Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-29 @ 12:24 AM
Study NCT ID:
NCT04551066
Status:
TERMINATED
Last Update Posted:
2025-10-21
First Post:
2020-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
To Evaluate the Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis (LIMBER-313)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Hungary'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D055728', 'term': 'Primary Myelofibrosis'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000656179', 'term': 'parsaclisib'}, {'id': 'C540383', 'term': 'ruxolitinib'}]}}, '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}, 'limitationsAndCaveats': {'description': 'Due to participants rolling over to another study (NCT02955940), no participants randomized to receive placebo plus ruxolitinib switched to treatment with parsaclisib plus ruxolitinib.'}}, 'adverseEventsModule': {'timeFrame': 'up to 960 days', 'description': 'Treatment-emergent adverse events, defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until 30 to 35 days after the last dose of parsaclisib/matching placebo or ruxolitinib, have been reported for the Safety Population.', 'eventGroups': [{'id': 'EG000', 'title': 'Parsaclisib Plus Ruxolitinib', 'description': 'Participants were randomized to receive parsaclisib plus ruxolitinib beginning on Day 1 and continued on this regimen as long as it was tolerated and the participants did not meet any discontinuation criteria. Participants with a Baseline platelet count ≥100 × 10\\^9/Liter received ruxolitinib 15 milligrams (mg) twice daily (BID). Participants with a Baseline platelet count of 50 to \\< 100 × 10\\^9/Liters inclusive received ruxolitinib 5 mg BID. Participants were also stratified according to the Dynamic International Prognostic Scoring System (DIPSS) risk category (high versus intermediate-2 versus intermediate-1). Participants received parsaclisib at a dose of 5 mg once daily (QD).', 'otherNumAtRisk': 125, 'deathsNumAtRisk': 125, 'otherNumAffected': 109, 'seriousNumAtRisk': 125, 'deathsNumAffected': 6, 'seriousNumAffected': 26}, {'id': 'EG001', 'title': 'Placebo Plus Ruxolitinib', 'description': 'Participants were randomized to receive placebo plus ruxolitinib beginning on Day 1 and continued on this regimen until they left the study. Participants with a Baseline platelet count ≥100 × 10\\^9/Liter received ruxolitinib 15 mg BID. Participants with a Baseline platelet count of 50 to \\< 100 × 10\\^9/Liters inclusive received ruxolitinib 5 mg BID. Participants were also stratified according to the DIPSS risk category (high versus intermediate-2 versus intermediate-1). Participants received matching placebo at a dose of 5 mg QD. After 24 weeks, participants randomized to receive placebo plus ruxolitinib could have switched to treatment with parsaclisib plus ruxolitinib per the regimen received during the first 24 weeks of the study. Treatment continued for as long as the regimen was tolerated and the participant did not meet any discontinuation criteria.', 'otherNumAtRisk': 127, 'deathsNumAtRisk': 127, 'otherNumAffected': 109, 'seriousNumAtRisk': 127, 'deathsNumAffected': 3, 'seriousNumAffected': 18}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 29, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 70, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 94, 'numAffected': 68}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 38, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 27, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cytomegalovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 28, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 30, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 14, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 11, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 48, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 38, 'numAffected': 19}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 31, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 33, 'numAffected': 21}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 16, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Blood fibrinogen decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Diverticulum intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Extradural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Herpes zoster meningomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypoparathyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Intervertebral discitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Intracranial mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Macular hole', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Myelitis transverse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Myxofibrosarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pneumocystis jirovecii pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pneumonia mycoplasmal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Rhinovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Varices oesophageal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving ≥35% Reduction in Spleen Volume From Baseline to Week 24 as Measured by Magnetic Resonance Imaging [MRI] (or Computed Tomography [CT] Scan in Applicable Participants)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parsaclisib Plus Ruxolitinib', 'description': 'Participants were randomized to receive parsaclisib plus ruxolitinib beginning on Day 1 and continued on this regimen as long as it was tolerated and the participants did not meet any discontinuation criteria. Participants with a Baseline platelet count ≥100 × 10\\^9/Liter received ruxolitinib 15 milligrams (mg) twice daily (BID). Participants with a Baseline platelet count of 50 to \\< 100 × 10\\^9/Liters inclusive received ruxolitinib 5 mg BID. Participants were also stratified according to the Dynamic International Prognostic Scoring System (DIPSS) risk category (high versus intermediate-2 versus intermediate-1). Participants received parsaclisib at a dose of 5 mg once daily (QD).'