Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2025-12-29 @ 12:08 PM
Study NCT ID:
NCT00569803
Status:
COMPLETED
Last Update Posted:
2016-09-22
First Post:
2007-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Subcutaneous Pharmacokinetics of Belatacept
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069594', 'term': 'Abatacept'}], 'ancestors': [{'id': 'D018796', 'term': 'Immunoconjugates'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)', 'description': 'Study initiated: December 2007\n\nStudy completed: August 2008\n\nParticipants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.', 'eventGroups': [{'id': 'EG000', 'title': 'Belatacept 50mg SC', 'description': 'Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume', 'otherNumAtRisk': 5, 'otherNumAffected': 2, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Belatacept 100mg SC', 'description': 'Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume', 'otherNumAtRisk': 5, 'otherNumAffected': 3, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Belatacept 125mg SC', 'description': 'Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume', 'otherNumAtRisk': 5, 'otherNumAffected': 3, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Belatacept 150mg SC', 'description': 'Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.', 'otherNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Belatacept 200mg SC', 'description': 'Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.', 'otherNumAtRisk': 5, 'otherNumAffected': 2, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Belatacept 250mg SC', 'description': 'Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.', 'otherNumAtRisk': 5, 'otherNumAffected': 2, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Belatacept 125mg IV', 'description': '125 mg Belatacept intravenous (IV) injection', 'otherNumAtRisk': 10, 'otherNumAffected': 7, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'PLACEBO', 'description': 'Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)', 'otherNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'All Belatacept', 'description': 'All participants treated with IV or SC Belatacept of any dose', 'otherNumAtRisk': 41, 'otherNumAffected': 23, 'seriousNumAtRisk': 41, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 41, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Arthropod sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Joint sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gynaecomastia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 41, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Sinus headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 41, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Muscle contractions involuntary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 41, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 41, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Observed Serum Concentration (Cmax) of Belatacept', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 50 mg Subcutaneous Injection', 'description': 'Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume'}, {'id': 'OG001', 'title': 'Belatacept 100 mg Subcutaneous Injection', 'description': 'Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume'}, {'id': 'OG002', 'title': 'Belatacept 125 mg Subcutaneous Injection', 'description': 'Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume'}, {'id': 'OG003', 'title': 'Belatacept 150 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG004', 'title': 'Belatacept 200 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG005', 'title': 'Belatacept 250 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG006', 'title': 'Belatacept 125 mg Intravenous Infusion', 'description': '125 mg Belatacept intravenous (IV) injection'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '30', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '34', 'groupId': 'OG001'}, {'value': '8.5', 'spread': '50', 'groupId': 'OG002'}, {'value': '11.1', 'spread': '19', 'groupId': 'OG003'}, {'value': '14.5', 'spread': '16', 'groupId': 'OG004'}, {'value': '14.5', 'spread': '18', 'groupId': 'OG005'}, {'value': '42.4', 'spread': '16', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116', 'description': 'Maximum observed serum concentration (Cmax) values were derived from serum concentration versus time data and reported in micrograms per milliliter (ug/mL).', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants treated with Belatacept'}, {'type': 'PRIMARY', 'title': 'Time of Maximum Observed Serum Concentration (Tmax) of Belatacept', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 50 mg Subcutaneous Injection', 'description': 'Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume'}, {'id': 'OG001', 'title': 'Belatacept 100 mg Subcutaneous Injection', 'description': 'Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume'}, {'id': 'OG002', 'title': 'Belatacept 125 mg Subcutaneous Injection', 'description': 'Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume'}, {'id': 'OG003', 'title': 'Belatacept 150 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG004', 'title': 'Belatacept 200 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG005', 'title': 'Belatacept 250 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG006', 'title': 'Belatacept 125 mg Intravenous Infusion', 'description': '125 mg Belatacept intravenous (IV) injection'}], 'classes': [{'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000', 'lowerLimit': '36', 'upperLimit': '96'}, {'value': '60', 'groupId': 'OG001', 'lowerLimit': '48', 'upperLimit': '120'}, {'value': '96', 'groupId': 'OG002', 'lowerLimit': '48', 'upperLimit': '144'}, {'value': '60', 'groupId': 'OG003', 'lowerLimit': '36', 'upperLimit': '96'}, {'value': '60', 'groupId': 'OG004', 'lowerLimit': '24', 'upperLimit': '84'}, {'value': '72', 'groupId': 'OG005', 'lowerLimit': '60', 'upperLimit': '96'}, {'value': '0.5', 'groupId': 'OG006', 'lowerLimit': '0.2', 'upperLimit': '2.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116', 'description': 'Time of maximum observed serum concentration (Tmax) values were derived from serum concentration versus time data for all participants treated with Belatacept.