Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-03-06 @ 2:04 PM
Study NCT ID:
NCT02187003
Status:
COMPLETED
Last Update Posted:
2025-03-11
First Post:
2014-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Rivipansel (GMI-1070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized Subjects With Sickle Cell Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}, {'id': 'D000098644', 'term': 'Vaso-Occlusive Crises'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C553182', 'term': 'rivipansel'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'debora@biossil.ai', 'phone': '978-245-7397', 'title': 'Head of Regulatory', 'organization': 'Biossil Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 up to the 35-day post discharge visit (up to an average of Day 43)', 'description': 'Same event may appear as AE and SAE, what is presented are distinct events. Safety analysis set population included all participants who received at least one 1 infusion of study drug. Participants aged 12 years and above were identified as Cohort 1 and participants aged 6-11 years were identified as Cohort 2; however, the primary analysis and study conclusions were based on the full study population.', 'eventGroups': [{'id': 'EG000', 'title': 'Rivipansel Treatment Arm', 'description': 'Participants with sickle cell disease (SCD) received intravenous (IV) infusion of rivipansel while hospitalized for treatment of a vaso-occlusive crisis (VOC). Participants aged \\>=12 years, with body weight \\>40 kilogram (kg) received a loading dose of 1680 milligram (mg) rivipansel on Day 1 followed by maintenance doses of 840 mg rivipansel administered at 12 hourly intervals.\n\nParticipants aged 6 to 11 years or any participant weighing \\<=40 kg received a loading dose of 40 milligram per kilogram body weight (mg/kg) rivipansel on Day 1 (maximum of 1680 mg) followed by maintenance doses of 20 mg/kg rivipansel (maximum of 840 mg) administered at 12 hourly intervals. Participants received rivipansel until they met the protocol-defined criteria for readiness-for-discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days.', 'otherNumAtRisk': 162, 'deathsNumAtRisk': 162, 'otherNumAffected': 137, 'seriousNumAtRisk': 162, 'deathsNumAffected': 0, 'seriousNumAffected': 52}, {'id': 'EG001', 'title': 'Placebo Treatment Arm', 'description': 'Participants with SCD received IV infusion of placebo (matched to rivipansel infusion) while hospitalized for treatment of a VOC. Participants received placebo on the same schedule used for rivipansel until they met the protocol-defined criteria for readiness-for- discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days', 'otherNumAtRisk': 158, 'deathsNumAtRisk': 158, 'otherNumAffected': 124, 'seriousNumAtRisk': 158, 'deathsNumAffected': 0, 'seriousNumAffected': 49}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Sickle cell anaemia with crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 17}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Sickle cell disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Infusion site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 33}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Ocular icterus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Haematocrit decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Oxygen saturation decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 29}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Acute chest syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 17}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Sickle cell anaemia with crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 34}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Lip blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Systemic inflammatory response syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Beta haemolytic streptococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Parainfluenzae virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Pilonidal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Staphylococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Thrombophlebitis septic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Vascular device infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Delayed haemolytic transfusion reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Blood culture positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Chest X-ray abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Liver function test increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Bone infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Priapism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Acute chest syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Respiratory disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Acute generalised exanthematous pustulosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Swelling face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Readiness for Discharge From Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivipansel Treatment Arm', 'description': 'Participants with sickle cell disease (SCD) received intravenous (IV) infusion of rivipansel while hospitalized for treatment of a vaso-occlusive crisis (VOC). Participants aged \\>=12 years, with body weight \\>40 kilogram (kg) received a loading dose of 1680 milligram (mg) rivipansel on Day 1 followed by maintenance doses of 840 mg rivipansel administered at 12 hourly intervals.\n\nParticipants aged 6 to 11 years or any participant weighing \\<=40 kg received a loading dose of 40 milligram per kilogram body weight (mg/kg) rivipansel on Day 1 (maximum of 1680 mg) followed by maintenance doses of 20 mg/kg rivipansel (maximum of 840 mg) administered at 12 hourly intervals. Participants received rivipansel until they met the protocol-defined criteria for readiness-for-discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days.'}, {'id': 'OG001', 'title': 'Placebo Treatment Arm', 'description': 'Participants with SCD received IV infusion of placebo (matched to rivipansel infusion) while hospitalized for treatment of a VOC. Participants received placebo on the same schedule used for rivipansel until they met the protocol-defined criteria for readiness-for- discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '87.78', 'groupId': 'OG000', 'lowerLimit': '65.68', 'upperLimit': '100.15'}, {'value': '93.47', 'groupId': 'OG001', 'lowerLimit': '74.67', 'upperLimit': '109.73'}]}]}], 'analyses': [{'pValue': '0.7944', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.22', 'groupDescription': 'A Cox proportional hazards regression model with age group and genotype group as stratification covariates was used to estimate the hazard ratio (Placebo/Rivipansel) and the corresponding 95 percent (%) confidence interval (CI). A stratified log-rank test with age group and genotype group as stratification variables was performed to evaluate P value.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 up to the latest day when all 6 criteria of readiness-for-discharge were met (up to an average of Day 8)', 'description': 'Time to readiness-for-discharge from hospital was defined as the difference (in hours) between the time and date when all criteria for readiness-for-discharge were met and the start time and date of the first infusion (loading dose) of study drug. Criteria for readiness-for-discharge were met when all of the applicable 6 criteria (in relation to treatment of VOC and complications related to the VOC) were documented to have occurred. The six criteria were: 1) only oral pain medication was required, 2) acute complications related to the VOC (such as acute chest syndrome, stroke, priapism) had resolved to the extent that management could be in an outpatient setting, 3) IV opioids had been discontinued, 4) IV hydration had been discontinued, 5) IV antibiotics had been discontinued and 6) red blood cell (RBC) transfusion was no longer required for treatment of this VOC.', 'unitOfMeasure': 'Hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included all participants who were randomized in the study. Participants aged 12 years and above were identified as Cohort 1 and participants aged 6-11 years were identified as Cohort 2; however, the primary analysis and study conclusions were based on the full study population in alignment with the primary study objective.'}, {'type': 'SECONDARY', 'title': 'Time to Discharge From Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivipansel Treatment Arm', 'description': 'Participants with sickle cell disease (SCD) received intravenous (IV) infusion of rivipansel while hospitalized for treatment of a vaso-occlusive crisis (VOC). Participants aged \\>=12 years, with body weight \\>40 kilogram (kg) received a loading dose of 1680 milligram (mg) rivipansel on Day 1 followed by maintenance doses of 840 mg rivipansel administered at 12 hourly intervals.