}, {'id': 'OG001', 'title': 'Placebo Plus Ruxolitinib', 'description': 'Participants were randomized to receive placebo plus ruxolitinib beginning on Day 1 and continued on this regimen until they left the study. Participants with a Baseline platelet count ≥100 × 10\\^9/Liter received ruxolitinib 15 mg BID. Participants with a Baseline platelet count of 50 to \\< 100 × 10\\^9/Liters inclusive received ruxolitinib 5 mg BID. Participants were also stratified according to the DIPSS risk category (high versus intermediate-2 versus intermediate-1). Participants received matching placebo at a dose of 5 mg QD. After 24 weeks, participants randomized to receive placebo plus ruxolitinib could have switched to treatment with parsaclisib plus ruxolitinib per the regimen received during the first 24 weeks of the study. Treatment continued for as long as the regimen was tolerated and the participant did not meet any discontinuation criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.8', 'groupId': 'OG000'}, {'value': '46.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4224', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.27', 'ciLowerLimit': '0.71', 'ciUpperLimit': '2.26', 'pValueComment': 'calculated from Cochran Mantel-Haenszel test stratified by Baseline platelet count ≥100 x 10\\^9/Liters versus 50 to \\<100 x 10\\^9/Liters inclusive', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; Week 24', 'description': 'Participants had an MRI of the upper and lower abdomen and pelvis to determine the spleen volume. A CT scan was substituted for participants who were not candidates for MRI or when MRI was not readily available. Determination of spleen length below the left costal margin was measured by palpation, using a flexible ruler provided by the sponsor.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants. Treatment groups were defined according to the treatment assignment at randomization regardless of the actual study drug the participant took during their participation. Participants who had both Baseline and Week 24 measurements, or discontinued treatment before 27APR2023, or reached Week 24 before 27APR2023 but were missing Week 24 assessments were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Had a ≥50% Reduction in Total Symptom Score (TSS) From Baseline to Week 24 as Measured by the Myelofibrosis Symptom Assessment Form v4.0 (MFSAF v4.0) Diary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parsaclisib Plus Ruxolitinib', 'description': 'Participants were randomized to receive parsaclisib plus ruxolitinib beginning on Day 1 and continued on this regimen as long as it was tolerated and the participants did not meet any discontinuation criteria. Participants with a Baseline platelet count ≥100 × 10\\^9/Liter received ruxolitinib 15 milligrams (mg) twice daily (BID). Participants with a Baseline platelet count of 50 to \\< 100 × 10\\^9/Liters inclusive received ruxolitinib 5 mg BID. Participants were also stratified according to the Dynamic International Prognostic Scoring System (DIPSS) risk category (high versus intermediate-2 versus intermediate-1). Participants received parsaclisib at a dose of 5 mg once daily (QD).'}, {'id': 'OG001', 'title': 'Placebo Plus Ruxolitinib', 'description': 'Participants were randomized to receive placebo plus ruxolitinib beginning on Day 1 and continued on this regimen until they left the study. Participants with a Baseline platelet count ≥100 × 10\\^9/Liter received ruxolitinib 15 mg BID. Participants with a Baseline platelet count of 50 to \\< 100 × 10\\^9/Liters inclusive received ruxolitinib 5 mg BID. Participants were also stratified according to the DIPSS risk category (high versus intermediate-2 versus intermediate-1). Participants received matching placebo at a dose of 5 mg QD. After 24 weeks, participants randomized to receive placebo plus ruxolitinib could have switched to treatment with parsaclisib plus ruxolitinib per the regimen received during the first 24 weeks of the study. Treatment continued for as long as the regimen was tolerated and the participant did not meet any discontinuation criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.8', 'groupId': 'OG000'}, {'value': '38.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5728', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.46', 'ciUpperLimit': '1.53', 'pValueComment': 'calculated from Cochran Mantel-Haenszel test stratified by Baseline platelet count ≥100 x 10\\^9/Liters versus 50 to \\<100 x 10\\^9/Liters inclusive', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; Week 24', 'description': 'Symptoms of myelofibrosis were assessed using the MFSAF v4.0 diary. The MFSAF v4.0 is composed of 7 individual symptom scores (fatigue, night sweats, itchiness, abdominal discomfort, pain under left ribs, early satiety, bone pain), each collected daily using a 0- (no symptoms) to 10-point (worst imaginable symptoms) scale. The daily TSS (0 to 70) is the sum of the 7 individual symptom scores collected on the same day. Higher TSS indicate more severe symptoms. The TSS was missing if there were any missing individual scores. Observations with missing dates were excluded from the analysis. The Baseline/Week 24 total score was defined as the average of the daily total scores from the last 7 days before the first dose of parsaclisib, placebo, or ruxolitinib/the Week 24 visit. The Baseline/Week 24 total scores was missing if there were ≥4 missing out of the 7 daily total scores.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Participants who had both Baseline and Week 24 measurements, or discontinued treatment before 27APR2023, or reached Week 24 before 27APR2023 but were missing Week 24 assessments were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change in TSS From Baseline to Week 24 as Measured by the MFSAF v4.0 Diary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parsaclisib Plus Ruxolitinib', 'description': 'Participants were randomized to receive parsaclisib plus ruxolitinib beginning on Day 1 and continued on this regimen as long as it was tolerated and the participants did not meet any discontinuation criteria. Participants with a Baseline platelet count ≥100 × 10\\^9/Liter received ruxolitinib 15 milligrams (mg) twice daily (BID). Participants with a Baseline platelet count of 50 to \\< 100 × 10\\^9/Liters inclusive received ruxolitinib 5 mg BID. Participants were also stratified according to the Dynamic International Prognostic Scoring System (DIPSS) risk category (high versus intermediate-2 versus intermediate-1). Participants received parsaclisib at a dose of 5 mg once daily (QD).'