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants treated with Belatacept'}, {'type': 'PRIMARY', 'title': 'Adjusted Geometric Means of Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC(0-T)) for Belatacept', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 50 mg Subcutaneous Injection', 'description': 'Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume'}, {'id': 'OG001', 'title': 'Belatacept 100 mg Subcutaneous Injection', 'description': 'Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume'}, {'id': 'OG002', 'title': 'Belatacept 125 mg Subcutaneous Injection', 'description': 'Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume'}, {'id': 'OG003', 'title': 'Belatacept 150 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG004', 'title': 'Belatacept 200 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG005', 'title': 'Belatacept 250 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG006', 'title': 'Belatacept 125 mg Intravenous Infusion', 'description': '125 mg Belatacept intravenous (IV) injection'}], 'classes': [{'categories': [{'measurements': [{'value': '2587', 'groupId': 'OG000', 'lowerLimit': '2132', 'upperLimit': '3139'}, {'value': '1848', 'groupId': 'OG001', 'lowerLimit': '1523', 'upperLimit': '2242'}, {'value': '2371', 'groupId': 'OG002', 'lowerLimit': '1954', 'upperLimit': '2876'}, {'value': '2703', 'groupId': 'OG003', 'lowerLimit': '2228', 'upperLimit': '3280'}, {'value': '2650', 'groupId': 'OG004', 'lowerLimit': '2184', 'upperLimit': '3215'}, {'value': '2193', 'groupId': 'OG005', 'lowerLimit': '1807', 'upperLimit': '2660'}, {'value': '3023', 'groupId': 'OG006', 'lowerLimit': '2637', 'upperLimit': '3466'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG006'], 'paramType': 'Ratio of Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.86', 'ciLowerLimit': '0.68', 'ciUpperLimit': '1.08', 'estimateComment': 'Ratio of Geometric Means: 50mg SC over 125mg IV', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG006'], 'paramType': 'Ratio of Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.61', 'ciLowerLimit': '0.48', 'ciUpperLimit': '0.77', 'estimateComment': 'Ratio of Geometric Means: 100mg SC over 125mg IV', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG006'], 'paramType': 'Ratio of Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.78', 'ciLowerLimit': '0.62', 'ciUpperLimit': '0.99', 'estimateComment': 'Ratio of Geometric Means: 125mg SC over 125mg IV', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003', 'OG006'], 'paramType': 'Ratio of Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.89', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.13', 'estimateComment': 'Ratio of Geometric Means: 150mg SC over 125mg IV', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG006'], 'paramType': 'Ratio of Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.88', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.11', 'estimateComment': 'Ratio of Geometric Means: 200mg SC over 125mg IV', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG006'], 'paramType': 'Ratio of Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.73', 'ciLowerLimit': '0.57', 'ciUpperLimit': '0.92', 'estimateComment': 'Ratio of Geometric Means: 250mg SC over 125mg IV', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116', 'description': 'Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUC(0-T)) was derived from serum concentration versus time data. Adjusted geometric means were reported in microgram hours per milliliter (ug\\*h/mL).', 'unitOfMeasure': 'ug*h/mL', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants treated with Belatacept'}, {'type': 'PRIMARY', 'title': 'Adjusted Geometric Means of Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) for Belatacept', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 50 mg Subcutaneous Injection', 'description': 'Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume'}, {'id': 'OG001', 'title': 'Belatacept 100 mg Subcutaneous Injection', 'description': 'Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume'}, {'id': 'OG002', 'title': 'Belatacept 125 mg Subcutaneous Injection', 'description': 'Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume'}, {'id': 'OG003', 'title': 'Belatacept 150 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG004', 'title': 'Belatacept 200 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG005', 'title': 'Belatacept 250 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG006', 'title': 'Belatacept 125 mg Intravenous Infusion', 'description': '125 mg Belatacept intravenous (IV) injection'}], 'classes': [{'categories': [{'measurements': [{'value': '2639', 'groupId': 'OG000', 'lowerLimit': '2172', 'upperLimit': '3205'}, {'value': '1851', 'groupId': 'OG001', 'lowerLimit': '1524', 'upperLimit': '2248'}, {'value': '2380', 'groupId': 'OG002', 'lowerLimit': '1959', 'upperLimit': '2891'}, {'value': '2719', 'groupId': 'OG003', 'lowerLimit': '2238', 'upperLimit': '3303'}, {'value': '2666', 'groupId': 'OG004', 'lowerLimit': '2194', 'upperLimit': '3238'}, {'value': '2201', 'groupId': 'OG005', 'lowerLimit': '1812', 'upperLimit': '2673'}, {'value': '3031', 'groupId': 'OG006', 'lowerLimit': '2642', 'upperLimit': '3478'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG006'], 'paramType': 'Ratio of Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.87', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.10', 'estimateComment': 'Ratio of Geometric Means: 50mg SC over 125mg IV', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG006'], 'paramType': 'Ratio of Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.61', 'ciLowerLimit': '0.48', 'ciUpperLimit': '0.77', 'estimateComment': 'Ratio of Geometric Means: 100mg SC over 125mg IV', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG006'], 'paramType': 'Ratio of Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.79', 'ciLowerLimit': '0.62', 'ciUpperLimit': '1.00', 'estimateComment': 'Ratio of Geometric Means: 125mg SC over 125mg IV', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003', 'OG006'], 'paramType': 'Ratio of Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.90', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.14', 'estimateComment': 'Ratio of Geometric Means: 150mg SC over 125mg IV', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG006'], 'paramType': 'Ratio of Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.88', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.12', 'estimateComment': 'Ratio of Geometric Means: 200mg SC over 125mg IV', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG005', 'OG006'], 'paramType': 'Ratio of Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.73', 'ciLowerLimit': '0.57', 'ciUpperLimit': '0.92', 'estimateComment': 'Ratio of Geometric Means: 250mg SC over 125mg IV', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116', 'description': 'Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) was derived from serum concentration versus time data. Adjusted geometric means were reported in microgram hours per milliliter (ug\\*h/mL)', 'unitOfMeasure': 'ug*h/mL', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants treated with Belatacept'}, {'type': 'PRIMARY', 'title': 'Serum Half-life (T-HALF) of Belatacept', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 50 mg Subcutaneous Injection', 'description': 'Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume'}, {'id': 'OG001', 'title': 'Belatacept 100 mg Subcutaneous Injection', 'description': 'Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume'}, {'id': 'OG002', 'title': 'Belatacept 125 mg Subcutaneous Injection', 'description': 'Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume'}, {'id': 'OG003', 'title': 'Belatacept 150 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG004', 'title': 'Belatacept 200 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG005', 'title': 'Belatacept 250 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG006', 'title': 'Belatacept 125 mg Intravenous Infusion', 'description': '125 mg Belatacept intravenous (IV) injection'}], 'classes': [{'categories': [{'measurements': [{'value': '112', 'spread': '25.7', 'groupId': 'OG000'}, {'value': '100', 'spread': '10.1', 'groupId': 'OG001'}, {'value': '135', 'spread': '47.6', 'groupId': 'OG002'}, {'value': '158', 'spread': '46.9', 'groupId': 'OG003'}, {'value': '161', 'spread': '45.3', 'groupId': 'OG004'}, {'value': '150', 'spread': '43.6', 'groupId': 'OG005'}, {'value': '130', 'spread': '27.6', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116', 'description': 'Serum half-life (T-HALF) was determined from serum concentration versus time data and was reported in hours.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants treated with Belatacept'}, {'type': 'PRIMARY', 'title': 'Apparent Total Body Clearance (CLT/F) of SC Belatacept', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 50 mg Subcutaneous Injection', 'description': 'Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume'}, {'id': 'OG001', 'title': 'Belatacept 100 mg Subcutaneous Injection', 'description': 'Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume'}, {'id': 'OG002', 'title': 'Belatacept 125 mg Subcutaneous Injection', 'description': 'Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume'}, {'id': 'OG003', 'title': 'Belatacept 150 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG004', 'title': 'Belatacept 200 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG005', 'title': 'Belatacept 250 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.4', 'spread': '27', 'groupId': 'OG000'}, {'value': '67.5', 'spread': '34', 'groupId': 'OG001'}, {'value': '52.5', 'spread': '31', 'groupId': 'OG002'}, {'value': '46.0', 'spread': '26', 'groupId': 'OG003'}, {'value': '46.9', 'spread': '21', 'groupId': 'OG004'}, {'value': '56.8', 'spread': '20', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116', 'description': 'Apparent total body clearance (CLT/F) was derived from serum concentration versus time data for all participants who received subcutaneous (SC) Belatacept injections. Units reported in milliliters per hour (mL/h).', 'unitOfMeasure': 'mL/h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants treated with SC Belatacept'}, {'type': 'PRIMARY', 'title': 'Total Body Clearance (CLT) of IV Belatacept', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 125 mg Intravenous Infusion', 'description': '125 mg Belatacept intravenous (IV) injection'}], 'classes': [{'categories': [{'measurements': [{'value': '41.2', 'spread': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116', 'description': 'Total body clearance (CLT) was derived from serum concentration versus time data for all participants that were treated with IV Belatacept. Units reported in milliliters per hour (mL/h)', 'unitOfMeasure': 'mL/h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants treated with IV Belatacept'}, {'type': 'PRIMARY', 'title': 'Volume of Distribution at Steady State (VSS) for IV Belatacept', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 125 mg Intravenous Infusion', 'description': '125 mg Belatacept intravenous (IV) injection'}], 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'spread': '1.27', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116', 'description': 'Volume of distribution at steady state (VSS) was derived from serum concentration versus time data for all participants treated with IV Belatacept.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants treated with IV Belatacept'}, {'type': 'PRIMARY', 'title': 'Apparent Volume of Distribution at Steady State (Vss/F) for SC Belatacept', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 50 mg Subcutaneous Injection', 'description': 'Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume'}, {'id': 'OG001', 'title': 'Belatacept 100 mg Subcutaneous Injection', 'description': 'Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume'}, {'id': 'OG002', 'title': 'Belatacept 125 mg Subcutaneous Injection', 'description': 'Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume'}, {'id': 'OG003', 'title': 'Belatacept 150 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG004', 'title': 'Belatacept 200 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG005', 'title': 'Belatacept 250 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.79', 'spread': '31.02', 'groupId': 'OG000'}, {'value': '15.30', 'spread': '28.79', 'groupId': 'OG001'}, {'value': '14.12', 'spread': '36.63', 'groupId': 'OG002'}, {'value': '12.75', 'spread': '14.20', 'groupId': 'OG003'}, {'value': '13.34', 'spread': '13.77', 'groupId': 'OG004'}, {'value': '15.82', 'spread': '11.92', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116', 'description': 'Apparent volume of distribution at steady state (Vss/F) was derived from concentration versus time data for all participants treated with subcutaneous (SC) Belatacept.