Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2026-01-01 @ 6:03 AM
Study NCT ID:
NCT02846532
Status:
COMPLETED
Last Update Posted:
2025-03-30
First Post:
2016-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetic, Pharmacodynamic, Safety, and Efficacy Study of Rivaroxaban for Thromboprophylaxis in Pediatric Participants 2 to 8 Years of Age After the Fontan Procedure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France', 'South Korea', 'Thailand']}, 'conditionBrowseModule': {'meshes': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D013923', 'term': 'Thromboembolism'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069552', 'term': 'Rivaroxaban'}, {'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'phone': '844-434-4210', 'title': 'SR DIRECTOR', 'organization': 'Janssen Research & Development, LLC'}, 'certainAgreement': {'otherDetails': 'If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 12 months', 'description': 'The safety population consisted of all participants in Part A who received at least 1 dose of study drug and all participants in Part B who were randomized and received at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months.", 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 11, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months.", 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 48, 'seriousNumAtRisk': 64, 'deathsNumAffected': 0, 'seriousNumAffected': 19}, {'id': 'EG002', 'title': 'Aspirin (Part B)', 'description': 'Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 26, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Increased Tendency to Bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Gingival Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Tooth Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Ear Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Gastroenteritis Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Otitis Media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Pharyngitis Streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Pharyngotonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Viral Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Arthropod Bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Ligament Sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Skin Abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Skin Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Traumatic Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Wound Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Musculoskeletal Stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Catarrh', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Chylothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Dermatitis Diaper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}], 'seriousEvents': [{'term': 'Cardiac Failure Congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Supraventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Periorbital Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Swelling Face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Gastroenteritis Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Stoma Site Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Vaccination Site Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Viral Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Wound Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Stoma Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Investigation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Weight Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Partial Seizures with Secondary Generalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Chylothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Shock Haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Any Thrombotic Event (Venous or Arterial and Symptomatic or Asymptomatic)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG002', 'title': 'Aspirin (Part B)', 'description': 'Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.'}], 'classes': [{'title': 'Any thrombotic event', 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}, {'value': '8.8', 'groupId': 'OG002'}]}]}, {'title': 'Ischemic stroke', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2.9', 'groupId': 'OG002'}]}]}, {'title': 'Pulmonary embolism', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Venous thrombosis', 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5.9', 'groupId': 'OG002'}]}]}, {'title': 'Arterial/intracardiac thrombosis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Other thrombosis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 months', 'description': 'Thrombotic event was defined as the appearance of a new thrombotic burden within the cardiovascular system on either routine surveillance or clinically indicated imaging, or the occurrence of a clinical event known to be strongly associated with thrombus (such as cardioembolic stroke, pulmonary embolism). The event included ischemic stroke, pulmonary embolism, venous thrombosis, arterial/intracardiac thrombosis, and other thrombosis.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants in Part A who received at least 1 dose of study drug and all participants in Part B who were randomized and received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Plasma Concentration of Rivaroxaban at Day 1 (0.5-1.5 Hours Postdose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '46.69', 'spread': '39.4', 'groupId': 'OG000'}, {'value': '92.86', 'spread': '72.