\n\nParticipants aged 6 to 11 years or any participant weighing \\<=40 kg received a loading dose of 40 milligram per kilogram body weight (mg/kg) rivipansel on Day 1 (maximum of 1680 mg) followed by maintenance doses of 20 mg/kg rivipansel (maximum of 840 mg) administered at 12 hourly intervals. Participants received rivipansel until they met the protocol-defined criteria for readiness-for-discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days.'}, {'id': 'OG001', 'title': 'Placebo Treatment Arm', 'description': 'Participants with SCD received IV infusion of placebo (matched to rivipansel infusion) while hospitalized for treatment of a VOC. Participants received placebo on the same schedule used for rivipansel until they met the protocol-defined criteria for readiness-for- discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days'}], 'classes': [{'categories': [{'measurements': [{'value': '86.75', 'groupId': 'OG000', 'lowerLimit': '71.25', 'upperLimit': '98.72'}, {'value': '90.67', 'groupId': 'OG001', 'lowerLimit': '72.10', 'upperLimit': '108.62'}]}]}], 'analyses': [{'pValue': '0.7156', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.19', 'groupDescription': 'A Cox proportional hazards regression model with age group and genotype group as stratification covariates was used to estimate the hazard ratio (Placebo/Rivipansel) and the corresponding 95% CI. A stratified log-rank test with age group and genotype group as stratification variables was performed to evaluate P- value.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 up to the latest day when the order of hospital discharge was issued by a qualified healthcare provider (up to an average of Day 8)', 'description': 'Time to discharge from hospital was defined as the difference (in hours) between the time and date of the hospital discharge order from a qualified healthcare provider and the start time and date of the first infusion (loading dose) of study drug.', 'unitOfMeasure': 'Hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included all participants who were randomized in the study. Participants aged 12 years and above were identified as Cohort 1 and participants aged 6-11 years were identified as Cohort 2; however, the primary analysis and study conclusions were based on the full study population in alignment with the primary study objective.'}, {'type': 'SECONDARY', 'title': 'Cumulative Intravenous (IV) Opioids Consumption From Time of Loading Dose of Study Drug to Discharge From Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivipansel Treatment Arm', 'description': 'Participants with sickle cell disease (SCD) received intravenous (IV) infusion of rivipansel while hospitalized for treatment of a vaso-occlusive crisis (VOC). Participants aged \\>=12 years, with body weight \\>40 kilogram (kg) received a loading dose of 1680 milligram (mg) rivipansel on Day 1 followed by maintenance doses of 840 mg rivipansel administered at 12 hourly intervals.\n\nParticipants aged 6 to 11 years or any participant weighing \\<=40 kg received a loading dose of 40 milligram per kilogram body weight (mg/kg) rivipansel on Day 1 (maximum of 1680 mg) followed by maintenance doses of 20 mg/kg rivipansel (maximum of 840 mg) administered at 12 hourly intervals. Participants received rivipansel until they met the protocol-defined criteria for readiness-for-discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days.'}, {'id': 'OG001', 'title': 'Placebo Treatment Arm', 'description': 'Participants with SCD received IV infusion of placebo (matched to rivipansel infusion) while hospitalized for treatment of a VOC. Participants received placebo on the same schedule used for rivipansel until they met the protocol-defined criteria for readiness-for- discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days'}], 'classes': [{'categories': [{'measurements': [{'value': '2.30', 'groupId': 'OG000', 'lowerLimit': '0.68', 'upperLimit': '6.03'}, {'value': '2.36', 'groupId': 'OG001', 'lowerLimit': '0.55', 'upperLimit': '6.99'}]}]}], 'analyses': [{'pValue': '0.8520', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-1.27', 'ciUpperLimit': '0.88', 'groupDescription': 'The difference in medians (Rivipansel- Placebo) was estimated by the difference of treatment medians from summary statistics. The corresponding 95% CI was estimated by a bootstrap method with stratification for age and genotype groups. P-value was from analysis of covariance (ANCOVA) model based on rank-transformed values using age group and genotype group as the stratification covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 up to the latest day when IV opioid was discontinued (up to an average of Day 8)', 'description': 'Cumulative IV opioid consumption was reported as cumulative IV opioid use (standardized using morphine equivalent units \\[MEU\\]), from the start of the first infusion (loading dose) of study drug until hospital discharge.', 'unitOfMeasure': 'MEU per kg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included all participants who were randomized in the study. Participants aged 12 years and above were identified as Cohort 1 and participants aged 6-11 years were identified as Cohort 2; however, the primary analysis and study conclusions were based on the full study population in alignment with the primary study objective.'}, {'type': 'SECONDARY', 'title': 'Time to Discontinuation of Intravenous (IV) Opioids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivipansel Treatment Arm', 'description': 'Participants with sickle cell disease (SCD) received intravenous (IV) infusion of rivipansel while hospitalized for treatment of a vaso-occlusive crisis (VOC). Participants aged \\>=12 years, with body weight \\>40 kilogram (kg) received a loading dose of 1680 milligram (mg) rivipansel on Day 1 followed by maintenance doses of 840 mg rivipansel administered at 12 hourly intervals.\n\nParticipants aged 6 to 11 years or any participant weighing \\<=40 kg received a loading dose of 40 milligram per kilogram body weight (mg/kg) rivipansel on Day 1 (maximum of 1680 mg) followed by maintenance doses of 20 mg/kg rivipansel (maximum of 840 mg) administered at 12 hourly intervals. Participants received rivipansel until they met the protocol-defined criteria for readiness-for-discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days.'}, {'id': 'OG001', 'title': 'Placebo Treatment Arm', 'description': 'Participants with SCD received IV infusion of placebo (matched to rivipansel infusion) while hospitalized for treatment of a VOC. Participants received placebo on the same schedule used for rivipansel until they met the protocol-defined criteria for readiness-for- discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days'}], 'classes': [{'categories': [{'measurements': [{'value': '67.20', 'groupId': 'OG000', 'lowerLimit': '53.32', 'upperLimit': '80.53'}, {'value': '68.45', 'groupId': 'OG001', 'lowerLimit': '53.75', 'upperLimit': '84.97'}]}]}], 'analyses': [{'pValue': '0.8593', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.26', 'groupDescription': 'A Cox proportional hazards regression model with age group and genotype group as stratification covariates was used to estimate the hazard ratio (Placebo/Rivipansel) and the corresponding 95% CI. A stratified log-rank test with age group and genotype group as stratification variables was performed to evaluate P- value.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 up to the latest day when IV opioid was discontinued (up to an average of Day 8)', 'description': 'Time to discontinuation of IV opioids was defined as the difference (in hours) between the stop time and date of the latest IV opioid dose and the start time and date of the first infusion (loading dose) of study drug.', 'unitOfMeasure': 'Hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included all participants who were randomized in the study. Participants aged 12 years and above were identified as Cohort 1 and participants aged 6-11 years were identified as Cohort 2; however, the primary analysis and study conclusions were based on the full study population in alignment with the primary study objective.'}, {'type': 'SECONDARY', 'title': 'Cumulative Intravenous (IV) Opioids Consumption Within First 24 Hours Post-Loading Dose of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivipansel Treatment Arm', 'description': 'Participants with sickle cell disease (SCD) received intravenous (IV) infusion of rivipansel while hospitalized for treatment of a vaso-occlusive crisis (VOC). Participants aged \\>=12 years, with body weight \\>40 kilogram (kg) received a loading dose of 1680 milligram (mg) rivipansel on Day 1 followed by maintenance doses of 840 mg rivipansel administered at 12 hourly intervals.