Viewing Study NCT03603106

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Ignite Creation Date: 2025-12-26 @ 5:18 PM
Ignite Modification Date: 2026-03-02 @ 5:51 PM
Study NCT ID: NCT03603106
Status: COMPLETED
Last Update Posted: 2021-05-14
First Post: 2018-07-16
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Pharmacokinetics, Pharmacodynamics Profile and Tolerance of P03277 in Healthy Subjects and Patients With Brain Lesions
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000656634', 'term': 'gadopiclenol'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jing.hao@guerbet.com', 'phone': '+33 (0) 1 45 91 50 00', 'title': 'Jing Hao, MD', 'organization': 'Guerbet'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': "For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.", 'description': 'All adverse events occuring pre- and post-injection are reported below.', 'eventGroups': [{'id': 'EG000', 'title': 'Part I (Phase I) P03277 0.025 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.025 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part I (Phase I) P03277 0.05 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.05 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part I (Phase I) P03277 0.075 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.075 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part I (Phase I) P03277 0.1 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.1 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part I (Phase I) P03277 0.2 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.2 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Part I (Phase I) P03277 0.3 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.3 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Part I (Phase I) Placebo', 'description': '3 healthy subjects per dose group received placebo in one single administration.\n\nPlacebo was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 11, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Part II (Phase IIA) P03277 0.05 mmol/kg', 'description': '3 patients received one single administration of P03277. P03277 was administered intravenously at 0.05 mmol/kg with a flow rate of 2 mL/s.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Part II (Phase IIA) P03277 0.075 mmol/kg', 'description': '3 patients received one single administration of P03277. P03277 was administered intravenously at 0.075 mmol/kg with a flow rate of 2 mL/s.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG009', 'title': 'Part II (Phase IIA) P03277 0.1 mmol/kg', 'description': '3 patients received one single administration of P03277. P03277 was administered intravenously at 0.1 mmol/kg with a flow rate of 2 mL/s.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'Part II (Phase IIA) P03277 0.2 mmol/kg', 'description': '3 patients received one single administration of P03277. P03277 was administered intravenously at 0.2 mmol/kg with a flow rate of 2 mL/s.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'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': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Injection site oedema', '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': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Fatigue', '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': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Catheter site dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'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': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Catheter site inflammation', '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': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Injection site coldness', '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': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Injection site 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': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Injection site haematoma', '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': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Injection site haemorrhage', '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': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Injection site inflammation', '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': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'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': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'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': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'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': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Nausea', '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': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Dysphonia', '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': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Dyspnoea', '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, 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'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'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': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Body temperature increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'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': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Dermatitis contact', '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': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Flushing', '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': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'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': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Decreased appetite', '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': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Pregnancy', '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': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'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': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Contusion', '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': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Dizziness postural', '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': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Sneezing', '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': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}], 'seriousEvents': [{'term': 'Abortion induced', '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': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetic (PK) Parameter Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Part I (Phase I) P03277 0.025 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.025 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'OG001', 'title': 'Part I (Phase I) P03277 0.05 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.05 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'OG002', 'title': 'Part I (Phase I) P03277 0.075 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.075 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'OG003', 'title': 'Part I (Phase I) P03277 0.1 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.1 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'OG004', 'title': 'Part I (Phase I) P03277 0.2 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.2 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'OG005', 'title': 'Part I (Phase I) P03277 0.3 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.3 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'OG006', 'title': 'Part II (Phase IIA) 0.05 mmol/kg', 'description': '3 patients received one single administration of P03277. P03277 was administered intravenously at 0.05 mmol/kg with a flow rate of 2 mL/s.'}, {'id': 'OG007', 'title': 'Part II (Phase IIA) 0.075 mmol/kg', 'description': '3 patients received one single administration of P03277. P03277 was administered intravenously at 0.075 mmol/kg with a flow rate of 2 mL/s.'}, {'id': 'OG008', 'title': 'Part II (Phase IIA) 0.1 mmol/kg', 'description': '3 patients received one single administration of P03277. P03277 was administered intravenously at 0.1 mmol/kg with a flow rate of 2 mL/s.'}, {'id': 'OG009', 'title': 'Part II (Phase IIA) 0.2 mmol/kg', 'description': '3 patients received one single administration of P03277. P03277 was administered intravenously at 0.2 mmol/kg with a flow rate of 2 mL/s.'}], 'classes': [{'categories': [{'measurements': [{'value': '248.7', 'spread': '54.5', 'groupId': 'OG000'}, {'value': '524.5', 'spread': '69.9', 'groupId': 'OG001'}, {'value': '698.7', 'spread': '378.9', 'groupId': 'OG002'}, {'value': '992.0', 'spread': '233.1', 'groupId': 'OG003'}, {'value': '2097.6', 'spread': '572.3', 'groupId': 'OG004'}, {'value': '3916.4', 'spread': '1114.8', 'groupId': 'OG005'}, {'value': '370.8', 'spread': '117.6', 'groupId': 'OG006'}, {'value': '618.2', 'spread': '439.7', 'groupId': 'OG007'}, {'value': '701.6', 'spread': '48.5', 'groupId': 'OG008'}, {'value': '1434.9', 'spread': '651.5', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline (30 minutes before injection) to 24 hours post-injection', 'description': 'Cmax = maximum concentration measured. Blood samples were taken to assess the P03277 concentration.', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In part I, one patient from the "0.025 mmol/kg" group was excluded from the pharmacokinetics analysis (incorrect volume of P03277 injected).\n\nIn part II, one patient from the "0.1 mmol/kg" group was excluded from the pharmacokinetics analysis (incorrect route of administration, high probability of extravasation).'}, {'type': 'PRIMARY', 'title': 'PK Parameter T1/2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Part I (Phase I) P03277 0.025 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'OG001', 'title': 'Part I (Phase I) P03277 0.05 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'OG002', 'title': 'Part I (Phase I) P03277 0.075 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'OG003', 'title': 'Part I (Phase I) P03277 0.1 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'OG004', 'title': 'Part I (Phase I) P03277 0.2 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'OG005', 'title': 'Part I (Phase I) P03277 0.3 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'OG006', 'title': 'Part II (Phase IIA) 0.05 mmol/kg', 'description': 'In each dose group, all 3 patients received one single administration of P03277.