Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT05073458
Status:
TERMINATED
Last Update Posted:
2025-11-03
First Post:
2021-09-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C000656179', 'term': 'parsaclisib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@incyte.com', 'phone': '1-855-463-3463', 'title': 'Study Director', 'organization': 'Incyte Corporation'}, 'certainAgreement': {'otherDetails': 'Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'up to 446 days', 'description': 'For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': "Participants received matching placebo QD for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years. Participants may have received parsaclisib before reaching Week 24.", 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Parsaclisib', 'description': "Participants received parsaclisib 2.5 milligrams (mg) once daily (QD) for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for an additional 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years.", 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 10, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Blood potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Catarrh', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Choluria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Cytomegalovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Faeces soft', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Iron overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Micturition disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Mood altered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Rash erythematous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}], 'seriousEvents': [{'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Immune-mediated enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Attaining a Durable Hemoglobin Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parsaclisib', 'description': "Participants received parsaclisib 2.5 milligrams (mg) once daily (QD) for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for an additional 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo QD for 24 weeks during the double-blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to Week 24', 'description': 'A durable hemoglobin response was defined as hemoglobin ≥10 grams per deciliter (g/dL) with an increase from Baseline of ≥2 g/dL not attributed to rescue therapy at ≥3 of the 4 available visits at Week 12 and/or later during the 24-week double-blind treatment period.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: all randomized participants who received at least 1 dose of study drug. Treatment groups were determined according to the actual treatment the participant received on Day 1 regardless of assigned study treatment. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a ≥3-point Increase From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parsaclisib', 'description': "Participants received parsaclisib 2.5 milligrams (mg) once daily (QD) for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for an additional 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo QD for 24 weeks during the double-blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; Week 24', 'description': 'The FACIT-F scale was developed to assess anemia-related fatigue. The FACIT-F is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days. A clinically meaningful change in the FACIT-F score was defined as ≥3-point increase from Baseline. Item scores range from 0 ("not at all") to 4 ("very much"), and the total score ranges from 0 to 52; lower scores indicate greater fatigue. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a 50 Meter Increase From Baseline to Week 24 in a 6-minute Walk Test (6MWT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo QD for 24 weeks during the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Parsaclisib', 'description': "Participants received parsaclisib 2.5 milligrams (mg) once daily (QD) for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for an additional 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years."}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; Week 24', 'description': 'The 6MWT is used to evaluate submaximal exercise capacity. It is a self-paced measurement of the distance that a participant can quickly walk on a flat, hard surface in a period of 6 minutes.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set. Only participants with available data were analyzed,'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo QD for 24 weeks during the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Placebo Followed by Parsaclisib', 'description': "Participants received matching placebo QD for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years. Participants may have received parsaclisib before reaching Week 24."}, {'id': 'OG002', 'title': 'Parsaclisib', 'description': "Participants received parsaclisib 2.5 milligrams (mg) once daily (QD) for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for an additional 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '28.5', 'spread': '5.96', 'groupId': 'OG000'}, {'value': '31.3', 'spread': '5.12', 'groupId': 'OG001'}, {'value': '31.1', 'spread': '7.78', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.2', 'spread': '5.63', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '7.16', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.6', 'spread': '6.58', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '8.56', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '5.91', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '7.36', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '9.09', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '7.78', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '2.63', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '5.20', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at End of Treatment, Double-blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20.0', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG000'}, {'value': '-8.0', 'spread': '9.90', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.5', 'spread': '6.86', 'groupId': 'OG001'}, {'value': '6.0', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-9.0', 