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants treated with SC Belatacept'}, {'type': 'SECONDARY', 'title': 'Effect of Number of Injection Sites on Subcutaneous Belatacept Absorption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 Injection Site', 'description': 'Participants receiving treatments of 50mg, 100mg and 125mg Subcutaneous Belatacept were injected at 1 site at the anterior thigh.'}, {'id': 'OG001', 'title': '2 Injection Sites', 'description': 'Participants receiving treatments of 150mg, 200mg and 250mg Subcutaneous Belatacept were injected at 2 sites; one injection equal to half the total dose was delivered to the anterior thigh on each side.'}], 'classes': [{'title': 'AUC(0-T)', 'categories': [{'measurements': [{'value': '898', 'groupId': 'OG000', 'lowerLimit': '794', 'upperLimit': '1017'}, {'value': '1002', 'groupId': 'OG001', 'lowerLimit': '885', 'upperLimit': '1134'}]}]}, {'title': 'AUC(INF)', 'categories': [{'measurements': [{'value': '906', 'groupId': 'OG000', 'lowerLimit': '799', 'upperLimit': '1027'}, {'value': '1007', 'groupId': 'OG001', 'lowerLimit': '888', 'upperLimit': '1142'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.90', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.07', 'estimateComment': 'AUC(0-T) Ratio of Geometric Means: 1 injection site over 2 injection sites', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.90', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.07', 'estimateComment': 'AUC(INF) Ratio of Geometric Means: 1 injection site over 2 injection sites', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116', 'description': 'AUC(0-T) and AUC(INF) for Belatacept were derived from serum concentration versus time data to assess the effect of number of injection sites on the subcutaneous absorption of Belatacept. All treatments were dose-normalized to 50mg. Adjusted geometric means reported in microgram hours per milliliter (ug\\*h/mL).\n\nAUC(0-T) = Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration.\n\nAUC(INF) = Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time.', 'unitOfMeasure': 'ug*h/mL', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants treated with Belatacept'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Vital Sign Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 50 mg Subcutaneous Injection', 'description': 'Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume'}, {'id': 'OG001', 'title': 'Belatacept 100 mg Subcutaneous Injection', 'description': 'Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume'}, {'id': 'OG002', 'title': 'Belatacept 125 mg Subcutaneous Injection', 'description': 'Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume'}, {'id': 'OG003', 'title': 'Belatacept 150 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG004', 'title': 'Belatacept 200 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG005', 'title': 'Belatacept 250 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG006', 'title': 'Belatacept 125 mg Intravenous Infusion', 'description': '125 mg Belatacept intravenous (IV) injection'}, {'id': 'OG007', 'title': 'Placebo', 'description': 'Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 day pre-dose, Days 1, 2, 5, 14, 28, 42, 86 and 116', 'description': 'Vital signs (body temperature, respiratory rate, seated blood pressure, and heart rate) were recorded at screening. All significant findings were evaluated by the investigator, and all abnormalities were listed.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Injection Site Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 50 mg Subcutaneous Injection', 'description': 'Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume'}, {'id': 'OG001', 'title': 'Belatacept 100 mg Subcutaneous Injection', 'description': 'Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume'}, {'id': 'OG002', 'title': 'Belatacept 125 mg Subcutaneous Injection', 'description': 'Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume'}, {'id': 'OG003', 'title': 'Belatacept 150 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG004', 'title': 'Belatacept 200 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG005', 'title': 'Belatacept 250 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG006', 'title': 'Belatacept 125 mg Intravenous Infusion', 'description': '125 mg Belatacept intravenous (IV) injection'}, {'id': 'OG007', 'title': 'Placebo', 'description': 'Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)'}], 'classes': [{'title': 'mild reaction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'moderate reaction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'severe reaction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0.5, 2, 6 and 24 hours post-dose, Days 3, 4, 5, 6, 7, 8, 14, 21 and 116', 'description': 'Participants were assessed for erythema, heat, pain, pruritis and swelling at the injection sites and were characterized by the investigator as mild, moderate or severe reactions.