\n\nP03277 was administered intravenously with a flow rate of 2 mL/s.'}, {'id': 'OG007', 'title': 'Part II (Phase IIA) 0.075 mmol/kg', 'description': 'In each dose group, all 3 patients received one single administration of P03277.\n\nP03277 was administered intravenously with a flow rate of 2 mL/s.'}, {'id': 'OG008', 'title': 'Part II (Phase IIA) 0.1 mmol/kg', 'description': 'In each dose group, all 3 patients received one single administration of P03277.\n\nP03277 was administered intravenously with a flow rate of 2 mL/s.'}, {'id': 'OG009', 'title': 'Part II (Phase IIA) 0.2 mmol/kg', 'description': 'In each dose group, all 3 patients received one single administration of P03277.\n\nP03277 was administered intravenously with a flow rate of 2 mL/s.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.65', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '1.50', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '1.58', 'spread': '0.30', 'groupId': 'OG002'}, {'value': '1.73', 'spread': '0.26', 'groupId': 'OG003'}, {'value': '1.82', 'spread': '0.35', 'groupId': 'OG004'}, {'value': '2.09', 'spread': '0.15', 'groupId': 'OG005'}, {'value': '1.90', 'spread': '0.04', 'groupId': 'OG006'}, {'value': '2.04', 'spread': '0.06', 'groupId': 'OG007'}, {'value': '1.79', 'spread': '0.17', 'groupId': 'OG008'}, {'value': '1.94', 'spread': '0.06', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline (30 minutes before injection) to 24 hours post-injection', 'description': 'T1/2 = terminal elimination half-life of the compound. Blood samples were taken to assess the P03277 concentration.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In part I, one patient from the "0.025 mmol/kg" group was excluded from the pharmacokinetics analysis (incorrect volume of P03277 injected).\n\nIn part II, one patient from the "0.1 mmol/kg" group was excluded from the pharmacokinetics analysis (incorrect route of administration, high probability of extravasation).'}, {'type': 'PRIMARY', 'title': 'PK Parameter Cl', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Part I (Phase I) P03277 0.025 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'OG001', 'title': 'Part I (Phase I) P03277 0.05 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'OG002', 'title': 'Part I (Phase I) P03277 0.075 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'OG003', 'title': 'Part I (Phase I) P03277 0.1 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'OG004', 'title': 'Part I (Phase I) P03277 0.2 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'OG005', 'title': 'Part I (Phase I) P03277 0.3 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'OG006', 'title': 'Part II (Phase IIA) 0.05 mmol/kg', 'description': 'In each dose group, all 3 patients received one single administration of P03277.\n\nP03277 was administered intravenously with a flow rate of 2 mL/s.'}, {'id': 'OG007', 'title': 'Part II (Phase IIA) 0.075 mmol/kg', 'description': 'In each dose group, all 3 patients received one single administration of P03277.\n\nP03277 was administered intravenously with a flow rate of 2 mL/s.'}, {'id': 'OG008', 'title': 'Part II (Phase IIA) 0.1 mmol/kg', 'description': 'In each dose group, all 3 patients received one single administration of P03277.\n\nP03277 was administered intravenously with a flow rate of 2 mL/s.'}, {'id': 'OG009', 'title': 'Part II (Phase IIA) 0.2 mmol/kg', 'description': 'In each dose group, all 3 patients received one single administration of P03277.\n\nP03277 was administered intravenously with a flow rate of 2 mL/s.'}], 'classes': [{'categories': [{'measurements': [{'value': '91.7', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '100.1', 'spread': '9.5', 'groupId': 'OG001'}, {'value': '106.4', 'spread': '20.7', 'groupId': 'OG002'}, {'value': '96.1', 'spread': '11.8', 'groupId': 'OG003'}, {'value': '101.3', 'spread': '10.9', 'groupId': 'OG004'}, {'value': '102.2', 'spread': '19.0', 'groupId': 'OG005'}, {'value': '105.3', 'spread': '13.5', 'groupId': 'OG006'}, {'value': '106.5', 'spread': '15.7', 'groupId': 'OG007'}, {'value': '108.6', 'spread': '5', 'groupId': 'OG008'}, {'value': '109.9', 'spread': '18.2', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline (30 minutes before injection) to 24 hours post-injection', 'description': 'Cl = total clearance. Blood samples were taken to assess the P03277 concentration.', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In part I, one patient from the "0.025 mmol/kg" group was excluded from the pharmacokinetics analysis (incorrect volume of P03277 injected).\n\nIn part II, one patient from the "0.1 mmol/kg" group was excluded from the pharmacokinetics analysis (incorrect route of administration, high probability of extravasation).'}, {'type': 'PRIMARY', 'title': 'PK Parameter Vd', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Part I (Phase I) P03277 0.025 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'OG001', 'title': 'Part I (Phase I) P03277 0.05 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'OG002', 'title': 'Part I (Phase I) P03277 0.075 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'OG003', 'title': 'Part I (Phase I) P03277 0.1 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'OG004', 'title': 'Part I (Phase I) P03277 0.2 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'OG005', 'title': 'Part I (Phase I) P03277 0.3 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'OG006', 'title': 'Part II (Phase IIA) 0.05 mmol/kg', 'description': 'In each dose group, all 3 patients received one single administration of P03277.