'spread': '13.89', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.0', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at End of Treatment, Open-label Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG001'}, {'value': '8.0', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at End of Treatment, Long-term Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Follow-up Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '2.83', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Day 1; Weeks 8, 12, 16, 20, 24, 28, 32, 40, 48, 56, and every 16 weeks post-Week 56', 'description': 'The FACIT-F scale was developed to assess anemia-related fatigue. The FACIT-F is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days. A clinically meaningful change in the FACIT-F score was defined as ≥3-point increase from Baseline. Item scores range from 0 ("not at all") to 4 ("very much"), and the total score ranges from 0 to 52; lower scores indicate greater fatigue. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. End of Treatment, Double-blind Period: assessment performed for participants who discontinued treatment before Week 24. End of Treatment, Open-label Period: assessment performed for participants who discontinued treatment after Week 24 and before Week 56. Follow-up Visit 3 occurred 12 weeks after the end of treatment visit.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo QD for 24 weeks during the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Placebo Followed by Parsaclisib', 'description': "Participants received matching placebo QD for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years. Participants may have received parsaclisib before reaching Week 24."}, {'id': 'OG002', 'title': 'Parsaclisib', 'description': "Participants received parsaclisib 2.5 milligrams (mg) once daily (QD) for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for an additional 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years."}], 'classes': [{'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '29.6', 'spread': '21.40', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '21.25', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '28.1', 'spread': '26.10', 'groupId': 'OG000'}, {'value': '15.30252', 'spread': '32.05', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.4', 'spread': '20.21', 'groupId': 'OG000'}, {'value': '21.9', 'spread': '27.65', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.1', 'spread': '31.07', 'groupId': 'OG000'}, {'value': '12.8', 'spread': '24.79', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.1', 'spread': '6.71', 'groupId': 'OG000'}, {'value': '14.8', 'spread': '16.97', 'groupId': 'OG002'}]}]}, {'title': 'End of Treatment, Double-blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '95.2', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG000'}, {'value': '-32.4', 'spread': '42.62', 'groupId': 'OG002'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '22.6', 'spread': '26.80', 'groupId': 'OG001'}, {'value': '18.8', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG002'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-26.9', 'spread': '40.55', 'groupId': 'OG001'}, {'value': '-4.8', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG002'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14.7', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG001'}]}]}, {'title': 'End of Treatment, Open-label Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-5.4', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG001'}, {'value': '25.0', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG002'}]}]}, {'title': 'Week 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG001'}]}]}, {'title': 'End of Treatment, Long-term Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant', 'groupId': 'OG001'}, {'value': '-5.1', 'spread': '10.41', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Day 1; Weeks 8, 12, 16, 20, 24, 28, 32, 40, 48, 56, and every 16 weeks post-Week 56', 'description': 'The FACIT-F scale was developed to assess anemia-related fatigue. The FACIT-F is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days. A clinically meaningful change in the FACIT-F score was defined as ≥3-point increase from Baseline. Item scores range from 0 ("not at all") to 4 ("very much"), and the total score ranges from 0 to 52; lower scores indicate greater fatigue. Percentage change from Baseline was calculated as (\\[the post-Baseline value minus the Baseline value\\]/Baseline value) x 100. End of Treatment, Double-blind Period: assessment performed for participants who discontinued treatment before Week 24. End of Treatment, Open-label Period: assessment performed for participants who discontinued treatment after Week 24 and before Week 56. Follow-up Visit 3 occurred 12 weeks after the end of treatment visit.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set. Only participants with available data were analyzed,'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hemoglobin at Each Post-Baseline Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo QD for 24 weeks during the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Placebo Followed by Parsaclisib', 'description': "Participants received matching placebo QD for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years. Participants may have received parsaclisib before reaching Week 24."