Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-26 @ 5:02 AM
Study NCT ID:
NCT01585766
Status:
COMPLETED
Last Update Posted:
2018-10-29
First Post:
2012-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Tolerability Study of MEDI-551, a B-cell Depleting Agent, to Treat Relapsing Forms of Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Czechia', 'United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D009165', 'term': 'Mycobacterium Infections, Nontuberculous'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000609745', 'term': 'inebilizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '301-398-1955', 'title': 'Armando Flor, MD, Director, Clinical Development', 'organization': 'MedImmune'}, 'certainAgreement': {'otherDetails': 'MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).', 'eventGroups': [{'id': 'EG000', 'title': 'PLACEBO-IV-SC', 'description': 'Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.', 'otherNumAtRisk': 7, 'otherNumAffected': 5, 'seriousNumAtRisk': 7, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'MEDI-551 60 Mg-SC', 'description': 'Participants received SC injection of 60 mg MEDI-551 on Day 1.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'MEDI-551 100 Mg-IV', 'description': 'Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.', 'otherNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'MEDI-551 300 Mg-SC', 'description': 'Participants received SC injection of 300 mg MEDI-551 on Day 1.', 'otherNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'MEDI-551 30 Mg-IV', 'description': 'Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.', 'otherNumAtRisk': 5, 'otherNumAffected': 4, 'seriousNumAtRisk': 5, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'MEDI-551 600 Mg-IV', 'description': 'Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Multiple sclerosis relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Urinary tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Multiple sclerosis relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PLACEBO-IV-SC', 'description': 'Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.'}, {'id': 'OG001', 'title': 'MEDI-551 30 Mg-IV', 'description': 'Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.'}, {'id': 'OG002', 'title': 'MEDI-551 60 Mg-SC', 'description': 'Participants received SC injection of 60 mg MEDI-551 on Day 1.'}, {'id': 'OG003', 'title': 'MEDI-551 100 Mg-IV', 'description': 'Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.'}, {'id': 'OG004', 'title': 'MEDI-551 300 Mg-SC', 'description': 'Participants received SC injection of 300 mg MEDI-551 on Day 1.'}, {'id': 'OG005', 'title': 'MEDI-551 600 Mg-IV', 'description': 'Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From study drug administration (Day 1) through the end of treatment period (Day 169)', 'description': 'An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A TEAE were the events between administration of study drug (Day 1) and Day 169 that were absent before treatment or that worsened relative to pre-treatment state. The AEs were summarized using Medical Dictionary for Regulatory Activities version 19.0', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population is defined as all participants who received any amount of study drug.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PLACEBO-IV-SC', 'description': 'Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.'}, {'id': 'OG001', 'title': 'MEDI-551 30 Mg-IV', 'description': 'Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.'}, {'id': 'OG002', 'title': 'MEDI-551 60 Mg-SC', 'description': 'Participants received SC injection of 60 mg MEDI-551 on Day 1.'}, {'id': 'OG003', 'title': 'MEDI-551 100 Mg-IV', 'description': 'Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.'}, {'id': 'OG004', 'title': 'MEDI-551 300 Mg-SC', 'description': 'Participants received SC injection of 300 mg MEDI-551 on Day 1.'}, {'id': 'OG005', 'title': 'MEDI-551 600 Mg-IV', 'description': 'Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From study drug administration (Day 1) through the long term follow up period (up to 18 months after early discontinuation visit or 24 week treatment period).', 'description': 'A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death, life-threatening, initial or prolonged inpatient hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect in the offspring of a participant who received the study drug. The TESAEs were the events between administration of study drug (Day 1) and long term follow up period (up to 18 months after early discontinuation visit or 24-week treatment period) that were absent before treatment or that worsened relative to pre-treatment state. The AEs were summarized using Medical Dictionary for Regulatory Activities version 19.0', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PLACEBO-IV-SC', 'description': 'Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.'}, {'id': 'OG001', 'title': 'MEDI-551 30 Mg-IV', 'description': 'Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.'