Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT03401112
Status:
COMPLETED
Last Update Posted:
2025-05-15
First Post:
2018-01-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of IMR-687 in Adult Participants With Sickle Cell Anemia (Homozygous HbSS or Sickle-β0 Thalassemia)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@imaratx.com', 'phone': '617-206-2020', 'title': 'Imara Clinical Operations', 'organization': 'Imara Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 (after dosing) through up to Week 24', 'description': 'Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \\[Without HU\\], IMR-687 100mg/200 mg \\[Without HU\\], IMR-687 50mg/100 mg \\[With HU\\] and for each placebo arm. Data are not available by dose escalation within arms.', 'eventGroups': [{'id': 'EG000', 'title': 'IMR-687 50 mg/100 mg (Without HU)', 'description': 'A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were not receiving daily HU.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'IMR-687 100 mg/200 mg (Without HU)', 'description': 'A starting dose of IMR-687 100 mg with dose escalation after 4 or 12 weeks, up to 200 mg was administered to participants who were not receiving daily HU.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 22, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'Placebo (Without HU)', 'description': 'Matching placebo was administered to participants who were not receiving daily HU.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 16, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG003', 'title': 'IMR-687 50 mg/100 mg (With HU)', 'description': 'A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 23, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG004', 'title': 'Placebo (With HU)', 'description': 'Matching placebo was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG005', 'title': 'All IMR-687', 'description': 'All participants who received IMR-687.', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 57, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 16}, {'id': 'EG006', 'title': 'All Placebo', 'description': 'All participants who received placebo.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 26, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Sickle cell anaemia with crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 15, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 15, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 14, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 23, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 44, 'numAffected': 24}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 37, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 14, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 21, 'numAffected': 14}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Ocular icterus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 18, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 31, 'numAffected': 22}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 12, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}], 'seriousEvents': [{'term': 'Sickle cell anaemia with crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hepatic lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Multiple injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Rash generalise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number Of Participants With Treatment-emergent Adverse Events (TEAEs) And Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '63', 'groupId': 'OG005'}, {'value': '30', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'IMR-687 50 mg/100 mg (Without HU)', 'description': 'A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were not receiving daily HU.'}, {'id': 'OG001', 'title': 'IMR-687 100 mg/200 mg (Without HU)', 'description': 'A starting dose of IMR-687 100 mg with dose escalation after 4 or 12 weeks, up to 200 mg was administered to participants who were not receiving daily HU.'}, {'id': 'OG002', 'title': 'Placebo (Without HU)', 'description': 'Matching placebo was administered to participants who were not receiving daily HU.'}, {'id': 'OG003', 'title': 'IMR-687 50 mg/100 mg (With HU)', 'description': 'A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.'}, {'id': 'OG004', 'title': 'Placebo (With HU)', 'description': 'Matching placebo was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.'}, {'id': 'OG005', 'title': 'All IMR-687', 'description': 'All participants who received IMR-687.'}, {'id': 'OG006', 'title': 'All Placebo', 'description': 'All participants who received placebo.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '59', 'groupId': 'OG005'}, {'value': '28', 'groupId': 'OG006'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 (after dosing) through up to Week 24', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An SAE was defined as any AE that resulted in 1 or more of the following outcomes: death, required or prolonged hospitalization, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, or other medically important event. A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who had received any amount of study drug.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic (PK) Of Participants Who Did Not Concomitantly Receive HU: Maximum Plasma Concentration (Cmax) Of IMR-687', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMR-687 50 mg/100 mg (Without HU)', 'description': 'A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were not receiving daily HU.'