Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-02-25 @ 7:02 PM
Study NCT ID:
NCT02101268
Status:
COMPLETED
Last Update Posted:
2023-05-23
First Post:
2014-03-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of Momelotinib Versus Best Available Therapy in Anemic or Thrombocytopenic Subjects With Primary Myelofibrosis (MF), Post-polycythemia Vera MF, or Post-essential Thrombocythemia MF
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055728', 'term': 'Primary Myelofibrosis'}], 'ancestors': [{'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C546012', 'term': 'N-(cyanomethyl)-4-(2-((4-(4-morpholinyl)phenyl)amino)-4-pyrimidinyl)benzamide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'Sierra Oncology, a GlaxoSmithKline company'}, 'certainAgreement': {'otherDetails': 'Agreements varied with individual investigators, but did not prohibit any investigator from publishing. Investigators were not to publish results of the study until a period of time (eg. 2 years) following completion of the trial at all participating institutions but could do so earlier with consent of the Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Best available therapy could also include the approved JAK inhibitor, ruxolitinib, and 88% of participants in the BAT arm continued to receive ruxolitinib.'}}, 'adverseEventsModule': {'timeFrame': 'Serious and other Adverse events were recorded that occurred from initiation of investigational product (IP) until 30 days after the last administration of IP regardless of cause or relationship. Serious events are monitored up to 12 weeks and all-cause mortality was assessed for up to 5 years.', 'eventGroups': [{'id': 'EG000', 'title': 'Momelotinib (MMB)', 'description': 'Participants received momelotinib orally once daily at a starting dose of 200 mg. Additional available strengths included 100 mg and 150 mg.', 'otherNumAtRisk': 104, 'deathsNumAtRisk': 104, 'otherNumAffected': 99, 'seriousNumAtRisk': 104, 'deathsNumAffected': 8, 'seriousNumAffected': 37}, {'id': 'EG001', 'title': 'Best Available Therapy (BAT)', 'description': 'Participants received treatment at doses and schedules determined by the investigator in accordance with standard of care. Therapy may have been changed at any time during the study except during the screening period. No active therapy was a permissible option.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 46, 'seriousNumAtRisk': 52, 'deathsNumAffected': 5, 'seriousNumAffected': 12}, {'id': 'EG002', 'title': 'MMB to MMB', 'description': 'After completion of the 24-week randomized treatment phase, participants randomized to the MMB group who tolerated and derived clinical benefit from MMB had the option to receive MMB at their current dose in an extended treatment phase for up to an additional 204 weeks. Available strengths included 100 mg, 150 mg and 200 mg.', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 63, 'seriousNumAtRisk': 64, 'deathsNumAffected': 29, 'seriousNumAffected': 33}, {'id': 'EG003', 'title': 'BAT to MMB', 'description': 'After completion of the 24-week randomized treatment phase, participants randomized to the BAT treatment arm had the option to receive MMB 200 mg once daily in an extended treatment phase for up to an additional 204 weeks. Additional available strengths included 100 mg and 150 mg.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 40, 'seriousNumAtRisk': 40, 'deathsNumAffected': 18, 'seriousNumAffected': 19}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Vitamin B1 deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Oral 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'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Post lumbar puncture syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Groin pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Chondrocalcinosis pyrophosphate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Joint effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Tumour lysis syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Metastatic squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Papillary thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Postmenopausal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Diabetic vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Vestibular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Retinal vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Erythema multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Splenic Response Rate at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Momelotinib (MMB)', 'description': 'Participants received momelotinib orally once daily at a starting dose of 200 mg. Additional available strengths included 100 mg and 150 mg.'