}, {'id': 'OG002', 'title': 'MEDI-551 60 Mg-SC', 'description': 'Participants received SC injection of 60 mg MEDI-551 on Day 1.'}, {'id': 'OG003', 'title': 'MEDI-551 100 Mg-IV', 'description': 'Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.'}, {'id': 'OG004', 'title': 'MEDI-551 300 Mg-SC', 'description': 'Participants received SC injection of 300 mg MEDI-551 on Day 1.'}, {'id': 'OG005', 'title': 'MEDI-551 600 Mg-IV', 'description': 'Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.'}], 'classes': [{'title': 'Hematology- Anaemia', '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'}]}]}, {'title': 'Hematology- White blood cell count decreased', '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'}]}]}, {'title': 'Serum chemistry- Liver function test increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Serum chemistry- Hyponatraemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From study drug administration (Day 1) through the end of treatment period (Day 169)', 'description': 'Any clinically significant change in laboratory evaluations were recorded as AEs. The following parameters were analyzed for laboratory evaluations: haematology, serum chemistry, and urinalysis. Number of participants with TEAEs related to laboratory evaluations were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Vital Sign Abnormalities Reported as TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PLACEBO-IV-SC', 'description': 'Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.'}, {'id': 'OG001', 'title': 'MEDI-551 30 Mg-IV', 'description': 'Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.'}, {'id': 'OG002', 'title': 'MEDI-551 60 Mg-SC', 'description': 'Participants received SC injection of 60 mg MEDI-551 on Day 1.'}, {'id': 'OG003', 'title': 'MEDI-551 100 Mg-IV', 'description': 'Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.'}, {'id': 'OG004', 'title': 'MEDI-551 300 Mg-SC', 'description': 'Participants received SC injection of 300 mg MEDI-551 on Day 1.'}, {'id': 'OG005', 'title': 'MEDI-551 600 Mg-IV', 'description': 'Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.'}], 'classes': [{'title': 'Blood pressure increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Blood pressure decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Tachycardia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From study drug administration (Day 1) through the end of treatment period (Day 169)', 'description': 'Vital sign parameters included blood pressure, temperature, pulse rate, and respiratory rate. The number of participants with TEAEs related to vital signs in participants were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI-551', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-551 30 Mg-IV', 'description': 'Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.'}, {'id': 'OG001', 'title': 'MEDI-551 60 Mg-SC', 'description': 'Participants received SC injection of 60 mg MEDI-551 on Day 1.'}, {'id': 'OG002', 'title': 'MEDI-551 100 Mg-IV', 'description': 'Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.'}, {'id': 'OG003', 'title': 'MEDI-551 300 Mg-SC', 'description': 'Participants received SC injection of 300 mg MEDI-551 on Day 1.'}, {'id': 'OG004', 'title': 'MEDI-551 600 Mg-IV', 'description': 'Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.14', 'groupId': 'OG000', 'lowerLimit': '0.11', 'upperLimit': '0.19'}, {'value': '2.98', 'groupId': 'OG001', 'lowerLimit': '2.87', 'upperLimit': '6.97'}, {'value': '0.07', 'groupId': 'OG002', 'lowerLimit': '0.01', 'upperLimit': '0.11'}, {'value': '7.92', 'groupId': 'OG003', 'lowerLimit': '7.82', 'upperLimit': '8.02'}, {'value': '0.12', 'groupId': 'OG004', 'lowerLimit': '0.11', 'upperLimit': '0.18'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169', 'description': 'The time to reach the maximum observed serum concentration of MEDI-551.', 'unitOfMeasure': 'Day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Serum Concentration (Cmax) of MEDI-551', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-551 30 Mg-IV', 'description': 'Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.'}, {'id': 'OG001', 'title': 'MEDI-551 60 Mg-SC', 'description': 'Participants received SC injection of 60 mg MEDI-551 on Day 1.'}, {'id': 'OG002', 'title': 'MEDI-551 100 Mg-IV', 'description': 'Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.'}, {'id': 'OG003', 'title': 'MEDI-551 300 Mg-SC', 'description': 'Participants received SC injection of 300 mg MEDI-551 on Day 1.'}, {'id': 'OG004', 'title': 'MEDI-551 600 Mg-IV', 'description': 'Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.9', 'spread': '13.2', 'groupId': 'OG000'}, {'value': '6.67', 'spread': '2.88', 'groupId': 'OG001'}, {'value': '43.1', 'spread': '11.4', 'groupId': 'OG002'}, {'value': '24.7', 'spread': '9.37', 'groupId': 'OG003'}, {'value': '248', 'spread': '66.8', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169', 'description': 'The maximum observed serum concentration (Cmax) of MEDI-551.', 'unitOfMeasure': 'microgram per milliliter (mcg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC 0-last) of MEDI-551', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-551 30 Mg-IV', 'description': 'Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.'