\n\nP03277 was administered intravenously with a flow rate of 2 mL/s.'}, {'id': 'OG007', 'title': 'Part II (Phase IIA) 0.075 mmol/kg', 'description': 'In each dose group, all 3 patients received one single administration of P03277.\n\nP03277 was administered intravenously with a flow rate of 2 mL/s.'}, {'id': 'OG008', 'title': 'Part II (Phase IIA) 0.1 mmol/kg', 'description': 'In each dose group, all 3 patients received one single administration of P03277.\n\nP03277 was administered intravenously with a flow rate of 2 mL/s.'}, {'id': 'OG009', 'title': 'Part II (Phase IIA) 0.2 mmol/kg', 'description': 'In each dose group, all 3 patients received one single administration of P03277.\n\nP03277 was administered intravenously with a flow rate of 2 mL/s.'}], 'classes': [{'categories': [{'measurements': [{'value': '13203', 'spread': '4122', 'groupId': 'OG000'}, {'value': '12945', 'spread': '1692', 'groupId': 'OG001'}, {'value': '14312', 'spread': '2742', 'groupId': 'OG002'}, {'value': '14351', 'spread': '2645', 'groupId': 'OG003'}, {'value': '15922', 'spread': '3224', 'groupId': 'OG004'}, {'value': '18487', 'spread': '3575', 'groupId': 'OG005'}, {'value': '17320', 'spread': '1942', 'groupId': 'OG006'}, {'value': '18796', 'spread': '2478', 'groupId': 'OG007'}, {'value': '16823', 'spread': '804', 'groupId': 'OG008'}, {'value': '18355', 'spread': '2522', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline (30 minutes before injection) to 24 hours post-injection', 'description': 'Vd = volume of distribution. Blood samples were taken to assess the P03277 concentration.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In part I, one patient from the "0.025 mmol/kg" group was excluded from the pharmacokinetics analysis (incorrect volume of P03277 injected).\n\nIn part II, one patient from the "0.1 mmol/kg" group was excluded from the pharmacokinetics analysis (incorrect route of administration, high probability of extravasation).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part I (Phase I) P03277 0.025 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.025 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'FG001', 'title': 'Part I (Phase I) P03277 0.05 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.05 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'FG002', 'title': 'Part I (Phase I) P03277 0.075 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.075 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'FG003', 'title': 'Part I (Phase I) P03277 0.1 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.1 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'FG004', 'title': 'Part I (Phase I) P03277 0.2 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.2 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'FG005', 'title': 'Part I (Phase I) P03277 0.3 mmol/kg', 'description': '6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.3 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'FG006', 'title': 'Part I (Phase I) Placebo', 'description': '3 healthy subjects per dose group received placebo in one single administration.\n\nPlacebo was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'FG007', 'title': 'Part II (Phase IIA) P03277 0.05 mmol/kg', 'description': '3 patients received one single administration of P03277. P03277 was administered intravenously at 0.05 mmol/kg with a flow rate of 2 mL/s.'}, {'id': 'FG008', 'title': 'Part II (Phase IIA) P03277 0.075 mmol/kg', 'description': '3 patients received one single administration of P03277. P03277 was administered intravenously at 0.075 mmol/kg with a flow rate of 2 mL/s.'}, {'id': 'FG009', 'title': 'Part II (Phase IIA) P03277 0.1 mmol/kg', 'description': '3 patients received one single administration of P03277. P03277 was administered intravenously at 0.1 mmol/kg with a flow rate of 2 mL/s.'}, {'id': 'FG010', 'title': 'Part II (Phase IIA) P03277 0.2 mmol/kg', 'description': '3 patients received one single administration of P03277. P03277 was administered intravenously at 0.2 mmol/kg with a flow rate of 2 mL/s.'}], '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': '18'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '3'}]}, {'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': '18'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '3'}]}, {'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': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'For part I, all patients who were not randomized were screening failures. For part II, all patients who were not allocated to a dose of P03277 were screening failures.'}, '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': '18', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '66', 'groupId': 'BG011'}]}], 'groups': [{'id': 'BG000', 'title': 'Part I (Phase I) P03277 0.025 mmol/kg', 'description': '6 subjects received P03277 in one single administration.\n\nP03277 was administered intravenously at 0.025 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'BG001', 'title': 'Part I (Phase I) P03277 0.05 mmol/kg', 'description': '6 subjects received P03277 in one single administration.