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1: 0.5-1.5 hours postdose', 'description': 'Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.', 'unitOfMeasure': 'micrograms per liter (mcg/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of study drug and had quantifiable rivaroxaban plasma concentrations. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Plasma Concentration of Rivaroxaban at Day 1 (1.5-4 Hours Postdose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '86.62', 'spread': '43.1', 'groupId': 'OG000'}, {'value': '103.61', 'spread': '62.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1: 1.5-4 hours postdose', 'description': 'Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.', 'unitOfMeasure': 'mcg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis set included all participants who received at least 1 dose of study drug and had quantifiable rivaroxaban plasma concentrations. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Plasma Concentration of Rivaroxaban at Day 4 (Up to 3 Hours Predose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '36.58', 'spread': '37.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 4: Up to 3 hours predose', 'description': 'Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.', 'unitOfMeasure': 'mcg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis set included all participants who received at least 1 dose of study drug and had quantifiable rivaroxaban plasma concentrations. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Plasma Concentration of Rivaroxaban at Day 4 (0.5-1.5 Hours Postdose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '107.58', 'spread': '54.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 4: 0.5-1.5 hours postdose', 'description': 'Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.', 'unitOfMeasure': 'mcg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis set included all participants who received at least 1 dose of study drug and had quantifiable rivaroxaban plasma concentrations. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Plasma Concentration of Rivaroxaban at Day 4 (1.5-4 Hours Postdose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '147.18', 'spread': '116', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 4: 1.5-4 hours postdose', 'description': 'Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.', 'unitOfMeasure': 'mcg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis set included all participants who received at least 1 dose of study drug and had quantifiable rivaroxaban plasma concentrations. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Plasma Concentration of Rivaroxaban at Day 4 (6-8 Hours Postdose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '66.81', 'spread': '64.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 4: 6-8 hours postdose', 'description': 'Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.', 'unitOfMeasure': 'mcg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis set included all participants who received at least 1 dose of study drug and had quantifiable rivaroxaban plasma concentrations. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Plasma Concentration of Rivaroxaban at Month 3 (Up to 3 Hours Predose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '38.23', 'spread': '25.7', 'groupId': 'OG000'}, {'value': '29.41', 'spread': '25.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3: Up to 3 hours predose', 'description': 'Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.', 'unitOfMeasure': 'mcg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis set included all participants who received at least 1 dose of study drug and had quantifiable rivaroxaban plasma concentrations. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Plasma Concentration of Rivaroxaban at Month 3 (0.5-1.5 Hours Postdose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '86.25', 'spread': '32.0', 'groupId': 'OG000'}, {'value': '94.12', 'spread': '82.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3: 0.5-1.5 hours postdose', 'description': 'Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.', 'unitOfMeasure': 'mcg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis set included all participants who received at least 1 dose of study drug and had quantifiable rivaroxaban plasma concentrations. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Plasma Concentration of Rivaroxaban at Month 3 (2.5-4 Hours Postdose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '96.67', 'spread': '58.4', 'groupId': 'OG000'}, {'value': '102.99', 'spread': '56.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3: 2.5-4 hours postdose', 'description': 'Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.', 'unitOfMeasure': 'mcg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis set included all participants who received at least 1 dose of study drug and had quantifiable rivaroxaban plasma concentrations. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Bleeding Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG002', 'title': 'Aspirin (Part B)', 'description': 'Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.'}], 'classes': [{'title': 'Any bleeding event', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '35.9', 'groupId': 'OG001'}, {'value': '41.2', 'groupId': 'OG002'}]}]}, {'title': 'Major Bleeding', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Clinically relevant non-major bleeding', 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}, {'value': '8.8', 'groupId': 'OG002'}]}]}, {'title': 'Trivial bleeding', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '32.8', 'groupId': 'OG001'}, {'value': '35.