}, {'id': 'OG001', 'title': 'Placebo Plus Ruxolitinib', 'description': 'Participants were randomized to receive placebo plus ruxolitinib beginning on Day 1 and continued on this regimen until they left the study. Participants with a Baseline platelet count ≥100 × 10\\^9/Liter received ruxolitinib 15 mg BID. Participants with a Baseline platelet count of 50 to \\< 100 × 10\\^9/Liters inclusive received ruxolitinib 5 mg BID. Participants were also stratified according to the DIPSS risk category (high versus intermediate-2 versus intermediate-1). Participants received matching placebo at a dose of 5 mg QD. After 24 weeks, participants randomized to receive placebo plus ruxolitinib could have switched to treatment with parsaclisib plus ruxolitinib per the regimen received during the first 24 weeks of the study. Treatment continued for as long as the regimen was tolerated and the participant did not meet any discontinuation criteria.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.8', 'spread': '14.29', 'groupId': 'OG000'}, {'value': '19.6', 'spread': '13.07', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.6', 'spread': '12.36', 'groupId': 'OG000'}, {'value': '-6.8', 'spread': '10.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 24', 'description': 'Symptoms of myelofibrosis were assessed using the MFSAF v4.0 diary. The MFSAF v4.0 is composed of 7 individual symptom scores (fatigue, night sweats, itchiness, abdominal discomfort, pain under left ribs, early satiety, bone pain), each collected daily using a 0- (no symptoms) to 10-point (worst imaginable symptoms) scale. The daily TSS (0 to 70) is the sum of the 7 individual symptom scores collected on the same day. Higher TSS indicate more severe symptoms. The TSS was missing if there were any missing individual scores. Observations with missing dates were excluded from the analysis. The Baseline/Week 24 total score was defined as the average of the daily total scores from the last 7 days before the first dose of parsaclisib, placebo, or ruxolitinib/the Week 24 visit. The Baseline/Week 24 total scores was missing if there were ≥4 missing out of the 7 daily total scores. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Time to the First ≥50% Reduction in TSS as Measured by the MFSAF v4.0 Diary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parsaclisib Plus Ruxolitinib', 'description': 'Participants were randomized to receive parsaclisib plus ruxolitinib beginning on Day 1 and continued on this regimen as long as it was tolerated and the participants did not meet any discontinuation criteria. Participants with a Baseline platelet count ≥100 × 10\\^9/Liter received ruxolitinib 15 milligrams (mg) twice daily (BID). Participants with a Baseline platelet count of 50 to \\< 100 × 10\\^9/Liters inclusive received ruxolitinib 5 mg BID. Participants were also stratified according to the Dynamic International Prognostic Scoring System (DIPSS) risk category (high versus intermediate-2 versus intermediate-1). Participants received parsaclisib at a dose of 5 mg once daily (QD).'}, {'id': 'OG001', 'title': 'Placebo Plus Ruxolitinib', 'description': 'Participants were randomized to receive placebo plus ruxolitinib beginning on Day 1 and continued on this regimen until they left the study. Participants with a Baseline platelet count ≥100 × 10\\^9/Liter received ruxolitinib 15 mg BID. Participants with a Baseline platelet count of 50 to \\< 100 × 10\\^9/Liters inclusive received ruxolitinib 5 mg BID. Participants were also stratified according to the DIPSS risk category (high versus intermediate-2 versus intermediate-1). Participants received matching placebo at a dose of 5 mg QD. After 24 weeks, participants randomized to receive placebo plus ruxolitinib could have switched to treatment with parsaclisib plus ruxolitinib per the regimen received during the first 24 weeks of the study. Treatment continued for as long as the regimen was tolerated and the participant did not meet any discontinuation criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '67.0', 'groupId': 'OG000', 'lowerLimit': '27.0', 'upperLimit': '131.0'}, {'value': '69.0', 'groupId': 'OG001', 'lowerLimit': '35.0', 'upperLimit': '143.0'}]}]}], 'analyses': [{'pValue': '0.9490', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'calculated from log-rank test stratified by Baseline platelet count ≥100 × 10\\^9/Liters versus 50 to \\<100 × 10\\^9/Liters inclusive', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline; up to Week 24', 'description': 'Symptoms of myelofibrosis were assessed using the MFSAF v4.0 diary. The MFSAF v4.0 is composed of 7 individual symptom scores (fatigue, night sweats, itchiness, abdominal discomfort, pain under left ribs, early satiety, bone pain), each collected daily using a 0- (no symptoms) to 10-point (worst imaginable symptoms) scale. The daily TSS (0 to 70) is the sum of the 7 individual symptom scores collected on the same day. Higher TSS indicate more severe symptoms. The TSS was missing if there were any missing individual scores. Observations with missing dates were excluded from the analysis. The Baseline/Week 24 total score was defined as the average of the daily total scores from the last 7 days before the first dose of parsaclisib, placebo, or ruxolitinib/the Week 24 visit. The Baseline/Week 24 total scores was missing if there were ≥4 missing out of the 7 daily total scores.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "ITT Population, including censored participants. Censored participants didn't have a response at any time up to the last assessment date. Participants who didn't have a \\>=50% reduction in TSS was censored at the time of the last assessment. Participants with a DIPSS risk level of Low Risk Level (0 prognostic points) were excluded from the analysis. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method with log-log transformation."