}, {'id': 'OG001', 'title': 'MEDI-551 60 Mg-SC', 'description': 'Participants received SC injection of 60 mg MEDI-551 on Day 1.'}, {'id': 'OG002', 'title': 'MEDI-551 100 Mg-IV', 'description': 'Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.'}, {'id': 'OG003', 'title': 'MEDI-551 300 Mg-SC', 'description': 'Participants received SC injection of 300 mg MEDI-551 on Day 1.'}, {'id': 'OG004', 'title': 'MEDI-551 600 Mg-IV', 'description': 'Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '436', 'spread': 'NA', 'comment': 'Standard deviation was not calculated due to limited sample size (n=2). Two out of five participants received only one dose and 1 participant had insufficient data.', 'groupId': 'OG000'}, {'value': '197', 'spread': '92.6', 'groupId': 'OG001'}, {'value': '1140', 'spread': '278', 'groupId': 'OG002'}, {'value': '788', 'spread': '455', 'groupId': 'OG003'}, {'value': '6850', 'spread': '1340', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169', 'description': 'The area under the concentration time curve from time 0 (dosing time) to the last measurable concentration (AUC 0-last) of MEDI-551.', 'unitOfMeasure': 'microgram*day per milliliter(mcg*day/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC 0-infinity) of MEDI-551', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-551 30 Mg-IV', 'description': 'Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.'}, {'id': 'OG001', 'title': 'MEDI-551 60 Mg-SC', 'description': 'Participants received SC injection of 60 mg MEDI-551 on Day 1.'}, {'id': 'OG002', 'title': 'MEDI-551 100 Mg-IV', 'description': 'Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.'}, {'id': 'OG003', 'title': 'MEDI-551 300 Mg-SC', 'description': 'Participants received SC injection of 300 mg MEDI-551 on Day 1.'}, {'id': 'OG004', 'title': 'MEDI-551 600 Mg-IV', 'description': 'Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '440', 'spread': 'NA', 'comment': 'Standard deviation was not calculated due to limited sample size (n=2). Two out of five participants received only one dose and 1 participant had insufficient data.', 'groupId': 'OG000'}, {'value': '201', 'spread': '91.5', 'groupId': 'OG001'}, {'value': '1150', 'spread': '286', 'groupId': 'OG002'}, {'value': '794', 'spread': '453', 'groupId': 'OG003'}, {'value': '6950', 'spread': '1430', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169', 'description': 'The area under the concentration-time curve from dosing extrapolated to infinity (AUC 0-infinity) of MEDI-551.', 'unitOfMeasure': 'mcg*day/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Dose Normalized Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC 0-infinity/D) of MEDI-551', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-551 30 Mg-IV', 'description': 'Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.'}, {'id': 'OG001', 'title': 'MEDI-551 60 Mg-SC', 'description': 'Participants received SC injection of 60 mg MEDI-551 on Day 1.'}, {'id': 'OG002', 'title': 'MEDI-551 100 Mg-IV', 'description': 'Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.'}, {'id': 'OG003', 'title': 'MEDI-551 300 Mg-SC', 'description': 'Participants received SC injection of 300 mg MEDI-551 on Day 1.'}, {'id': 'OG004', 'title': 'MEDI-551 600 Mg-IV', 'description': 'Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.34', 'spread': 'NA', 'comment': 'Standard deviation was not calculated due to limited sample size (n=2). Two out of five participants received only one dose and 1 participant had insufficient data.', 'groupId': 'OG000'}, {'value': '3.35', 'spread': '1.52', 'groupId': 'OG001'}, {'value': '5.75', 'spread': '1.43', 'groupId': 'OG002'}, {'value': '2.65', 'spread': '1.51', 'groupId': 'OG003'}, {'value': '5.79', 'spread': '1.19', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169', 'description': 'The AUC (0-infinity)/D is the area under concentration-time curve extrapolated to infinity post dose normalized by MEDI-551.', 'unitOfMeasure': 'mcg*day/mL/mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Clearance of MEDI-551', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-551 30 Mg-IV', 'description': 'Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.'}, {'id': 'OG001', 'title': 'MEDI-551 60 Mg-SC', 'description': 'Participants received SC injection of 60 mg MEDI-551 on Day 1.'}, {'id': 'OG002', 'title': 'MEDI-551 100 Mg-IV', 'description': 'Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.'}, {'id': 'OG003', 'title': 'MEDI-551 300 Mg-SC', 'description': 'Participants received SC injection of 300 mg MEDI-551 on Day 1.'