\n\nP03277 was administered intravenously at 0.05 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'BG002', 'title': 'Part I (Phase I) P03277 0.075 mmol/kg', 'description': '6 subjects received P03277 in one single administration.\n\nP03277 was administered intravenously at 0.075 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'BG003', 'title': 'Part I (Phase I) P03277 0.1 mmol/kg', 'description': '6 subjects received P03277 in one single administration.\n\nP03277 was administered intravenously at 0.1 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'BG004', 'title': 'Part I (Phase I) P03277 0.2 mmol/kg', 'description': '6 subjects received P03277 in one single administration.\n\nP03277 was administered intravenously at 0.2 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'BG005', 'title': 'Part I (Phase I) P03277 0.3 mmol/kg', 'description': '6 subjects received P03277 in one single administration.\n\nP03277 was administered intravenously at 0.3 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'BG006', 'title': 'Part I (Phase I) Placebo', 'description': '3 healthy subjects per dose group received placebo in one single administration.\n\nPlacebo was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.'}, {'id': 'BG007', 'title': 'Part II (Phase IIA) P03277 0.05 mmol/kg', 'description': '3 patients received one single administration of P03277.\n\nP03277 was administered intravenously at 0.05 mmol/kg with a flow rate of 2 mL/s.'}, {'id': 'BG008', 'title': 'Part II (Phase IIA) P03277 0.075 mmol/kg', 'description': '3 patients received one single administration of P03277.\n\nP03277 was administered intravenously at 0.075 mmol/kg with a flow rate of 2 mL/s.'}, {'id': 'BG009', 'title': 'Part II (Phase IIA) P03277 0.1 mmol/kg', 'description': '3 patients received one single administration of P03277.\n\nP03277 was administered intravenously at 0.1 mmol/kg with a flow rate of 2 mL/s.'}, {'id': 'BG010', 'title': 'Part II (Phase IIA) P03277 0.2 mmol/kg', 'description': '3 patients received one single administration of P03277.\n\nP03277 was administered intravenously at 0.2 mmol/kg with a flow rate of 2 mL/s.'}, {'id': 'BG011', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.0', 'groupId': 'BG000', 'lowerLimit': '22', 'upperLimit': '30'}, {'value': '25.5', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '37'}, {'value': '27.5', 'groupId': 'BG002', 'lowerLimit': '23', 'upperLimit': '40'}, {'value': '25.5', 'groupId': 'BG003', 'lowerLimit': '23', 'upperLimit': '41'}, {'value': '23.0', 'groupId': 'BG004', 'lowerLimit': '18', 'upperLimit': '36'}, {'value': '33.5', 'groupId': 'BG005', 'lowerLimit': '23', 'upperLimit': '42'}, {'value': '26.5', 'groupId': 'BG006', 'lowerLimit': '19', 'upperLimit': '43'}, {'value': '40.0', 'groupId': 'BG007', 'lowerLimit': '37', 'upperLimit': '50'}, {'value': '56.0', 'groupId': 'BG008', 'lowerLimit': '25', 'upperLimit': '57'}, {'value': '56.0', 'groupId': 'BG009', 'lowerLimit': '53', 'upperLimit': '61'}, {'value': '53.0', 'groupId': 'BG010', 'lowerLimit': '50', 'upperLimit': '58'}, {'value': '28.0', 'groupId': 'BG011', 'lowerLimit': '18', 'upperLimit': '61'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '32', 'groupId': 'BG011'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '34', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '81.65', 'groupId': 'BG000', 'lowerLimit': '52.2', 'upperLimit': '87.4'}, {'value': '71.60', 'groupId': 'BG001', 'lowerLimit': '54.0', 'upperLimit': '83.6'}, {'value': '65.00', 'groupId': 'BG002', 'lowerLimit': '56.4', 'upperLimit': '93.0'}, {'value': '72.50', 'groupId': 'BG003', 'lowerLimit': '62.0', 'upperLimit': '99.2'}, {'value': '69.30', 'groupId': 'BG004', 'lowerLimit': '68.2', 'upperLimit': '87.6'}, {'value': '72.50', 'groupId': 'BG005', 'lowerLimit': '61.6', 'upperLimit': '88.6'}, {'value': '67.90', 'groupId': 'BG006', 'lowerLimit': '56.8', 'upperLimit': '89.4'}, {'value': '87.20', 'groupId': 'BG007', 'lowerLimit': '85.8', 'upperLimit': '89.0'}, {'value': '80.40', 'groupId': 'BG008', 'lowerLimit': '71.2', 'upperLimit': '87.4'}, {'value': '87.20', 'groupId': 'BG009', 'lowerLimit': '82.4', 'upperLimit': '102.8'}, {'value': '85.80', 'groupId': 'BG010', 'lowerLimit': '79.4', 'upperLimit': '101.6'}, {'value': '72.85', 'groupId': 'BG011', 'lowerLimit': '52.2', 'upperLimit': '102.8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': 'All patients who received one injection of product (placebo or P03277 for Part I, P03277 for Part II).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Part I: Sequential administration within each group of healthy subjects was established.\n\nPart II: The administration to patients within the same day was sequential to ensure the well-being of the patients. At least a 1-hour interval between 2 administrations had to be respected.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2015-04-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-12', 'studyFirstSubmitDate': '2018-07-16', 'resultsFirstSubmitDate': '2018-11-20', 'studyFirstSubmitQcDate': '2018-07-26', 'lastUpdatePostDateStruct': {'date': '2021-05-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-29', 'studyFirstPostDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-04-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic (PK) Parameter Cmax', 'timeFrame': 'From baseline (30 minutes before injection) to 24 hours post-injection', 'description': 'Cmax = maximum concentration measured. Blood samples were taken to assess the P03277 concentration.'