}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parsaclisib Plus Ruxolitinib', 'description': 'Participants were randomized to receive parsaclisib plus ruxolitinib beginning on Day 1 and continued on this regimen as long as it was tolerated and the participants did not meet any discontinuation criteria. Participants with a Baseline platelet count ≥100 × 10\\^9/Liter received ruxolitinib 15 milligrams (mg) twice daily (BID). Participants with a Baseline platelet count of 50 to \\< 100 × 10\\^9/Liters inclusive received ruxolitinib 5 mg BID. Participants were also stratified according to the Dynamic International Prognostic Scoring System (DIPSS) risk category (high versus intermediate-2 versus intermediate-1). Participants received parsaclisib at a dose of 5 mg once daily (QD).'}, {'id': 'OG001', 'title': 'Placebo Plus Ruxolitinib', 'description': 'Participants were randomized to receive placebo plus ruxolitinib beginning on Day 1 and continued on this regimen until they left the study. Participants with a Baseline platelet count ≥100 × 10\\^9/Liter received ruxolitinib 15 mg BID. Participants with a Baseline platelet count of 50 to \\< 100 × 10\\^9/Liters inclusive received ruxolitinib 5 mg BID. Participants were also stratified according to the DIPSS risk category (high versus intermediate-2 versus intermediate-1). Participants received matching placebo at a dose of 5 mg QD. After 24 weeks, participants randomized to receive placebo plus ruxolitinib could have switched to treatment with parsaclisib plus ruxolitinib per the regimen received during the first 24 weeks of the study. Treatment continued for as long as the regimen was tolerated and the participant did not meet any discontinuation criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Due to participants rolling over to another study (NCT02955940), the follow-up time was not long enough to estimate the median and the upper and lower limits of the confidence interval.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Due to participants rolling over to another study (NCT02955940), the follow-up time was not long enough to estimate the median and the upper and lower limits of the confidence interval.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 749 days', 'description': 'Overall survival was defined as the interval between the randomization date and the date of death due to any cause.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Treatment-emergent Adverse Event (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parsaclisib Plus Ruxolitinib', 'description': 'Participants were randomized to receive parsaclisib plus ruxolitinib beginning on Day 1 and continued on this regimen as long as it was tolerated and the participants did not meet any discontinuation criteria. Participants with a Baseline platelet count ≥100 × 10\\^9/Liter received ruxolitinib 15 milligrams (mg) twice daily (BID). Participants with a Baseline platelet count of 50 to \\< 100 × 10\\^9/Liters inclusive received ruxolitinib 5 mg BID. Participants were also stratified according to the Dynamic International Prognostic Scoring System (DIPSS) risk category (high versus intermediate-2 versus intermediate-1). Participants received parsaclisib at a dose of 5 mg once daily (QD).'}, {'id': 'OG001', 'title': 'Placebo Plus Ruxolitinib', 'description': 'Participants were randomized to receive placebo plus ruxolitinib beginning on Day 1 and continued on this regimen until they left the study. Participants with a Baseline platelet count ≥100 × 10\\^9/Liter received ruxolitinib 15 mg BID. Participants with a Baseline platelet count of 50 to \\< 100 × 10\\^9/Liters inclusive received ruxolitinib 5 mg BID. Participants were also stratified according to the DIPSS risk category (high versus intermediate-2 versus intermediate-1). Participants received matching placebo at a dose of 5 mg QD. After 24 weeks, participants randomized to receive placebo plus ruxolitinib could have switched to treatment with parsaclisib plus ruxolitinib per the regimen received during the first 24 weeks of the study. Treatment continued for as long as the regimen was tolerated and the participant did not meet any discontinuation criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 960 days', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is 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 treatment. A TEAE is defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 30 to 35 days after the last dose of parsaclisib/matching placebo or ruxolitinib.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all participants who received at least 1 dose of parsaclisib, placebo, or ruxolitinib. Treatment groups for this population were determined according to the actual treatment the participant received regardless of assigned study drug treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Grade 3 or Higher TEAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parsaclisib Plus Ruxolitinib', 'description': 'Participants were randomized to receive parsaclisib plus ruxolitinib beginning on Day 1 and continued on this regimen as long as it was tolerated and the participants did not meet any discontinuation criteria. Participants with a Baseline platelet count ≥100 × 10\\^9/Liter received ruxolitinib 15 milligrams (mg) twice daily (BID). Participants with a Baseline platelet count of 50 to \\< 100 × 10\\^9/Liters inclusive received ruxolitinib 5 mg BID. Participants were also stratified according to the Dynamic International Prognostic Scoring System (DIPSS) risk category (high versus intermediate-2 versus intermediate-1). Participants received parsaclisib at a dose of 5 mg once daily (QD).'}, {'id': 'OG001', 'title': 'Placebo Plus Ruxolitinib', 'description': 'Participants were randomized to receive placebo plus ruxolitinib beginning on Day 1 and continued on this regimen until they left the study. Participants with a Baseline platelet count ≥100 × 10\\^9/Liter received ruxolitinib 15 mg BID. Participants with a Baseline platelet count of 50 to \\< 100 × 10\\^9/Liters inclusive received ruxolitinib 5 mg BID. Participants were also stratified according to the DIPSS risk category (high versus intermediate-2 versus intermediate-1). Participants received matching placebo at a dose of 5 mg QD. After 24 weeks, participants randomized to receive placebo plus ruxolitinib could have switched to treatment with parsaclisib plus ruxolitinib per the regimen received during the first 24 weeks of the study. Treatment continued for as long as the regimen was tolerated and the participant did not meet any discontinuation criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 960 days', 'description': 'An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. A TEAE is defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 30 to 35 days after the last dose of parsaclisib/matching placebo or ruxolitinib. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local or noninvasive intervention indicated; limiting instrumental activities of daily living (ADL). Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4: life-threatening urgent intervention indicated. Grade 5: death related to AE.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Time of Onset of a ≥35% Reduction in Spleen Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parsaclisib Plus Ruxolitinib', 'description': 'Participants were randomized to receive parsaclisib plus ruxolitinib beginning on Day 1 and continued on this regimen as long as it was tolerated and the participants did not meet any discontinuation criteria. Participants with a Baseline platelet count ≥100 × 10\\^9/Liter received ruxolitinib 15 milligrams (mg) twice daily (BID). Participants with a Baseline platelet count of 50 to \\< 100 × 10\\^9/Liters inclusive received ruxolitinib 5 mg BID. Participants were also stratified according to the Dynamic International Prognostic Scoring System (DIPSS) risk category (high versus intermediate-2 versus intermediate-1). Participants received parsaclisib at a dose of 5 mg once daily (QD).'}, {'id': 'OG001', 'title': 'Placebo Plus Ruxolitinib', 'description': 'Participants were randomized to receive placebo plus ruxolitinib beginning on Day 1 and continued on this regimen until they left the study. Participants with a Baseline platelet count ≥100 × 10\\^9/Liter received ruxolitinib 15 mg BID. Participants with a Baseline platelet count of 50 to \\< 100 × 10\\^9/Liters inclusive received ruxolitinib 5 mg BID. Participants were also stratified according to the DIPSS risk category (high versus intermediate-2 versus intermediate-1). Participants received matching placebo at a dose of 5 mg QD. After 24 weeks, participants randomized to receive placebo plus ruxolitinib could have switched to treatment with parsaclisib plus ruxolitinib per the regimen received during the first 24 weeks of the study. Treatment continued for as long as the regimen was tolerated and the participant did not meet any discontinuation criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.0', 'groupId': 'OG000', 'lowerLimit': '86.0', 'upperLimit': '99.0'}, {'value': '92.0', 'groupId': 'OG001', 'lowerLimit': '87.0', 'upperLimit': '253.0'}]}]}], 'analyses': [{'pValue': '0.1085', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'calculated from log-rank test stratified by Baseline platelet count ≥100 × 10\\^9/Liters versus 50 to \\<100 × 10\\^9/Liters inclusive', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 925 days', 'description': 'The time to the first ≥35% reduction in spleen volume is defined as the time from randomization to the first time participants had ≥35% reduction in spleen volume.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "ITT Population, including censored participants. Censored participants didn't have a response at any time up to the last assessment date. Participants who didn't have a \\>=35% reduction in spleen volume were censored at the time of the last assessment. Participants with a DIPSS risk level of Low Risk Level (0 prognostic points) were excluded from the analysis. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method with log-log transformation."}, {'type': 'SECONDARY', 'title': 'Duration of Maintenance of a ≥35% Reduction in Spleen Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parsaclisib Plus Ruxolitinib', 'description': 'Participants were randomized to receive parsaclisib plus ruxolitinib beginning on Day 1 and continued on this regimen as long as it was tolerated and the participants did not meet any discontinuation criteria. Participants with a Baseline platelet count ≥100 × 10\\^9/Liter received ruxolitinib 15 milligrams (mg) twice daily (BID). Participants with a Baseline platelet count of 50 to \\< 100 × 10\\^9/Liters inclusive received ruxolitinib 5 mg BID. Participants were also stratified according to the Dynamic International Prognostic Scoring System (DIPSS) risk category (high versus intermediate-2 versus intermediate-1). Participants received parsaclisib at a dose of 5 mg once daily (QD).'}, {'id': 'OG001', 'title': 'Placebo Plus Ruxolitinib', 'description': 'Participants were randomized to receive placebo plus ruxolitinib beginning on Day 1 and continued on this regimen until they left the study. Participants with a Baseline platelet count ≥100 × 10\\^9/Liter received ruxolitinib 15 mg BID. Participants with a Baseline platelet count of 50 to \\< 100 × 10\\^9/Liters inclusive received ruxolitinib 5 mg BID. Participants were also stratified according to the DIPSS risk category (high versus intermediate-2 versus intermediate-1). Participants received matching placebo at a dose of 5 mg QD. After 24 weeks, participants randomized to receive placebo plus ruxolitinib could have switched to treatment with parsaclisib plus ruxolitinib per the regimen received during the first 24 weeks of the study. Treatment continued for as long as the regimen was tolerated and the participant did not meet any discontinuation criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '505.0', 'comment': 'The upper limit of the confidence interval was not estimable because too few participants lost a \\>=35% reduction in spleen volume at the time of rollover to another study (NCT02955940).', 'groupId': 'OG000', 'lowerLimit': '339.