}, {'id': 'OG004', 'title': 'MEDI-551 600 Mg-IV', 'description': 'Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '139', 'spread': 'NA', 'comment': 'Standard deviation was not calculated due to limited sample size (n=2). Two out of five participants received only one dose and 1 participant had insufficient data.', 'groupId': 'OG000'}, {'value': '351', 'spread': '177', 'groupId': 'OG001'}, {'value': '181', 'spread': '44.5', 'groupId': 'OG002'}, {'value': '457', 'spread': '214', 'groupId': 'OG003'}, {'value': '180', 'spread': '41.5', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169', 'description': 'Systemic clearance (CL) for MEDI-551 IV cohorts and apparent clearance (CL/F) for MEDI-551 SC cohorts were calculated', 'unitOfMeasure': 'mL/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Terminal Elimination Half-life (t1/2) of MEDI-551', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-551 30 Mg-IV', 'description': 'Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.'}, {'id': 'OG001', 'title': 'MEDI-551 60 Mg-SC', 'description': 'Participants received SC injection of 60 mg MEDI-551 on Day 1.'}, {'id': 'OG002', 'title': 'MEDI-551 100 Mg-IV', 'description': 'Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.'}, {'id': 'OG003', 'title': 'MEDI-551 300 Mg-SC', 'description': 'Participants received SC injection of 300 mg MEDI-551 on Day 1.'}, {'id': 'OG004', 'title': 'MEDI-551 600 Mg-IV', 'description': 'Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.7', 'spread': 'NA', 'comment': 'Standard deviation was not calculated due to limited sample size (n=2). Two out of five participants received only one dose and 1 participant had insufficient data.', 'groupId': 'OG000'}, {'value': '12.3', 'spread': '1.71', 'groupId': 'OG001'}, {'value': '17.7', 'spread': '6.27', 'groupId': 'OG002'}, {'value': '15.1', 'spread': '4.31', 'groupId': 'OG003'}, {'value': '18.7', 'spread': '2.03', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169', 'description': 'The terminal elimination half-life (t1/2) was estimated based on the plasma concentrations of MEDI-551.', 'unitOfMeasure': 'Day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Absolute Subcutaneous Bioavailability (F%) of MEDI-551', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-551 60 Mg-SC', 'description': 'Participants received SC injection of 60 mg MEDI-551 on Day 1.'}, {'id': 'OG001', 'title': 'MEDI-551 300 Mg-SC', 'description': 'Participants received SC injection of 300 mg MEDI-551 on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Predose (Day 1) and Days 4, 8, 15, 29, 57, 85, 113, 141, and 169', 'description': 'Bioavailability (F%) is the fraction of the study drug absorbed through non-intravenous administration compared with the corresponding intravenous administration of the same drug.', 'unitOfMeasure': 'Percentage of bioavailability', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Absolute CD20 B-cell Count at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PLACEBO-IV-SC', 'description': 'Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.'}, {'id': 'OG001', 'title': 'MEDI-551 30 Mg-IV', 'description': 'Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.'}, {'id': 'OG002', 'title': 'MEDI-551 60 Mg-SC', 'description': 'Participants received SC injection of 60 mg MEDI-551 on Day 1.'}, {'id': 'OG003', 'title': 'MEDI-551 100 Mg-IV', 'description': 'Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.'}, {'id': 'OG004', 'title': 'MEDI-551 300 Mg-SC', 'description': 'Participants received SC injection of 300 mg MEDI-551 on Day 1.'}, {'id': 'OG005', 'title': 'MEDI-551 600 Mg-IV', 'description': 'Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '190', 'spread': '99.1', 'groupId': 'OG000'}, {'value': '173', 'spread': '36.1', 'groupId': 'OG001'}, {'value': '180', 'spread': '108', 'groupId': 'OG002'}, {'value': '183', 'spread': '65.5', 'groupId': 'OG003'}, {'value': '366', 'spread': '257', 'groupId': 'OG004'}, {'value': '201', 'spread': '91.3', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Days -28 to -1)', 'description': 'Baseline absolute CD20 count is measured as the average between screening and predose on Day 1.', 'unitOfMeasure': 'cells/mcL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Time to 90 Percent (%) CD20 B-cell Depletion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PLACEBO-IV-SC', 'description': 'Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.'}, {'id': 'OG001', 'title': 'MEDI-551 30 Mg-IV', 'description': 'Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.'}, {'id': 'OG002', 'title': 'MEDI-551 60 Mg-SC', 'description': 'Participants received SC injection of 60 mg MEDI-551 on Day 1.'}, {'id': 'OG003', 'title': 'MEDI-551 100 Mg-IV', 'description': 'Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.'}, {'id': 'OG004', 'title': 'MEDI-551 300 Mg-SC', 'description': 'Participants received SC injection of 300 mg MEDI-551 on Day 1.'}, {'id': 'OG005', 'title': 'MEDI-551 600 Mg-IV', 'description': 'Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.0', 'spread': '1.10', 'groupId': 'OG001', 'lowerLimit': '13.0', 'upperLimit': '16.0'}, {'value': '88.0', 'spread': '50.3', 'groupId': 'OG002', 'lowerLimit': '4.00', 'upperLimit': '94.0'}, {'value': '25.0', 'spread': '6.19', 'groupId': 'OG003', 'lowerLimit': '15.0', 'upperLimit': '29.0'}, {'value': '15.0', 'spread': '4.04', 'groupId': 'OG004', 'lowerLimit': '15.0', 'upperLimit': '22.0'}, {'value': '14.5', 'spread': '5.65', 'groupId': 'OG005', 'lowerLimit': '4.00', 'upperLimit': '17.