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 months', 'description': 'Bleeding events were categorized into major, clinically relevant non-major bleeding (CRNM), and trivial bleeding events. Major bleeding: overt bleeding and associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more; or leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults; or occurring in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal; or contributing to death. CRNM bleeding: overt bleeding not meeting the criteria for major bleeding but associated with: Medical intervention, or Unscheduled contact with a physician, cessation of study treatment, or Discomfort for the subject such as pain, or Impairment of activities of daily life. Trivial bleeding: any other overt bleeding event that does not meet criteria for CRNM bleeding.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants in Part A who received at least 1 dose of study drug and all participants in Part B who were randomized and received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Absolute Prothrombin Time (PT) at Day 1 (0.5-1.5 Hours Postdose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '15.46', 'spread': '1.90', 'groupId': 'OG000'}, {'value': '18.02', 'spread': '2.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1: 0.5-1.5 hours postdose', 'description': 'Absolute prothrombin time was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacodynamic (PD) analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, activated partial thromboplastin time (aPTT), and/or anti-factor Xa (FXa) activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Absolute PT at Day 1 (1.5-4 Hours Postdose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '16.58', 'spread': '1.84', 'groupId': 'OG000'}, {'value': '18.76', 'spread': '2.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1: 1.5-4 hours postdose', 'description': 'Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Absolute PT at Day 4 (Up to 3 Hours Predose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '15.21', 'spread': '1.54', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 4: Up to 3 hours predose', 'description': 'Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average the participants included in the given time-range is presented here.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Absolute PT at Day 4 (0.5-1.5 Hours Postdose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '17.95', 'spread': '2.10', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 4: 0.5-1.5 hours postdose', 'description': 'Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacodynamic (PD) analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Absolute PT at Day 4 (1.5-4 Hours Postdose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '18.73', 'spread': '3.30', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 4: 1.5-4 hours postdose', 'description': 'Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacodynamic (PD) analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Absolute PT at Day 4 (6-8 Hours Postdose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '16.13', 'spread': '2.13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 4: 6-8 hours postdose', 'description': 'Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Absolute PT at Month 3 (Up to 3 Hours Predose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '17.59', 'spread': '2.65', 'groupId': 'OG000'}, {'value': '16.45', 'spread': '2.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3: Up to 3 hours predose', 'description': 'Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Absolute PT at Month 3 (0.5-1.5 Hours Postdose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '20.13', 'spread': '3.55', 'groupId': 'OG000'}, {'value': '18.89', 'spread': '3.69', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3: 0.5-1.5 hours postdose', 'description': 'Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Absolute PT at Month 3 (2.5-4 Hours Postdose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '19.14', 'spread': '2.61', 'groupId': 'OG000'}, {'value': '19.69', 'spread': '2.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3: 2.5-4 hours postdose', 'description': 'Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Activated Partial Thromboplastin Time (aPTT) at Day 1 (0.5-1.5 Hours Postdose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '31.4', 'spread': '4.68', 'groupId': 'OG000'}, {'value': '30.69', 'spread': '8.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1: 0.5-1.5 hours postdose', 'description': 'aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'aPTT at Day 1 (1.5-4 Hours Postdose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '32.83', 'spread': '3.79', 'groupId': 'OG000'}, {'value': '30.25', 'spread': '3.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1: 1.5-4 hours postdose', 'description': 'aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and average of the participants included in the given time-range is presented here.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'aPTT at Day 4 (Up to 3 Hours Predose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '33.08', 'spread': '5.68', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 4: Up to 3 hours predose', 'description': 'aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'aPTT at Day 4 (0.5-1.5 Hours Postdose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '36.17', 'spread': '6.99', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 4: 0.5-1.5 hours postdose', 'description': 'aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average the participants included in the given time-range is presented here.