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median and the upper limit of the confidence interval were not estimable because too few participants lost a \\>=35% reduction in spleen volume at the time of rollover to another study (NCT02955940).', 'groupId': 'OG001', 'lowerLimit': '337.0', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.6127', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'calculated from log-rank test stratified by Baseline platelet count ≥100 × 10\\^9/Liters versus 50 to \\<100 × 10\\^9/Liters inclusive', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 925 days', 'description': 'The duration of ≥35% reduction from Baseline in spleen volume was defined as the interval between the first spleen volume measurement that was a ≥35% reduction from Baseline and the date of the first measurement that was no longer a ≥35% reduction from Baseline.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Participants with DIPSS risk level being low risk level (0 prognostic points) have been excluded from the analysis. Only those participants with a ≥35% reduction in spleen volume who then had a loss of ≥35% reduction in spleen volume with a 25% increase from NADIR were analyzed. If the maintenance end date was not observed before the database cutoff, the duration was censored at the last assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Parsaclisib Plus Ruxolitinib', 'description': 'Participants were randomized to receive parsaclisib plus ruxolitinib beginning on Day 1 and continued on this regimen as long as it was tolerated and the participants did not meet any discontinuation criteria. Participants with a Baseline platelet count ≥100 × 10\\^9/Liter received ruxolitinib 15 milligrams (mg) twice daily (BID). Participants with a Baseline platelet count of 50 to \\< 100 × 10\\^9/Liters inclusive received ruxolitinib 5 mg BID. Participants were also stratified according to the Dynamic International Prognostic Scoring System (DIPSS) risk category (high versus intermediate-2 versus intermediate-1). Participants received parsaclisib at a dose of 5 mg once daily (QD).'}, {'id': 'FG001', 'title': 'Placebo Plus Ruxolitinib', 'description': 'Participants were randomized to receive placebo plus ruxolitinib beginning on Day 1 and continued on this regimen until they left the study. Participants with a Baseline platelet count ≥100 × 10\\^9/Liter received ruxolitinib 15 mg BID. Participants with a Baseline platelet count of 50 to \\< 100 × 10\\^9/Liters inclusive received ruxolitinib 5 mg BID. Participants were also stratified according to the DIPSS risk category (high versus intermediate-2 versus intermediate-1). Participants received matching placebo at a dose of 5 mg QD. After 24 weeks, participants randomized to receive placebo plus ruxolitinib could have switched to treatment with parsaclisib plus ruxolitinib per the regimen received during the first 24 weeks of the study. Treatment continued for as long as the regimen was tolerated and the participant did not meet any discontinuation criteria.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '125'}, {'groupId': 'FG001', 'numSubjects': '127'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '125'}, {'groupId': 'FG001', 'numSubjects': '127'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '117'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Awaiting Rollover to Another Study to Receive Ruxolitinib', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Concomitant Diagnosis of Mature Plasmacytoid Dendritic Cell Proliferation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'This study was conducted at 93 study sites in Austria, Belgium, China, Denmark, Finland, France, Germany, Israel, Italy, Japan, Norway, Poland, South Korea, Spain, Turkey, the United Kingdom, and the United States.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Parsaclisib Plus Ruxolitinib', 'description': 'Participants were randomized to receive parsaclisib plus ruxolitinib beginning on Day 1 and continued on this regimen as long as it was tolerated and the participants did not meet any discontinuation criteria. Participants with a Baseline platelet count ≥100 × 10\\^9/Liter received ruxolitinib 15 milligrams (mg) twice daily (BID). Participants with a Baseline platelet count of 50 to \\< 100 × 10\\^9/Liters inclusive received ruxolitinib 5 mg BID. Participants were also stratified according to the Dynamic International Prognostic Scoring System (DIPSS) risk category (high versus intermediate-2 versus intermediate-1). Participants received parsaclisib at a dose of 5 mg once daily (QD).'}, {'id': 'BG001', 'title': 'Placebo Plus Ruxolitinib', 'description': 'Participants were randomized to receive placebo plus ruxolitinib beginning on Day 1 and continued on this regimen until they left the study. Participants with a Baseline platelet count ≥100 × 10\\^9/Liter received ruxolitinib 15 mg BID. Participants with a Baseline platelet count of 50 to \\< 100 × 10\\^9/Liters inclusive received ruxolitinib 5 mg BID. Participants were also stratified according to the DIPSS risk category (high versus intermediate-2 versus intermediate-1). Participants received matching placebo at a dose of 5 mg QD. After 24 weeks, participants randomized to receive placebo plus ruxolitinib could have switched to treatment with parsaclisib plus ruxolitinib per the regimen received during the first 24 weeks of the study. Treatment continued for as long as the regimen was tolerated and the participant did not meet any discontinuation criteria.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.2', 'spread': '10.34', 'groupId': 'BG000'}, {'value': '63.3', 'spread': '10.90', 'groupId': 'BG001'}, {'value': '63.3', 'spread': '10.61', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White or Caucasian', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Captured as "Not Hispanic, Latino or Spanish" in Database', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Turkish', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-14', 'size': 1183858, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-07-10T12:08', 'hasProtocol': True}, {'date': '2022-04-26', 'size': 601397, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-07-10T12:08', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Triple blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 252}}, 'statusModule': {'whyStopped': 'The study was terminated due to futility.