\n\nParticipants aged 6 to 11 years or any participant weighing \\<=40 kg received a loading dose of 40 milligram per kilogram body weight (mg/kg) rivipansel on Day 1 (maximum of 1680 mg) followed by maintenance doses of 20 mg/kg rivipansel (maximum of 840 mg) administered at 12 hourly intervals. Participants received rivipansel until they met the protocol-defined criteria for readiness-for-discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days.'}, {'id': 'OG001', 'title': 'Placebo Treatment Arm', 'description': 'Participants with SCD received IV infusion of placebo (matched to rivipansel infusion) while hospitalized for treatment of a VOC. Participants received placebo on the same schedule used for rivipansel until they met the protocol-defined criteria for readiness-for- discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.80', 'groupId': 'OG000', 'lowerLimit': '0.37', 'upperLimit': '1.39'}, {'value': '0.82', 'groupId': 'OG001', 'lowerLimit': '0.40', 'upperLimit': '1.56'}]}]}], 'analyses': [{'pValue': '0.9332', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.16', 'groupDescription': 'The difference in medians (Rivipansel- Placebo) was estimated by the difference of treatment medians from summary statistics. The corresponding 95% CI was estimated by a bootstrap method with stratification for age and genotype groups. P value was from ANCOVA model based on rank-transformed values using age group and genotype group as the stratification covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours post first IV infusion of loading dose of study drug on Day 1', 'description': 'Cumulative IV opioid consumption (standardized using MEU) was reported as IV opioid use in the first 24 hours from the start time of the first IV infusion (loading dose) of study drug.', 'unitOfMeasure': 'MEU per kg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included all participants who were randomized in the study. Participants aged 12 years and above were identified as Cohort 1 and participants aged 6-11 years were identified as Cohort 2; however, the primary analysis and study conclusions were based on the full study population in alignment with the primary study objective.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Re-hospitalized for Vaso-Occlusive Crisis (VOC) Within 3 Days of Discharge From Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivipansel Treatment Arm', 'description': 'Participants with sickle cell disease (SCD) received intravenous (IV) infusion of rivipansel while hospitalized for treatment of a vaso-occlusive crisis (VOC). Participants aged \\>=12 years, with body weight \\>40 kilogram (kg) received a loading dose of 1680 milligram (mg) rivipansel on Day 1 followed by maintenance doses of 840 mg rivipansel administered at 12 hourly intervals.\n\nParticipants aged 6 to 11 years or any participant weighing \\<=40 kg received a loading dose of 40 milligram per kilogram body weight (mg/kg) rivipansel on Day 1 (maximum of 1680 mg) followed by maintenance doses of 20 mg/kg rivipansel (maximum of 840 mg) administered at 12 hourly intervals. Participants received rivipansel until they met the protocol-defined criteria for readiness-for-discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days.'}, {'id': 'OG001', 'title': 'Placebo Treatment Arm', 'description': 'Participants with SCD received IV infusion of placebo (matched to rivipansel infusion) while hospitalized for treatment of a VOC. Participants received placebo on the same schedule used for rivipansel until they met the protocol-defined criteria for readiness-for- discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5349', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.17', 'ciLowerLimit': '-5.19', 'ciUpperLimit': '2.46', 'groupDescription': 'P values and 95% CI for the difference in percentages were based on the exact method by Chan and Zhang.', 'statisticalMethod': 'Chan and Zhang', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 3 days of discharge from hospital, where discharge from hospital was any day from Day 1 to an average of Day 8', 'description': 'Percentage of participants who were re-hospitalized for a vaso-occlusive crisis (VOC) within 3 days of discharge from hospital are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population included all participants who were randomized in the study. Participants aged 12 years and above were identified as Cohort 1 and participants aged 6-11 years were identified as Cohort 2; however, the primary analysis and study conclusions were based on the full study population in alignment with the primary study objective.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) as Per Genotype', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivipansel Treatment Arm', 'description': 'Participants with sickle cell disease (SCD) received intravenous (IV) infusion of rivipansel while hospitalized for treatment of a vaso-occlusive crisis (VOC). Participants aged \\>=12 years, with body weight \\>40 kilogram (kg) received a loading dose of 1680 milligram (mg) rivipansel on Day 1 followed by maintenance doses of 840 mg rivipansel administered at 12 hourly intervals.\n\nParticipants aged 6 to 11 years or any participant weighing \\<=40 kg received a loading dose of 40 milligram per kilogram body weight (mg/kg) rivipansel on Day 1 (maximum of 1680 mg) followed by maintenance doses of 20 mg/kg rivipansel (maximum of 840 mg) administered at 12 hourly intervals. Participants received rivipansel until they met the protocol-defined criteria for readiness-for-discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days.'}, {'id': 'OG001', 'title': 'Placebo Treatment Arm', 'description': 'Participants with SCD received IV infusion of placebo (matched to rivipansel infusion) while hospitalized for treatment of a VOC. Participants received placebo on the same schedule used for rivipansel until they met the protocol-defined criteria for readiness-for- discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days'}], 'classes': [{'title': 'Treatment Emergent AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Genotype Category 1', 'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}, {'title': 'Genotype Category 2', 'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Treatment Emergent SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Genotype Category 1', 'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'title': 'Genotype Category 2', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 up to the 35-day post discharge visit (up to an average of Day 43)', 'description': 'AE: any untoward medical occurrence in a participant who received investigational product without regard to possibility of a causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. An adverse event was considered a treatment-emergent adverse event (TEAE) if the event started during the effective duration of treatment (all events that started on or after the first dosing). AEs included both serious and non-serious adverse events.\n\nParticipants with AEs and SAEs were categorized by genotype categories. Category 1= participants with hemoglobin SS, hemoglobin S beta0 thalassemia and hemoglobin SD; category 2= participants with hemoglobin SC, hemoglobin S beta+ thalassemia and hemoglobin S-Variant (other than HbSD).', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set population included all participants who received at least 1 infusion of study drug. Here, "Number Analyzed" signifies number of participants evaluable for specified rows. Participants aged 12 years and above were identified as Cohort 1 and participants aged 6-11 years were identified as Cohort 2; however, the primary analysis and study conclusions were based on the full study population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Treatment Emergent Adverse Event (AEs) as Per Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivipansel Treatment Arm', 'description': 'Participants with sickle cell disease (SCD) received intravenous (IV) infusion of rivipansel while hospitalized for treatment of a vaso-occlusive crisis (VOC). Participants aged \\>=12 years, with body weight \\>40 kilogram (kg) received a loading dose of 1680 milligram (mg) rivipansel on Day 1 followed by maintenance doses of 840 mg rivipansel administered at 12 hourly intervals.\n\nParticipants aged 6 to 11 years or any participant weighing \\<=40 kg received a loading dose of 40 milligram per kilogram body weight (mg/kg) rivipansel on Day 1 (maximum of 1680 mg) followed by maintenance doses of 20 mg/kg rivipansel (maximum of 840 mg) administered at 12 hourly intervals. Participants received rivipansel until they met the protocol-defined criteria for readiness-for-discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days.'