPTT (in the absence of a Lupus anticoagulant) \\> 2.0 x ULN. Exception: Subjects receiving warfarin are excluded, however, those receiving other anticoagulant therapy who have a higher INR/aPTT may be permitted to enroll to this study after discussion with the medical monitor.\n29. History of confirmed progressive multifocal leukoencephalopathy (PML)"}, 'identificationModule': {'nctId': 'NCT02970318', 'briefTitle': "A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL", 'organization': {'class': 'INDUSTRY', 'fullName': 'Acerta Pharma BV'}, 'officialTitle': "A Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator's Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects With R/R Chronic Lymphocytic Leukemia", 'orgStudyIdInfo': {'id': 'ACE-CL-309'}, 'secondaryIdInfos': [{'id': '2015-004454-17', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acalabrutinib (ACP-196)', 'description': 'Acalabrutinib (ACP-196) Monotherapy', 'interventionNames': ['Drug: Acalabrutinib (ACP-196)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rituximab Plus Idelalisib or Bendamustine', 'description': "Investigator's Choice of Rituximab Plus Idelalisib or Bendamustine", 'interventionNames': ['Drug: Rituximab', 'Drug: Idelalisib', 'Drug: Bendamustine']}], 'interventions': [{'name': 'Acalabrutinib (ACP-196)', 'type': 'DRUG', 'description': 'Acalabrutinib monotherapy', 'armGroupLabels': ['Acalabrutinib (ACP-196)']}, {'name': 'Rituximab', 'type': 'DRUG', 'description': 'Rituximab in combination with idelalisib or bendamustine', 'armGroupLabels': ['Rituximab Plus Idelalisib or Bendamustine']}, {'name': 'Idelalisib', 'type': 'DRUG', 'description': 'Idelalisib in combination with rituximab', 'armGroupLabels': ['Rituximab Plus Idelalisib or Bendamustine']}, {'name': 'Bendamustine', 'type': 'DRUG', 'description': 'Bendamustine in combination with rituximab', 'armGroupLabels': ['Rituximab Plus Idelalisib or Bendamustine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research 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