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Days -28 to -1) to long-term follow-up (LTFU) (Up to 18 months after EDV or 24 Week treatment period)', 'description': 'Time in days of first observation where CD20 counts fall to or below 10 percent (%) of baseline.', 'unitOfMeasure': 'Day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. No participants in placebo-IV-SC group reached 90% CD20 B-cell depletion.'}, {'type': 'SECONDARY', 'title': 'Duration of Suppression Greater Than or Equal to 90 % of CD20 B-cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PLACEBO-IV-SC', 'description': 'Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.'}, {'id': 'OG001', 'title': 'MEDI-551 30 Mg-IV', 'description': 'Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.'}, {'id': 'OG002', 'title': 'MEDI-551 60 Mg-SC', 'description': 'Participants received SC injection of 60 mg MEDI-551 on Day 1.'}, {'id': 'OG003', 'title': 'MEDI-551 100 Mg-IV', 'description': 'Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.'}, {'id': 'OG004', 'title': 'MEDI-551 300 Mg-SC', 'description': 'Participants received SC injection of 300 mg MEDI-551 on Day 1.'}, {'id': 'OG005', 'title': 'MEDI-551 600 Mg-IV', 'description': 'Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '149', 'spread': '62.8', 'groupId': 'OG001', 'lowerLimit': '69.0', 'upperLimit': '200'}, {'value': '100', 'spread': '28.3', 'groupId': 'OG002', 'lowerLimit': '77.0', 'upperLimit': '123'}, {'value': '180', 'spread': '39.2', 'groupId': 'OG003', 'lowerLimit': '140', 'upperLimit': '229'}, {'value': '211', 'spread': '17.3', 'groupId': 'OG004', 'lowerLimit': '175', 'upperLimit': '213'}, {'value': '254', 'spread': '45.3', 'groupId': 'OG005', 'lowerLimit': '244', 'upperLimit': '332'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Days -28 to -1) to LTFU (Up to 18 months after EDV or 24 Week treatment period)', 'description': 'Time in days of last observation where CD20 counts remain at or below 10% of baseline. Participants whose samples are available were analyzed for this outcome measure.', 'unitOfMeasure': 'Day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. No participants were included in placebo-IV-SC group since no participant reached 90% depletion.'}, {'type': 'SECONDARY', 'title': 'Maximum Change From Baseline in Absolute CD20 of Peripheral Blood B-cell Count to LTFU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PLACEBO-IV-SC', 'description': 'Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.'}, {'id': 'OG001', 'title': 'MEDI-551 30 Mg-IV', 'description': 'Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.'}, {'id': 'OG002', 'title': 'MEDI-551 60 Mg-SC', 'description': 'Participants received SC injection of 60 mg MEDI-551 on Day 1.'}, {'id': 'OG003', 'title': 'MEDI-551 100 Mg-IV', 'description': 'Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.'}, {'id': 'OG004', 'title': 'MEDI-551 300 Mg-SC', 'description': 'Participants received SC injection of 300 mg MEDI-551 on Day 1.'}, {'id': 'OG005', 'title': 'MEDI-551 600 Mg-IV', 'description': 'Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.0', 'spread': '31.2', 'groupId': 'OG000'}, {'value': '99.8', 'spread': '0.0770', 'groupId': 'OG001'}, {'value': '99.2', 'spread': '0.787', 'groupId': 'OG002'}, {'value': '99.7', 'spread': '0.225', 'groupId': 'OG003'}, {'value': '99.8', 'spread': '0.182', 'groupId': 'OG004'}, {'value': '99.8', 'spread': '0.237', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Days -28 to -1) to LTFU (Up to 18 months after EDV or 24 Week treatment period)', 'description': 'The maximum degree of depletion (intensity) measured during the course of the study for each participant by subtracting 100 from the lowest observed percent of baseline value.', 'unitOfMeasure': 'Percentage of cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants Positive for Anti-Drug Antibodies to MEDI-551', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PLACEBO-IV-SC', 'description': 'Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.'}, {'id': 'OG001', 'title': 'MEDI-551 30 Mg-IV', 'description': 'Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.'}, {'id': 'OG002', 'title': 'MEDI-551 60 Mg-SC', 'description': 'Participants received SC injection of 60 mg MEDI-551 on Day 1.'}, {'id': 'OG003', 'title': 'MEDI-551 100 Mg-IV', 'description': 'Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.'}, {'id': 'OG004', 'title': 'MEDI-551 300 Mg-SC', 'description': 'Participants received SC injection of 300 mg MEDI-551 on Day 1.'}, {'id': 'OG005', 'title': 'MEDI-551 600 Mg-IV', 'description': 'Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.'