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-06', 'studyFirstSubmitDate': '2020-09-11', 'resultsFirstSubmitDate': '2024-07-10', 'studyFirstSubmitQcDate': '2020-09-11', 'lastUpdatePostDateStruct': {'date': '2025-10-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2024-09-23', 'studyFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving ≥35% Reduction in Spleen Volume From Baseline to Week 24 as Measured by Magnetic Resonance Imaging [MRI] (or Computed Tomography [CT] Scan in Applicable Participants)', 'timeFrame': 'Baseline; Week 24', 'description': 'Participants had an MRI of the upper and lower abdomen and pelvis to determine the spleen volume. A CT scan was substituted for participants who were not candidates for MRI or when MRI was not readily available. Determination of spleen length below the left costal margin was measured by palpation, using a flexible ruler provided by the sponsor.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Had a ≥50% Reduction in Total Symptom Score (TSS) From Baseline to Week 24 as Measured by the Myelofibrosis Symptom Assessment Form v4.0 (MFSAF v4.0) Diary', 'timeFrame': 'Baseline; Week 24', 'description': 'Symptoms of myelofibrosis were assessed using the MFSAF v4.0 diary. The MFSAF v4.0 is composed of 7 individual symptom scores (fatigue, night sweats, itchiness, abdominal discomfort, pain under left ribs, early satiety, bone pain), each collected daily using a 0- (no symptoms) to 10-point (worst imaginable symptoms) scale. The daily TSS (0 to 70) is the sum of the 7 individual symptom scores collected on the same day. Higher TSS indicate more severe symptoms. The TSS was missing if there were any missing individual scores. Observations with missing dates were excluded from the analysis. The Baseline/Week 24 total score was defined as the average of the daily total scores from the last 7 days before the first dose of parsaclisib, placebo, or ruxolitinib/the Week 24 visit. The Baseline/Week 24 total scores was missing if there were ≥4 missing out of the 7 daily total scores.'}, {'measure': 'Change in TSS From Baseline to Week 24 as Measured by the MFSAF v4.0 Diary', 'timeFrame': 'Baseline; Week 24', 'description': 'Symptoms of myelofibrosis were assessed using the MFSAF v4.0 diary. The MFSAF v4.0 is composed of 7 individual symptom scores (fatigue, night sweats, itchiness, abdominal discomfort, pain under left ribs, early satiety, bone pain), each collected daily using a 0- (no symptoms) to 10-point (worst imaginable symptoms) scale. The daily TSS (0 to 70) is the sum of the 7 individual symptom scores collected on the same day. Higher TSS indicate more severe symptoms. The TSS was missing if there were any missing individual scores. Observations with missing dates were excluded from the analysis. The Baseline/Week 24 total score was defined as the average of the daily total scores from the last 7 days before the first dose of parsaclisib, placebo, or ruxolitinib/the Week 24 visit. The Baseline/Week 24 total scores was missing if there were ≥4 missing out of the 7 daily total scores. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.'}, {'measure': 'Time to the First ≥50% Reduction in TSS as Measured by the MFSAF v4.0 Diary', 'timeFrame': 'Baseline; up to Week 24', 'description': 'Symptoms of myelofibrosis were assessed using the MFSAF v4.0 diary. The MFSAF v4.0 is composed of 7 individual symptom scores (fatigue, night sweats, itchiness, abdominal discomfort, pain under left ribs, early satiety, bone pain), each collected daily using a 0- (no symptoms) to 10-point (worst imaginable symptoms) scale. The daily TSS (0 to 70) is the sum of the 7 individual symptom scores collected on the same day. Higher TSS indicate more severe symptoms. The TSS was missing if there were any missing individual scores. Observations with missing dates were excluded from the analysis. The Baseline/Week 24 total score was defined as the average of the daily total scores from the last 7 days before the first dose of parsaclisib, placebo, or ruxolitinib/the Week 24 visit. The Baseline/Week 24 total scores was missing if there were ≥4 missing out of the 7 daily total scores.'}, {'measure': 'Overall Survival', 'timeFrame': 'up to 749 days', 'description': 'Overall survival was defined as the interval between the randomization date and the date of death due to any cause.'}, {'measure': 'Number of Participants With Any Treatment-emergent Adverse Event (TEAE)', 'timeFrame': 'up to 960 days', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is 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 treatment. A TEAE is defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 30 to 35 days after the last dose of parsaclisib/matching placebo or ruxolitinib.'}, {'measure': 'Number of Participants With Any Grade 3 or Higher TEAE', 'timeFrame': 'up to 960 days', 'description': 'An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. A TEAE is defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 30 to 35 days after the last dose of parsaclisib/matching placebo or ruxolitinib. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local or noninvasive intervention indicated; limiting instrumental activities of daily living (ADL). Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4: life-threatening urgent intervention indicated. Grade 5: death related to AE.'}, {'measure': 'Time of Onset of a ≥35% Reduction in Spleen Volume', 'timeFrame': 'up to 925 days', 'description': 'The time to the first ≥35% reduction in spleen volume is defined as the time from randomization to the first time participants had ≥35% reduction in spleen volume.'}, {'measure': 'Duration of Maintenance of a ≥35% Reduction in Spleen Volume', 'timeFrame': 'up to 925 days', 'description': 'The duration of ≥35% reduction from Baseline in spleen volume was defined as the interval between the first spleen volume measurement that was a ≥35% reduction from Baseline and the date of the first measurement that was no longer a ≥35% reduction from Baseline.