}, {'id': 'OG001', 'title': 'Placebo Treatment Arm', 'description': 'Participants with SCD received IV infusion of placebo (matched to rivipansel infusion) while hospitalized for treatment of a VOC. Participants received placebo on the same schedule used for rivipansel until they met the protocol-defined criteria for readiness-for- discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days'}], 'classes': [{'title': 'Mild', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 up to the 35-day post discharge visit (up to an average of Day 43)', 'description': "AE: any untoward medical occurrence in a participant who received investigational product without regard to possibility of a causal relationship. AEs were classified according to the severity in 3 categories a) mild - AEs did not interfere with participant's usual function, b) moderate - AEs interfered to some extent with participant's usual function, c) severe - AEs interfered significantly with participant's usual function.", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set population included all participants who received at least 1 infusion of study drug. Participants aged 12 years and above were identified as Cohort 1 and participants aged 6-11 years were identified as Cohort 2; however, the primary analysis and study conclusions were based on the full study population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Clinical Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivipansel Treatment Arm', 'description': 'Participants with sickle cell disease (SCD) received intravenous (IV) infusion of rivipansel while hospitalized for treatment of a vaso-occlusive crisis (VOC). Participants aged \\>=12 years, with body weight \\>40 kilogram (kg) received a loading dose of 1680 milligram (mg) rivipansel on Day 1 followed by maintenance doses of 840 mg rivipansel administered at 12 hourly intervals.\n\nParticipants aged 6 to 11 years or any participant weighing \\<=40 kg received a loading dose of 40 milligram per kilogram body weight (mg/kg) rivipansel on Day 1 (maximum of 1680 mg) followed by maintenance doses of 20 mg/kg rivipansel (maximum of 840 mg) administered at 12 hourly intervals. Participants received rivipansel until they met the protocol-defined criteria for readiness-for-discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days.'}, {'id': 'OG001', 'title': 'Placebo Treatment Arm', 'description': 'Participants with SCD received IV infusion of placebo (matched to rivipansel infusion) while hospitalized for treatment of a VOC. Participants received placebo on the same schedule used for rivipansel until they met the protocol-defined criteria for readiness-for- discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days'}], 'classes': [{'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 up to the 35-day post discharge visit (up to an average of Day 43)', 'description': 'Hematology: hemoglobin, hematocrit, erythrocytes \\<0.8\\*lower limit of normal (LLN), reticulocytes \\<0.5\\*LLN \\>1.5\\*ULN, platelets\\<0.5\\*LLN\\>1.75\\*upper limit of normal (ULN), reticulocytes/erythrocytes\\<0.5\\*LLN\\>1.5\\*ULN, leukocytes \\<0.6\\*LLN \\>1.5\\*ULN, lymphocytes, lymphocytes/leukocytes, neutrophils, neutrophils/leukocytes \\<0.8\\*LLN \\>1.2\\*ULN, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes monocytes/leukocytes \\>1.2\\*ULN. Clinical chemistry: bilirubin, direct, bilirubin, indirect bilirubin\\>1.5\\*ULN, aspartate aminotransferase (AT), alanine AT, lactate dehydrogenase, alkaline phosphatase\\>3.0\\*ULN, urea nitrogen, urea, creatinine \\>1.3\\*ULN, sodium\\<0.95\\*LLN\\>1.05\\*ULN, potassium, chloride, bicarbonate\\<0.9\\*LLN\\>1.1\\*ULN, glucose\\<0.6\\*LLN\\>1.5\\*ULN, estimated glomerular filtration rate \\<=60. Urinalysis: urine glucose, ketones, urine protein, urine hemoglobin, nitrite, leukocyte esterase \\>=1.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set population included all participants who received at least 1 infusion of study drug. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Participants aged 12 years and above were identified as Cohort 1 and participants aged 6-11 years were identified as Cohort 2; however, the primary analysis and study conclusions were based on the full study population."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Increase in Grades From Baseline in Clinical Laboratory Parameters Over the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivipansel Treatment Arm', 'description': 'Participants with sickle cell disease (SCD) received intravenous (IV) infusion of rivipansel while hospitalized for treatment of a vaso-occlusive crisis (VOC). Participants aged \\>=12 years, with body weight \\>40 kilogram (kg) received a loading dose of 1680 milligram (mg) rivipansel on Day 1 followed by maintenance doses of 840 mg rivipansel administered at 12 hourly intervals.\n\nParticipants aged 6 to 11 years or any participant weighing \\<=40 kg received a loading dose of 40 milligram per kilogram body weight (mg/kg) rivipansel on Day 1 (maximum of 1680 mg) followed by maintenance doses of 20 mg/kg rivipansel (maximum of 840 mg) administered at 12 hourly intervals. Participants received rivipansel until they met the protocol-defined criteria for readiness-for-discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days.'}, {'id': 'OG001', 'title': 'Placebo Treatment Arm', 'description': 'Participants with SCD received IV infusion of placebo (matched to rivipansel infusion) while hospitalized for treatment of a VOC. Participants received placebo on the same schedule used for rivipansel until they met the protocol-defined criteria for readiness-for- discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days'}], 'classes': [{'title': 'Hemoglobin : >=1 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin : >=2 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin : >=3 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin : >=4 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Reticulocytes/Erythrocytes : >=1 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Reticulocytes/Erythrocytes : >=2 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Reticulocytes/Erythrocytes : >=3 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Reticulocytes/Erythrocytes : >=4 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Platelets : >=1 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Platelets : >=2 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Platelets : >=3 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Platelets : >=4 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Leukocytes : >=1 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Leukocytes : >=2 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Leukocytes : >=3 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Leukocytes : >=4 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Direct Bilirubin : >=1 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Direct Bilirubin : >=2 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Direct Bilirubin : >=3 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Direct Bilirubin : >=4 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Indirect Bilirubin : >=1 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Indirect Bilirubin : >=2 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Indirect Bilirubin : >=3 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Indirect Bilirubin : >=4 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase : >=1 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase : >=2 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase : >=3 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase : >=4 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase : >=1 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase : >=2 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase : >=3 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase : >=4 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lactate Dehydrogenase : >=1 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Lactate Dehydrogenase : >=2 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Lactate Dehydrogenase : >=3 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lactate Dehydrogenase : >=4 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urea Nitrogen : >=1 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Urea Nitrogen : >=2 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urea Nitrogen : >=3 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urea Nitrogen : >=4 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine : >=1 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine : >=2 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine : >=3 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine : >=4 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urine Protein : >=1 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urine Protein : >=2 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urine Protein : >=3 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urine