}], 'classes': [{'title': 'Day 1 (Baseline)', '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'}]}]}, {'title': 'Day 29', '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'}]}]}, {'title': 'Day 85', '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'}]}]}, {'title': 'Day 169', '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Days 1, 29, 85 and 169', 'description': 'A participant was considered anti-drug antibody positive across the study if they had a positive reading at any time point during the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PLACEBO-IV-SC', 'description': 'Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.'}, {'id': 'FG001', 'title': 'MEDI-551 30 Mg-IV', 'description': 'Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.'}, {'id': 'FG002', 'title': 'MEDI-551 60 Mg-SC', 'description': 'Participants received SC injection of 60 mg MEDI-551 on Day 1.'}, {'id': 'FG003', 'title': 'MEDI-551 100 Mg-IV', 'description': 'Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.'}, {'id': 'FG004', 'title': 'MEDI-551 300 Mg-SC', 'description': 'Participants received SC injection of 300 mg MEDI-551 on Day 1.'}, {'id': 'FG005', 'title': 'MEDI-551 600 Mg-IV', 'description': 'Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted from 30 Jul 2012 to 20 Jun 2016 in United States, Poland, Spain, and Ukraine.', 'preAssignmentDetails': 'A total of 56 participants were screened in this study. Out of which 28 participants were enrolled and randomized into the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '28', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'PLACEBO-IV-SC', 'description': 'Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.'}, {'id': 'BG001', 'title': 'MEDI-551 30 Mg-IV', 'description': 'Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.'}, {'id': 'BG002', 'title': 'MEDI-551 60 Mg-SC', 'description': 'Participants received SC injection of 60 mg MEDI-551 on Day 1.'}, {'id': 'BG003', 'title': 'MEDI-551 100 Mg-IV', 'description': 'Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.'}, {'id': 'BG004', 'title': 'MEDI-551 300 Mg-SC', 'description': 'Participants received SC injection of 300 mg MEDI-551 on Day 1.'}, {'id': 'BG005', 'title': 'MEDI-551 600 Mg-IV', 'description': 'Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.0', 'spread': '15.9', 'groupId': 'BG000'}, {'value': '42.4', 'spread': '7.8', 'groupId': 'BG001'}, {'value': '46.7', 'spread': '16.3', 'groupId': 'BG002'}, {'value': '46.5', 'spread': '13.8', 'groupId': 'BG003'}, {'value': '56.0', 'spread': '6.1', 'groupId': 'BG004'}, {'value': '44.2', 'spread': '10.1', 'groupId': 'BG005'}, {'value': '45.4', 'spread': '12.0', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Population is defined as all participants who received any amount of study drug. One participant in the 30 mg IV dose cohort received an incorrect dose of study drug due to kits not administered according to the IVRS; the participant received MEDI-551 100 mg IV instead of 30 mg on Day 1.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2016-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-08', 'studyFirstSubmitDate': '2012-04-09', 'resultsFirstSubmitDate': '2017-06-13', 'studyFirstSubmitQcDate': '2012-04-24', 'lastUpdatePostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-08', 'studyFirstPostDateStruct': {'date': '2012-04-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-01-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'From study drug administration (Day 1) through the end of treatment period (Day 169)', 'description': 'An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A TEAE were the events between administration of study drug (Day 1) and Day 169 that were absent before treatment or that worsened relative to pre-treatment state. The AEs were summarized using Medical Dictionary for Regulatory Activities version 19.0'}, {'measure': 'Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'From study drug administration (Day 1) through the long term follow up period (up to 18 months after early discontinuation visit or 24 week treatment period).', 'description': 'A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death, life-threatening, initial or prolonged inpatient hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect in the offspring of a participant who received the study drug. The TESAEs were the events between administration of study drug (Day 1) and long term follow up period (up to 18 months after early discontinuation visit or 24-week treatment period) that were absent before treatment or that worsened relative to pre-treatment state. The AEs were summarized using Medical Dictionary for Regulatory Activities version 19.0'}, {'measure': 'Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs', 'timeFrame': 'From study drug administration (Day 1) through the end of treatment period (Day 169)', 'description': 'Any clinically significant change in laboratory evaluations were recorded as AEs. The following parameters were analyzed for laboratory evaluations: haematology, serum chemistry, and urinalysis. Number of participants with TEAEs related to laboratory evaluations were reported.'