}, {'id': 'OG001', 'title': 'Best Available Therapy (BAT)', 'description': 'Participants received treatment at doses and schedules determined by the investigator in accordance with standard of care. Therapy may have been changed at any time during the study except during the screening period. No active therapy was a permissible option.'}], 'classes': [{'categories': [{'title': 'Responder', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Nonresponder', 'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.90', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Proportion Difference - Stratified CMH', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.10', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': 'Splenic response rate at Week 24 is defined as the percentage of participants who achieved a spleen volume reduction of ≥ 35% from baseline at the Week 24 assessment as measured by MRI or CT.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Symptom Score (TSS) Response Rate at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Momelotinib (MMB)', 'description': 'Participants received momelotinib orally once daily at a starting dose of 200 mg. Additional available strengths included 100 mg and 150 mg.'}, {'id': 'OG001', 'title': 'Best Available Therapy (BAT)', 'description': 'Participants received treatment at doses and schedules determined by the investigator in accordance with standard of care. Therapy may have been changed at any time during the study except during the screening period. No active therapy was a permissible option.'}], 'classes': [{'categories': [{'title': 'Responder', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Nonresponder', 'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Proportion Difference - Stratified CMH', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.20', 'ciLowerLimit': '0.09', 'ciUpperLimit': '0.32', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': 'Total symptom score (TSS) is defined as the percentage of participants who achieved a ≥50% reduction in TSS at Week 24 versus baseline as measured by the modified Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) v2.0 diary. Response rate was calculated using the average of the daily TSS from a consecutive 28-day period prior to Week 24, which had ≥20 daily TSS available.\n\nThe modified MPN-SAF patient-reported outcome instrument consisted of 8 items assessing worst daily incidence of tiredness, filling up quickly, abdominal discomfort, night sweats, itching, bone pain, pain under ribs on left side, and inactivity. Scoring of TSS in this study was based on 7 of these items, (0-70) excluding inactivity. These items assess the impact experienced by the participant in the 24 hours prior to completing the questionnaire. All items are measured using a 0 to 10 Numeric Rating Scale, with 0 corresponding to "Absent" and 10 corresponding to "Worst Imaginable."', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TSS rate analysis at Week 24 only included participants with TSS \\> 0 at baseline or with TSS = 0 at baseline but with TSS \\> 0 or missing at Week 24.'}, {'type': 'SECONDARY', 'title': 'Rate of Red Blood Cell (RBC) Transfusion in the Randomized Treatment Phase, (the Average Number of RBC Units Transfused Per Month Not Associated With Overt Bleeding)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Momelotinib (MMB)', 'description': 'Participants received momelotinib orally once daily at a starting dose of 200 mg. Additional available strengths included 100 mg and 150 mg.'}, {'id': 'OG001', 'title': 'Best Available Therapy (BAT)', 'description': 'Participants received treatment at doses and schedules determined by the investigator in accordance with standard of care. Therapy may have been changed at any time during the study except during the screening period. No active therapy was a permissible option.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.4'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.8'}]}]}], 'analyses': [{'pValue': '0.38', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.49', 'ciUpperLimit': '1.31', 'estimateComment': 'A smaller ratio represents larger benefit.', 'statisticalMethod': 'Negative Binomial Model, Adjusted', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Week 24', 'description': 'Rate of RBC transfusion is defined as the average number of RBC units transfused not associated with clinically overt bleeding per subject-month during the randomized treatment Phase.', 'unitOfMeasure': 'units/month', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'RBC Transfusion Independence Rate at Week 24, (Defined as Absence of RBC Transfusions and no Hemoglobin Level Below 8 g/dL in the 12 Weeks Prior to Week 24, Excluding Cases Associated With Clinically Overt Bleeding)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Momelotinib (MMB)', 'description': 'Participants received momelotinib orally once daily at a starting dose of 200 mg. Additional available strengths included 100 mg and 150 mg.'