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'aPTT at Day 4 (1.5-4 Hours Postdose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '37.58', 'spread': '8.45', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 4: 1.5-4 hours postdose', 'description': 'aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average for the participants included in the given time-range is presented here.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'aPTT at Day 4 (6-8 Hours Postdose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '32.83', 'spread': '5.94', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 4: 6-8 hours postdose', 'description': 'aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'aPTT at Month 3 (Up to 3 Hours Predose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '25.36', 'spread': '3.76', 'groupId': 'OG000'}, {'value': '28.70', 'spread': '3.76', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3: Up to 3 hours predose', 'description': 'aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'aPTT at Month 3 (0.5-1.5 Hours Postdose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '26.60', 'spread': '2.55', 'groupId': 'OG000'}, {'value': '31.15', 'spread': '4.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3: 0.5-1.5 hours postdose', 'description': 'aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'aPTT at Month 3 (2.5-4 Hours Postdose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '26.74', 'spread': '1.79', 'groupId': 'OG000'}, {'value': '31.67', 'spread': '3.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3: 2.5-4 hours postdose', 'description': 'aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Anti-FXa at Day 1 (0.5-1.5 Hours Postdose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '66.93', 'spread': '23.9', 'groupId': 'OG000'}, {'value': '99.46', 'spread': '60.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1: 0.5-1.5 hours postdose', 'description': 'Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.', 'unitOfMeasure': 'mcg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Anti-FXa at Day 1 (1.5-4 Hours Postdose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '74.06', 'spread': '32.4', 'groupId': 'OG000'}, {'value': '104.57', 'spread': '55.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1: 1.5-4 hours postdose', 'description': 'Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.', 'unitOfMeasure': 'mcg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Anti-FXa at Day 4 (6-8 Hours Postdose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '74.21', 'spread': '60.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 4: 6-8 hours postdose', 'description': 'Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.', 'unitOfMeasure': 'mcg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Anti-FXa at Month 3 (Up to 3 Hours Predose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '60.51', 'spread': '29.4', 'groupId': 'OG000'}, {'value': '53.41', 'spread': '15.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3: Up to 3 hours predose', 'description': 'Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.', 'unitOfMeasure': 'mcg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG002', 'title': 'Aspirin (Part B)', 'description': 'Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '91.7', 'groupId': 'OG000'}, {'value': '85.9', 'groupId': 'OG001'}, {'value': '85.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 months', 'description': 'TEAEs were defined as those adverse events (AEs) that occurred from the first day of study drug to the last day of study drug + 2 days inclusive. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants in Part A who received at least 1 dose of study drug and all participants in Part B who were randomized and received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Anti-FXa at Month 3 (0.5-1.5 Hours Postdose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '110.90', 'spread': '75.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3: 0.5-1.5 hours postdose', 'description': 'Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.', 'unitOfMeasure': 'mcg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Anti-FXa at Month 3 (2.5-4 Hours Postdose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'OG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '93.48', 'spread': '50.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3: 2.5-4 hours postdose', 'description': 'Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.', 'unitOfMeasure': 'mcg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PD analysis set included all participants who received at least 1 dose of study drug and had quantifiable and time-matched PT, aPTT, and/or anti-FXa activity values were included in the descriptive PD analysis. Here, 'N' (number of participants analyzed) signifies number of participants that were analyzed for this outcome measure."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'FG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'FG002', 'title': 'Aspirin (Part B)', 'description': 'Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '112', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Rivaroxaban (Part A)', 'description': "Participants received rivaroxaban as 0.1 percent (%) (1 milligram per milliliter \\[mg/ml\\]) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to less than \\[\\<\\] 8 kilograms \\[kg\\] participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg; and 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'BG001', 'title': 'Rivaroxaban (Part B)', 'description': "Participants received rivaroxaban as 0.1% (1 mg/ml) oral suspension with target exposure matching to that of rivaroxaban 10 mg given once daily in adults as per participant's body weight adjusted total daily dosing administered as two doses 12 hours apart (7 to \\<8 kg participant received 2.2 mg; 8 to \\<10 kg received 3.2 mg; 10 to \\<12 kg received 3.4 mg; 12 to \\<20 kg received 4.0 mg and; 20 to \\<30 kg received 5.0 mg) (morning and evening dosing), up to 12 months."