Protein : >=4 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils : >=1 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils : >=2 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils : >=3 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils : >=4 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'eGFR : >=1 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'eGFR : >=2 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'eGFR : >=3 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'eGFR : >=4 grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to the 35-day post discharge visit (up to an average of Day 43)', 'description': 'Hemoglobin(grade \\[G\\] 0:\\>11g/dl,G1:\\>9-11g/dl,G2:\\>7-9g/dl,G3:5-7g/dl,G4:\\<5g/dl),reticulocytes count(G0:\\<1%,G1:1-5%,G2:\\>5-10%,G3:\\>10-20%,G4:\\>20%),leukocytes(G0:\\<=upper limit of normal \\[ULN\\],G1:\\>ULN-15,000/mm\\^3,G2:\\>15,000- 20,000/mm\\^3,G3:\\>20,000- 50,000/mm\\^, G4:\\>50,000/mm\\^3),neutrophils(G0:\\>=LLN, G1:\\<LLN-1,500/mm\\^3, G2:\\<1,500-1,000/mm\\^3, G3:\\<1,000-500/mm\\^3, G4:\\<500/mm\\^3),blood urea nitrogen, creatinine(G0:\\<=ULN, G1:\\>ULN-1.5\\*UL, G2:\\>1.5-3.0\\*ULN, G3:\\>3.0\\*ULN, G4:\\>6.0\\*ULN), lactate dehydrogenase, alanine transaminase, aspartate aminotransferase(G0:\\<=ULN, G1:\\>ULN-3.0\\*ULN, G2:\\>3.0-5.0\\*ULN, G3:\\>5.0-20.0\\*ULN, G4:\\>20.0\\*ULN), bilirubin(G0:\\<=ULN, G1:\\>ULN-1.5\\*ULN, G2:\\>1.5-3.0\\*ULN, G3:\\>3.0-10.0\\*ULN, G4:\\>10.0\\*ULN), urine protein(G0:0-15mg/dL, G1:\\>15-30mg/dL, G2:\\>30-100mg/dL, G3:\\>100-300mg/dL, G4:\\>300mg/dL), platelet(G0:\\>=150K, G1:\\>=100K-\\<150K, G2:\\>=50K \\<100K, G3:\\<50K), eGFR (G0:\\>=90 mL/min/1.73m\\^2, G1:\\>=60-\\<90mL/min/1.73m\\^2, G2:\\>=30-\\<60mL/min/1.73m\\^2, G3:\\>=15-\\<30mL/min/1.73m\\^2, G4:\\<15 mL/min/1.73m\\^2)', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set population included all participants who received at least 1 infusion of drug. Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure; Number Analyzed signifies participants evaluable for specific rows. Participants aged 12 years and above were identified as Cohort 1 and participants aged 6-11 years were identified as Cohort 2; however, the primary analysis and study conclusions were based on the full study population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Clinically Significant Changes in Physical Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivipansel Treatment Arm', 'description': 'Participants with sickle cell disease (SCD) received intravenous (IV) infusion of rivipansel while hospitalized for treatment of a vaso-occlusive crisis (VOC). Participants aged \\>=12 years, with body weight \\>40 kilogram (kg) received a loading dose of 1680 milligram (mg) rivipansel on Day 1 followed by maintenance doses of 840 mg rivipansel administered at 12 hourly intervals.\n\nParticipants aged 6 to 11 years or any participant weighing \\<=40 kg received a loading dose of 40 milligram per kilogram body weight (mg/kg) rivipansel on Day 1 (maximum of 1680 mg) followed by maintenance doses of 20 mg/kg rivipansel (maximum of 840 mg) administered at 12 hourly intervals. Participants received rivipansel until they met the protocol-defined criteria for readiness-for-discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days.'}, {'id': 'OG001', 'title': 'Placebo Treatment Arm', 'description': 'Participants with SCD received IV infusion of placebo (matched to rivipansel infusion) while hospitalized for treatment of a VOC. Participants received placebo on the same schedule used for rivipansel until they met the protocol-defined criteria for readiness-for- discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days'}], 'classes': [{'title': 'Post-screening up to end of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Post-discharge to 35 days post-discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Post-screening up to end of treatment (up to an average of Day 8), From Post-discharge up to 35 days post-discharge (up to an average of Day 43)', 'description': 'Physical examination included assessment of the general appearance and the skin, head, ears, eyes, nose, mouth, throat, spine, neck, thyroid, chest, extremities, lymph nodes and abdomen (including liver and kidneys) plus the respiratory, cardiovascular, musculoskeletal, neurological and genitourinary systems. Clinical significance was assessed by the Investigator.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set population included all participants who received at least 1 infusion of study drug. Participants aged 12 years and above were identified as Cohort 1 and participants aged 6-11 years were identified as Cohort 2; however, the primary analysis and study conclusions were based on the full study population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Treatment Related Changes From Baseline in Vital Signs Over the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivipansel Treatment Arm', 'description': 'Participants with sickle cell disease (SCD) received intravenous (IV) infusion of rivipansel while hospitalized for treatment of a vaso-occlusive crisis (VOC). Participants aged \\>=12 years, with body weight \\>40 kilogram (kg) received a loading dose of 1680 milligram (mg) rivipansel on Day 1 followed by maintenance doses of 840 mg rivipansel administered at 12 hourly intervals.\n\nParticipants aged 6 to 11 years or any participant weighing \\<=40 kg received a loading dose of 40 milligram per kilogram body weight (mg/kg) rivipansel on Day 1 (maximum of 1680 mg) followed by maintenance doses of 20 mg/kg rivipansel (maximum of 840 mg) administered at 12 hourly intervals. Participants received rivipansel until they met the protocol-defined criteria for readiness-for-discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days.'}, {'id': 'OG001', 'title': 'Placebo Treatment Arm', 'description': 'Participants with SCD received IV infusion of placebo (matched to rivipansel infusion) while hospitalized for treatment of a VOC. Participants received placebo on the same schedule used for rivipansel until they met the protocol-defined criteria for readiness-for- discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 1) up to the 35-day post discharge visit (up to an average of Day 43)', 'description': 'Vital signs included temperature, respiratory rate, pulse rate and systolic and diastolic blood pressure. Relatedness to treatment was assessed by the Investigator.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set population included all participants who received at least 1 infusion of study drug. Participants aged 12 years and above were identified as Cohort 1 and participants aged 6-11 years were identified as Cohort 2; however, the primary analysis and study conclusions were based on the full study population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Adjudicated Acute Chest Syndrome (ACS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivipansel Treatment Arm', 'description': 'Participants with sickle cell disease (SCD) received intravenous (IV) infusion of rivipansel while hospitalized for treatment of a vaso-occlusive crisis (VOC). Participants aged \\>=12 years, with body weight \\>40 kilogram (kg) received a loading dose of 1680 milligram (mg) rivipansel on Day 1 followed by maintenance doses of 840 mg rivipansel administered at 12 hourly intervals.\n\nParticipants aged 6 to 11 years or any participant weighing \\<=40 kg received a loading dose of 40 milligram per kilogram body weight (mg/kg) rivipansel on Day 1 (maximum of 1680 mg) followed by maintenance doses of 20 mg/kg rivipansel (maximum of 840 mg) administered at 12 hourly intervals. Participants received rivipansel until they met the protocol-defined criteria for readiness-for-discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days.'}, {'id': 'OG001', 'title': 'Placebo Treatment Arm', 'description': 'Participants with SCD received IV infusion of placebo (matched to rivipansel infusion) while hospitalized for treatment of a VOC. Participants received placebo on the same schedule used for rivipansel until they met the protocol-defined criteria for readiness-for- discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days'}], 'classes': [{'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000'}, {'value': '10.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3020', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.336', 'ciLowerLimit': '-10.024', 'ciUpperLimit': '2.968', 'statisticalMethod': 'Chan and Zhang', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to the 35-day post discharge visit (up to an average of Day 43)', 'description': 'Investigator reported events of Acute Chest Syndrome (ACS) and other reported respiratory events were sent for adjudication by the Acute Chest Syndrome Safety Endpoint Adjudication Committee. The committee, which consisted of physicians with relevant SCD expertise, evaluated these events and determined whether they were consistent with cases of ACS.