}, {'id': 'OG001', 'title': 'Best Available Therapy (BAT)', 'description': 'Participants received treatment at doses and schedules determined by the investigator in accordance with standard of care. Therapy may have been changed at any time during the study except during the screening period. No active therapy was a permissible option.'}], 'classes': [{'categories': [{'title': 'Responder', 'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Nonresponder', 'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Proportion Difference - Stratified CMH', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.23', 'ciLowerLimit': '0.09', 'ciUpperLimit': '0.37', 'estimateComment': 'A larger proportion represents larger benefit.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': 'RBC transfusion independence rate is the percentage of participants who achieved transfusion independence at Week 24 (responders). RBC transfusion independence is defined as absence of RBC transfusions and no hemoglobin level below 8 g/dL in the 12 weeks prior to Week 24, excluding cases associated with clinically overt bleeding. Transfusion dependence, (non-responder) is defined as at least 4 units of RBC transfusion, or a Hgb level below 8 g/dL, in the 8 weeks prior to week 24.\n\nMethods used to assess this outcome measure include collection and recording of any instances of RBC transfusions and collection and recording of any local or central lab hemoglobin measurements', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'RBC Transfusion Dependence Rate at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Momelotinib (MMB)', 'description': 'Participants received momelotinib orally once daily at a starting dose of 200 mg. Additional available strengths included 100 mg and 150 mg.'}, {'id': 'OG001', 'title': 'Best Available Therapy (BAT)', 'description': 'Participants received treatment at doses and schedules determined by the investigator in accordance with standard of care. Therapy may have been changed at any time during the study except during the screening period. No active therapy was a permissible option.'}], 'classes': [{'categories': [{'title': 'Dependent', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}, {'title': 'Nondependent', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.10', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Proportion Difference - Stratified CMH', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '0.03', 'estimateComment': 'A smaller proportion represents larger benefit.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': 'RBC transfusion dependence is the percentage of participants who are transfusion dependent at Week 24, defined as at least 4 units of RBC transfusions, or a hemoglobin level below 8 g/dL in the 8 weeks prior to Week 24, excluding cases associated with clinically overt bleeding.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Momelotinib (MMB)', 'description': 'Participants received momelotinib orally once daily at a starting dose of 200 mg. Additional available strengths included 100 mg and 150 mg.'}, {'id': 'FG001', 'title': 'Best Available Therapy (BAT)', 'description': 'Participants received treatment at doses and schedules determined by the investigator in accordance with standard of care. Therapy may have been changed at any time during the study except during the screening period. No active therapy was a permissible option.'}, {'id': 'FG002', 'title': 'MMB to MMB', 'description': 'After completion of the 24-week randomized treatment phase, participants randomized to the MMB group who tolerated and derived clinical benefit from MMB had the option to receive MMB at their current dose in an extended treatment phase for up to an additional 204 weeks. Available strengths included 100 mg, 150 mg and 200 mg.'}, {'id': 'FG003', 'title': 'BAT to MMB', 'description': 'After completion of the 24-week randomized treatment phase, participants randomized to the BAT treatment arm had the option to receive MMB 200 mg once daily in an extended treatment phase for up to an additional 204 weeks. Additional available strengths included 100 mg and 150 mg.'