Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-03-07 @ 9:30 PM
Study NCT ID:
NCT04103034
Status:
COMPLETED
Last Update Posted:
2024-03-18
First Post:
2019-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A SAD/MAD Study of Safety, Tolerability and Pharmacologic Activity of BT200 in Normal Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D002537', 'term': 'Intracranial Arteriosclerosis'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003894', 'term': 'Deamino Arginine Vasopressin'}], 'ancestors': [{'id': 'D001127', 'term': 'Arginine Vasopressin'}, {'id': 'D014667', 'term': 'Vasopressins'}, {'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tia.defeo-fraulini@bandtherapeutics.com', 'phone': '7819186561', 'title': 'Tia DeFeo-Fraulini', 'organization': 'Band Therapeutics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from time of screening up to 56 days post dose', 'eventGroups': [{'id': 'EG000', 'title': 'BT200 0.18mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 0.18mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'BT200 0.6mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 0.6mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'BT200 1.8mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 1.8mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'BT200 6.0mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 6.0mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'BT200 12.0mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 12.0mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'BT200 24.0mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 24.0mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'BT200 24.0mg Rep', 'description': 'Subjects will receive a single subcutaneous (SC) dose of BT200 24.0mg by gradual SC infusion\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': 'Placebo SAD', 'description': 'Subjects will receive a single subcutaneous dose of placebo\n\nPlacebo: Sterile saline for injection', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 16, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG008', 'title': 'BT200 Loading Dose 12.0mg, Maintenance Doses of 12.0 mg', 'description': 'Subjects will receive an initial subcutaneous loading doses of BT200 12.0mg followed by 4 weekly (every 7 days) maintenance doses of BT200 12.0mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'BT200 Loading Doses 24.0mg, Maintenance Doses of 24.0 mg', 'description': 'Subjects will receive an initial subcutaneous loading dose of BT200 24mg followed by 4 weekly (every 7 days) maintenance doses of BT200 24mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG010', 'title': 'Placebo MAD', 'description': 'Subjects will receive an initial subcutaneous loading dose of Placebo followed by 4 weekly (every 7 days) maintenance doses of placebo\n\nPlacebo: Sterile saline for injection', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': 'BT200 48.0mg + Desmopressin Challenge', 'description': 'Subjects will receive a single subcutaneous dose of BT200 48.0mg followed by IV infusion (over 30 min) of 0.3µg/kg desmopressin administered 24 hours after single dose of BT200\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide\n\nDesmopressin: Sterile solution for injection', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG012', 'title': 'Placebo + Desmopressin Challenge Dose', 'description': 'Subjects will receive a single subcutaneous dose of placebo followed by IV infusion (over 30 min of 0.3µg/kg desmopressin administered 24 hours after single dose of placebo\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide\n\nDesmopressin: Sterile solution for injection', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG013', 'title': 'Placebo Infusion', 'description': 'Subjects will receive a single IV dose of placebo administered over 24 hours\n\nPlacebo: Sterile saline for injection', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG014', 'title': 'BT200 36.0mg', 'description': 'Subjects will receive a single subcutaneous (SC) dose of BT200 36.0mg by gradual SC infusion\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG015', 'title': 'BT200 48.0 mg', 'description': 'Subjects will receive a single subcutaneous dose (SC) of BT200 48.0mg by gradual SC infusion\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG016', 'title': 'BT200 18.0 mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 18.o mg', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG017', 'title': 'BT200 24mg IV Infusion', 'description': 'Subjects will receive a single IV dose of BT200 24mg administered over 24 hours', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG017', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Infected dermal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Root canal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG015', 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0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Skin discoloration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'seriousEvents': [{'term': 'Back pain', 'notes': 'Grade 3 SAE of back pain considered unrelated to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Humerus fracture', 'notes': 'Grade 3 SAE of humerus fracture considered unrelated to study dug', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Intervertebral disc protrusion', 'notes': 'Grade 