}, {'id': 'OG002', 'title': 'Parsaclisib', 'description': "Participants received parsaclisib 2.5 milligrams (mg) once daily (QD) for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for an additional 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '86.5', 'spread': '15.31', 'groupId': 'OG000'}, {'value': '85.3', 'spread': '12.97', 'groupId': 'OG001'}, {'value': '98.4', 'spread': '21.53', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-9.3', 'spread': '29.09', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '11.76', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.4', 'spread': '14.29', 'groupId': 'OG000'}, {'value': '14.2', 'spread': '13.14', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '6.38', 'groupId': 'OG000'}, {'value': '14.3', 'spread': '16.83', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.7', 'spread': '14.07', 'groupId': 'OG000'}, {'value': '15.0', 'spread': '18.95', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '16.5', 'spread': '17.41', 'groupId': 'OG000'}, {'value': '16.5', 'spread': '16.32', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13.8', 'spread': '19.69', 'groupId': 'OG000'}, {'value': '20.5', 'spread': '11.01', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19.5', 'spread': '15.76', 'groupId': 'OG000'}, {'value': '22.4', 'spread': '16.41', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.3', 'spread': '6.08', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '1.53', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19.5', 'spread': '14.80', 'groupId': 'OG000'}, {'value': '19.3', 'spread': '22.28', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at End of Treatment, Double-blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-62.4', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG000'}, {'value': '11.0', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14.0', 'spread': '9.60', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '24.33', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18.9', 'spread': '19.58', 'groupId': 'OG001'}, {'value': '8.3', 'spread': '26.48', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.1', 'spread': '32.67', 'groupId': 'OG001'}, {'value': '27.0', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19.0', 'spread': '31.32', 'groupId': 'OG001'}, {'value': '26.0', 'spread': '11.31', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '22.8', 'spread': '18.01', 'groupId': 'OG001'}, {'value': '18.5', 'spread': '13.44', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21.5', 'spread': '12.02', 'groupId': 'OG001'}, {'value': '26.5', 'spread': '7.78', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25.0', 'spread': '21.21', 'groupId': 'OG001'}, {'value': '27.5', 'spread': '14.85', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '22.5', 'spread': '21.92', 'groupId': 'OG001'}, {'value': '32.0', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at End of Treatment, Open-label Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '127.7', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG001'}, {'value': '124.0', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '17.5', 'spread': '12.02', 'groupId': 'OG001'}, {'value': '36.0', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.0', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at End of Treatment, Long-term Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '86.0', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Follow-up Visit 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '40.0', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG001'}, {'value': '11.0', 'spread': '7.62', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Follow-up Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '32.0', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG001'}, {'value': '12.5', 'spread': '17.52', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Follow-up Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23.0', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG001'}, {'value': '20.3', 'spread': '9.95', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Day 1; Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and every 8 weeks post-Week 56', 'description': 'Change from Baseline was calculated as the post-Baseline value minus the Baseline value. End of Treatment, Double-blind Period: assessment performed for participants who discontinued treatment before Week 24. End of Treatment, Open-label Period: assessment performed for participants who discontinued treatment after Week 24 and before Week 56. Follow-up Visits 1, 2, and 3 occurred 4, 8, and 12 weeks, respectively, after the end of treatment visit.', 'unitOfMeasure': 'grams per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Hemoglobin at Each Post-Baseline Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo QD for 24 weeks during the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Placebo Followed by Parsaclisib', 'description': "Participants received matching placebo QD for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years. Participants may have received parsaclisib before reaching Week 24."}, {'id': 'OG002', 'title': 'Parsaclisib', 'description': "Participants received parsaclisib 2.5 milligrams (mg) once daily (QD) for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for an additional 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years."}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-12.3', 'spread': '41.18', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '13.82', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.5', 'spread': '16.87', 'groupId': 'OG000'}, {'value': '14.2', 'spread': '13.68', 'groupId': 'OG002'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.4', 'spread': '7.42', 'groupId': 'OG000'}, {'value': '14.2', 'spread': '18.21', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14.0', 'spread': '14.59', 'groupId': 'OG000'}, {'value': '14.3', 'spread': '19.65', 'groupId': 'OG002'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '17.8', 'spread': '17.44', 'groupId': 'OG000'}, {'value': '16.5', 'spread': '17.59', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13.6', 'spread': '21.15', 'groupId': 'OG000'}, {'value': '20.7', 'spread': '12.36', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21.7', 'spread': '16.02', 'groupId': 'OG000'}, {'value': '23.2', 'spread': '17.81', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18.5', 'spread': '9.32', 'groupId': 'OG000'}, {'value': '7.6', 'spread': '2.11', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '22.7', 'spread': '15.52', 'groupId': 'OG000'}, {'value': '19.4', 'spread': '22.70', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at End of Treatment, Double-blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-87.9', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG000'}, {'value': '12.0', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG002'}]}]}, {'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.2', 'spread': '9.34', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '24.52', 'groupId': 'OG002'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23.4', 