}, {'id': 'BG002', 'title': 'Aspirin (Part B)', 'description': 'Participants received aspirin (acetylsalicylic acid) 5 mg/kg once daily up to 12 months.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '0.67', 'groupId': 'BG000'}, {'value': '4.1', 'spread': '1.74', 'groupId': 'BG001'}, {'value': '4.2', 'spread': '1.8', 'groupId': 'BG002'}, {'value': '3.9', 'spread': '1.74', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'ARGENTINA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'BELGIUM', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'BRAZIL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}, {'title': 'CANADA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'JAPAN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'MALAYSIA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}, {'title': 'MEXICO', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'NETHERLANDS', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'SPAIN', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'UNITED STATES', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-07-27', 'size': 1706073, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-01-13T05:10', 'hasProtocol': True}, {'date': '2019-05-16', 'size': 1336382, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-01-13T05:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'dispFirstSubmitDate': '2021-07-13', 'completionDateStruct': {'date': '2020-07-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-28', 'studyFirstSubmitDate': '2016-07-25', 'dispFirstSubmitQcDate': '2021-07-13', 'resultsFirstSubmitDate': '2022-01-13', 'studyFirstSubmitQcDate': '2016-07-25', 'dispFirstPostDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-02', 'studyFirstPostDateStruct': {'date': '2016-07-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Any Thrombotic Event (Venous or Arterial and Symptomatic or Asymptomatic)', 'timeFrame': 'Up to 12 months', 'description': 'Thrombotic event was defined as the appearance of a new thrombotic burden within the cardiovascular system on either routine surveillance or clinically indicated imaging, or the occurrence of a clinical event known to be strongly associated with thrombus (such as cardioembolic stroke, pulmonary embolism). The event included ischemic stroke, pulmonary embolism, venous thrombosis, arterial/intracardiac thrombosis, and other thrombosis.'}, {'measure': 'Plasma Concentration of Rivaroxaban at Day 1 (0.5-1.5 Hours Postdose)', 'timeFrame': 'Day 1: 0.5-1.5 hours postdose', 'description': 'Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.'}, {'measure': 'Plasma Concentration of Rivaroxaban at Day 1 (1.5-4 Hours Postdose)', 'timeFrame': 'Day 1: 1.5-4 hours postdose', 'description': 'Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.'}, {'measure': 'Plasma Concentration of Rivaroxaban at Day 4 (Up to 3 Hours Predose)', 'timeFrame': 'Day 4: Up to 3 hours predose', 'description': 'Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.'}, {'measure': 'Plasma Concentration of Rivaroxaban at Day 4 (0.5-1.5 Hours Postdose)', 'timeFrame': 'Day 4: 0.5-1.5 hours postdose', 'description': 'Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.'}, {'measure': 'Plasma Concentration of Rivaroxaban at Day 4 (1.5-4 Hours Postdose)', 'timeFrame': 'Day 4: 1.5-4 hours postdose', 'description': 'Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.'}, {'measure': 'Plasma Concentration of Rivaroxaban at Day 4 (6-8 Hours Postdose)', 'timeFrame': 'Day 4: 6-8 hours postdose', 'description': 'Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.'}, {'measure': 'Plasma Concentration of Rivaroxaban at Month 3 (Up to 3 Hours Predose)', 'timeFrame': 'Month 3: Up to 3 hours predose', 'description': 'Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.'}, {'measure': 'Plasma Concentration of Rivaroxaban at Month 3 (0.5-1.5 Hours Postdose)', 'timeFrame': 'Month 3: 0.5-1.5 hours postdose', 'description': 'Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.'}, {'measure': 'Plasma Concentration of Rivaroxaban at Month 3 (2.5-4 Hours Postdose)', 'timeFrame': 'Month 3: 2.5-4 hours postdose', 'description': 'Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.'}, {'measure': 'Percentage of Participants With Bleeding Events', 'timeFrame': 'Up to 12 months', 'description': 'Bleeding events were categorized into major, clinically relevant non-major bleeding (CRNM), and trivial bleeding events. Major bleeding: overt bleeding and associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more; or leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults; or occurring in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal; or contributing to death. CRNM bleeding: overt bleeding not meeting the criteria for major bleeding but associated with: Medical intervention, or Unscheduled contact with a physician, cessation of study treatment, or Discomfort for the subject such as pain, or Impairment of activities of daily life. Trivial bleeding: any other overt bleeding event that does not meet criteria for CRNM bleeding.'}, {'measure': 'Absolute Prothrombin Time (PT) at Day 1 (0.5-1.5 Hours Postdose)', 'timeFrame': 'Day 1: 0.5-1.5 hours postdose', 'description': 'Absolute prothrombin time was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.'