}, {'measure': 'Number of Participants With Vital Sign Abnormalities Reported as TEAEs', 'timeFrame': 'From study drug administration (Day 1) through the end of treatment period (Day 169)', 'description': 'Vital sign parameters included blood pressure, temperature, pulse rate, and respiratory rate. The number of participants with TEAEs related to vital signs in participants were reported.'}], 'secondaryOutcomes': [{'measure': 'Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI-551', 'timeFrame': 'Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169', 'description': 'The time to reach the maximum observed serum concentration of MEDI-551.'}, {'measure': 'Maximum Observed Serum Concentration (Cmax) of MEDI-551', 'timeFrame': 'Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169', 'description': 'The maximum observed serum concentration (Cmax) of MEDI-551.'}, {'measure': 'Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC 0-last) of MEDI-551', 'timeFrame': 'Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169', 'description': 'The area under the concentration time curve from time 0 (dosing time) to the last measurable concentration (AUC 0-last) of MEDI-551.'}, {'measure': 'Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC 0-infinity) of MEDI-551', 'timeFrame': 'Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169', 'description': 'The area under the concentration-time curve from dosing extrapolated to infinity (AUC 0-infinity) of MEDI-551.'}, {'measure': 'Dose Normalized Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC 0-infinity/D) of MEDI-551', 'timeFrame': 'Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169', 'description': 'The AUC (0-infinity)/D is the area under concentration-time curve extrapolated to infinity post dose normalized by MEDI-551.'}, {'measure': 'Clearance of MEDI-551', 'timeFrame': 'Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169', 'description': 'Systemic clearance (CL) for MEDI-551 IV cohorts and apparent clearance (CL/F) for MEDI-551 SC cohorts were calculated'}, {'measure': 'Terminal Elimination Half-life (t1/2) of MEDI-551', 'timeFrame': 'Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169', 'description': 'The terminal elimination half-life (t1/2) was estimated based on the plasma concentrations of MEDI-551.'}, {'measure': 'Absolute Subcutaneous Bioavailability (F%) of MEDI-551', 'timeFrame': 'Predose (Day 1) and Days 4, 8, 15, 29, 57, 85, 113, 141, and 169', 'description': 'Bioavailability (F%) is the fraction of the study drug absorbed through non-intravenous administration compared with the corresponding intravenous administration of the same drug.'}, {'measure': 'Absolute CD20 B-cell Count at Baseline', 'timeFrame': 'Baseline (Days -28 to -1)', 'description': 'Baseline absolute CD20 count is measured as the average between screening and predose on Day 1.'}, {'measure': 'Time to 90 Percent (%) CD20 B-cell Depletion', 'timeFrame': 'Baseline (Days -28 to -1) to long-term follow-up (LTFU) (Up to 18 months after EDV or 24 Week treatment period)', 'description': 'Time in days of first observation where CD20 counts fall to or below 10 percent (%) of baseline.'}, {'measure': 'Duration of Suppression Greater Than or Equal to 90 % of CD20 B-cell Count', 'timeFrame': 'Baseline (Days -28 to -1) to LTFU (Up to 18 months after EDV or 24 Week treatment period)', 'description': 'Time in days of last observation where CD20 counts remain at or below 10% of baseline. Participants whose samples are available were analyzed for this outcome measure.'}, {'measure': 'Maximum Change From Baseline in Absolute CD20 of Peripheral Blood B-cell Count to LTFU', 'timeFrame': 'Baseline (Days -28 to -1) to LTFU (Up to 18 months after EDV or 24 Week treatment period)', 'description': 'The maximum degree of depletion (intensity) measured during the course of the study for each participant by subtracting 100 from the lowest observed percent of baseline value.'}, {'measure': 'Number of Participants Positive for Anti-Drug Antibodies to MEDI-551', 'timeFrame': 'Days 1, 29, 85 and 169', 'description': 'A participant was considered anti-drug antibody positive across the study if they had a positive reading at any time point during the study.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MAb, B cell, depletion, RMS'], 'conditions': ['Multiple Sclerosis, Relapsing Forms']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and tolerability of ascending intravenous (IV) and subcutaneous (SC) doses of MEDI-551 in adult subjects with relapsing forms of multiple sclerosis (MS).', 'detailedDescription': 'This is a Phase 1, multicenter, multinational, randomized, blinded, placebo-controlled, dose-escalation study to evaluate the safety and tolerability of IV and SC doses of MEDI-551 in adult subjects with relapsing forms of MS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed relapsing form of MS (ie, RRMS, SPMS, PRMS, or CIS) according to revised 2010 McDonald criteria and MRI brain lesions consistent with MS on screening\n* At least 1 documented relapse within the past 3 