'spread': '25.16', 'groupId': 'OG001'}, {'value': '9.7', 'spread': '27.56', 'groupId': 'OG002'}]}]}, {'title': 'Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.6', 'spread': '36.17', 'groupId': 'OG001'}, {'value': '30.0', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG002'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23.6', 'spread': '40.57', 'groupId': 'OG001'}, {'value': '29.0', 'spread': '12.41', 'groupId': 'OG002'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '29.3', 'spread': '26.69', 'groupId': 'OG001'}, {'value': '20.6', 'spread': '14.85', 'groupId': 'OG002'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '29.7', 'spread': '18.67', 'groupId': 'OG001'}, {'value': '29.6', 'spread': '8.46', 'groupId': 'OG002'}]}]}, {'title': 'Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '34.9', 'spread': '31.46', 'groupId': 'OG001'}, {'value': '30.7', 'spread': '16.35', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '31.6', 'spread': '32.12', 'groupId': 'OG001'}, {'value': '35.6', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at End of Treatment, Open-label Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '31.7', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG001'}, {'value': '25.3', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG002'}]}]}, {'title': 'Week 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '24.3', 'spread': '18.21', 'groupId': 'OG001'}, {'value': '40.0', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG002'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.1', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at End of Treatment, Long-term Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.9', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Visit 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '41.2', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG001'}, {'value': '11.5', 'spread': '8.19', 'groupId': 'OG002'}]}]}, {'title': 'Follow-up Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '33.0', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG001'}, {'value': '14.5', 'spread': '19.47', 'groupId': 'OG002'}]}]}, {'title': 'Follow-up Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23.7', 'spread': 'NA', 'comment': 'The standard deviation cannot be calculated for a single participant.', 'groupId': 'OG001'}, {'value': '23.4', 'spread': '13.52', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Day 1; Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and every 8 weeks post-Week 56', 'description': 'Percentage change from Baseline was calculated as (\\[the post-Baseline value minus the Baseline value\\]/Baseline value) x 100. End of Treatment, Double-blind Period: assessment performed for participants who discontinued treatment before Week 24. End of Treatment, Open-label Period: assessment performed for participants who discontinued treatment after Week 24 and before Week 56. Follow-up Visits 1, 2, and 3 occurred 4, 8, and 12 weeks, respectively, after the end of treatment visit.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Received Transfusions From Week 6 to Week 24 and From Week 24 to Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo QD for 24 weeks during the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Placebo Followed by Parsaclisib', 'description': "Participants received matching placebo QD for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years. Participants may have received parsaclisib before reaching Week 24."}, {'id': 'OG002', 'title': 'Parsaclisib', 'description': "Participants received parsaclisib 2.5 milligrams (mg) once daily (QD) for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for an additional 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years."}], 'classes': [{'title': 'Week 6 to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '42.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 to Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6 to Week 24; Week 24 to Week 48', 'description': 'Transfusion was permitted as a rescue treatment. Rescue medication was to be considered if the absolute hemoglobin level continued to decline, there was a \\> 1 g/dL decrease in hemoglobin from the prior assessment, or the participant developed new or worsening symptoms of warm autoimmune hemolytic anemia (wAIHA).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set. Only participants with available data were analyzed. The number of participants analyzed at Weeks 6 to 24 reflects the number of participants who received study drug for at least 43 days. The number of participants analyzed at Weeks 24 to 48 reflects the number of participants who received study drug during the open-label period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Daily Corticosteroid Dose at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo QD for 24 weeks during the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Parsaclisib', 'description': "Participants received parsaclisib 2.5 milligrams (mg) once daily (QD) for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for an additional 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.3', 'spread': '5.77', 'groupId': 'OG000'}, {'value': '20.8', 'spread': '10.21', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.1', 'spread': '14.02', 'groupId': 'OG000'}, {'value': '-4.8', 'spread': '10.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 24', 'description': 'A new or increased dose of corticosteroids (prednisone or equivalent) from the Day 1 dose was permitted as rescue treatment. Rescue medication was to be considered if the absolute hemoglobin level continued to decline, there was a \\> 1 g/dL decrease in hemoglobin from the prior assessment, or the participant developed new or worsening symptoms of wAIHA. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.', 'unitOfMeasure': 'milligrams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Daily Corticosteroid Dose at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo QD for 24 weeks during the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Parsaclisib', 'description': "Participants received parsaclisib 2.5 milligrams (mg) once daily (QD) for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for an additional 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years."