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['INCB050465', 'ruxolitinib', 'parsaclisib', 'LIMBER', 'MF', 'Myelofibrosis', 'Myeloproliferative Neoplasms', 'Myoproliferative Neoplasms'], 'conditions': ['Myelofibrosis', 'Primary Myelofibrosis', 'Post Essential Thrombocythemia Myelofibrosis', 'Post Polycythemia Vera Myelofibrosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.incyteclinicaltrials.com/limber/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare the efficacy of parsaclisib when combined with ruxolitinb versus placebo combined with ruxolitinib in participants with myelofibrosis.', 'detailedDescription': 'This is a Phase 3, randomized, double-blind study of the combination of the PI3Kδ inhibitor parsaclisib or matching placebo and the JAK1/2 inhibitor ruxolitinib in participants with PMF or secondary MF (PPV-MF or PET-MF) with DIPSS risk category of intermediate or high. Prospective participants must have not received prior MF therapy with a JAK inhibitor or a PI3K inhibitor. After participants have been determined to be eligible for the study and completed the baseline symptom diary assessment for 7 days, they will be randomized to 1 of 2 treatment groups, with stratification for platelet count (≥ 100 × 10\\^9/L vs 50 to \\< 100 × 10\\^9/L inclusive) and DIPSS risk category (high vs intermediate-2 vs intermediate-1).\n\nOnce all enrolled participants completed the week 24 assessments the study will be unblinded and and participants randomized to placebo will have the opportunity to cross over to begin receiving parsaclisib, together with continued ruxolitinib, as long as hematology parameters are adequate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of PMF, PPV-MF, or PET-MF.\n* DIPSS risk category of intermediate-1, intermediate-2, or high.\n* Palpable spleen of ≥ 5 cm below the left costal margin on physical examination at the screening visit.\n* Active symptoms of MF at the screening visit, as demonstrated by the presence of a TSS of ≥ 10 using the Screening Symptom Form.\n* Participants with an ECOG performance status score of 0, 1, or 2.\n* Screening bone marrow biopsy specimen and pathology report(s) available that was obtained within the prior 2 months or willingness to undergo a bone marrow biopsy at screening/baseline; willingness to undergo bone marrow biopsy at Week 24 and every 24 weeks there after. Screening/baseline biopsy specimen must show diagnosis of MF.\n* Life expectancy of at least 24 weeks.\n* Willingness to avoid pregnancy or fathering children.\n\nExclusion Criteria:\n\n* Prior use of any JAK inhibitor.\n* Prior therapy with any drug that inhibits PI3K (examples of drugs targeting this pathway include but are not limited to INCB040093, idelalisib, duvelisib, buparlisib, copanlisib, and umbralisib).\n* Use of experimental drug therapy for MF or any other standard drug (eg, danazol, hydroxyurea) used for MF within 3 months of starting study drug and/or lack of recovery from all toxicities from previous therapy to ≤ Grade 1.\n* Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications.\n* Recent history of inadequate bone marrow reserve.\n* Inadequate liver and renal function at screening.\n* Active bacterial, fungal, parasitic, or viral infection that requires therapy.\n* Active HBV or HCV infection that requires treatment or at risk for HBV reactivation.\n* Known HIV infection.\n* Uncontrolled, severe, or unstable cardiac disease that in the investigator's opinion may jeopardize the safety of the participant or compliance with the Protocol.\n* Active invasive malignancy over the previous 2 years.\n* Splenic irradiation within 6 months before receiving the first dose of study drug.\n* Concurrent use of any prohibited medications.\n* Active alcohol or drug addiction that would interfere with the ability to comply with the study requirements.\n* Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half lives(whichever is longer) before the first dose of study drug or anticipated during the study.\n* Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.\n* Currently breastfeeding or pregnant.\n* Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.\n* History of Grade 3 or 4 irAEs from prior immunotherapy.\n* Receipt of any live vaccine within 30 days of the first dose of study drug"}, 'identificationModule': {'nctId': 'NCT04551066', 'briefTitle': 'To Evaluate the Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis (LIMBER-313)', 'nctIdAliases': ['NCT04816578'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Combination of PI3Kδ Inhibitor Parsaclisib and Ruxolitinib in Participants With Myelofibrosis', 'orgStudyIdInfo': {'id': 'INCB 50465-313/LIMBER-313'}, 'secondaryIdInfos': [{'id': '2020-003130-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A : parsaclisib + ruxolitinib', 'description': 'Participants will receive parsaclisib and ruxolitinib starting from Day 1 for the duration of study, ruxolitinib dose will be determined by baseline platelet count.', 'interventionNames': ['Drug: parsaclisib', 'Drug: ruxolitinib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group B : placebo + ruxolitinib', 'description': 'Participants will receive placebo and ruxolitinib starting from Day 1 for the duration of study, ruxolitinib dose will be determined by baseline platelet count.', 'interventionNames': ['Drug: ruxolitinib', 'Drug: placebo']}], 'interventions': [{'name': 'parsaclisib', 'type': 'DRUG', 'otherNames': ['INCB050465'], 'description': 'parsaclisib will be administered QD orally', 'armGroupLabels': ['Group A : parsaclisib + ruxolitinib']}, {'name': 'ruxolitinib', 'type': 'DRUG', 'otherNames': ['Jakafi', 'Jakavi'], 'description': 'ruxolitinib will be administered BID orally', 'armGroupLabels': ['Group A : parsaclisib + ruxolitinib', 'Group B : placebo + ruxolitinib']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo will be administered QD orally', 'armGroupLabels': ['Group B : placebo + ruxolitinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Alaska Oncology and Hematology', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Rochester', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '94704', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Health Alta Bates Summit Medical Center Absmc Alta Bates Summit Comprehensive Cancer Center', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'CCARE', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': 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