}], 'periods': [{'title': 'Randomized Treatment Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'The MMB group is only applicable to the randomized treatment phase. Participants who complete the randomized phase and continue to receive MMB in the extended treatment phase constitute the MMB to MMB group.', 'groupId': 'FG000', 'numSubjects': '104'}, {'comment': 'The BAT group is only applicable to the randomized treatment phase. Participants who complete the randomized phase and begin receiving MMB in the extended treatment phase constitute the BAT to MMB group.', 'groupId': 'FG001', 'numSubjects': '52'}, {'comment': 'The MMB to MMB group is only applicable to the extended treatment phase.', 'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'The BAT to MMB group is only applicable to the extended treatment phase.', 'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Subject Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Symptomatic Spleen Growth', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Extended Treatment Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'The MMB group is only applicable to the randomized treatment phase. Participants who complete the randomized phase and continue to receive MMB in the extended treatment phase constitute the MMB to MMB group.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'The BAT group is only applicable to the randomized treatment phase. Participants who complete the randomized phase and begin receiving MMB in the extended treatment phase constitute the BAT to MMB group.', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'Of 77 participants in the MMB group who completed the randomized treatment phase, 64 entered the extended treatment phase to continue receiving MMB.', 'groupId': 'FG002', 'numSubjects': '64'}, {'comment': 'Of 41 participants in the BAT group who completed the randomized treatment phase, 40 entered the extended treatment phase to begin receiving MMB.', 'groupId': 'FG003', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '64'}, {'groupId': 'FG003', 'numSubjects': '40'}]}], 'dropWithdraws': [{'type': 'Subject Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '18'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Transferred to Study SRA-MMB-4365', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '4'}]}]}], 'recruitmentDetails': '156 participants were randomized at 52 centers in 8 countries.', 'preAssignmentDetails': 'Participants were screened within 30 days before randomization to determine eligibility for participation in the study. Participants who were not randomized within the 30-day screening window were considered screen failures. At randomization, participants were randomly assigned 2:1 to MMB:BAT.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '156', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Momelotinib (MMB)', 'description': 'Participants received momelotinib orally once daily at a starting dose of 200 mg. Additional available strengths included 100 mg and 150 mg.'}, {'id': 'BG001', 'title': 'Best Available Therapy (BAT)', 'description': 'Participants received treatment at doses and schedules determined by the investigator in accordance with standard of care. Therapy may have been changed at any time during the study except during the screening period. No active therapy was a permissible option.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.0', 'groupId': 'BG000', 'lowerLimit': '41', 'upperLimit': '92'}, {'value': '69.5', 'groupId': 'BG001', 'lowerLimit': '52', 'upperLimit': '82'}, {'value': '68.0', 'groupId': 'BG002', 'lowerLimit': '41', 'upperLimit': '92'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Not Permitted', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Transfusion Dependent', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Total Symptom Score (TSS)', 'classes': [{'categories': [{'title': '< 18', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}, {'title': '>= 18', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'See secondary outcome description', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '75.4', 'groupId': 'BG000', 'lowerLimit': '68.0', 'upperLimit': '87.0'}, {'value': '74.0', 'groupId': 'BG001', 'lowerLimit': '62.0', 'upperLimit': '81.3'}, {'value': '75.0', 'groupId': 'BG002', 'lowerLimit': '66.0', 'upperLimit': '85.7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '170.0', 'groupId': 'BG000', 'lowerLimit': '164.0', 'upperLimit': '177.8'}, {'value': '168.0', 'groupId': 'BG001', 'lowerLimit': '160.0', 'upperLimit': '175.0'}, {'value': '170.0', 'groupId': 'BG002', 'lowerLimit': '162.5', 'upperLimit': '176.