}, {'id': 'OG001', 'title': 'IMR-687 100 mg/200 mg (Without HU)', 'description': 'A starting dose of IMR-687 100 mg with dose escalation after 4 or 12 weeks, up to 200 mg was administered to participants who were not receiving daily HU.'}], 'classes': [{'title': 'Day 1: Single Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '512', 'spread': '30.1', 'groupId': 'OG000'}, {'value': '1130', 'spread': '33.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 25: Steady State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1290', 'spread': '36.4', 'groupId': 'OG000'}, {'value': '2180', 'spread': '24.1', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 and Week 25', 'description': 'For PK assessments of participants who did not concomitantly receive HU, serial blood samples for IMR-687 plasma concentrations were drawn predose at 0.5, 1, 1.5, 2, 4, 6, and 8 hours after administration of study drug; and at 24 hours after administration of study drug. Day 1 (single-dose) and steady-state (Week 25) assessments are presented.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis population consisted of all participants with sufficient sampling for PK parameter evaluation.'}, {'type': 'SECONDARY', 'title': 'PK Of Participants Who Did Not Concomitantly Receive HU: Area Under The Concentration-time Curve (AUC) From Time 0 To 24 Hours Postdose (AUC0-24h) Of IMR-687', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMR-687 50 mg/100 mg (Without HU)', 'description': 'A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were not receiving daily HU.'}, {'id': 'OG001', 'title': 'IMR-687 100 mg/200 mg (Without HU)', 'description': 'A starting dose of IMR-687 100 mg with dose escalation after 4 or 12 weeks, up to 200 mg was administered to participants who were not receiving daily HU.'}], 'classes': [{'title': 'Day 1: Single Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2850', 'spread': '12.5', 'groupId': 'OG000'}, {'value': '6590', 'spread': '17.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 25: Steady State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8420', 'spread': '24.1', 'groupId': 'OG000'}, {'value': '15000', 'spread': '22.3', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 and Week 25', 'description': 'For PK assessments of participants who did not concomitantly receive HU, serial blood samples for IMR-687 plasma concentrations were drawn predose at 0.5, 1, 1.5, 2, 4, 6, and 8 hours after administration of study drug; and at 24 hours after administration of study drug. Day 1 (single-dose) and steady-state (Week 25) assessments are presented.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis population consisted of all participants with sufficient sampling for PK parameter evaluation.'}, {'type': 'SECONDARY', 'title': 'PK Of Participants Who Concomitantly Received HU: Cmax Of IMR-687', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IMR-687 50 mg/100 mg (With HU)', 'description': 'A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.'}], 'classes': [{'title': 'Day 1: Single Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '657', 'spread': '24.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 17: Steady State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1370', 'spread': '18.6', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 and Week 17', 'description': 'For PK assessments of participants who concomitantly received HU, serial blood samples for IMR-687 PK were drawn predose at 0.5, 1, 1.5, 2, 4, 6, and 8 hours after administration of study drug; and at 24 hours after administration of study drug. Day 1 (single-dose) and steady-state (Week 17) assessments are presented.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis population consisted of all participants with sufficient sampling for PK parameter evaluation.'}, {'type': 'SECONDARY', 'title': 'PK Of Participants Who Concomitantly Received HU: AUC0-24h Of IMR-687', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IMR-687 50 mg/100 mg (With HU)', 'description': 'A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.'}], 'classes': [{'title': 'Day 1: Single Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3090', 'spread': '34.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 17: Steady State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7300', 'spread': '16.1', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 and Week 17', 'description': 'For PK assessments of participants who concomitantly received HU, serial blood samples for IMR-687 plasma concentrations were drawn predose at 0.5, 1, 1.5, 2, 4, 6, and 8 hours after administration of study drug; and at 24 hours after administration of study drug. Day 1 (single-dose) and steady-state (Week 17) assessments are presented.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis population consisted of all participants with sufficient sampling for PK parameter evaluation.'}, {'type': 'SECONDARY', 'title': 'PK Of Participants Who Concomitantly Received HU: Cmax Of HU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMR-687 50 mg/100 mg (With HU)', 'description': 'A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were also receiving daily HU. HU doses ranged from 500 to 2000 mg.'