}], 'classes': [{'categories': [{'measurements': [{'value': '81.0', 'spread': '140.21', 'groupId': 'OG000'}, {'value': '-22.0', 'spread': '60.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 24', 'description': 'A new or increased dose of corticosteroids (prednisone or equivalent) from the Day 1 dose was permitted as rescue treatment. Rescue medication was to be considered if the absolute hemoglobin level continued to decline, there was a \\> 1 g/dL decrease in hemoglobin from the prior assessment, or the participant developed new or worsening symptoms of wAIHA. Percentage change from Baseline was calculated as (\\[the post-Baseline value minus the Baseline value\\]/Baseline value) x 100.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Required Rescue Therapy at Any Visit From Week 6 Through Week 24, and From Week 24 to Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo QD for 24 weeks during the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Placebo Followed by Parsaclisib', 'description': "Participants received matching placebo QD for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years. Participants may have received parsaclisib before reaching Week 24."}, {'id': 'OG002', 'title': 'Parsaclisib', 'description': "Participants received parsaclisib 2.5 milligrams (mg) once daily (QD) for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for an additional 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years."}], 'classes': [{'title': 'Week 6 to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 to Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG001'}, {'value': '20.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6 to Week 24; Week 24 to Week 48', 'description': 'Rescue medication was to be considered if the absolute hemoglobin level continued to decline, there was a \\> 1 g/dL decrease in hemoglobin from the prior assessment, or the participant developed new or worsening symptoms of wAIHA.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Treatment-emergent Adverse Event (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo QD for 24 weeks during the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Placebo Followed by Parsaclisib', 'description': "Participants received matching placebo QD for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years. Participants may have received parsaclisib before reaching Week 24."}, {'id': 'OG002', 'title': 'Parsaclisib', 'description': "Participants received parsaclisib 2.5 milligrams (mg) once daily (QD) for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for an additional 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years."}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 446 days', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. TEAEs were defined as AEs reported for the first time or the worsening of pre-existing events after the first dose of study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any ≥Grade 3 TEAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo QD for 24 weeks during the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Placebo Followed by Parsaclisib', 'description': "Participants received matching placebo QD for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years. Participants may have received parsaclisib before reaching Week 24."}, {'id': 'OG002', 'title': 'Parsaclisib', 'description': "Participants received parsaclisib 2.5 milligrams (mg) once daily (QD) for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for an additional 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years."}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 446 days', 'description': 'An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. TEAEs were defined as AEs reported for the first time or the worsening of pre-existing events after the first dose of study drug. The severity of AEs were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Parsaclisib', 'description': "Participants received parsaclisib 2.5 milligrams (mg) once daily (QD) for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for an additional 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years."}, {'id': 'FG001', 'title': 'Placebo Followed by Parsaclisib', 'description': "Participants received matching placebo QD for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years. Participants may have received parsaclisib before reaching Week 24."}], 'periods': [{'title': '24-week Double-blind Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': '24-week Open-label Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Long-term Extension Period (~2 Years)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'This study was designed to evaluate parsaclisib 2.5 mg QD compared with placebo over a 24-week double-blind treatment period followed by a 24-week open-label treatment period with parsaclisib. Participants could then continue to receive parsaclisib in a long-term extension period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Parsaclisib', 'description': "Participants received parsaclisib 2.5 milligrams (mg) once daily (QD) for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for an additional 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years."}, {'id': 'BG001', 'title': 'Placebo Followed by Parsaclisib', 'description': "Participants received matching placebo QD for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years. Participants may have received parsaclisib before reaching Week 24."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.3', 'spread': '14.28', 'groupId': 'BG000'}, {'value': '57.8', 'spread': '15.54', 'groupId': 'BG001'}, {'value': '60.23', 'spread': '14.42', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White/Caucasian', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-10', 'size': 1186293, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-10-09T11:45', 'hasProtocol': True}, {'date': '2024-01-17', 'size': 361550, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-10-09T11:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Study will be a 24 week double-blind period followed by a 24 week open-label period, followed by a long term extension period.