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cm', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '25.9', 'groupId': 'BG000', 'lowerLimit': '23.6', 'upperLimit': '28.2'}, {'value': '26.1', 'groupId': 'BG001', 'lowerLimit': '23.5', 'upperLimit': '29.1'}, {'value': '26.0', 'groupId': 'BG002', 'lowerLimit': '23.6', 'upperLimit': '28.6'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Hemoglobin', 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'groupId': 'BG000', 'lowerLimit': '7.9', 'upperLimit': '10.7'}, {'value': '9.2', 'groupId': 'BG001', 'lowerLimit': '8.5', 'upperLimit': '10.1'}, {'value': '9.0', 'groupId': 'BG002', 'lowerLimit': '8.1', 'upperLimit': '10.6'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'g/dL', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'dispFirstSubmitDate': '2017-01-05', 'completionDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-10', 'studyFirstSubmitDate': '2014-03-28', 'dispFirstSubmitQcDate': '2017-02-13', 'resultsFirstSubmitDate': '2023-02-23', 'studyFirstSubmitQcDate': '2014-03-28', 'dispFirstPostDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-10', 'studyFirstPostDateStruct': {'date': '2014-04-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Splenic Response Rate at Week 24', 'timeFrame': 'Week 24', 'description': 'Splenic response rate at Week 24 is defined as the percentage of participants who achieved a spleen volume reduction of ≥ 35% from baseline at the Week 24 assessment as measured by MRI or CT.'}], 'secondaryOutcomes': [{'measure': 'Total Symptom Score (TSS) Response Rate at Week 24', 'timeFrame': 'Week 24', 'description': 'Total symptom score (TSS) is defined as the percentage of participants who achieved a ≥50% reduction in TSS at Week 24 versus baseline as measured by the modified Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) v2.0 diary. Response rate was calculated using the average of the daily TSS from a consecutive 28-day period prior to Week 24, which had ≥20 daily TSS available.\n\nThe modified MPN-SAF patient-reported outcome instrument consisted of 8 items assessing worst daily incidence of tiredness, filling up quickly, abdominal discomfort, night sweats, itching, bone pain, pain under ribs on left side, and inactivity. Scoring of TSS in this study was based on 7 of these items, (0-70) excluding inactivity. These items assess the impact experienced by the participant in the 24 hours prior to completing the questionnaire. All items are measured using a 0 to 10 Numeric Rating Scale, with 0 corresponding to "Absent" and 10 corresponding to "Worst Imaginable."'}, {'measure': 'Rate of Red Blood Cell (RBC) Transfusion in the Randomized Treatment Phase, (the Average Number of RBC Units Transfused Per Month Not Associated With Overt Bleeding)', 'timeFrame': 'Baseline to Week 24', 'description': 'Rate of RBC transfusion is defined as the average number of RBC units transfused not associated with clinically overt bleeding per subject-month during the randomized treatment Phase.'}, {'measure': 'RBC Transfusion Independence Rate at Week 24, (Defined as Absence of RBC Transfusions and no Hemoglobin Level Below 8 g/dL in the 12 Weeks Prior to Week 24, Excluding Cases Associated With Clinically Overt Bleeding)', 'timeFrame': 'Week 24', 'description': 'RBC transfusion independence rate is the percentage of participants who achieved transfusion independence at Week 24 (responders). RBC transfusion independence is defined as absence of RBC transfusions and no hemoglobin level below 8 g/dL in the 12 weeks prior to Week 24, excluding cases associated with clinically overt bleeding. Transfusion dependence, (non-responder) is defined as at least 4 units of RBC transfusion, or a Hgb level below 8 g/dL, in the 8 weeks prior to week 24.\n\nMethods used to assess this outcome measure include collection and recording of any instances of RBC transfusions and collection and recording of any local or central lab hemoglobin measurements'}, {'measure': 'RBC Transfusion Dependence Rate at Week 24', 'timeFrame': 'Week 24', 'description': 'RBC transfusion dependence is the percentage of participants who are transfusion dependent at Week 24, defined as at least 4 units of RBC transfusions, or a hemoglobin level below 8 g/dL in the 8 weeks prior to Week 24, excluding cases associated with clinically overt bleeding.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Myelofibrosis (PMF)', 'Post-polycythemia Vera (Post-PV)', 'Post-essential Thrombocythemia Myelofibrosis (Post-ET MF)']}, 'referencesModule': {'references': [{'pmid': '40535755', 'type': 'DERIVED', 'citation': "Mesa RA, Talpaz M, Mazerolle F, Gorsh B, M'Hari M, Regnault A, Ellis C, Wang Z, Purser M, Liu T, Strouse B, Patnaik D. Time Without Transfusion Reliance (TWiTR): Integrating Survival Quality Into Myelofibrosis Treatment Strategies Based on the Phase 3 SIMPLIFY-1, SIMPLIFY-2, and MOMENTUM Trials. EJHaem. 