}, {'id': 'OG001', 'title': 'Placebo (With HU)', 'description': 'Participants who were receiving daily HU were administered placebo. HU doses ranged from 500 to 2000 mg.'}], 'classes': [{'title': 'Baseline 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.3', 'spread': '36.7', 'groupId': 'OG000'}, {'value': '20.6', 'spread': '87.8', 'groupId': 'OG001'}]}]}, {'title': 'Baseline 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.8', 'spread': '38.1', 'groupId': 'OG000'}, {'value': '25.4', 'spread': '98.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.5', 'spread': '55.2', 'groupId': 'OG000'}, {'value': '20.5', 'spread': '127', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (1 and 2) and Week 17', 'description': 'For PK assessments of participants who concomitantly received HU, serial blood samples for HU PK were drawn predose and at 0.5, 1, 1.5, 3, 6, 8, and 10 hours after self-administration of the prescribed dose of HU. HU in the presence (end of treatment \\[EOT\\]: Week 17) or absence of IMR-687 (Baselines 1 and 2) are presented. HU concentration data were not sorted with respect to HU dose.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis population consisted of all participants with sufficient sampling for PK parameter evaluation.'}, {'type': 'SECONDARY', 'title': 'PK Of Participants Who Concomitantly Received HU: AUC0-24h Of HU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMR-687 50 mg/100 mg (With HU)', 'description': 'A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.'}, {'id': 'OG001', 'title': 'Placebo (With HU)', 'description': 'Participants who were receiving daily HU were administered placebo. HU doses ranged from 500 to 2000 mg.'}], 'classes': [{'title': 'Baseline 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.2', 'spread': '32.4', 'groupId': 'OG000'}, {'value': '113', 'spread': '87.7', 'groupId': 'OG001'}]}]}, {'title': 'Baseline 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '103', 'spread': '30.7', 'groupId': 'OG000'}, {'value': '129', 'spread': '71.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '122', 'spread': '23.0', 'groupId': 'OG000'}, {'value': '91.4', 'spread': '127', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (1 and 2) and Week 17', 'description': 'For PK assessments of participants who concomitantly received HU, serial blood samples for HU PK were drawn predose and at 0.5, 1, 1.5, 3, 6, 8, and 10 hours after self-administration of the prescribed dose of HU. HU in the presence (EOT: Week 17) or absence of IMR-687 (Baselines 1 and 2) are presented. HU concentration data were not sorted with respect to HU dose.', 'unitOfMeasure': 'h*μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis population consisted of all participants with sufficient sampling for PK parameter evaluation.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline In F-Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'IMR-687 50 mg/100 mg (Without HU)', 'description': 'A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were not receiving daily HU.'}, {'id': 'OG001', 'title': 'IMR-687 100 mg/200 mg (Without HU)', 'description': 'A starting dose of IMR-687 100 mg with dose escalation after 4 or 12 weeks, up to 200 mg was administered to participants who were not receiving daily HU.'}, {'id': 'OG002', 'title': 'Pooled IMR-687 (Without HU)', 'description': 'All participants administered IMR-687 who were not receiving daily HU.'}, {'id': 'OG003', 'title': 'Placebo (Without HU)', 'description': 'Matching placebo was administered to participants who were not receiving daily HU.'}, {'id': 'OG004', 'title': 'IMR-687 50 mg/100 mg (With HU)', 'description': 'A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.'}, {'id': 'OG005', 'title': 'Placebo (With HU)', 'description': 'Matching placebo was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.97', 'spread': '4.07', 'groupId': 'OG000'}, {'value': '5.66', 'spread': '2.87', 'groupId': 'OG001'}, {'value': '4.81', 'spread': '2.48', 'groupId': 'OG002'}, {'value': '-6.00', 'spread': '3.77', 'groupId': 'OG003'}, {'value': '-2.49', 'spread': '6.00', 'groupId': 'OG004'}, {'value': '7.38', 'spread': '15.54', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, EOT (Week 25 for participants without HU and Weeks 17 or 25 for participants with HU)', 'description': 'Absolute least squares (LS) mean change from baseline at EOT is presented. Change from baseline in pharmacodynamic (PD) biomarkers was analyzed using mixed models for repeated measures with covariate of treatment, visit, treatment-by-visit interaction, and baseline value.', 'unitOfMeasure': 'percentage of F-cells', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who had samples for PD analysis sufficient to obtain at least 1 valid PD observation, without protocol deviations or events that would be expected to affect the PD analysis.'}, {'type': 'POST_HOC', 'title': 'Number Of Participants With Vaso-occlusive Crisis (VOCs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '63', 'groupId': 'OG005'}, {'value': '30', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'IMR-687 50 mg/100 mg (Without HU)', 'description': 'A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were not receiving daily HU.'