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set population included all participants who received at least 1 infusion of study drug. Participants aged 12 years and above were identified as Cohort 1 and participants aged 6-11 years were identified as Cohort 2; however, the primary analysis and study conclusions were based on the full study population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Severe Adjudicated and/or Generalized Cutaneous Manifestations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivipansel Treatment Arm', 'description': 'Participants with sickle cell disease (SCD) received intravenous (IV) infusion of rivipansel while hospitalized for treatment of a vaso-occlusive crisis (VOC). Participants aged \\>=12 years, with body weight \\>40 kilogram (kg) received a loading dose of 1680 milligram (mg) rivipansel on Day 1 followed by maintenance doses of 840 mg rivipansel administered at 12 hourly intervals.\n\nParticipants aged 6 to 11 years or any participant weighing \\<=40 kg received a loading dose of 40 milligram per kilogram body weight (mg/kg) rivipansel on Day 1 (maximum of 1680 mg) followed by maintenance doses of 20 mg/kg rivipansel (maximum of 840 mg) administered at 12 hourly intervals. Participants received rivipansel until they met the protocol-defined criteria for readiness-for-discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days.'}, {'id': 'OG001', 'title': 'Placebo Treatment Arm', 'description': 'Participants with SCD received IV infusion of placebo (matched to rivipansel infusion) while hospitalized for treatment of a VOC. Participants received placebo on the same schedule used for rivipansel until they met the protocol-defined criteria for readiness-for- discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5429', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.203', 'ciLowerLimit': '-2.379', 'ciUpperLimit': '5.104', 'statisticalMethod': 'Chan and Zhang', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to the 35-day post discharge visit (up to an average of Day 43)', 'description': 'Investigator reported cutaneous events were sent for adjudication by the Cutaneous Manifestations Safety Endpoint Adjudication Committee. The committee, which consisted of dermatologists, evaluated these events and determined whether they were cases of severe and/or generalized cutaneous manifestations and specifically whether any event was consistent with Acute Generalized Exanthematous Pustulosis.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set population included all participants who received at least 1 infusion of study drug. Participants aged 12 years and above were identified as Cohort 1 and participants aged 6-11 years were identified as Cohort 2; however, the primary analysis and study conclusions were based on the full study population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Re-hospitalized for Vaso-Occlusive Crisis (VOC) Within 7, 14 and 30 Days of Discharge From Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivipansel Treatment Arm', 'description': 'Participants with sickle cell disease (SCD) received intravenous (IV) infusion of rivipansel while hospitalized for treatment of a vaso-occlusive crisis (VOC). Participants aged \\>=12 years, with body weight \\>40 kilogram (kg) received a loading dose of 1680 milligram (mg) rivipansel on Day 1 followed by maintenance doses of 840 mg rivipansel administered at 12 hourly intervals.\n\nParticipants aged 6 to 11 years or any participant weighing \\<=40 kg received a loading dose of 40 milligram per kilogram body weight (mg/kg) rivipansel on Day 1 (maximum of 1680 mg) followed by maintenance doses of 20 mg/kg rivipansel (maximum of 840 mg) administered at 12 hourly intervals. Participants received rivipansel until they met the protocol-defined criteria for readiness-for-discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days.'}, {'id': 'OG001', 'title': 'Placebo Treatment Arm', 'description': 'Participants with SCD received IV infusion of placebo (matched to rivipansel infusion) while hospitalized for treatment of a VOC. Participants received placebo on the same schedule used for rivipansel until they met the protocol-defined criteria for readiness-for- discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days'}], 'classes': [{'title': 'Within 7 Days', 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '5.7', 'groupId': 'OG001'}]}]}, {'title': 'Within 14 Days', 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000'}, {'value': '8.9', 'groupId': 'OG001'}]}]}, {'title': 'Within 30 Days', 'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000'}, {'value': '17.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days of discharge; Within 14 days of discharge; Within 30 days of discharge, where discharge from hospital was any day from Day 1 to an average of Day 8', 'description': 'Percentage of participants re-hospitalized for VOC within 7, 14 and 30 days of hospital discharge.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set population included all participants who received at least 1 infusion of study drug. Participants aged 12 years and above were identified as Cohort 1 and participants aged 6-11 years were identified as Cohort 2; however, the primary analysis and study conclusions were based on the full study population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rivipansel Treatment Arm', 'description': 'Participants with sickle cell disease (SCD) received intravenous (IV) infusion of rivipansel while hospitalized for treatment of a vaso-occlusive crisis (VOC). Participants aged \\>=12 years, with body weight \\>40 kilogram (kg) received a loading dose of 1680 milligram (mg) rivipansel on Day 1 followed by maintenance doses of 840 mg rivipansel administered at 12 hourly intervals.\n\nParticipants aged 6 to 11 years or any participant weighing \\<=40 kg received a loading dose of 40 milligram per kilogram body weight (mg/kg) rivipansel on Day 1 (maximum of 1680 mg) followed by maintenance doses of 20 mg/kg rivipansel (maximum of 840 mg) administered at 12 hourly intervals. Participants received rivipansel until they met the protocol-defined criteria for readiness-for-discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days.'}, {'id': 'FG001', 'title': 'Placebo Treatment Arm', 'description': 'Participants with SCD received IV infusion of placebo (matched to rivipansel infusion) while hospitalized for treatment of a VOC. Participants received placebo on the same schedule used for rivipansel until they met the protocol-defined criteria for readiness-for- discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '173'}, {'groupId': 'FG001', 'numSubjects': '172'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}, {'groupId': 'FG001', 'numSubjects': '158'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '146'}, {'groupId': 'FG001', 'numSubjects': '141'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '31'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Parent/Guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'This was a randomized, blinded study to treat subjects \\>=6 years of age with SCD, experiencing an acute VOC event requiring hospitalization. Participants aged 12 years and above were identified as Cohort 1 and participants aged 6-11 years were identified as Cohort 2; however, the primary analysis and study conclusions were based on the full study population in alignment with the primary study objective.', 'preAssignmentDetails': 'Due to the short duration of time allowed to dose upon a VOC event, an optional screening may have occurred while the participant was well. Patients were neither enrolled nor randomized to study treatment until a VOC occurred, at which time the formal assessment of eligibility for enrollment into the study was performed. Of the 475 screened participants, 345 participants experiencing an acute VOC event were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '345', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rivipansel Treatment Arm', 'description': 'Participants with sickle cell disease (SCD) received intravenous (IV) infusion of rivipansel while hospitalized for treatment of a vaso-occlusive crisis (VOC). Participants aged \\>=12 years, with body weight \\>40 kilogram (kg) received a loading dose of 1680 milligram (mg) rivipansel on Day 1 followed by maintenance doses of 840 mg rivipansel administered at 12 hourly intervals.\n\nParticipants aged 6 to 11 years or any participant weighing \\<=40 kg received a loading dose of 40 milligram per kilogram body weight (mg/kg) rivipansel on Day 1 (maximum of 1680 mg) followed by maintenance doses of 20 mg/kg rivipansel (maximum of 840 mg) administered at 12 hourly intervals. Participants received rivipansel until they met the protocol-defined criteria for readiness-for-discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days.'