2025 Jun 18;6(3):e70075. doi: 10.1002/jha2.70075. eCollection 2025 Jun."}, {'pmid': '39516087', 'type': 'DERIVED', 'citation': 'Harrison CN, Mesa R, Talpaz M, Gupta V, Gerds AT, Perkins A, Goh YT, Fox ML, McLornan D, Palmer J, Foltz L, Vannucchi A, Koschmieder S, Passamonti F, Lee SE, Ellis C, Strouse B, Gonzalez Carreras FJ, Oh ST. Longitudinal Assessment of Transfusion Intensity in Patients With JAK Inhibitor-Naive or -Experienced Myelofibrosis Treated With Momelotinib. Clin Lymphoma Myeloma Leuk. 2025 Mar;25(3):199-211. doi: 10.1016/j.clml.2024.10.001. Epub 2024 Oct 16.'}, {'pmid': '38990433', 'type': 'DERIVED', 'citation': 'Harrison CN, Vannucchi AM, Recher C, Passamonti F, Gerds AT, Hernandez-Boluda JC, Yacoub A, Sirhan S, Ellis C, Patel B, Strouse B, Platzbecker U. Momelotinib versus Continued Ruxolitinib or Best Available Therapy in JAK Inhibitor-Experienced Patients with Myelofibrosis and Anemia: Subgroup Analysis of SIMPLIFY-2. Adv Ther. 2024 Sep;41(9):3722-3735. doi: 10.1007/s12325-024-02928-4. Epub 2024 Jul 11.'}, {'pmid': '37042865', 'type': 'DERIVED', 'citation': 'Verstovsek S, Mesa R, Gupta V, Lavie D, Dubruille V, Cambier N, Platzbecker U, Hus M, Xicoy B, Oh ST, Kiladjian JJ, Vannucchi AM, Gerds A, Egyed M, Mayer J, Sacha T, Kawashima J, Morris M, Huang M, Harrison C. Momelotinib long-term safety and survival in myelofibrosis: integrated analysis of phase 3 randomized controlled trials. Blood Adv. 2023 Jul 25;7(14):3582-3591. doi: 10.1182/bloodadvances.2022009311.'}, {'pmid': '29275119', 'type': 'DERIVED', 'citation': 'Harrison CN, Vannucchi AM, Platzbecker U, Cervantes F, Gupta V, Lavie D, Passamonti F, Winton EF, Dong H, Kawashima J, Maltzman JD, Kiladjian JJ, Verstovsek S. Momelotinib versus best available therapy in patients with myelofibrosis previously treated with ruxolitinib (SIMPLIFY 2): a randomised, open-label, phase 3 trial. Lancet Haematol. 2018 Feb;5(2):e73-e81. doi: 10.1016/S2352-3026(17)30237-5. Epub 2017 Dec 20.'}]}, 'descriptionModule': {'briefSummary': 'This study is to determine the efficacy of momelotinib (MMB) versus best available therapy (BAT) in anemic or thrombocytopenic adults with primary myelofibrosis (PMF), or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (Post-PV/ET MF) who were treated with ruxolitinib as measured by splenic response rate at Week 24 (SRR24).\n\nParticipants will be randomized to receive either MMB or BAT for 24 weeks during the randomized treatment phase, after which they will be eligible to receive MMB in an extended treatment phase for up to an additional 204 weeks. After discontinuation of study medication, assessments will continue for 12 additional weeks, after which participants will be contacted for survival follow-up approximately every 6 months for up to 5 years from the date of enrollment or until study termination. For those subjects planning to continue treatment with MMB following the end of the study, the End of Treatment, 30-day, 12-Week, and survival follow-up visits are not required.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Palpable splenomegaly at least 5 cm below left costal margin\n* Confirmed diagnosis of PMF in accordance, or Post-PV/ET MF\n* Currently or previously treated with ruxolitinib for PMF or Post-PV/ET MF for at least 28 days, and characterized by\n\n * Requirement for RBC transfusion while on ruxolitinib treatment, OR\n * Dose adjustment of ruxolitinib to \\< 20 mg twice daily at start of or during ruxolitinib treatment AND at least one of the following while on ruxolitinib treatment:\n\n * ≥ Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 thrombocytopenia, OR\n * ≥ CTCAE Grade 3 anemia, OR\n * ≥ CTCAE Grade 3 hematoma (bleed)\n* High risk OR intermediate-2 risk as defined by Dynamic International Prognostic Scoring System (DIPSS), OR intermediate-1 risk as defined by DIPSS and associated with symptomatic splenomegaly, and/or hepatomegaly\n* If receiving myelofibrosis therapy, must be on a stable dose of the same regimen for at least 2 weeks prior to screen date and through the screening period\n* If not receiving myelofibrosis therapy, must remain off therapy for at least 2 weeks prior to screen date and through the screening period\n* Acceptable laboratory assessments obtained within 14 days prior to Randomization\n\n * Absolute neutrophil count (ANC) \\> 0.75 x 10\\^9/L in the absence of