}, {'id': 'OG001', 'title': 'IMR-687 100 mg/200 mg (Without HU)', 'description': 'A starting dose of IMR-687 100 mg with dose escalation after 4 or 12 weeks, up to 200 mg was administered to participants who were not receiving daily HU.'}, {'id': 'OG002', 'title': 'Placebo (Without HU)', 'description': 'Matching placebo was administered to participants who were not receiving daily HU.'}, {'id': 'OG003', 'title': 'IMR-687 50 mg/100 mg (With HU)', 'description': 'A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.'}, {'id': 'OG004', 'title': 'Placebo (With HU)', 'description': 'Matching placebo was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.'}, {'id': 'OG005', 'title': 'All IMR-687', 'description': 'All participants who received IMR-687.'}, {'id': 'OG006', 'title': 'All Placebo', 'description': 'All participants who received placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}, {'value': '21', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 (after dosing) through up to Week 24', 'description': 'VOCs include the events of acute painful crisis and acute chest symptoms (includes fever, cough, sputum production, shortness of breath, tachypnea, hypoxia, and chest pain).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who had received any amount of study drug.'}, {'type': 'POST_HOC', 'title': 'Time To First VOC Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'IMR-687 50 mg/100 mg', 'description': 'All participants who had a starting dose of IMR-687 50 mg (with HU and without HU) with dose escalation up to 100 mg was administered.'}, {'id': 'OG001', 'title': 'IMR-687 100 mg/200 mg', 'description': 'All participants who had a starting dose of IMR-687 100 mg with dose escalation up to 200 mg was administered.'}, {'id': 'OG002', 'title': 'All IMR-687', 'description': 'All participants who received IMR-687.'}, {'id': 'OG003', 'title': 'All Placebo', 'description': 'All participants who received placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median and upper confidence limit were non-estimable due to insufficient number of participants with an event to estimate variability and build a confidence interval.', 'groupId': 'OG000', 'lowerLimit': '60.00', 'upperLimit': 'NA'}, {'value': '139.00', 'comment': 'The upper confidence limit was non-estimable due to insufficient number of participants with an event to estimate variability and build a confidence interval.', 'groupId': 'OG001', 'lowerLimit': '35.00', 'upperLimit': 'NA'}, {'value': '169.00', 'comment': 'The upper confidence limit was non-estimable due to insufficient number of participants with an event to estimate variability and build a confidence interval.', 'groupId': 'OG002', 'lowerLimit': '80.00', 'upperLimit': 'NA'}, {'value': '87.00', 'groupId': 'OG003', 'lowerLimit': '26.00', 'upperLimit': '167.00'}]}]}], 'analyses': [{'pValue': '0.0686', 'groupIds': ['OG000', 'OG001', 'OG003'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0294', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 (after dosing) through up to Week 24', 'description': 'VOCs include the events of acute painful crisis and acute chest symptoms (includes fever, cough, sputum production, shortness of breath, tachypnea, hypoxia, and chest pain). Time to first VOC event was assessed by Kaplan Meier analysis. For this analysis, HU and without HU population groups were pooled for IMR-687 and placebo. In addition, pooled IMR-687 (all doses) are presented.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pooled data from the IMR-687 dose groups (IMR-687 50mg/100 mg \\[Without HU\\]+ IMR-687 100mg/200 mg \\[Without HU\\] + IMR-687 50mg/100 mg \\[With HU\\]) and pooled data from the placebo arms (With and without HU) were used to provide a larger sample size for the analysis of time to 1st event.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IMR-687 50 mg/100 mg (Without HU)', 'description': 'A starting dose of IMR-687 50 milligrams (mg) with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were not receiving daily hydroxyurea (HU).'}, {'id': 'FG001', 'title': 'IMR-687 100 mg/200 mg (Without HU)', 'description': 'A starting dose of IMR-687 100 mg with dose escalation after 4 or 12 weeks, up to 200 mg was administered to participants who were not receiving daily HU.'}, {'id': 'FG002', 'title': 'Placebo (Without HU)', 'description': 'Matching placebo was administered to participants who were not receiving daily HU.'}, {'id': 'FG003', 'title': 'IMR-687 50 mg/100 mg (With HU)', 'description': 'A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.'}, {'id': 'FG004', 'title': 'Placebo (With HU)', 'description': 'Matching placebo was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '27'}, {'groupId': 'FG004', 'numSubjects': '10'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '25'}, {'groupId': 'FG004', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '21'}, {'groupId': 'FG004', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Did not Meet Inclusion Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Study was Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Day 1 Assessment not Done', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Not Dosed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Missed Clinical Visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Missed Doses', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Study participants were enrolled at 13 sites in 2 countries (United Kingdom and United States).