3 SAE of intervertebral disc protrusion considered unrelated to study drug', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Prostate cancer', 'notes': 'Grade 3 SAE of prostate cancer considered unrelated to study drug', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}, {'value': '6', 'groupId': 'OG014'}, {'value': '6', 'groupId': 'OG015'}, {'value': '6', 'groupId': 'OG016'}, {'value': '6', 'groupId': 'OG017'}]}], 'groups': [{'id': 'OG000', 'title': 'BT200 0.18mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 0.18mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG001', 'title': 'BT200 0.6mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 0.6mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG002', 'title': 'BT200 1.8mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 1.8mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG003', 'title': 'BT200 6.0mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 6.0mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG004', 'title': 'BT200 12.0mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 12.0mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG005', 'title': 'BT200 24.0mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 24.0mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG006', 'title': 'BT200 24.0mg Rep', 'description': 'Subjects will receive a single subcutaneous (SC) dose of BT200 24.0mg by gradual SC infusion\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG007', 'title': 'Placebo SAD', 'description': 'Subjects will receive a single subcutaneous dose of placebo\n\nPlacebo: Sterile saline for injection'}, {'id': 'OG008', 'title': 'BT200 Loading Dose 12.0mg, Maintenance Doses of 12.0 mg', 'description': 'Subjects will receive an initial subcutaneous loading doses of BT200 12.0mg followed by 4 weekly (every 7 days) maintenance doses of BT200 12.0mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG009', 'title': 'BT200 Loading Doses 24.0mg, Maintenance Doses of 24.0 mg', 'description': 'Subjects will receive an initial subcutaneous loading dose of BT200 24mg followed by 4 weekly (every 7 days) maintenance doses of BT200 24mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG010', 'title': 'Placebo MAD', 'description': 'Subjects will receive an initial subcutaneous loading dose of Placebo followed by 4 weekly (every 7 days) maintenance doses of placebo\n\nPlacebo: Sterile saline for injection'}, {'id': 'OG011', 'title': 'BT200 48.0mg + Desmopressin Challenge', 'description': 'Subjects will receive a single subcutaneous dose of BT200 48.0mg followed by IV infusion (over 30 min) of 0.3µg/kg desmopressin administered 24 hours after single dose of BT200\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide\n\nDesmopressin: Sterile solution for injection'}, {'id': 'OG012', 'title': 'Placebo + Desmopressin Challenge Dose', 'description': 'Subjects will receive a single subcutaneous dose of placebo followed by IV infusion (over 30 min of 0.3µg/kg desmopressin administered 24 hours after single dose of placebo\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide\n\nDesmopressin: Sterile solution for injection'}, {'id': 'OG013', 'title': 'Placebo Infusion', 'description': 'Subjects will receive a single IV dose of placebo administered over 24 hours\n\nPlacebo: Sterile saline for injection'}, {'id': 'OG014', 'title': 'BT200 36.0mg', 'description': 'Subjects will receive a single subcutaneous (SC) dose of BT200 36.0mg by gradual SC infusion\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG015', 'title': 'BT200 48.0 mg', 'description': 'Subjects will receive a single subcutaneous dose (SC) of BT200 48.0mg by gradual SC infusion\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG016', 'title': 'BT200 18.0 mg', 'description': 'Subjects will receive a single subcutaneous (SC) dose of BT200 18.0mg by gradual SC infusion\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG017', 'title': 'BT200 24mg IV Infusion', 'description': 'Subjects will receive a single IV dose of BT200 24mg administered over 24 hours\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '3', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline through 8 weeks after dosing up to 56 days', 'description': 'Any AE or bleeding event related to study treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'SECONDARY', 'title': 'Measured Area Under the Curve (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}, {'value': '6', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'BT200 0.18mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 0.18mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG001', 'title': 'BT200 0.6mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 0.6mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG002', 'title': 'BT200 1.8mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 1.8mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG003', 'title': 'BT200 6.0mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 6.0mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG004', 'title': 'BT200 12.0mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 12.0mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG005', 'title': 'BT200 24.0mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 24.0mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG006', 'title': 'BT200 24.0mg Rep', 'description': 'Subjects will