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Physical Examination Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 50 mg Subcutaneous Injection', 'description': 'Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume'}, {'id': 'OG001', 'title': 'Belatacept 100 mg Subcutaneous Injection', 'description': 'Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume'}, {'id': 'OG002', 'title': 'Belatacept 125 mg Subcutaneous Injection', 'description': 'Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume'}, {'id': 'OG003', 'title': 'Belatacept 150 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG004', 'title': 'Belatacept 200 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG005', 'title': 'Belatacept 250 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG006', 'title': 'Belatacept 125 mg Intravenous Infusion', 'description': '125 mg Belatacept intravenous (IV) injection'}, {'id': 'OG007', 'title': 'Placebo', 'description': 'Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1, 2, 5, 14, 28, 42, 86, 116', 'description': 'All clinically significant deviations from normal physical examinations were reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Electrocardiogram (ECG) Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 50 mg Subcutaneous Injection', 'description': 'Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume'}, {'id': 'OG001', 'title': 'Belatacept 100 mg Subcutaneous Injection', 'description': 'Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume'}, {'id': 'OG002', 'title': 'Belatacept 125 mg Subcutaneous Injection', 'description': 'Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume'}, {'id': 'OG003', 'title': 'Belatacept 150 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG004', 'title': 'Belatacept 200 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG005', 'title': 'Belatacept 250 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG006', 'title': 'Belatacept 125 mg Intravenous Infusion', 'description': '125 mg Belatacept intravenous (IV) injection'}, {'id': 'OG007', 'title': 'Placebo', 'description': 'Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)'}], 'classes': [{'title': 'Screening (Day 1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Study Discharge (Day 116)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1 and 116', 'description': 'Participants underwent a 12-lead ECG assessment at Screening (Day 1) and Study Discharge (Day 116). All investigator-assessed ECG abnormalities were reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Marked Hematology Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 50 mg Subcutaneous Injection', 'description': 'Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume'}, {'id': 'OG001', 'title': 'Belatacept 100 mg Subcutaneous Injection', 'description': 'Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume'}, {'id': 'OG002', 'title': 'Belatacept 125 mg Subcutaneous Injection', 'description': 'Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume'}, {'id': 'OG003', 'title': 'Belatacept 150 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG004', 'title': 'Belatacept 200 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG005', 'title': 'Belatacept 250 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG006', 'title': 'Belatacept 125 mg Intravenous Infusion', 'description': '125 mg Belatacept intravenous (IV) injection'}, {'id': 'OG007', 'title': 'Placebo', 'description': 'Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)'}], 'classes': [{'title': 'Hemoglobin', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Hematocrit', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Platelet Count', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Leukocytes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Neutrophils + Bands (absolute)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Lymphocytes (absolute)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Monocytes (absolute)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Basophils (absolute)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Eosinophils (absolute)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116', 'description': 'LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities:\n\nHemoglobin (grams per deciliter:g/dL): \\<0.85\\*Pre-Rx. Hematocrit (%): \\<0.85\\*Pre-Rx. Platelet Count (\\*10\\^9 cells per liter:c/L): \\<0.85\\*LLN or \\>1.5\\*ULN (if Pre-Rx\\<LLN, use \\<0.85\\*Pre-Rx).\n\nLeukocytes (\\*10\\^3 cells per microliter: c/uL): \\<0.9\\*LLN, \\>1.2\\*ULN (if Pre-Rx\\<LLN, use \\<0.85\\*Pre-Rx or \\>ULN, if Pre-Rx\\>ULN, use \\>1.15\\*Pre-Rx or \\<LLN) Neutrophils+Bands (\\*10\\^3 c/uL): \\<=1.500. Lymphocytes (\\*10\\^3 c/uL): \\<0.750 or \\>7.500. Monocytes (\\*10\\^3 c/uL): \\>2.000. Basophils (\\*10\\^3 c/uL): \\>0.400. Eosinophils (\\*10\\^3 c/uL): \\>0.750.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Marked Serum Chemistry Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 50 mg Subcutaneous Injection', 'description': 'Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume'}, {'id': 'OG001', 'title': 'Belatacept 100 mg Subcutaneous Injection', 'description': 'Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume'}, {'id': 'OG002', 'title': 'Belatacept 125 mg Subcutaneous Injection', 'description': 'Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume'}, {'id': 'OG003', 'title': 'Belatacept 150 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG004', 'title': 'Belatacept 200 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG005', 'title': 'Belatacept 250 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG006', 'title': 'Belatacept 125 mg Intravenous Infusion', 'description': '125 mg Belatacept intravenous (IV) injection'}, {'id': 'OG007', 'title': 'Placebo', 'description': 'Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)'}], 'classes': [{'title': 'Alkaline Phosphatase', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Aspartate Aminotransferase', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Alanine Aminotransferase', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Bilirubin', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Blood Urea Nitrogen', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Creatinine', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Sodium, Serum', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Potassium, Serum', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Chloride, Serum', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Calcium, Total', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Phosphorus, Inorganic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116', 'description': 'LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities:\n\nAlkaline Phosphatase (units per liter: U/L), Aspartate Aminotransferase (U/L), Alanine Aminotransferase (U/L): \\>1.25\\*ULN (if Pre-Rx\\>ULN, use \\>1.25\\*Pre-Rx).