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '93', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'IMR-687 50 mg/100 mg (Without HU)', 'description': 'A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were not receiving daily HU.'}, {'id': 'BG001', 'title': 'IMR-687 100 mg/200 mg (Without HU)', 'description': 'A starting dose of IMR-687 100 mg with dose escalation after 4 or 12 weeks, up to 200 mg was administered to participants who were not receiving daily HU.'}, {'id': 'BG002', 'title': 'Placebo (Without HU)', 'description': 'Matching placebo was administered to participants who were not receiving daily HU.'}, {'id': 'BG003', 'title': 'IMR-687 50 mg/100 mg (With HU)', 'description': 'A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.'}, {'id': 'BG004', 'title': 'Placebo (With HU)', 'description': 'Matching placebo was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.7', 'spread': '8.7', 'groupId': 'BG000'}, {'value': '32.0', 'spread': '9.3', 'groupId': 'BG001'}, {'value': '35.2', 'spread': '8.4', 'groupId': 'BG002'}, {'value': '32.4', 'spread': '9.1', 'groupId': 'BG003'}, {'value': '28.8', 'spread': '7.1', 'groupId': 'BG004'}, {'value': '32.8', 'spread': '8.8', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '61', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '86', 'groupId': 'BG005'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}]}, {'title': 'Unknown Ethnicity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '89', 'groupId': 'BG005'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants who had received any amount of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-28', 'size': 1524317, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-08-25T23:16', 'hasProtocol': True}, {'date': '2020-12-22', 'size': 2229588, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-08-25T23:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Double-blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2018-01-02', 'resultsFirstSubmitDate': '2021-08-27', 'studyFirstSubmitQcDate': '2018-01-09', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-22', 'studyFirstPostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline In F-Cells', 'timeFrame': 'Baseline, EOT (Week 25 for participants without HU and Weeks 17 or 25 for participants with HU)', 'description': 'Absolute least squares (LS) mean change from baseline at EOT is presented. Change from baseline in pharmacodynamic (PD) biomarkers was analyzed using mixed models for repeated measures with covariate of treatment, visit, treatment-by-visit interaction, and baseline value.'}], 'primaryOutcomes': [{'measure': 'Number Of Participants With Treatment-emergent Adverse Events (TEAEs) And Serious Adverse Events (SAEs)', 'timeFrame': 'Day 1 (after dosing) through up to Week 24', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An SAE was defined as any AE that resulted in 1 or more of the following outcomes: death, required or prolonged hospitalization, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, or other medically important event. A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic (PK) Of Participants Who Did Not Concomitantly Receive HU: Maximum Plasma Concentration (Cmax) Of IMR-687', 'timeFrame': 'Day 1 and Week 25', 'description': 'For PK assessments of participants who did not concomitantly receive HU, serial blood samples for IMR-687 plasma concentrations were drawn predose at 0.5, 1, 1.5, 2, 4, 6, and 8 hours after administration of study drug; and at 24 hours after administration of study drug. Day 1 (single-dose) and steady-state (Week 25) assessments are presented.'}, {'measure': 'PK Of Participants Who Did Not Concomitantly Receive HU: Area Under The Concentration-time Curve (AUC) From Time 0 To 24 Hours Postdose (AUC0-24h) Of IMR-687', 'timeFrame': 'Day 1 and Week 25', 'description': 'For PK assessments of participants who did not concomitantly receive HU, serial blood samples for IMR-687 plasma concentrations were drawn predose at 0.5, 1, 1.5, 2, 4, 6, and 8 hours after administration of study drug; and at 24 hours after administration of study drug. Day 1 (single-dose) and steady-state (Week 25) assessments are presented.'}, {'measure': 'PK Of Participants Who Concomitantly Received HU: Cmax Of IMR-687', 'timeFrame': 'Day 1 and Week 17', 'description': 'For PK assessments of participants who concomitantly received HU, serial blood samples for IMR-687 PK were drawn predose at 0.5, 1, 1.5, 2, 4, 6, and 8 hours after administration of study drug; and at 24 hours after administration of study drug. Day 1 (single-dose) and steady-state (Week 17) assessments are presented.'}, {'measure': 'PK Of Participants Who Concomitantly Received HU: AUC0-24h Of IMR-687', 'timeFrame': 'Day 1 and Week 17', 'description': 'For PK assessments of participants who concomitantly received HU, serial blood samples for IMR-687 plasma concentrations were drawn predose at 0.5, 1, 1.5, 2, 4, 6, and 8 hours after administration of study drug; and at 24 hours after administration of study drug. Day 1 (single-dose) and steady-state (Week 17) assessments are presented.'