receive a single subcutaneous (SC) dose of BT200 24.0mg by gradual SC infusion\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG007', 'title': 'BT200 Loading Dose 24.0mg, Maintenance Doses of 12.0 mg', 'description': 'Subjects will receive an initial subcutaneous loading doses of BT200 24.0mg followed by 4 weekly (every 7 days) maintenance doses of BT200 12.0mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG008', 'title': 'BT200 Loading Doses 48.0mg, Maintenance Doses of 24.0 mg', 'description': 'Subjects will receive an initial subcutaneous loading dose of BT200 48mg followed by 4 weekly (every 7 days) maintenance doses of BT200 24mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG009', 'title': 'BT200 48.0mg + Desmopressin Challenge', 'description': 'Subjects will receive a single subcutaneous dose of BT200 48.0mg followed by IV infusion (over 30 min) of 0.3µg/kg desmopressin administered 24 hours after single dose of BT200\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide\n\nDesmopressin: Sterile solution for injection'}, {'id': 'OG010', 'title': 'BT200 36.0mg', 'description': 'Subjects will receive a single subcutaneous (SC) dose of BT200 36.0mg by gradual SC infusion\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG011', 'title': 'BT200 48.0 mg', 'description': 'Subjects will receive a single subcutaneous dose (SC) of BT200 48.0mg by gradual SC infusion\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG012', 'title': 'BT200 18.0 mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 18.o mg'}, {'id': 'OG013', 'title': 'BT200 24mg IV Infusion', 'description': 'Subjects will receive a single IV dose of BT200 24mg administered over 24 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '1.159', 'spread': '0.72594', 'groupId': 'OG000'}, {'value': '5.405', 'spread': '2.1113', 'groupId': 'OG001'}, {'value': '11.50', 'spread': '6.5663', 'groupId': 'OG002'}, {'value': '64.39', 'spread': '22.534', 'groupId': 'OG003'}, {'value': '161.6', 'spread': '43.427', 'groupId': 'OG004'}, {'value': '259.5', 'spread': '99.216', 'groupId': 'OG005'}, {'value': '265.3', 'spread': '59.127', 'groupId': 'OG006'}, {'value': '409.4', 'spread': '32.347', 'groupId': 'OG007'}, {'value': '806.8', 'spread': '187.25', 'groupId': 'OG008'}, {'value': '675.9', 'spread': '204.80', 'groupId': 'OG009'}, {'value': '366.2', 'spread': '78.610', 'groupId': 'OG010'}, {'value': '638.8', 'spread': '90.467', 'groupId': 'OG011'}, {'value': '220.3', 'spread': '64.58', 'groupId': 'OG012'}, {'value': '555.4', 'spread': '126.99', 'groupId': 'OG013'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through 8 weeks after dosing up to 56 days', 'description': 'Measured Area Under the Curve at timepoints pre-dose, 0.5h, 1h, 4h, 8h,14h, 24h, 48h, 72h, 96h, 168h, 14d, 21d, 28d, 42d, 56d post dose', 'unitOfMeasure': 'h*ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population-(h\\*ug/mL)'}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}, {'value': '6', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'BT200 0.18mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 0.18mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG001', 'title': 'BT200 0.6mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 0.6mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG002', 'title': 'BT200 1.8mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 1.8mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG003', 'title': 'BT200 6.0mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 6.0mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG004', 'title': 'BT200 12.0mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 12.0mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG005', 'title': 'BT200 24.0mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 24.0mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG006', 'title': 'BT200 24.0mg Rep', 'description': 'Subjects will receive a single subcutaneous (SC) dose of BT200 24.0mg by gradual SC infusion\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG007', 'title': 'BT200 Loading Dose 24.0mg, Maintenance Doses of 12.0 mg', 'description': 'Subjects will receive an initial subcutaneous loading doses of BT200 24.0mg followed by 4 weekly (every 7 days) maintenance doses of BT200 12.0mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG008', 'title': 'BT200 Loading Doses 48.0mg, Maintenance Doses of 24.0 mg', 'description': 'Subjects will receive an initial subcutaneous loading dose of BT200 48mg followed by 4 weekly (every 7 days) maintenance doses of BT200 24mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG009', 'title': 'BT200 48.0mg + Desmopressin Challenge', 'description': 'Subjects will receive a single subcutaneous dose of BT200 48.0mg followed by IV infusion (over 30 min) of 0.3µg/kg desmopressin administered 24 hours after single dose of BT200\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide\n\nDesmopressin: Sterile solution for injection'}, {'id': 'OG010', 'title': 'BT200 36.0mg', 'description': 'Subjects will receive a single subcutaneous (SC) dose of BT200 36.0mg by gradual SC infusion\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG011', 'title': 'BT200 48.0 mg', 'description': 'Subjects will receive a single subcutaneous dose (SC) of BT200 48.0mg by gradual SC infusion\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG012', 'title': 'BT200 18.0 mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 18.o mg'}, {'id': 'OG013', 'title': 'BT200 24mg IV Infusion', 'description': 'Subjects will receive a single IV dose of BT200 24mg administered over 24 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01025', 'spread': '0.0055459', 'groupId': 'OG000'}, {'value': '0.04688', 'spread': '0.018522', 'groupId': 'OG001'}, {'value': '0.09432', 'spread': '0.035964', 'groupId': 'OG002'}, {'value': '0.5087', 'spread': '0.18430', 'groupId': 'OG003'}, {'value': '1.258', 'spread': '0.35540', 'groupId': 'OG004'}, {'value': '2.092', 'spread': '0.07627', 'groupId': 'OG005'}, {'value': '2.080', 'spread': '0.46217', 'groupId': 'OG006'}, {'value': '3.013', 'spread': '0.25185', 'groupId': 'OG007'}, {'value': '5.823', 'spread': '1.3606', 'groupId': 'OG008'}, {'value': '6.598', 'spread': '2.6719', 'groupId': 'OG009'}, {'value': '3.248', 'spread': '11724', 'groupId': 'OG010'}, {'value': '5.525', 'spread': '0.95429', 'groupId': 'OG011'}, {'value': '1.742', 'spread': '0.49545', 'groupId': 'OG012'}, {'value': '5.037', 'spread': '1.3953', 'groupId': 'OG013'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through 8 weeks after dosing up to 56 days', 'description': 'Maximum plasma Concentration measured at pre-dose, 0.5h, 1h, 4h, 8h,14h, 24h, 48h, 72h, 96h, 168h, 14d, 21d, 28d, 42d, 56d', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Plasma Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}, {'value': '6', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'BT200 0.18mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 0.18mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG001', 'title': 'BT200 0.6mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 0.6mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG002', 'title': 'BT200 1.8mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 1.8mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG003', 'title': 'BT200 6.0mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 6.0mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG004', 'title': 'BT200 12.0mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 12.0mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG005', 'title': 'BT200 24.0mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 24.0mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG006', 'title': 'BT200 24.0mg Rep', 'description': 'Subjects will receive a single subcutaneous (SC) dose of BT200 24.0mg by gradual SC infusion\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG007', 'title': 'BT200 Loading Dose 24.0mg, Maintenance Doses of 12.0 mg', 'description': 'Subjects will receive an initial subcutaneous loading doses of BT200 24.0mg followed by 4 weekly (every 7 days) maintenance doses of BT200 12.0mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG008', 'title': 'BT200 Loading Doses 48.0mg, Maintenance Doses of 24.0 mg', 'description': 'Subjects will receive an initial subcutaneous loading dose of BT200 48mg followed by 4 weekly (every 7 days) maintenance doses of BT200 24mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG009', 'title': 'BT200 48.0mg + Desmopressin Challenge', 'description': 'Subjects will receive a single subcutaneous dose of BT200 48.0mg followed by IV infusion (over 30 min) of 0.3µg/kg desmopressin administered 24 hours after single dose of BT200\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide\n\nDesmopressin: Sterile solution for injection'}, {'id': 'OG010', 'title': 'BT200 36.0mg', 'description': 'Subjects will receive a single subcutaneous (SC) dose of BT200 36.0mg by gradual SC infusion\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG011', 'title': 'BT200 48.0 mg', 'description': 'Subjects will receive a single subcutaneous dose (SC) of BT200 48.0mg by gradual SC infusion\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'OG012', 'title': 'BT200 18.0 mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 18.o mg'}, {'id': 'OG013', 'title': 'BT200 24mg IV Infusion', 'description': 'Subjects will receive a single IV dose of BT200 24mg administered over 24 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '111.867', 'spread': '111.7018', 'groupId': 'OG000'}, {'value': '80.433', 'spread': '20.2385', 'groupId': 'OG001'}, {'value': '72.364', 'spread': '22.0757', 'groupId': 'OG002'}, {'value': '100.239', 'spread': '53.4433', 'groupId': 'OG003'}, {'value': '72.761', 'spread': '21.4536', 'groupId': 'OG004'}, {'value': '100.247', 'spread': '38.5146', 'groupId': 'OG005'}, {'value': '88.517', 'spread': '19.7697', 'groupId': 'OG006'}, {'value': '29.892', 'spread': '25.8845', 'groupId': 'OG007'}, {'value': '12.811', 'spread': '17.9877', 'groupId': 'OG008'}, {'value': '105.919', 'spread': '18.9321', 'groupId': 'OG009'}, {'value': '139.647', 'spread': '46.6683', 'groupId': 'OG010'}, {'value': '107.892', 'spread': '113.4475', 'groupId': 'OG011'}, {'value': '100.247', 'spread': '38.5146', 'groupId': 'OG012'}, {'value': '23.864', 'spread': '0.2642', 'groupId': 'OG013'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through 8 weeks after dosing up to 56 days', 'description': 'Time to maximum plasma concentration measured at pre-dose, 0.5h, 1h, 4h, 8h,14h, 24h, 48h, 72h, 96h, 168h, 14d, 21d, 28d, 42d, 56d', 'unitOfMeasure': '(h)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BT200 0.18mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 