years prior to screening\n* EDSS between 0.0 and 6.5 at screening\n* Have no more than 20 Gd-enhancing T1 brain lesions detected by cranial MRI scan\n\nExclusion Criteria:\n\n* Subjects with impaired renal function\n* Major surgery within 8 weeks of the screening visit\n* Subjects who are unable to undergo cranial MRI scan\n* A history of hypersensitivity to Gd-containing MRI contrast agents\n* Has received within 1 year prior to screening: monoclonal antibodies, experimental B-cell depleting agents, or treatment with natalizumab (Tysabri) for greater than 3 months\n* Receiving monthly methylprednisone or equivalent glucocorticoid for disease modification of a relapsing form of MS\n* Known sensitivity to acetaminophen/paracetamol, diphenhydramine or equivalent antihistamine, methylprednisolone or equivalent glucocorticoid, or to any component of the investigational drug\n* Diagnosis of PPMS, neuromyelitis optica, or other non-MS variant of neuro-inflammatory or demyelinating diseases\n* Any history of opportunistic infection or the presence of active infection within two months prior to screening or any herpes zoster infection that has not resolved within 12 weeks prior to screening\n* Any clinically significant findings during the screening phase, including physical, neurological, laboratory, or ECG examination as per protocol'}, 'identificationModule': {'nctId': 'NCT01585766', 'briefTitle': 'Safety and Tolerability Study of MEDI-551, a B-cell Depleting Agent, to Treat Relapsing Forms of Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedImmune LLC'}, 'officialTitle': 'A Phase 1 Randomized Study of MEDI-551 in Subjects With Relapsing Forms of Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'CD-IA-MEDI-551-1102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MEDI-551 30 MG-IV', 'description': 'Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.', 'interventionNames': ['Drug: MEDI-551 30 MG-IV']}, {'type': 'EXPERIMENTAL', 'label': 'MEDI-551 60 MG-SC', 'description': 'Participants received SC injection of 60 mg MEDI-551 on Day 1.', 'interventionNames': ['Drug: MEDI-551 60 MG-SC']}, {'type': 'EXPERIMENTAL', 'label': 'MEDI-551 100 MG-IV', 'description': 'Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.', 'interventionNames': ['Drug: MEDI-551 100 MG-IV']}, {'type': 'EXPERIMENTAL', 'label': 'MEDI-551 300 MG-SC', 'description': 'Participants received SC injection of 300 mg MEDI-551 on Day 1.', 'interventionNames': ['Drug: MEDI-551 300 MG-SC']}, {'type': 'EXPERIMENTAL', 'label': 'MEDI-551 600 MG-IV', 'description': 'Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.', 'interventionNames': ['Drug: MEDI-551 600 MG-IV']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PLACEBO-IV-SC', 'description': 'Participants received either a fixed IV dose of placebo matching with MEDI- 551 on Days 1 and 15 or SC injection on Day 1.', 'interventionNames': ['Drug: PLACEBO-IV-SC']}], 'interventions': [{'name': 'MEDI-551 30 MG-IV', 'type': 'DRUG', 'description': 'Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.', 'armGroupLabels': ['MEDI-551 30 MG-IV']}, {'name': 'MEDI-551 60 MG-SC', 'type': 'DRUG', 'description': 'Participants received SC injection of 60 mg MEDI-551 on Day 1.', 'armGroupLabels': ['MEDI-551 60 MG-SC']}, {'name': 'PLACEBO-IV-SC', 'type': 'DRUG', 'description': 'Participants received either a fixed IV dose of placebo matching with MEDI- 551 on Days 1 and 15 or SC injection on Day 1', 'armGroupLabels': ['PLACEBO-IV-SC']}, {'name': 'MEDI-551 100 MG-IV', 'type': 'DRUG', 'description': 'Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.', 'armGroupLabels': ['MEDI-551 100 MG-IV']}, {'name': 'MEDI-551 300 MG-SC', 'type': 'DRUG', 'description': 'Participants received SC injection of 300 mg MEDI-551 on Day 1.', 'armGroupLabels': ['MEDI-551 300 MG-SC']}, {'name': 'MEDI-551 600 MG-IV', 'type': 'DRUG', 'description': 'Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.', 'armGroupLabels': ['MEDI-551 600 MG-IV']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'Marlton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.89122, 'lon': -74.92183}}, {'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'city': 'Cordova', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.15565, 'lon': -89.7762}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Katowice', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'city': 'Szczecin', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Girona', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}, {'city': 'Seville', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Donetsk', 'country': 'Ukraine', 'facility': 'Research Site', 'geoPoint': {'lat': 48.023, 'lon': 37.80224}}, {'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Research Site', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}], 'overallOfficials': [{'name': 'Armando Flor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MedImmune LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MedImmune LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}