\n\nBilirubin (milligrams per deciliter: mg/dL): \\>1.1\\*ULN (if Pre-Rx\\>ULN, use \\>1.25\\*Pre-Rx).\n\nBlood Urea Nitrogen (mg/dL): \\>1.1\\*ULN (if Pre-Rx\\>ULN, use \\>1.2\\*Pre-Rx). Creatinine (mg/dL): \\>1.33\\*Pre-Rx. Sodium (milliequivalents per Liter: mEq/L): \\<0.95\\*LLN, \\>1.05\\*ULN (if Pre-Rx\\<LLN: \\<0.95\\*Pre-Rx, \\>ULN. If Pre-Rx\\>ULN: \\>1.05\\*Pre-Rx, \\<LLN).\n\nPotassium(mEq/L), Chloride (mEq/L), Calcium(mg/dL): \\<0.9\\*LLN, \\>1.1\\*ULN (if Pre-Rx\\<LLN: \\<0.9\\*Pre-Rx, \\>ULN. If Pre-Rx\\>ULN: \\>1.1\\*Pre-Rx, \\<LLN).\n\nPhosphorus (mg/dL): \\<0.85\\*LLN, \\>1.25\\*ULN (if Pre-Rx\\<LLN, \\<0.85\\*Pre-Rx, \\>ULN. if Pre-Rx\\>ULN: \\>1.25\\*Pre-Rx, \\<LLN).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Marked Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 50 mg Subcutaneous Injection', 'description': 'Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume'}, {'id': 'OG001', 'title': 'Belatacept 100 mg Subcutaneous Injection', 'description': 'Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume'}, {'id': 'OG002', 'title': 'Belatacept 125 mg Subcutaneous Injection', 'description': 'Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume'}, {'id': 'OG003', 'title': 'Belatacept 150 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG004', 'title': 'Belatacept 200 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG005', 'title': 'Belatacept 250 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG006', 'title': 'Belatacept 125 mg Intravenous Infusion', 'description': '125 mg Belatacept intravenous (IV) injection'}, {'id': 'OG007', 'title': 'Placebo', 'description': 'Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)'}], 'classes': [{'title': 'Glucose, Fasting Serum', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Protein, Total', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Albumin', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Uric Acid', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Lactate Dehydrogenase', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116', 'description': 'LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities:\n\nGlucose (mg/dL): \\<0.8\\*LLN, \\>1.5\\*ULN (if Pre-Rx\\<LLN: \\<0.8\\*Pre-Rx, \\>ULN. If Pre-Rx\\>ULN: \\>2.0\\*Pre-Rx, \\<LLN).\n\nProtein (grams per deciliter: g/dL): \\<0.9\\*LLN, \\>1.1\\*ULN (if Pre-Rx\\<LLN: \\<0.9\\*Pre-Rx, \\>ULN. If Pre-Rx\\>ULN: \\>1.1\\*Pre-Rx, \\<LLN).\n\nAlbumin (g/dL): \\<0.9\\*LLN (if Pre-Rx\\<LLN: \\<0.9\\*Pre-Rx). Uric Acid (mg.dL): \\>1.2\\*ULN (if Pre-Rx\\>ULN: \\>1.25\\*Pre-Rx). Lactate Dehydrogenase (U/L): \\>1.25\\*ULN (if Pre-Rx\\>ULN: \\>1.5\\*Pre-Rx)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positive Immunogenicity to Belatacept', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 50 mg Subcutaneous Injection', 'description': 'Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume'}, {'id': 'OG001', 'title': 'Belatacept 100 mg Subcutaneous Injection', 'description': 'Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume'}, {'id': 'OG002', 'title': 'Belatacept 125 mg Subcutaneous Injection', 'description': 'Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume'}, {'id': 'OG003', 'title': 'Belatacept 150 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG004', 'title': 'Belatacept 200 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG005', 'title': 'Belatacept 250 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'OG006', 'title': 'Belatacept 125 mg Intravenous Infusion', 'description': '125 mg Belatacept intravenous (IV) injection'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1, 14, 28, 42, 56, 86, 116', 'description': 'The number of participants with positive immunogenicity to Belatacept was reported for each arm. Positive immunogenicity was defined as the presence of a positive antibody response generated against Belatacept.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants treated with Belatacept'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Belatacept 50 mg Subcutaneous Injection', 'description': 'Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume'}, {'id': 'FG001', 'title': 'Belatacept 100 mg Subcutaneous Injection', 'description': 'Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume'}, {'id': 'FG002', 'title': 'Belatacept 125 mg Subcutaneous Injection', 'description': 'Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume'}, {'id': 'FG003', 'title': 'Belatacept 150 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'FG004', 'title': 'Belatacept 200 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'FG005', 'title': 'Belatacept 250 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'FG006', 'title': 'Belatacept 125 mg Intravenous Infusion', 'description': '125 mg Belatacept intravenous (IV) injection'}, {'id': 'FG007', 'title': 'Placebo', 'description': 'Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '10'}, {'groupId': 'FG007', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '10'}, {'groupId': 'FG007', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'injection syringe leaked during dosing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '153 participants were enrolled, with 106 discontinuing prior to study drug administration because they no longer met study criteria or they withdrew consent. 47 participants met all eligibility criteria and received study medication. 1 subject, who received an incomplete dose due to an injection syringe leak, was replaced.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '47', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'Belatacept 50 mg Subcutaneous Injection', 'description': 'Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume'}, {'id': 'BG001', 'title': 'Belatacept 100 mg Subcutaneous Injection', 'description': 'Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume'}, {'id': 'BG002', 'title': 'Belatacept 125 mg Subcutaneous Injection', 'description': 'Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume'}, {'id': 'BG003', 'title': 'Belatacept 150 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'BG004', 'title': 'Belatacept 200 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'BG005', 'title': 'Belatacept 250 mg Subcutaneous Injections', 'description': 'Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.'