0.18mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'FG001', 'title': 'BT200 0.6mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 0.6mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'FG002', 'title': 'BT200 1.8mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 1.8mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'FG003', 'title': 'BT200 6.0mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 6.0mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'FG004', 'title': 'BT200 12.0mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 12.0mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'FG005', 'title': 'BT200 24.0mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 24.0mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'FG006', 'title': 'BT200 24.0mg Rep', 'description': 'Subjects will receive a single subcutaneous (SC) dose of BT200 24.0mg by gradual SC infusion\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'FG007', 'title': 'Placebo SAD', 'description': 'Subjects will receive a single subcutaneous dose of placebo\n\nPlacebo: Sterile saline for injection'}, {'id': 'FG008', 'title': 'BT200 Loading Dose 24.0mg, Maintenance Doses of 12.0 mg', 'description': 'Subjects will receive an initial subcutaneous loading doses of BT200 24.0mg followed by 4 weekly (every 7 days) maintenance doses of BT200 12.0mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'FG009', 'title': 'BT200 Loading Doses 48.0mg, Maintenance Doses of 24.0 mg', 'description': 'Subjects will receive an initial subcutaneous loading dose of BT200 48mg followed by 4 weekly (every 7 days) maintenance doses of BT200 24mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'FG010', 'title': 'Placebo MAD', 'description': 'Subjects will receive an initial subcutaneous loading dose of Placebo followed by 4 weekly (every 7 days) maintenance doses of placebo\n\nPlacebo: Sterile saline for injection'}, {'id': 'FG011', 'title': 'BT200 48.0mg + Desmopressin Challenge', 'description': 'Subjects will receive a single subcutaneous dose of BT200 48.0mg followed by IV infusion (over 30 min) of 0.3µg/kg desmopressin administered 24 hours after single dose of BT200\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide\n\nDesmopressin: Sterile solution for injection'}, {'id': 'FG012', 'title': 'Placebo + Desmopressin Challenge Dose', 'description': 'Subjects will receive a single subcutaneous dose of placebo followed by IV infusion (over 30 min of 0.3µg/kg desmopressin administered 24 hours after single dose of placebo\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide\n\nDesmopressin: Sterile solution for injection'}, {'id': 'FG013', 'title': 'Placebo Infusion', 'description': 'Subjects will receive a single IV dose of placebo administered over 24 hours\n\nPlacebo: Sterile saline for injection'}, {'id': 'FG014', 'title': 'BT200 36.0mg', 'description': 'Subjects will receive a single subcutaneous (SC) dose of BT200 36.0mg by gradual SC infusion\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'FG015', 'title': 'BT200 48.0 mg', 'description': 'Subjects will receive a single subcutaneous dose (SC) of BT200 48.0mg by gradual SC infusion\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'FG016', 'title': 'BT200 18.0 mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 18.o mg'}, {'id': 'FG017', 'title': 'BT200 24mg IV Infusion', 'description': 'Subjects will receive a single IV dose of BT200 24mg administered over 24 hours'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '20'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '4'}, {'groupId': 'FG011', 'numSubjects': '6'}, {'groupId': 'FG012', 'numSubjects': '2'}, {'groupId': 'FG013', 'numSubjects': '2'}, {'groupId': 'FG014', 'numSubjects': '6'}, {'groupId': 'FG015', 'numSubjects': '6'}, {'groupId': 'FG016', 'numSubjects': '6'}, {'groupId': 'FG017', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '19'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '2'}, {'groupId': 'FG011', 'numSubjects': '6'}, {'groupId': 'FG012', 'numSubjects': '2'}, {'groupId': 'FG013', 'numSubjects': '2'}, {'groupId': 'FG014', 'numSubjects': '5'}, {'groupId': 'FG015', 'numSubjects': '4'}, {'groupId': 'FG016', 'numSubjects': '6'}, {'groupId': 'FG017', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'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'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '2'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '1'}, {'groupId': 'FG015', 'numSubjects': '2'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Subjects were recruited from the Medical University of Vienna Phase 1 Unit's database of Normal Human Volunteers and a recruitment vendor was also employed."