}, {'measure': 'Absolute PT at Day 1 (1.5-4 Hours Postdose)', 'timeFrame': 'Day 1: 1.5-4 hours postdose', 'description': 'Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.'}, {'measure': 'Absolute PT at Day 4 (Up to 3 Hours Predose)', 'timeFrame': 'Day 4: Up to 3 hours predose', 'description': 'Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average the participants included in the given time-range is presented here.'}, {'measure': 'Absolute PT at Day 4 (0.5-1.5 Hours Postdose)', 'timeFrame': 'Day 4: 0.5-1.5 hours postdose', 'description': 'Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.'}, {'measure': 'Absolute PT at Day 4 (1.5-4 Hours Postdose)', 'timeFrame': 'Day 4: 1.5-4 hours postdose', 'description': 'Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.'}, {'measure': 'Absolute PT at Day 4 (6-8 Hours Postdose)', 'timeFrame': 'Day 4: 6-8 hours postdose', 'description': 'Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.'}, {'measure': 'Absolute PT at Month 3 (Up to 3 Hours Predose)', 'timeFrame': 'Month 3: Up to 3 hours predose', 'description': 'Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.'}, {'measure': 'Absolute PT at Month 3 (0.5-1.5 Hours Postdose)', 'timeFrame': 'Month 3: 0.5-1.5 hours postdose', 'description': 'Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.'}, {'measure': 'Absolute PT at Month 3 (2.5-4 Hours Postdose)', 'timeFrame': 'Month 3: 2.5-4 hours postdose', 'description': 'Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.'}, {'measure': 'Activated Partial Thromboplastin Time (aPTT) at Day 1 (0.5-1.5 Hours Postdose)', 'timeFrame': 'Day 1: 0.5-1.5 hours postdose', 'description': 'aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.'}, {'measure': 'aPTT at Day 1 (1.5-4 Hours Postdose)', 'timeFrame': 'Day 1: 1.5-4 hours postdose', 'description': 'aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and average of the participants included in the given time-range is presented here.'}, {'measure': 'aPTT at Day 4 (Up to 3 Hours Predose)', 'timeFrame': 'Day 4: Up to 3 hours predose', 'description': 'aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.'}, {'measure': 'aPTT at Day 4 (0.5-1.5 Hours Postdose)', 'timeFrame': 'Day 4: 0.5-1.5 hours postdose', 'description': 'aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average the participants included in the given time-range is presented here.'}, {'measure': 'aPTT at Day 4 (1.5-4 Hours Postdose)', 'timeFrame': 'Day 4: 1.5-4 hours postdose', 'description': 'aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average for the participants included in the given time-range is presented here.'}, {'measure': 'aPTT at Day 4 (6-8 Hours Postdose)', 'timeFrame': 'Day 4: 6-8 hours postdose', 'description': 'aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.'}, {'measure': 'aPTT at Month 3 (Up to 3 Hours Predose)', 'timeFrame': 'Month 3: Up to 3 hours predose', 'description': 'aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.'}, {'measure': 'aPTT at Month 3 (0.5-1.5 Hours Postdose)', 'timeFrame': 'Month 3: 0.5-1.5 hours postdose', 'description': 'aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.'}, {'measure': 'aPTT at Month 3 (2.5-4 Hours Postdose)', 'timeFrame': 'Month 3: 2.5-4 hours postdose', 'description': 'aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.'}, {'measure': 'Anti-FXa at Day 1 (0.5-1.5 Hours Postdose)', 'timeFrame': 'Day 1: 0.5-1.5 hours postdose', 'description': 'Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.'}, {'measure': 'Anti-FXa at Day 1 (1.5-4 Hours Postdose)', 'timeFrame': 'Day 1: 1.5-4 hours postdose', 'description': 'Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.'}, {'measure': 'Anti-FXa at Day 4 (6-8 Hours Postdose)', 'timeFrame': 'Day 4: 6-8 hours postdose', 'description': 'Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.'}, {'measure': 'Anti-FXa at Month 3 (Up to 3 Hours Predose)', 'timeFrame': 'Month 3: Up to 3 hours predose', 'description': 'Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.'}, {'measure': 'Anti-FXa at Month 3 (0.5-1.5 Hours Postdose)', 'timeFrame': 'Month 3: 0.5-1.5 hours postdose', 'description': 'Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.'}, {'measure': 'Anti-FXa at Month 3 (2.5-4 Hours Postdose)', 'timeFrame': 'Month 3: 2.5-4 hours postdose', 'description': 'Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to 12 months', 'description': 'TEAEs were defined as those adverse events (AEs) that occurred from the first day of study drug to the last day of study drug + 2 days inclusive. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thromboembolism', 'Fontan Procedure', 'Children'], 'conditions': ['Thrombosis']}, 'referencesModule': {'references': [{'pmid': '34558312', 'type': 'DERIVED', 'citation': 'McCrindle BW, Michelson AD, Van Bergen AH, Suzana Horowitz E, Pablo Sandoval J, Justino H, Harris KC, Jefferies JL, Miriam Pina L, Peluso C, Nessel K, Lu W, Li JS; UNIVERSE Study Investigators *. Thromboprophylaxis for Children Post-Fontan Procedure: Insights From the UNIVERSE Study. J Am Heart Assoc. 2021 Nov 16;10(22):e021765. doi: 10.1161/JAHA.120.021765. Epub 2021 Sep 24.'