}, {'id': 'BG001', 'title': 'Placebo Treatment Arm', 'description': 'Participants with SCD received IV infusion of placebo (matched to rivipansel infusion) while hospitalized for treatment of a VOC. Participants received placebo on the same schedule used for rivipansel until they met the protocol-defined criteria for readiness-for- discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '22.00', 'spread': '10.61', 'groupId': 'BG000'}, {'value': '21.34', 'spread': '10.20', 'groupId': 'BG001'}, {'value': '21.67', 'spread': '10.40', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '183', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '320', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race: Black', 'categories': [{'measurements': [{'value': '167', 'groupId': 'BG000'}, {'value': '159', 'groupId': 'BG001'}, {'value': '326', 'groupId': 'BG002'}]}]}, {'title': 'Race: White', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Race: Other', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set population included all participants who were randomized in the study. Participants aged 12 years and above were identified as Cohort 1 and participants aged 6-11 years were identified as Cohort 2; however, the primary analysis and study conclusions were based on the full study population in alignment with the primary study objective.\n\nFull analysis set population included all participants who were randomized in the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-01', 'size': 15615344, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-02-14T13:41', 'hasProtocol': True}, {'date': '2019-07-10', 'size': 10050348, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-02-14T13:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 345}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'dispFirstSubmitDate': '2020-05-05', 'completionDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2014-06-12', 'dispFirstSubmitQcDate': '2020-05-07', 'resultsFirstSubmitDate': '2024-02-26', 'studyFirstSubmitQcDate': '2014-07-07', 'dispFirstPostDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-18', 'studyFirstPostDateStruct': {'date': '2014-07-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) as Per Genotype', 'timeFrame': 'Day 1 up to the 35-day post discharge visit (up to an average of Day 43)', 'description': 'AE: any untoward medical occurrence in a participant who received investigational product without regard to possibility of a causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. An adverse event was considered a treatment-emergent adverse event (TEAE) if the event started during the effective duration of treatment (all events that started on or after the first dosing). AEs included both serious and non-serious adverse events.\n\nParticipants with AEs and SAEs were categorized by genotype categories. Category 1= participants with hemoglobin SS, hemoglobin S beta0 thalassemia and hemoglobin SD; category 2= participants with hemoglobin SC, hemoglobin S beta+ thalassemia and hemoglobin S-Variant (other than HbSD).'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Event (AEs) as Per Severity', 'timeFrame': 'Day 1 up to the 35-day post discharge visit (up to an average of Day 43)', 'description': "AE: any untoward medical occurrence in a participant who received investigational product without regard to possibility of a causal relationship. AEs were classified according to the severity in 3 categories a) mild - AEs did not interfere with participant's usual function, b) moderate - AEs interfered to some extent with participant's usual function, c) severe - AEs interfered significantly with participant's usual function."}, {'measure': 'Number of Participants With Clinical Laboratory Abnormalities', 'timeFrame': 'Day 1 up to the 35-day post discharge visit (up to an average of Day 43)', 'description': 'Hematology: hemoglobin, hematocrit, erythrocytes \\<0.8\\*lower limit of normal (LLN), reticulocytes \\<0.5\\*LLN \\>1.5\\*ULN, platelets\\<0.5\\*LLN\\>1.75\\*upper limit of normal (ULN), reticulocytes/erythrocytes\\<0.5\\*LLN\\>1.5\\*ULN, leukocytes \\<0.6\\*LLN \\>1.5\\*ULN, lymphocytes, lymphocytes/leukocytes, neutrophils, neutrophils/leukocytes \\<0.8\\*LLN \\>1.2\\*ULN, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes monocytes/leukocytes \\>1.2\\*ULN. Clinical chemistry: bilirubin, direct, bilirubin, indirect bilirubin\\>1.5\\*ULN, aspartate aminotransferase (AT), alanine AT, lactate dehydrogenase, alkaline phosphatase\\>3.0\\*ULN, urea nitrogen, urea, creatinine \\>1.3\\*ULN, sodium\\<0.95\\*LLN\\>1.05\\*ULN, potassium, chloride, bicarbonate\\<0.9\\*LLN\\>1.1\\*ULN, glucose\\<0.6\\*LLN\\>1.5\\*ULN, estimated glomerular filtration rate \\<=60. Urinalysis: urine glucose, ketones, urine protein, urine hemoglobin, nitrite, leukocyte esterase \\>=1.'}, {'measure': 'Number of Participants With Increase in Grades From Baseline in Clinical Laboratory Parameters Over the Study', 'timeFrame': 'Baseline up to the 35-day post discharge visit (up to an average of Day 43)', 'description': 'Hemoglobin(grade \\[G\\] 0:\\>11g/dl,G1:\\>9-11g/dl,G2:\\>7-9g/dl,G3:5-7g/dl,G4:\\<5g/dl),reticulocytes count(G0:\\<1%,G1:1-5%,G2:\\>5-10%,G3:\\>10-20%,G4:\\>20%),leukocytes(G0:\\<=upper limit of normal \\[ULN\\],G1:\\>ULN-15,000/mm\\^3,G2:\\>15,000- 20,000/mm\\^3,G3:\\>20,000- 50,000/mm\\^, G4:\\>50,000/mm\\^3),neutrophils(G0:\\>=LLN, G1:\\<LLN-1,500/mm\\^3, G2:\\<1,500-1,000/mm\\^3, G3:\\<1,000-500/mm\\^3, G4:\\<500/mm\\^3),blood urea nitrogen, creatinine(G0:\\<=ULN, G1:\\>ULN-1.5\\*UL, G2:\\>1.5-3.0\\*ULN, G3:\\>3.0\\*ULN, G4:\\>6.0\\*ULN), lactate dehydrogenase, alanine transaminase, aspartate aminotransferase(G0:\\<=ULN, G1:\\>ULN-3.0\\*ULN, G2:\\>3.0-5.0\\*ULN, G3:\\>5.0-20.0\\*ULN, G4:\\>20.0\\*ULN), bilirubin(G0:\\<=ULN, G1:\\>ULN-1.5\\*ULN, G2:\\>1.5-3.0\\*ULN, G3:\\>3.0-10.0\\*ULN, G4:\\>10.0\\*ULN), urine protein(G0:0-15mg/dL, G1:\\>15-30mg/dL, G2:\\>30-100mg/dL, G3:\\>100-300mg/dL, G4:\\>300mg/dL), platelet(G0:\\>=150K, G1:\\>=100K-\\<150K, G2:\\>=50K \\<100K, G3:\\<50K), eGFR (G0:\\>=90 mL/min/1.73m\\^2, G1:\\>=60-\\<90mL/min/1.73m\\^2, G2:\\>=30-\\<60mL/min/1.73m\\^2, G3:\\>=15-\\<30mL/min/1.73m\\^2, G4:\\<15 mL/min/1.73m\\^2)'}, {'measure': 'Number of Participants With Clinically Significant Changes in Physical Examination', 'timeFrame': 'From Post-screening up to end of treatment (up to an average of Day 8), From Post-discharge up to 35 days post-discharge (up to an average of Day 43)', 'description': 'Physical examination included assessment of the general appearance and the skin, head, ears, eyes, nose, mouth, throat, spine, neck, thyroid, chest, extremities, lymph nodes and abdomen (including liver and kidneys) plus the respiratory, cardiovascular, musculoskeletal, neurological and genitourinary systems. Clinical significance was assessed by the Investigator.'}, {'measure': 'Number of Participants With Treatment Related Changes From Baseline in Vital Signs Over the Study', 'timeFrame': 'Baseline (Day 1) up to the 35-day post discharge visit (up to an average of Day 43)', 'description': 'Vital signs included temperature, respiratory rate, pulse rate and systolic and diastolic blood pressure. Relatedness to treatment was assessed by the Investigator.'}, {'measure': 'Percentage of Participants With Adjudicated Acute Chest Syndrome (ACS)', 'timeFrame': 'Day 1 up to the 35-day post discharge visit (up to an average of Day 43)', 'description': 'Investigator reported events of Acute Chest Syndrome (ACS) and other reported respiratory events were sent for adjudication by the Acute Chest Syndrome Safety Endpoint Adjudication Committee. The committee, which consisted of physicians with relevant SCD expertise, evaluated these events and determined whether they were consistent with cases of ACS.'}, {'measure': 'Percentage of Participants With Severe Adjudicated and/or Generalized Cutaneous Manifestations', 'timeFrame': 'Day 1 up to the 35-day post discharge visit (up to an average of Day 43)', 'description': 'Investigator reported cutaneous events were sent for adjudication by the Cutaneous Manifestations Safety Endpoint Adjudication Committee. The committee, which consisted of dermatologists, evaluated these events and determined whether they were cases of severe and/or generalized cutaneous manifestations and specifically whether any event was consistent with Acute Generalized Exanthematous Pustulosis.'}, {'measure': 'Percentage of Participants Re-hospitalized for Vaso-Occlusive Crisis (VOC) Within 7, 14 and 30 Days of Discharge From Hospital', 'timeFrame': 'Within 7 days of discharge; Within 14 days of discharge; Within 30 days of discharge, where discharge from hospital was any day from Day 1 to an average of Day 8', 'description': 'Percentage of participants re-hospitalized for VOC within 7, 14 and 30 days of hospital discharge.'