}, {'measure': 'PK Parameter T1/2', 'timeFrame': 'From baseline (30 minutes before injection) to 24 hours post-injection', 'description': 'T1/2 = terminal elimination half-life of the compound. Blood samples were taken to assess the P03277 concentration.'}, {'measure': 'PK Parameter Cl', 'timeFrame': 'From baseline (30 minutes before injection) to 24 hours post-injection', 'description': 'Cl = total clearance. Blood samples were taken to assess the P03277 concentration.'}, {'measure': 'PK Parameter Vd', 'timeFrame': 'From baseline (30 minutes before injection) to 24 hours post-injection', 'description': 'Vd = volume of distribution. Blood samples were taken to assess the P03277 concentration.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers', 'Brain Lesion']}, 'referencesModule': {'references': [{'pmid': '30870257', 'type': 'DERIVED', 'citation': 'Hao J, Bourrinet P, Desche P. Assessment of Pharmacokinetic, Pharmacodynamic Profile, and Tolerance of Gadopiclenol, A New High Relaxivity GBCA, in Healthy Subjects and Patients With Brain Lesions (Phase I/IIa Study). Invest Radiol. 2019 Jul;54(7):396-402. doi: 10.1097/RLI.0000000000000556.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study was to evaluate the safety (clinical and biological) and pharmacokinetics (plasma and urine) profile of P03277 following single administration at ascending dose levels in healthy subjects.', 'detailedDescription': 'This single-center, single ascending dose, phase I/IIa study was divided into 2 parts, involving both healthy subjects and patients with brain lesions:\n\n* Study Part I included healthy subjects: double-blind, randomized, placebo control;\n* Study Part II included patients with brain lesions: open-label.\n\nIn Part I, the following 6 dosing groups were investigated:\n\n* Group 1: 0.025 mmol/kg\n* Group 2: 0.05 mmol/kg\n* Group 3: 0.075 mmol/kg\n* Group 4: 0.1 mmol/kg\n* Group 5: 0.2 mmol/kg\n* Group 6: 0.3 mmol/kg\n\nHealthy subjects were included and were then administered with P03277 or placebo and were to undergo MRI examination according to the randomization scheme.\n\nIn Part II, the following 4 doses groups were investigated:\n\n* Group 7: 0.05 mmol/kg\n* Group 8: 0.075 mmol/kg\n* Group 9: 0.1 mmol/kg\n* Group 10: 0.2 mmol/kg\n\nPatients with brain lesions were included and were then administered with P03277 and underwent MRI examination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Part I: Subjects between 18 and 45 years old (inclusive), with a body mass index (BMI) of 18 to 30 kg/m² (exclusive) and in a good health.\n* Part II: Patients 18 years old and older and having at least one brain lesion with a disruption of the blood brain barrier (BBB) and/or with abnormal vascularity in the brain. This/these lesion(s) must have been detected by previous imaging evaluation (Computed Tomography or MRI).'}, 'identificationModule': {'nctId': 'NCT03603106', 'briefTitle': 'Pharmacokinetics, Pharmacodynamics Profile and Tolerance of P03277 in Healthy Subjects and Patients With Brain Lesions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Guerbet'}, 'officialTitle': 'Assessment of Pharmacokinetics, Pharmacodynamics Profile and Tolerance of P03277 in Healthy Subjects and Patients With Brain Lesions', 'orgStudyIdInfo': {'id': 'GDX-44-003'}, 'secondaryIdInfos': [{'id': '2013-004428-12', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part I (Phase I)', 'description': 'In each dose group (0.025, 0.05, 0.075, 0.1, 0.2 and 0.3 mmol/kg), 9 healthy subjects were to be included: 6 subjects received P03277 and 3 subjects received placebo in one single intravenous administration.', 'interventionNames': ['Drug: P03277', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part II (Phase IIA)', 'description': 'In each dose group (0.05, 0.075, 0.1 and 0.2 mmol/kg), all 3 patients received one single intravenous administration of P03277.', 'interventionNames': ['Drug: P03277']}], 'interventions': [{'name': 'P03277', 'type': 'DRUG', 'otherNames': ['Gadopiclenol'], 'description': 'Part I: P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.\n\nPart II: P03277 was administered intravenously with a flow rate of 2 mL/s.', 'armGroupLabels': ['Part I (Phase I)', 'Part II (Phase IIA)']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['NaCl 0.9%'], 'description': 'Part I: Placebo was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.\n\nPart II: Placebo was administered intravenously with a flow rate of 2 mL/s.', 'armGroupLabels': ['Part I (Phase I)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2060', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Clinical Pharmacology unit, SGS Life Science Services', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}], 'overallOfficials': [{'name': 'Wouter Haazen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SGS Clinical Pharmacology Unit'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guerbet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}