}], 'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217051&parentIdentifier=CR108075&attachmentIdentifier=ecc7606d-69c9-4747-8c64-2f0ad414eacd&fileName=2015-002610-76-_Receipt.png&versionIdentifier=', 'label': 'ERF update upload receipt'}]}, 'descriptionModule': {'briefSummary': 'The Purpose of this study is to characterize the single and multiple-dose pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/ PD) profiles after oral rivaroxaban therapy administered to pediatric participants 2 to 8 years of age with single ventricle physiology who have completed the Fontan procedure within 4 months prior to enrollment (Part A) and to evaluate the safety and efficacy of rivaroxaban, administered twice daily (exposure matched to rivaroxaban 10 milligram \\[mg\\] once daily in adults) compared to acetylsalicylic acid (ASA), given once daily (approximately 5 milligram per kilogram \\[mg/kg\\]) for thromboprophylaxis in pediatric participants 2 to 8 years of age with single ventricle physiology who have completed the Fontan procedure within 4 months prior to enrollment.', 'detailedDescription': 'Part A: This part includes a 12-day Initial PK, PD, and Safety Assessment Period. Participants in Part A will not participate in Part B. Randomization in Part B of this study will begin once the cumulative data from the Initial PK, PD, and Safety Assessment Period in Part A are deemed acceptable by the Independent Data Monitoring Committee. Part A of the study will consist of an up to 21-day Screening Period, a 12-day Initial PK, PD, and Safety Assessment Period, a 12-month Open-Label Treatment Period, and a 30-day Follow-Up phone contact. Part B: Participants will be randomly assigned to two treatment groups and randomization ratio will be 2:1 for rivaroxaban and ASA. ASA will be used as control. There will be an up to a 21-day Screening Period, a 12 month Open-Label Treatment Period and a 30-day Follow-Up phone contact.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant must be considered to be clinically stable by the investigator and able to tolerate oral or enteral administration of a suspension formulation and oral/enteral feedings\n* Satisfactory initial post-Fontan transthoracic echocardiographic Screening as defined in the Post-Fontan Echocardiographic Examination Research Protocol\n* Parent/legally acceptable representative must sign an informed consent form (ICF) and child assent will also be provided, if applicable, according to local requirements\n\nExclusion Criteria:\n\n* Evidence of thrombosis, including those that are asymptomatic confirmed by post-Fontan procedure transthoracic echocardiogram, or other imaging techniques, during the Screening period of the study\n* History of gastrointestinal disease or surgery associated with clinically relevant impaired absorption\n* History of or signs/symptoms suggestive of protein-losing enteropathy\n* Active bleeding or high risk for bleeding contraindicating antiplatelet or anticoagulant therapy, including a history of intracranial bleeding\n* Platelet count less than (\\<)50\\*10\\^9/Liters (L) at Screening\n* Estimated glomerular filtration rate (eGFR) \\<30 milliliters per minute per 1.73 meter square (mL/min/1.73m\\^2)\n* Known clinically significant liver disease'}, 'identificationModule': {'nctId': 'NCT02846532', 'acronym': 'UNIVERSE', 'briefTitle': 'Pharmacokinetic, Pharmacodynamic, Safety, and Efficacy Study of Rivaroxaban for Thromboprophylaxis in Pediatric Participants 2 to 8 Years of Age After the Fontan Procedure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'A Prospective, Open-Label, Active-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age After the Fontan Procedure', 'orgStudyIdInfo': {'id': 'CR108075'}, 'secondaryIdInfos': [{'id': '39039039CHD3001', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}, {'id': '2015-002610-76', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rivaroxaban', 'interventionNames': ['Drug: Rivaroxaban']}, {'type': 'EXPERIMENTAL', 'label': 'Acetylsalicylic Acid', 'interventionNames': ['Drug: Acetylsalicylic Acid']}], 'interventions': [{'name': 'Rivaroxaban', 'type': 'DRUG', 'description': 'Participants will receive oral suspension containing rivaroxaban 1 milligram per milliliter (mg/ml) twice daily in Part A and Part B. Following total daily doses of Rivaroxaban will be administered based on the weight of the participants: 7 to \\<8 kilogram (kg) will receive 2.2 milligram (mg); 8 to \\<10 kg will receive 3.2 mg; 10 to\\<12 kg will receive 3.4 mg; 12 to \\<20 will receive 4.0 mg and 20 to \\<30 will receive 5.0 mg.', 'armGroupLabels': ['Rivaroxaban']}, {'name': 'Acetylsalicylic Acid', 'type': 'DRUG', 'description': 'Participants will receive 5 milligram per kilogram (mg/kg) of acetylsalicylic acid once daily up to 12 months in Part B.', 'armGroupLabels': ['Acetylsalicylic Acid']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'city': 'Oak Lawn', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.71087, 'lon': -87.75811}}, {'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Hershey', 'state': 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'country': 'Japan', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Kuala Lumpur', 'country': 'Malaysia', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'city': 'México', 'country': 'Mexico', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}, {'city': 'Leiden', 'country': 'Netherlands', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Utrecht', 'country': 'Netherlands', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'city': 'A Coruña', 'country': 'Spain', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'city': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Bilbao', 'country': 'Spain', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'city': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Valencia', 'country': 'Spain', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Janssen Research & Development, LLC Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Research & Development, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Research & Development, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Bayer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}