growth factor in the prior 7 days\n * Peripheral blood blast count \\< 10%\n * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x the upper limit of the normal range (ULN) (≤ 5 x ULN if liver is involved by extramedullary hematopoiesis as judged by the investigator or if related to iron chelator therapy that was started within the prior 60 days)\n * Calculated creatinine clearance of ≥ 45 mL/min\n * Direct bilirubin ≤ 2.0 x ULN\n* Life expectancy \\> 24 weeks\n* Negative serum pregnancy test for female subjects (unless surgically sterile or greater than two years post-menopausal)\n* Males and females of childbearing potential must agree to use protocol-specified method(s) of contraception\n* Females who are nursing must agree to discontinue nursing before the first dose of MMB\n* Able to understand and willing to sign informed consent form (ICF)\n\nKey Exclusion Criteria:\n\n* Prior splenectomy\n* Splenic irradiation within 3 months prior to Randomization\n* Use of investigational agent within 28 days prior to Randomization\n* Prior treatment with MMB\n* Hematopoietic growth factor (granulocyte growth factor, erythropoiesis stimulating agent, thrombopoietin mimetic) within 28 days prior to Randomization\n* Uncontrolled inter-current illness, per protocol\n* Known positive status for human immunodeficiency virus (HIV)\n* Chronic active or acute viral hepatitis A, B, or C infection, or hepatitis B or C carrier\n* Presence of peripheral neuropathy ≥ CTCAE Grade 2\n* Unwilling or unable to undergo a MRI or CT Scan per study protocol requirements\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02101268', 'acronym': 'Simplify 2', 'briefTitle': 'Efficacy of Momelotinib Versus Best Available Therapy in Anemic or Thrombocytopenic Subjects With Primary Myelofibrosis (MF), Post-polycythemia Vera MF, or Post-essential Thrombocythemia MF', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sierra Oncology LLC - a GSK company'}, 'officialTitle': 'A Phase 3, Randomized Study To Evaluate the Efficacy of Momelotinib Versus Best Available Therapy in Anemic or Thrombocytopenic Subjects With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis Who Were Treated With Ruxolitinib', 'orgStudyIdInfo': {'id': 'GS-US-352-1214'}, 'secondaryIdInfos': [{'id': '2013-005007-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: Momelotinib', 'description': 'Participants will receive open-label momelotinib for 24 weeks during the randomized treatment phase, after which they will be eligible to receive momelotinib in an extended treatment phase for up to an additional 204 weeks.', 'interventionNames': ['Drug: Momelotinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2: Best Available Therapy (BAT)', 'description': 'Participants in the BAT treatment arm will receive open-label treatment at doses and schedules determined by the investigator in accordance with standard of care. Therapy may be changed at any time during the study except during the screening period. After completion of the randomized treatment phase, participants will be eligible to receive momelotinib for the duration of the study during the extended treatment phase for up to 204 weeks.', 'interventionNames': ['Drug: Best Available Therapy (BAT)']}], 'interventions': [{'name': 'Momelotinib', 'type': 'DRUG', 'otherNames': ['GS-0387', 'CYT387'], 'description': 'Momelotinib tablet administered orally once daily', 'armGroupLabels': ['Arm 1: Momelotinib']}, {'name': 'Best Available Therapy (BAT)', 'type': 'DRUG', 'description': 'Regimens for BAT may include but are not limited to chemotherapy (eg hydroxyurea), anagrelide, corticosteroid, hematopoietic growth factor, immunomodulating agent, androgen, interferon, and may include no myelofibrosis treatment.', 'armGroupLabels': ['Arm 2: Best Available Therapy (BAT)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, 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'Salamanca', 'country': 'Spain', 'geoPoint': {'lat': 40.42972, 'lon': -3.67975}}, {'city': 'Valencia', 'country': 'Spain', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Zaragoza', 'country': 'Spain', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}, {'city': 'Birmingham', 'state': 'England', 'country': 'United Kingdom', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Leeds', 'state': 'England', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'city': 'Leicester', 'state': 'England', 'country': 'United Kingdom', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Gilead Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sierra Oncology LLC - a GSK company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}