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'whyStopped': 'A business decision was made to discontinue further enrollment. There were no safety concerns that contributed to this decision.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-15', 'studyFirstSubmitDate': '2021-09-28', 'resultsFirstSubmitDate': '2024-10-09', 'studyFirstSubmitQcDate': '2021-09-29', 'lastUpdatePostDateStruct': {'date': '2025-11-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2024-12-19', 'studyFirstPostDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Attaining a Durable Hemoglobin Response', 'timeFrame': 'up to Week 24', 'description': 'A durable hemoglobin response was defined as hemoglobin ≥10 grams per deciliter (g/dL) with an increase from Baseline of ≥2 g/dL not attributed to rescue therapy at ≥3 of the 4 available visits at Week 12 and/or later during the 24-week double-blind treatment period.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With a ≥3-point Increase From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Week 24', 'timeFrame': 'Baseline; Week 24', 'description': 'The FACIT-F scale was developed to assess anemia-related fatigue. The FACIT-F is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days. A clinically meaningful change in the FACIT-F score was defined as ≥3-point increase from Baseline. Item scores range from 0 ("not at all") to 4 ("very much"), and the total score ranges from 0 to 52; lower scores indicate greater fatigue. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.'}, {'measure': 'Percentage of Participants With a 50 Meter Increase From Baseline to Week 24 in a 6-minute Walk Test (6MWT)', 'timeFrame': 'Baseline; Week 24', 'description': 'The 6MWT is used to evaluate submaximal exercise capacity. It is a self-paced measurement of the distance that a participant can quickly walk on a flat, hard surface in a period of 6 minutes.'}, {'measure': 'Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit', 'timeFrame': 'Baseline; Day 1; Weeks 8, 12, 16, 20, 24, 28, 32, 40, 48, 56, and every 16 weeks post-Week 56', 'description': 'The FACIT-F scale was developed to assess anemia-related fatigue. The FACIT-F is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days. A clinically meaningful change in the FACIT-F score was defined as ≥3-point increase from Baseline. Item scores range from 0 ("not at all") to 4 ("very much"), and the total score ranges from 0 to 52; lower scores indicate greater fatigue. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. End of Treatment, Double-blind Period: assessment performed for participants who discontinued treatment before Week 24. End of Treatment, Open-label Period: assessment performed for participants who discontinued treatment after Week 24 and before Week 56. Follow-up Visit 3 occurred 12 weeks after the end of treatment visit.'}, {'measure': 'Percentage Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit', 'timeFrame': 'Baseline; Day 1; Weeks 8, 12, 16, 20, 24, 28, 32, 40, 48, 56, and every 16 weeks post-Week 56', 'description': 'The FACIT-F scale was developed to assess anemia-related fatigue. The FACIT-F is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days. A clinically meaningful change in the FACIT-F score was defined as ≥3-point increase from Baseline. Item scores range from 0 ("not at all") to 4 ("very much"), and the total score ranges from 0 to 52; lower scores indicate greater fatigue. Percentage change from Baseline was calculated as (\\[the post-Baseline value minus the Baseline value\\]/Baseline value) x 100. End of Treatment, Double-blind Period: assessment performed for participants who discontinued treatment before Week 24. End of Treatment, Open-label Period: assessment performed for participants who discontinued treatment after Week 24 and before Week 56. Follow-up Visit 3 occurred 12 weeks after the end of treatment visit.'}, {'measure': 'Change From Baseline in Hemoglobin at Each Post-Baseline Visit', 'timeFrame': 'Baseline; Day 1; Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and every 8 weeks post-Week 56', 'description': 'Change from Baseline was calculated as the post-Baseline value minus the Baseline value. End of Treatment, Double-blind Period: assessment performed for participants who discontinued treatment before Week 24. End of Treatment, Open-label Period: assessment performed for participants who discontinued treatment after Week 24 and before Week 56. Follow-up Visits 1, 2, and 3 occurred 4, 8, and 12 weeks, respectively, after the end of treatment visit.'}, {'measure': 'Percentage Change From Baseline in Hemoglobin at Each Post-Baseline Visit', 'timeFrame': 'Baseline; Day 1; Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and every 8 weeks post-Week 56', 'description': 'Percentage change from Baseline was calculated as (\\[the post-Baseline value minus the Baseline value\\]/Baseline value) x 100. End of Treatment, Double-blind Period: assessment performed for participants who discontinued treatment before Week 24. End of Treatment, Open-label Period: assessment performed for participants who discontinued treatment after Week 24 and before Week 56. Follow-up Visits 1, 2, and 3 occurred 4, 8, and 12 weeks, respectively, after the end of treatment visit.'}, {'measure': 'Percentage of Participants Who Received Transfusions From Week 6 to Week 24 and From Week 24 to Week 48', 'timeFrame': 'Week 6 to Week 24; Week 24 to Week 48', 'description': 'Transfusion was permitted as a rescue treatment. Rescue medication was to be considered if the absolute hemoglobin level continued to decline, there was a \\> 1 g/dL decrease in hemoglobin from the prior assessment, or the participant developed new or worsening symptoms of warm autoimmune hemolytic anemia (wAIHA).'}, {'measure': 'Change From Baseline in Daily Corticosteroid Dose at Week 24', 'timeFrame': 'Baseline; Week 24', 'description': 'A new or increased dose of corticosteroids (prednisone or equivalent) from the Day 1 dose was permitted as rescue treatment. Rescue medication was to be considered if the absolute hemoglobin level continued to decline, there was a \\> 1 g/dL decrease in hemoglobin from the prior assessment, or the participant developed new or worsening symptoms of wAIHA. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.'