}, {'id': 'BG006', 'title': 'Belatacept 125 mg Intravenous Infusion', 'description': '125 mg Belatacept intravenous (IV) injection'}, {'id': 'BG007', 'title': 'Placebo', 'description': 'Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30', 'spread': '11', 'groupId': 'BG000'}, {'value': '27', 'spread': '12', 'groupId': 'BG001'}, {'value': '28', 'spread': '12', 'groupId': 'BG002'}, {'value': '34', 'spread': '18', 'groupId': 'BG003'}, {'value': '31', 'spread': '11', 'groupId': 'BG004'}, {'value': '31', 'spread': '10', 'groupId': 'BG005'}, {'value': '32', 'spread': '16', 'groupId': 'BG006'}, {'value': '27', 'spread': '6', 'groupId': 'BG007'}, {'value': '30', 'spread': '12', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '21', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '26', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-16', 'studyFirstSubmitDate': '2007-11-30', 'resultsFirstSubmitDate': '2016-07-05', 'studyFirstSubmitQcDate': '2007-12-06', 'lastUpdatePostDateStruct': {'date': '2016-09-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-07-05', 'studyFirstPostDateStruct': {'date': '2007-12-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Serum Concentration (Cmax) of Belatacept', 'timeFrame': 'Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116', 'description': 'Maximum observed serum concentration (Cmax) values were derived from serum concentration versus time data and reported in micrograms per milliliter (ug/mL).'}, {'measure': 'Time of Maximum Observed Serum Concentration (Tmax) of Belatacept', 'timeFrame': 'Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116', 'description': 'Time of maximum observed serum concentration (Tmax) values were derived from serum concentration versus time data for all participants treated with Belatacept.'}, {'measure': 'Adjusted Geometric Means of Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC(0-T)) for Belatacept', 'timeFrame': 'Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116', 'description': 'Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUC(0-T)) was derived from serum concentration versus time data. Adjusted geometric means were reported in microgram hours per milliliter (ug\\*h/mL).'}, {'measure': 'Adjusted Geometric Means of Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) for Belatacept', 'timeFrame': 'Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116', 'description': 'Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) was derived from serum concentration versus time data. Adjusted geometric means were reported in microgram hours per milliliter (ug\\*h/mL)'}, {'measure': 'Serum Half-life (T-HALF) of Belatacept', 'timeFrame': 'Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116', 'description': 'Serum half-life (T-HALF) was determined from serum concentration versus time data and was reported in hours.'}, {'measure': 'Apparent Total Body Clearance (CLT/F) of SC Belatacept', 'timeFrame': 'Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116', 'description': 'Apparent total body clearance (CLT/F) was derived from serum concentration versus time data for all participants who received subcutaneous (SC) Belatacept injections. Units reported in milliliters per hour (mL/h).'}, {'measure': 'Total Body Clearance (CLT) of IV Belatacept', 'timeFrame': 'Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116', 'description': 'Total body clearance (CLT) was derived from serum concentration versus time data for all participants that were treated with IV Belatacept. Units reported in milliliters per hour (mL/h)'}, {'measure': 'Volume of Distribution at Steady State (VSS) for IV Belatacept', 'timeFrame': 'Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116', 'description': 'Volume of distribution at steady state (VSS) was derived from serum concentration versus time data for all participants treated with IV Belatacept.'}, {'measure': 'Apparent Volume of Distribution at Steady State (Vss/F) for SC Belatacept', 'timeFrame': 'Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116', 'description': 'Apparent volume of distribution at steady state (Vss/F) was derived from concentration versus time data for all participants treated with subcutaneous (SC) Belatacept.'}], 'secondaryOutcomes': [{'measure': 'Effect of Number of Injection Sites on Subcutaneous Belatacept Absorption', 'timeFrame': 'Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116', 'description': 'AUC(0-T) and AUC(INF) for Belatacept were derived from serum concentration versus time data to assess the effect of number of injection sites on the subcutaneous absorption of Belatacept. All treatments were dose-normalized to 50mg. Adjusted geometric means reported in microgram hours per milliliter (ug\\*h/mL).\n\nAUC(0-T) = Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration.\n\nAUC(INF) = Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time.'}, {'measure': 'Number of Participants With Vital Sign Abnormalities', 'timeFrame': '1 day pre-dose, Days 1, 2, 5, 14, 28, 42, 86 and 116', 'description': 'Vital signs (body temperature, respiratory rate, seated blood pressure, and heart rate) were recorded at screening. All significant findings were evaluated by the investigator, and all abnormalities were listed.'}, {'measure': 'Number of Participants With Injection Site Reactions', 'timeFrame': '0.5, 2, 6 and 24 hours post-dose, Days 3, 4, 5, 6, 7, 8, 14, 21 and 116', 'description': 'Participants were assessed for erythema, heat, pain, pruritis and swelling at the injection sites and were characterized by the investigator as mild, moderate or severe reactions.'}, {'measure': 'Number of Participants With Physical Examination Abnormalities', 'timeFrame': 'Days 1, 2, 5, 14, 28, 42, 86, 116', 'description': 'All clinically significant deviations from normal physical examinations were reported.'