}], 'primaryOutcomes': [{'measure': 'Time to Readiness for Discharge From Hospital', 'timeFrame': 'Day 1 up to the latest day when all 6 criteria of readiness-for-discharge were met (up to an average of Day 8)', 'description': 'Time to readiness-for-discharge from hospital was defined as the difference (in hours) between the time and date when all criteria for readiness-for-discharge were met and the start time and date of the first infusion (loading dose) of study drug. Criteria for readiness-for-discharge were met when all of the applicable 6 criteria (in relation to treatment of VOC and complications related to the VOC) were documented to have occurred. The six criteria were: 1) only oral pain medication was required, 2) acute complications related to the VOC (such as acute chest syndrome, stroke, priapism) had resolved to the extent that management could be in an outpatient setting, 3) IV opioids had been discontinued, 4) IV hydration had been discontinued, 5) IV antibiotics had been discontinued and 6) red blood cell (RBC) transfusion was no longer required for treatment of this VOC.'}], 'secondaryOutcomes': [{'measure': 'Time to Discharge From Hospital', 'timeFrame': 'Day 1 up to the latest day when the order of hospital discharge was issued by a qualified healthcare provider (up to an average of Day 8)', 'description': 'Time to discharge from hospital was defined as the difference (in hours) between the time and date of the hospital discharge order from a qualified healthcare provider and the start time and date of the first infusion (loading dose) of study drug.'}, {'measure': 'Cumulative Intravenous (IV) Opioids Consumption From Time of Loading Dose of Study Drug to Discharge From Hospital', 'timeFrame': 'Day 1 up to the latest day when IV opioid was discontinued (up to an average of Day 8)', 'description': 'Cumulative IV opioid consumption was reported as cumulative IV opioid use (standardized using morphine equivalent units \\[MEU\\]), from the start of the first infusion (loading dose) of study drug until hospital discharge.'}, {'measure': 'Time to Discontinuation of Intravenous (IV) Opioids', 'timeFrame': 'Day 1 up to the latest day when IV opioid was discontinued (up to an average of Day 8)', 'description': 'Time to discontinuation of IV opioids was defined as the difference (in hours) between the stop time and date of the latest IV opioid dose and the start time and date of the first infusion (loading dose) of study drug.'}, {'measure': 'Cumulative Intravenous (IV) Opioids Consumption Within First 24 Hours Post-Loading Dose of Study Drug', 'timeFrame': '24 hours post first IV infusion of loading dose of study drug on Day 1', 'description': 'Cumulative IV opioid consumption (standardized using MEU) was reported as IV opioid use in the first 24 hours from the start time of the first IV infusion (loading dose) of study drug.'}, {'measure': 'Percentage of Participants Re-hospitalized for Vaso-Occlusive Crisis (VOC) Within 3 Days of Discharge From Hospital', 'timeFrame': 'Within 3 days of discharge from hospital, where discharge from hospital was any day from Day 1 to an average of Day 8', 'description': 'Percentage of participants who were re-hospitalized for a vaso-occlusive crisis (VOC) within 3 days of discharge from hospital are reported.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sickle Cell Anemia', 'Sickle Cell Disease', 'Sickle Cell Disorders', 'pain crisis', 'vaso-occlusive crisis', 'rivipansel', 'GMI-1070', 'selectin inhibitor', 'SCD', 'VOC'], 'conditions': ['Anemia, Sickle Cell']}, 'referencesModule': {'references': [{'pmid': '35981565', 'type': 'DERIVED', 'citation': 'Dampier CD, Telen MJ, Wun T, Brown RC, Desai P, El Rassi F, Fuh B, Kanter J, Pastore Y, Rothman J, Taylor JG, Readett D, Sivamurthy KM, Tammara B, Tseng LJ, Lozier JN, Thackray H, Magnani JL, Hassell KL; RESET Investigators. A randomized clinical trial of the efficacy and safety of rivipansel for sickle cell vaso-occlusive crisis. Blood. 2023 Jan 12;141(2):168-179. doi: 10.1182/blood.2022015797.'}, {'pmid': '35120836', 'type': 'DERIVED', 'citation': 'Rebelo AL, Chevalier MT, Russo L, Pandit A. Role and therapeutic implications of protein glycosylation in neuroinflammation. Trends Mol Med. 2022 Apr;28(4):270-289. doi: 10.1016/j.molmed.2022.01.004. Epub 2022 Feb 1.'}]}, 'descriptionModule': {'briefSummary': 'This is a clinical study evaluating the efficacy and safety of rivipansel (GMI-1070) in treating subjects with sickle cell disease (SCD) who are 6 years of age or older experiencing a pain crisis necessitating hospitalization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 6 years of age.\n* Documented diagnosis of sickle cell disease.\n* Diagnosis of vaso-occlusive crisis necessitating admission to the hospital with treatment including IV opioids.\n* Able to receive the first dose of study drug within 24 hours from the administration of IV opioids.\n\nExclusion Criteria:\n\n* Serious systemic infection\n* Acute Chest Syndrome\n* Serious concomitant medical problems (for example, stroke)\n* SCD pain atypical of VOC\n* Severe renal or hepatic impairment\n* Chronic pain rather than a presentation of acute VOC'}, 'identificationModule': {'nctId': 'NCT02187003', 'briefTitle': 'Efficacy and Safety of Rivipansel (GMI-1070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized Subjects With Sickle Cell Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biossil Inc.'}, 'officialTitle': 'A Phase 3, Multicenter ,Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Rivipansel (GMI-1070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized Subjects With Sickle Cell Disease', 'orgStudyIdInfo': {'id': 'B5201002'}, 'secondaryIdInfos': [{'id': 'RESET', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rivipansel Treatment Arm', 'interventionNames': ['Drug: Rivipansel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Treatment Arm', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Rivipansel', 'type': 'DRUG', 'otherNames': ['GMI-1070'], 'description': 'Rivipansel (GMI-1070) will be infused intravenously every 12 hours up to 15 doses maximum. Subjects aged 12 and over who weigh more than 40 kilograms will receive a dose of 1680 mg of rivipansel, followed by a dose of 840 mg of rivipansel every 12 hours. All subjects aged 6 to 11 years and any subject who weighs 40 kilograms or less, will receive weight-based dosing (mg/kg) of 40 mg/kg of rivipansel (maximum of 1680 mg) followed by a dose of 20 mg/kg of rivipansel (maximum of 840 mg) every 12 hours.', 'armGroupLabels': ['Rivipansel Treatment Arm']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['phosphate buffered saline (PBS)'], 'description': 'Placebo (phosphate buffered saline) will be infused intravenously every 12 hours up to 15 doses maximum.', 'armGroupLabels': ['Placebo Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36604', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': "University of South Alabama Children's and Women's Hospital", 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Hospital Research Pharmacy", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Hospital", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': "UCSF Benioff Children's Hospital Oakland", 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Medical Center Main Hospital', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado CTRC', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '20001', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Howard University Center for Sickle Cell Disease', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Medstar Health Research Institute', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20060', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Howard University Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33908', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': "Golisano Children's Hospital of Southwest Florida", 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'UF Health Davis Cancer Pavillion and Shands Med Plaza', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'UF Health Shands Cancer Hospital', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'UF Health Shands Hospital', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Jackson Memorial Hospital', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University Of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Drug Service Tampa General Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa General Hospital Center of Research Excellence', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa General Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': "St. Joseph's Children's Hospital", 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, 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