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '20', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}, {'value': '2', 'groupId': 'BG012'}, {'value': '2', 'groupId': 'BG013'}, {'value': '6', 'groupId': 'BG014'}, {'value': '6', 'groupId': 'BG015'}, {'value': '6', 'groupId': 'BG016'}, {'value': '6', 'groupId': 'BG017'}, {'value': '112', 'groupId': 'BG018'}]}], 'groups': [{'id': 'BG000', 'title': 'BT200 0.18mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 0.18mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'BG001', 'title': 'BT200 0.6mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 0.6mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'BG002', 'title': 'BT200 1.8mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 1.8mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'BG003', 'title': 'BT200 6.0mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 6.0mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'BG004', 'title': 'BT200 12.0mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 12.0mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'BG005', 'title': 'BT200 24.0mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 24.0mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'BG006', 'title': 'BT200 24.0mg Rep', 'description': 'Subjects will receive a single subcutaneous (SC) dose of BT200 24.0mg by gradual SC infusion\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'BG007', 'title': 'Placebo SAD', 'description': 'Subjects will receive a single subcutaneous dose of placebo\n\nPlacebo: Sterile saline for injection'}, {'id': 'BG008', 'title': 'BT200 Loading Dose 12.0mg, Maintenance Doses of 12.0 mg', 'description': 'Subjects will receive an initial subcutaneous loading doses of BT200 12.0mg followed by 4 weekly (every 7 days) maintenance doses of BT200 12.0mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'BG009', 'title': 'BT200 Loading Doses 24.0mg, Maintenance Doses of 24.0 mg', 'description': 'Subjects will receive an initial subcutaneous loading dose of BT200 24mg followed by 4 weekly (every 7 days) maintenance doses of BT200 24mg\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'BG010', 'title': 'Placebo MAD', 'description': 'Subjects will receive an initial subcutaneous loading dose of Placebo followed by 4 weekly (every 7 days) maintenance doses of placebo\n\nPlacebo: Sterile saline for injection'}, {'id': 'BG011', 'title': 'BT200 48.0mg + Desmopressin Challenge', 'description': 'Subjects will receive a single subcutaneous dose of BT200 48.0mg followed by IV infusion (over 30 min) of 0.3µg/kg desmopressin administered 24 hours after single dose of BT200\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide\n\nDesmopressin: Sterile solution for injection'}, {'id': 'BG012', 'title': 'Placebo + Desmopressin Challenge Dose', 'description': 'Subjects will receive a single subcutaneous dose of placebo followed by IV infusion (over 30 min of 0.3µg/kg desmopressin administered 24 hours after single dose of placebo\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide\n\nDesmopressin: Sterile solution for injection'}, {'id': 'BG013', 'title': 'Placebo Infusion', 'description': 'Subjects will receive a single IV dose of placebo administered over 24 hours\n\nPlacebo: Sterile saline for injection'}, {'id': 'BG014', 'title': 'BT200 36.0mg', 'description': 'Subjects will receive a single subcutaneous (SC) dose of BT200 36.0mg by gradual SC infusion\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'BG015', 'title': 'BT200 48.0 mg', 'description': 'Subjects will receive a single subcutaneous dose (SC) of BT200 48.0mg by gradual SC infusion\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'BG016', 'title': 'BT200 18.0 mg', 'description': 'Subjects will receive a single subcutaneous (SC) dose of BT200 18.0mg by gradual SC infusion\n\nBT200: BT200 is a PEGylated synthetic RNA oligonucleotide'}, {'id': 'BG017', 'title': 'BT 200 24mg IV Infusion', 'description': 'Subjects will receive a single IV dose of BT200 24mg administered over 24 hours'}, {'id': 'BG018', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '3', 'groupId': 'BG018'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '19', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}, {'value': '2', 'groupId': 'BG012'}, {'value': '2', 'groupId': 'BG013'}, {'value': '6', 'groupId': 'BG014'}, {'value': '6', 'groupId': 'BG015'}, {'value': '6', 'groupId': 'BG016'}, {'value': '6', 'groupId': 'BG017'}, {'value': '109', 'groupId': 'BG018'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '0', 'groupId': 'BG018'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '2', 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{'value': '5', 'groupId': 'BG015'}, {'value': '6', 'groupId': 'BG016'}, {'value': '6', 'groupId': 'BG017'}, {'value': '101', 'groupId': 'BG018'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '0', 'groupId': 'BG018'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '20', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}, {'value': '2', 'groupId': 'BG012'}, {'value': '2', 'groupId': 'BG013'}, {'value': '6', 'groupId': 'BG014'}, {'value': '6', 'groupId': 'BG015'}, {'value': '6', 'groupId': 'BG016'}, {'value': '6', 'groupId': 'BG017'}, {'value': '112', 'groupId': 'BG018'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '0', 'groupId': 'BG018'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '0', 'groupId': 'BG018'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '1', 'groupId': 'BG016'}, {'value': '1', 'groupId': 'BG017'}, {'value': '5', 'groupId': 'BG018'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '0', 'groupId': 'BG018'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '1', 'groupId': 'BG018'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '20', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}, {'value': '2', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}, {'value': '6', 'groupId': 'BG014'}, {'value': '6', 'groupId': 'BG015'}, {'value': '5', 'groupId': 'BG016'}, {'value': '5', 'groupId': 'BG017'}, {'value': '106', 'groupId': 