}, {'measure': 'PK Of Participants Who Concomitantly Received HU: Cmax Of HU', 'timeFrame': 'Baseline (1 and 2) and Week 17', 'description': 'For PK assessments of participants who concomitantly received HU, serial blood samples for HU PK were drawn predose and at 0.5, 1, 1.5, 3, 6, 8, and 10 hours after self-administration of the prescribed dose of HU. HU in the presence (end of treatment \\[EOT\\]: Week 17) or absence of IMR-687 (Baselines 1 and 2) are presented. HU concentration data were not sorted with respect to HU dose.'}, {'measure': 'PK Of Participants Who Concomitantly Received HU: AUC0-24h Of HU', 'timeFrame': 'Baseline (1 and 2) and Week 17', 'description': 'For PK assessments of participants who concomitantly received HU, serial blood samples for HU PK were drawn predose and at 0.5, 1, 1.5, 3, 6, 8, and 10 hours after self-administration of the prescribed dose of HU. HU in the presence (EOT: Week 17) or absence of IMR-687 (Baselines 1 and 2) are presented. HU concentration data were not sorted with respect to HU dose.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sickle Cell Disease']}, 'descriptionModule': {'briefSummary': 'Study of IMR-687 in adult participants with sickle cell anemia (SCA) (homozygous HbSS or sickle-β0 thalassemia).', 'detailedDescription': 'This is a proof-of-concept study in adult SCA participants, ages 18 to 55 years old, to examine the safety, tolerability, and pharmacokinetic (PK), as well as the potential pharmacodynamic (PD) effects and clinical efficacy, of IMR-687 across a range of doses.\n\nIMR-687 was administered in 2 populations of participants with SCA: those who were not receiving hydroxyurea (HU) and those who were receiving a stable dose of HU according to standard of care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Male or female participants with confirmed SCA\n* Age 18 to 55 years, inclusive\n* For participants on HU, must have been on a stable dose for at least 60 days prior to screening\n\nKey Exclusion Criteria:\n\n* Total hemoglobin \\>12.5 or \\<6 grams/deciliter\n* Red blood cell transfusion within 60 days of baseline\n* \\>7 hospitalizations for vaso-occlusive crises (VOCs) within the last year\n* Estimated glomerular filtration rate \\<50 milliliter/minute\n* Aspartate aminotransferase/alanine aminotransferase \\>3x the upper limit of normal'}, 'identificationModule': {'nctId': 'NCT03401112', 'briefTitle': 'A Study of IMR-687 in Adult Participants With Sickle Cell Anemia (Homozygous HbSS or Sickle-β0 Thalassemia)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cardurion Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study of IMR-687 in Adult Patients With Sickle Cell Anaemia (Homozygous HbSS or Sickle-β0 Thalassemia)', 'orgStudyIdInfo': {'id': 'IMR-SCD-102'}, 'secondaryIdInfos': [{'id': '2017-000653-39', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IMR-687 50 mg/100 mg', 'description': 'A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants. Duration of administration was 16 (Week 17) or 24 weeks (Week 25).', 'interventionNames': ['Drug: IMR-687']}, {'type': 'EXPERIMENTAL', 'label': 'IMR-687 100 mg/200 mg', 'description': 'A starting dose of IMR-687 100 mg with dose escalation after 4 or 12 weeks, up to 200 mg was administered to participants. Duration of administration was 24 weeks (Week 25).', 'interventionNames': ['Drug: IMR-687']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo was administered for 16 (Week 17) or 24 weeks (Week 25).', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'IMR-687', 'type': 'DRUG', 'description': 'Oral administration of IMR-687 once daily with or without HU.', 'armGroupLabels': ['IMR-687 100 mg/200 mg', 'IMR-687 50 mg/100 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral administration of placebo once daily with or without HU.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': "UCSF Benioff Children's Hospital Oakland", 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '06030', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'University of Connecticut Health Center', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Foundation for Sickle Cell Disease Research', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60644', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Loretto Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '76508', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Scott & White Health', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}, {'zip': 'B18 7QH', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Sandwell & West Birmingham Hospital', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'BS2 8ED', 'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Bristol Haematology and Oncology Centre', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'E1 1BB', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NW1 2PG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'University College London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE1 9RT', 'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'OX3 7LE', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Oxford Cancer & Haematology Centre, The Churchill Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Regulatory Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cardurion Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardurion Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Imara, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}