}, {'measure': 'Number of Participants With Electrocardiogram (ECG) Abnormalities', 'timeFrame': 'Days 1 and 116', 'description': 'Participants underwent a 12-lead ECG assessment at Screening (Day 1) and Study Discharge (Day 116). All investigator-assessed ECG abnormalities were reported.'}, {'measure': 'Number of Participants With Marked Hematology Laboratory Abnormalities', 'timeFrame': 'Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116', 'description': 'LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities:\n\nHemoglobin (grams per deciliter:g/dL): \\<0.85\\*Pre-Rx. Hematocrit (%): \\<0.85\\*Pre-Rx. Platelet Count (\\*10\\^9 cells per liter:c/L): \\<0.85\\*LLN or \\>1.5\\*ULN (if Pre-Rx\\<LLN, use \\<0.85\\*Pre-Rx).\n\nLeukocytes (\\*10\\^3 cells per microliter: c/uL): \\<0.9\\*LLN, \\>1.2\\*ULN (if Pre-Rx\\<LLN, use \\<0.85\\*Pre-Rx or \\>ULN, if Pre-Rx\\>ULN, use \\>1.15\\*Pre-Rx or \\<LLN) Neutrophils+Bands (\\*10\\^3 c/uL): \\<=1.500. Lymphocytes (\\*10\\^3 c/uL): \\<0.750 or \\>7.500. Monocytes (\\*10\\^3 c/uL): \\>2.000. Basophils (\\*10\\^3 c/uL): \\>0.400. Eosinophils (\\*10\\^3 c/uL): \\>0.750.'}, {'measure': 'Number of Participants With Marked Serum Chemistry Abnormalities', 'timeFrame': 'Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116', 'description': 'LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities:\n\nAlkaline Phosphatase (units per liter: U/L), Aspartate Aminotransferase (U/L), Alanine Aminotransferase (U/L): \\>1.25\\*ULN (if Pre-Rx\\>ULN, use \\>1.25\\*Pre-Rx).\n\nBilirubin (milligrams per deciliter: mg/dL): \\>1.1\\*ULN (if Pre-Rx\\>ULN, use \\>1.25\\*Pre-Rx).\n\nBlood Urea Nitrogen (mg/dL): \\>1.1\\*ULN (if Pre-Rx\\>ULN, use \\>1.2\\*Pre-Rx). Creatinine (mg/dL): \\>1.33\\*Pre-Rx. Sodium (milliequivalents per Liter: mEq/L): \\<0.95\\*LLN, \\>1.05\\*ULN (if Pre-Rx\\<LLN: \\<0.95\\*Pre-Rx, \\>ULN. If Pre-Rx\\>ULN: \\>1.05\\*Pre-Rx, \\<LLN).\n\nPotassium(mEq/L), Chloride (mEq/L), Calcium(mg/dL): \\<0.9\\*LLN, \\>1.1\\*ULN (if Pre-Rx\\<LLN: \\<0.9\\*Pre-Rx, \\>ULN. If Pre-Rx\\>ULN: \\>1.1\\*Pre-Rx, \\<LLN).\n\nPhosphorus (mg/dL): \\<0.85\\*LLN, \\>1.25\\*ULN (if Pre-Rx\\<LLN, \\<0.85\\*Pre-Rx, \\>ULN. if Pre-Rx\\>ULN: \\>1.25\\*Pre-Rx, \\<LLN).'}, {'measure': 'Number of Participants With Marked Laboratory Abnormalities', 'timeFrame': 'Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116', 'description': 'LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities:\n\nGlucose (mg/dL): \\<0.8\\*LLN, \\>1.5\\*ULN (if Pre-Rx\\<LLN: \\<0.8\\*Pre-Rx, \\>ULN. If Pre-Rx\\>ULN: \\>2.0\\*Pre-Rx, \\<LLN).\n\nProtein (grams per deciliter: g/dL): \\<0.9\\*LLN, \\>1.1\\*ULN (if Pre-Rx\\<LLN: \\<0.9\\*Pre-Rx, \\>ULN. If Pre-Rx\\>ULN: \\>1.1\\*Pre-Rx, \\<LLN).\n\nAlbumin (g/dL): \\<0.9\\*LLN (if Pre-Rx\\<LLN: \\<0.9\\*Pre-Rx). Uric Acid (mg.dL): \\>1.2\\*ULN (if Pre-Rx\\>ULN: \\>1.25\\*Pre-Rx). Lactate Dehydrogenase (U/L): \\>1.25\\*ULN (if Pre-Rx\\>ULN: \\>1.5\\*Pre-Rx)'}, {'measure': 'Number of Participants With Positive Immunogenicity to Belatacept', 'timeFrame': 'Days 1, 14, 28, 42, 56, 86, 116', 'description': 'The number of participants with positive immunogenicity to Belatacept was reported for each arm. Positive immunogenicity was defined as the presence of a positive antibody response generated against Belatacept.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Transplantation']}, 'descriptionModule': {'briefSummary': 'Pharmacokinetics, Bioavailability, Safety and Immunogenicity of Single Doses of Belatacept Administered Subcutaneously to Healthy Subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women ages 18 to 65 years old\n* Subjects must weigh less than or equal to 100 kg\n\nExclusion Criteria:\n\n* Inability to tolerate injections or IV infusions\n* autoimmune disorders\n* TB\n* herpes\n* HCV\n* HBV\n* HIV\n* bacterial or viral infection\n* history of cancer'}, 'identificationModule': {'nctId': 'NCT00569803', 'briefTitle': 'Subcutaneous Pharmacokinetics of Belatacept', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Pharmacokinetics, Safety and Immunogenicity of Single Doses of Belatacept Administered Subcutaneously to Healthy Subjects', 'orgStudyIdInfo': {'id': 'IM103-046'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Belatacept 50 mg Subcutaneous Injection', 'description': 'Belatacept 50 mg subcutaneous (SC) injection', 'interventionNames': ['Drug: belatacept']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Belatacept 100 mg Subcutaneous Injection', 'description': 'Belatacept 100 mg SC injection', 'interventionNames': ['Drug: belatacept']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Belatacept 125 mg Subcutaneous Injection', 'description': 'Belatacept 125 mg SC injection', 'interventionNames': ['Drug: belatacept']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Belatacept 150 mg Subcutaneous Injections', 'description': '2 SC injections of 75 mg Belatacept', 'interventionNames': ['Drug: belatacept']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Belatacept 200 mg Subcutaneous Injections', 'description': '2 SC injections of 100 mg Belatacept', 'interventionNames': ['Drug: belatacept']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Belatacept 250 mg Subcutaneous Injections', 'description': '2 SC injections of 125 mg Belatacept', 'interventionNames': ['Drug: belatacept']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Belatacept 125 mg Intravenous Infusion', 'description': '125 mg Belatacept intravenous (IV) injection', 'interventionNames': ['Drug: belatacept']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'SC injection of placebo solution', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'belatacept', 'type': 'DRUG', 'description': 'single dose, 116 days', 'armGroupLabels': ['Belatacept 100 mg Subcutaneous Injection', 'Belatacept 125 mg Intravenous Infusion', 'Belatacept 125 mg Subcutaneous Injection', 'Belatacept 150 mg Subcutaneous Injections', 'Belatacept 200 mg Subcutaneous Injections', 'Belatacept 250 mg Subcutaneous Injections', 'Belatacept 50 mg Subcutaneous Injection']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78744', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Ppd Development', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}