}, {'measure': 'Percentage Change From Baseline in Daily Corticosteroid Dose at Week 24', 'timeFrame': 'Baseline; Week 24', 'description': 'A new or increased dose of corticosteroids (prednisone or equivalent) from the Day 1 dose was permitted as rescue treatment. Rescue medication was to be considered if the absolute hemoglobin level continued to decline, there was a \\> 1 g/dL decrease in hemoglobin from the prior assessment, or the participant developed new or worsening symptoms of wAIHA. Percentage change from Baseline was calculated as (\\[the post-Baseline value minus the Baseline value\\]/Baseline value) x 100.'}, {'measure': 'Percentage of Participants Who Required Rescue Therapy at Any Visit From Week 6 Through Week 24, and From Week 24 to Week 48', 'timeFrame': 'Week 6 to Week 24; Week 24 to Week 48', 'description': 'Rescue medication was to be considered if the absolute hemoglobin level continued to decline, there was a \\> 1 g/dL decrease in hemoglobin from the prior assessment, or the participant developed new or worsening symptoms of wAIHA.'}, {'measure': 'Number of Participants With Any Treatment-emergent Adverse Event (TEAE)', 'timeFrame': 'up to 446 days', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. TEAEs were defined as AEs reported for the first time or the worsening of pre-existing events after the first dose of study drug.'}, {'measure': 'Number of Participants With Any ≥Grade 3 TEAE', 'timeFrame': 'up to 446 days', 'description': 'An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. TEAEs were defined as AEs reported for the first time or the worsening of pre-existing events after the first dose of study drug. The severity of AEs were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Warm Autoimmune Hemolytic Anemia (wAIHA)'], 'conditions': ['Warm Autoimmune Hemolytic Anemia (wAIHA)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of parsaclisib compared with placebo in participants with Primary Warm Autoimmune Hemolytic Anemia (wAIHA),', 'detailedDescription': 'Prospective participants must have primary wAIHA as well as other protocol-defined criteria. After participants have been determined to be eligible for the study, they will be randomized to 2:1, with stratification factor of corticosteroid dose and hemoglobin (Hgb \\<9 g/dL or ≥ 9 g/dL). Once a participant has completed the week 24 assessments in the double-blind period, the participant will have the opportunity to receive parsaclisib in the open-label treatment which will last up to another 24 weeks. Participants may then continue to receive parsaclisib in a long-term extension period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of primary warm AIHA.\n* Participants who have at least 1 unsuccessful prior therapy for warm AIHA or unable to receive or tolerate other therapies.\n* Hemoglobin ≥ 6.5 to \\< 10 g/dL with symptoms of anemia at screening.\n* FACIT-F score ≤ 43 at screening.\n* Willingness to avoid pregnancy or fathering children.\n* Willingness to receive PJP prophylaxis.\n* Further inclusion criteria apply.\n\nExclusion Criteria:\n\n* Women who are pregnant, breastfeeding or who are planning a pregnancy.\n* Diagnosis of other types of AIHA (CAD, cold agglutinin syndrome, mixed-type AIHA or paroxysmal cold hemoglobinuria).\n* Secondary warm AIHA from any cause or diagnosis of Evans syndrome.\n* Splenectomy less than 3 months before randomization.\n* Participants with a history or ongoing significant illness as assessed by the investigator.\n* Participants with a current of medical history of a malignancy within the past 5 years except basal or squamous cell skin cancer that has been removed and considered cured, or superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy.\n* Participants know to be infected with HIV, Hepatitis B, or hepatitis C.\n* Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment or exposure to a live vaccine.\n* Participants with laboratory values outside of the protocol defined ranges.\n* Further exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT05073458', 'acronym': 'PATHWAY', 'briefTitle': 'Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia', 'orgStudyIdInfo': {'id': 'INCB 50465-309'}, 'secondaryIdInfos': [{'id': '2021-002844-66', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A: Parsaclisib', 'description': "Participants will receive parsaclisib for 24 weeks (double-blind period). Participant who completed the double-blind period and tolerating the study treatment upon investigator's opinion will continue into open-label period for an additional 24 weeks. Participants may then continue to receive parsaclisib in a long-term extension period.", 'interventionNames': ['Drug: parsaclisinib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group B: Placebo followed by Parsaclisib', 'description': 'Participants will receive placebo for 24 weeks (double-blind period). Participants who completed the double-blind period will receive parsaclisib in the 24 week open-label period. Participants may then continue to receive parsaclisib in a long-term extension period.', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'parsaclisinib', 'type': 'DRUG', 'otherNames': ['INCB050465'], 'description': 'parsaclisib will be administered QD orally', 'armGroupLabels': ['Group A: Parsaclisib']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo will be administered QD orally follwed by Parsaclisinib in the open label period', 'armGroupLabels': ['Group B: Placebo followed by Parsaclisib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90089', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Investigative Site US005', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90603', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'Investigative Site US004', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '33165', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigative Site US006', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Investigative Site US012', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Investigative Site US007', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Investigative Site US002', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27858', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigative Site US003', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '44718', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigative Site US009', 'geoPoint': {'lat': 40.79895, 'lon': 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'facility': 'Investigative Site CA001', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Investigative Site FR002', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '13285', 'city': 'Marseille', 'country': 'France', 'facility': 'Investigative Site FR003', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Investigative Site FR001', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'Investigative Site DE001', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Investigative Site DE002', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '31096', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Investigative Site IL002', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '2210001', 'city': 'Nahariya', 'country': 'Israel', 'facility': 'Investigative Site IL001', 'geoPoint': {'lat': 33.00892, 'lon': 35.09814}}, {'zip': '50134', 'city': 'Florence', 'country': 'Italy', 'facility': 'Investigative Site IT003', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '20122', 'city': 'Milan', 'country': 'Italy', 'facility': 'Investigative Site IT002', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '28100', 'city': 'Novara', 'country': 'Italy', 'facility': 'Investigative Site IT001', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}, {'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'Investigative Site IT004', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'zip': '00168', 'city': 'Rome', 'country': 'Italy', 'facility': 'Investigative Site IT006', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '34125', 'city': 'Trieste', 'country': 'Italy', 'facility': 'Investigative Site IT005', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}, {'zip': '807-8556', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Investigative Site JP008', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '259-1193', 'city': 'Isehara', 'country': 'Japan', 'facility': 'Investigative Site JP004', 'geoPoint': {'lat': 35.39932, 'lon': 139.31019}}, {'zip': '467-8602', 'city': 'Nagoya', 'country': 'Japan', 'facility': 'Investigative Site JP006', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '700-8557', 'city': 'Okayama', 'country': 'Japan', 'facility': 'Investigative Site JP009', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '701-0192', 'city': 'Okayama', 'country': 'Japan', 'facility': 'Investigative Site JP002', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '589-8511', 'city': 'Osakasayama-shi', 'country': 'Japan', 'facility': 'Investigative Site JP010'}, {'zip': '350-0495', 'city': 'Saitama', 'country': 'Japan', 'facility': 'Investigative Site JP005', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '980-8574', 'city': 'Sendai', 'country': 'Japan', 'facility': 'Investigative Site JP007', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'zip': '565-0871', 'city': 'Suita-shi', 'country': 'Japan', 'facility': 'Investigative Site JP001'}, {'zip': '141-8625', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Investigative Site JP003', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '3015CA', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Investigative Site NL001', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '59220', 'city': 'Legnica', 'country': 'Poland', 'facility': 'Investigative Site PL001', 'geoPoint': {'lat': 51.21006, 'lon': 16.1619}}, {'zip': '93-510', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Investigative Site PL006', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '33-300', 'city': 'Nowy Sącz', 'country': 'Poland', 'facility': 'Investigative Site PL003', 'geoPoint': {'lat': 49.62177, 'lon': 20.69705}}, {'zip': '45-372', 'city': 'Opole', 'country': 'Poland', 'facility': 'Investigative Site PL005', 'geoPoint': {'lat': 50.67119, 'lon': 17.92604}}, {'zip': '58-309', 'city': 'Wałbrzych', 'country': 'Poland', 'facility': 'Investigative Site PL004', 'geoPoint': {'lat': 50.77141, 'lon': 16.28432}}, {'zip': '53-439', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Investigative Site PL002', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '08916', 'city': 'Badalona', 'country': 'Spain', 'facility': 'Investigative Site ES006', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Investigative Site ES001', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28006', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Investigative Site ES003', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '30008', 'city': 'Murcia', 'country': 'Spain', 'facility': 'Investigative Site ES005', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'zip': '43005', 'city': 'Tarragona', 'country': 'Spain', 'facility': 'Investigative Site ES004', 'geoPoint': {'lat': 41.11905, 'lon': 1.24544}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Investigative Site ES002', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': 'G4 0SF', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Investigative Site GB002', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'W12 0HS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Investigative Site GB006', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NR4 7UY', 'city': 'Norwich', 'country': 'United Kingdom', 'facility': 'Investigative Site GB003', 'geoPoint': {'lat': 52.62783, 'lon': 1.29834}}, {'zip': 'PL6 8DH', 'city': 'Plymouth', 'country': 'United Kingdom', 'facility': 'Investigative Site GB004', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'zip': 'RG1 5AN', 'city': 'Reading', 'country': 'United Kingdom', 'facility': 'Investigative Site GB005', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}], 'overallOfficials': [{'name': 'Kathleen Butler, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Incyte Corporation'}]}, 'ipdSharingStatementModule': {'url': 'https://www.incyte.com/our-company/compliance-and-transparency', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.', 'ipdSharing': 'YES', 'description': 'Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThe trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency', 'accessCriteria': 'Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Incyte Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}