'BG018'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '0', 'groupId': 'BG018'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '0', 'groupId': 'BG018'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Austria', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '20', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}, {'value': '2', 'groupId': 'BG012'}, {'value': '2', 'groupId': 'BG013'}, {'value': '6', 'groupId': 'BG014'}, {'value': '6', 'groupId': 'BG015'}, {'value': '6', 'groupId': 'BG016'}, {'value': '6', 'groupId': 'BG017'}, {'value': '112', 'groupId': 'BG018'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-22', 'size': 401390, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-10-06T14:46', 'hasProtocol': True}, {'date': '2020-09-17', 'size': 948184, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-10-06T15:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-06', 'studyFirstSubmitDate': '2019-09-19', 'resultsFirstSubmitDate': '2022-10-06', 'studyFirstSubmitQcDate': '2019-09-23', 'lastUpdatePostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-06', 'studyFirstPostDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0', 'timeFrame': 'Baseline through 8 weeks after dosing up to 56 days', 'description': 'Any AE or bleeding event related to study treatment'}], 'secondaryOutcomes': [{'measure': 'Measured Area Under the Curve (AUC)', 'timeFrame': 'Baseline through 8 weeks after dosing up to 56 days', 'description': 'Measured Area Under the Curve at timepoints pre-dose, 0.5h, 1h, 4h, 8h,14h, 24h, 48h, 72h, 96h, 168h, 14d, 21d, 28d, 42d, 56d post dose'}, {'measure': 'Maximum Plasma Concentration (Cmax)', 'timeFrame': 'Baseline through 8 weeks after dosing up to 56 days', 'description': 'Maximum plasma Concentration measured at pre-dose, 0.5h, 1h, 4h, 8h,14h, 24h, 48h, 72h, 96h, 168h, 14d, 21d, 28d, 42d, 56d'}, {'measure': 'Time to Maximum Plasma Concentration (Tmax)', 'timeFrame': 'Baseline through 8 weeks after dosing up to 56 days', 'description': 'Time to maximum plasma concentration measured at pre-dose, 0.5h, 1h, 4h, 8h,14h, 24h, 48h, 72h, 96h, 168h, 14d, 21d, 28d, 42d, 56d'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Secondary Stroke Prevention'], 'conditions': ['Cerebrovascular Stroke', 'Large-Artery Atherosclerosis (Embolus/Thrombosis)', 'Intracranial Arteriosclerosis']}, 'referencesModule': {'references': [{'pmid': '29847840', 'type': 'BACKGROUND', 'citation': 'Buchtele N, Schwameis M, Gilbert JC, Schorgenhofer C, Jilma B. Targeting von Willebrand Factor in Ischaemic Stroke: Focus on Clinical Evidence. Thromb Haemost. 2018 Jun;118(6):959-978. doi: 10.1055/s-0038-1648251. Epub 2018 May 30.'}, {'pmid': '34818873', 'type': 'RESULT', 'citation': 'Kovacevic KD, Grafeneder J, Schorgenhofer C, Gelbenegger G, Gager G, Firbas C, Quehenberger P, Jilma-Stohlawetz P, Bileck A, Zhu S, Gilbert JC, Beliveau M, Jilma B, Derhaschnig U. The von Willebrand factor A-1 domain binding aptamer BT200 elevates plasma levels of von Willebrand factor and factor VIII: a first-in-human trial. Haematologica. 2022 Sep 1;107(9):2121-2132. doi: 10.3324/haematol.2021.279948.'}, {'pmid': '34818875', 'type': 'RESULT', 'citation': 'Denis CV, Lenting PJ. How to keep the factor VIII/von Willebrand factor complex in the circulation. Haematologica. 2022 Sep 1;107(9):2011-2013. doi: 10.3324/haematol.2021.280222. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Study BT200-01 is a first in human (FIH) study in male and female normal human volunteers (NHVs) that uses an Integrated Protocol Design. This Phase 1 study will comprise 4 sub-parts: Part A, a single ascending dose (SAD) study; Part B, a multiple ascending dose (MAD) study; Part C, a desmopressin challenge study to explore (i) whether desmopressin could be used as an antidote, and/or (ii) whether desmopressin stimulated vonWillebrand Factor (VWF) release is overcome with increasing BT200 doses; and Part D, a relative bioavailability (BA) study.\n\nThe primary objective of this study is to assess the safety and tolerability profile of BT200 in NHVs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy male or female volunteers, age ≥ 18 years old at screening\n2. If female, must be post-menopausal or status post hysterectomy\n3. Able to comprehend and to give informed consent\n4. Able to cooperate with the Investigator, to comply with the requirements of the study, and to complete the full sequence of protocol-related procedures\n\nExclusion Criteria:\n\n1. Clinically significant medical history (including von Willebrand Disease, thrombocytopathy, or any type of bleeding diathesis) or ongoing chronic illness that would jeopardize the safety of the subject or compromise the quality of the data derived from his/her participation in this study\n2. Clinically relevant abnormal findings on physical examination or clinically relevant laboratory abnormalities\n3. History of infusion hypersensitivity reactions, significant drug allergy, or anaphylactic reactions\n4. Substance abuse, mental illness, or any reason that makes it unlikely in the judgment of the Investigator for the subject to be able to comply fully with study procedures\n5. Use of medication during 2 weeks before the start of the study, which in the judgment of the Investigator may adversely affect the subject's welfare or the integrity of the study's results\n6. Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days or 5 elimination half-lives (whichever is longer) prior to treatment start"}, 'identificationModule': {'nctId': 'NCT04103034', 'briefTitle': 'A SAD/MAD Study of Safety, Tolerability and Pharmacologic Activity of BT200 in Normal Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Band Therapeutics'}, 'officialTitle': 'A Single/Multiple Ascending Dose Phase 1 Study of the Safety, Tolerability and Pharmacologic Activity of BT200 in Normal Human Volunteers', 'orgStudyIdInfo': {'id': 'BT200-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BT200 0.18mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 0.18mg', 'interventionNames': ['Drug: BT200']}, {'type': 'EXPERIMENTAL', 'label': 'BT200 0.6mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 0.6mg', 'interventionNames': ['Drug: BT200']}, {'type': 'EXPERIMENTAL', 'label': 'BT200 1.8mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 1.8mg', 'interventionNames': ['Drug: BT200']}, {'type': 'EXPERIMENTAL', 'label': 'BT200 6.0mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 6.0mg', 'interventionNames': ['Drug: BT200']}, {'type': 'EXPERIMENTAL', 'label': 'BT200 12.0mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 12.0mg', 'interventionNames': ['Drug: BT200']}, {'type': 'EXPERIMENTAL', 'label': 'BT200 24.0mg', 'description': 'Subjects will receive a single subcutaneous dose of BT200 24.0mg', 'interventionNames': ['Drug: BT200']}, {'type': 'EXPERIMENTAL', 'label': 'BT200 24.0mg rep', 'description': 'Subjects will receive a single subcutaneous (SC) dose of BT200 24.0mg by gradual SC infusion', 'interventionNames': ['Drug: BT200']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo SAD', 'description': 'Subjects will receive a single subcutaneous dose of placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BT200 loading dose 12.0mg, maintenance doses of 12.0 mg', 'description': 'Subjects will receive an initial subcutaneous loading doses of BT200 12.0mg followed by 4 weekly (every 7 days) maintenance doses of BT200 12.0mg', 'interventionNames': ['Drug: BT200']}, {'type': 'EXPERIMENTAL', 'label': 'BT200 loading doses 24.0mg, maintenance doses of 24.0 mg', 'description': 'Subjects will receive an initial subcutaneous loading dose of BT200 24mg followed by 4 weekly (every 7 days) maintenance doses of BT200 24mg', 'interventionNames': ['Drug: BT200']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo MAD', 'description': 'Subjects will receive an initial subcutaneous loading dose of Placebo followed by 4 weekly (every 7 days) maintenance doses of placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BT200 48.0mg + desmopressin challenge', 'description': 'Subjects will receive a single subcutaneous dose of BT200 48.0mg followed by IV infusion (over 30 min) of 0.3µg/kg desmopressin administered 24 hours after single dose of BT200', 'interventionNames': ['Drug: BT200', 'Drug: Desmopressin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + desmopressin challenge dose', 'description': 'Subjects will receive a single subcutaneous dose of placebo followed by IV infusion (over 30 min of 0.3µg/kg desmopressin administered 24 hours after single dose of placebo', 'interventionNames': ['Drug: BT200', 'Drug: Desmopressin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo infusion', 'description': 'Subjects will receive a single IV dose of placebo administered over 24 hours', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BT200 36.0mg', 'description': 'Subjects will receive a single subcutaneous (SC) dose of BT200 36.0mg by gradual SC infusion', 'interventionNames': ['Drug: BT200']}, {'type': 'EXPERIMENTAL', 'label': 'BT200 48.0 mg', 'description': 'Subjects will receive a single subcutaneous dose (SC) of BT200 48.0mg by gradual SC infusion', 'interventionNames': ['Drug: BT200']}, {'type': 'EXPERIMENTAL', 'label': 'BT200 18.0 mg', 'description': 'Subjects will receive a single subcutaneous (SC) dose of BT200 18.0mg by gradual SC infusion', 'interventionNames': ['Drug: BT200']}, {'type': 'EXPERIMENTAL', 'label': 'BT200 24mg IV infusion', 'description': 'Subjects will receive a single IV dose of BT200 24mg administered over 24 hours', 'interventionNames': ['Drug: BT200']}], 'interventions': [{'name': 'BT200', 'type': 'DRUG', 'description': 'BT200 is a PEGylated synthetic RNA oligonucleotide', 'armGroupLabels': ['BT200 0.18mg', 'BT200 0.6mg', 'BT200 1.8mg', 'BT200 12.0mg', 'BT200 18.0 mg', 'BT200 24.0mg', 'BT200 24.0mg rep', 'BT200 24mg IV infusion', 'BT200 36.0mg', 'BT200 48.0 mg', 'BT200 48.0mg + desmopressin challenge', 'BT200 6.0mg', 'BT200 loading dose 12.0mg, maintenance doses of 12.0 mg', 'BT200 loading doses 24.0mg, maintenance doses of 24.0 mg', 'Placebo + desmopressin challenge dose']}, {'name': 'Desmopressin', 'type': 'DRUG', 'otherNames': ['MINIRIN® Injection'], 'description': 'Sterile solution for injection', 'armGroupLabels': ['BT200 48.0mg + desmopressin challenge', 'Placebo + desmopressin challenge dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Sterile saline for injection', 'armGroupLabels': ['Placebo MAD', 'Placebo SAD', 'Placebo infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'James C Gilbert, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Band Therapeutics'}, {'name': 'Ulla Derhaschnig, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Band Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}