Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:10 AM
Study NCT ID:
NCT03755934
Status:
TERMINATED
Last Update Posted:
2024-09-19
First Post:
2018-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of MEDI7352 in Participants With Painful Diabetic Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Spain'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003929', 'term': 'Diabetic Neuropathies'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '+1-877-240-9479', 'title': 'Global Clinical Lead', 'organization': 'AstraZeneca Clinical Study Information Center'}, 'certainAgreement': {'otherDetails': 'AstraZeneca has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Dose-response relationship outcome was not evaluated by MCP-MOD because of insufficient number of doses. The study was prematurely terminated due to longer enrolment time than was anticipated. A combined population PK analysis was reported separately from the main CSR as a stand-alone report.'}}, 'adverseEventsModule': {'timeFrame': 'Day 1 through 20.42 weeks (maximum observed duration)', 'description': 'Safety population included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received 6 doses of intravenous (IV) placebo infusion matched to MEDl7352 during 12-week treatment period.', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 30, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'MEDl7352 Low Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'MEDl7352 Meduim Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 10, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'MEDI7352 High Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 23, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Eye infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Urinary tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 24, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Allodynia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Orthostatic intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Diabetic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Sensory disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Blood glucose decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Coagulation test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Glomerular filtration rate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'White blood cells urine positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Bacterial test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Lymph node palpable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Protein urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Urine analysis abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Frequent bowel movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Change of bowel habit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hypoaesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Muscle twitching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Soft tissue mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Musculoskeletal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Pain in jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hand dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Lichenification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Skin burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Catheter site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Facial pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Gravitational oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Nail injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Repetitive strain injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Conjunctival hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Eye haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Retinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Lymphoedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Orthostatic hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Skin papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Bruxism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Urinary tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}], 'seriousEvents': [{'term': 'Lung abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Weekly Average of Average Daily Pain Score to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 6 doses of intravenous (IV) placebo infusion matched to MEDl7352 during 12-week treatment period.'}, {'id': 'OG001', 'title': 'MEDl7352 Low Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG002', 'title': 'MEDl7352 Meduim Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG003', 'title': 'MEDI7352 High Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.244', 'spread': '1.7327', 'groupId': 'OG000'}, {'value': '-3.387', 'spread': '1.9605', 'groupId': 'OG001'}, {'value': '-0.615', 'spread': '1.0431', 'groupId': 'OG002'}, {'value': '-2.699', 'spread': '2.0819', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0437', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.96', 'ciLowerLimit': '-3.87', 'ciUpperLimit': '-0.06', 'pValueComment': 'ANCOVA by dose using NRS baseline value and co-medication as covariates, with CFB to Week 12 (LOCF) as dependent variable was used to derive p-value.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.961', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1878', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '-0.36', 'ciUpperLimit': '1.79', 'pValueComment': 'ANCOVA by dose using NRS baseline value and co-medication as covariates, with CFB to Week 12 (LOCF) as dependent variable was used to derive p-value.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.541', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0009', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.39', 'ciLowerLimit': '-2.19', 'ciUpperLimit': '-0.58', 'pValueComment': 'ANCOVA by dose using NRS baseline value and co-medication as covariates, with CFB to Week 12 (LOCF) as dependent variable was used to derive p-value.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.407', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -7 to Day -1, inclusive) through Week 12', 'description': 'Change from baseline to Week 12 in weekly average of average daily pain score is reported. Participants assessed their perceived daily average neuropathic pain over the previous 24 hours using an 11-point numerical rating scale (NRS), with 0 representing no pain and 10 representing the worst pain imaginable. Participants were instructed to assess their average daily pain at approximately the same time every morning, and to record the response in a subject diary (electronic patient-reported outcome \\[ePRO\\]).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population included all participants who received at least 1 dose of any double-blind study drug and have at least 1 daily NRS assessment while receiving the treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Weekly Average of Average Daily Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 6 doses of intravenous (IV) placebo infusion matched to MEDl7352 during 12-week treatment period.'}, {'id': 'OG001', 'title': 'MEDl7352 Low Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG002', 'title': 'MEDl7352 Meduim Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG003', 'title': 'MEDI7352 High Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.385', 'spread': '0.6863', 'groupId': 'OG000'}, {'value': '-1.089', 'spread': '1.0258', 'groupId': 'OG001'}, {'value': '-0.311', 'spread': '0.6285', 'groupId': 'OG002'}, {'value': '-0.540', 'spread': '1.2503', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.563', 'spread': '1.0173', 'groupId': 'OG000'}, {'value': '-2.173', 'spread': '1.4266', 'groupId': 'OG001'}, {'value': '-0.144', 'spread': '0.9143', 'groupId': 'OG002'}, {'value': '-1.508', 'spread': '1.5130', 'groupId': 'OG003'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.955', 'spread': '1.3236', 'groupId': 'OG000'}, {'value': '-2.458', 'spread': '2.2156', 'groupId': 'OG001'}, {'value': '-0.578', 'spread': '1.0715', 'groupId': 'OG002'}, {'value': '-2.044', 'spread': '1.7916', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.236', 'spread': '1.6026', 'groupId': 'OG000'}, {'value': '-2.393', 'spread': '2.0249', 'groupId': 'OG001'}, {'value': '-0.690', 'spread': '1.2819', 'groupId': 'OG002'}, {'value': '-2.372', 'spread': '2.0607', 'groupId': 'OG003'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.418', 'spread': '1.6274', 'groupId': 'OG000'}, {'value': '-2.595', 'spread': '2.2003', 'groupId': 'OG001'}, {'value': '-0.712', 'spread': '1.2164', 'groupId': 'OG002'}, {'value': '-2.629', 'spread': '1.9943', 'groupId': 'OG003'}]}]}, {'title': 'Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.764', 'spread': '1.8415', 'groupId': 'OG000'}, {'value': '-2.607', 'spread': '2.2020', 'groupId': 'OG001'}, {'value': '-0.550', 'spread': '1.2333', 'groupId': 'OG002'}, {'value': '-2.559', 'spread': '2.1241', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -7 to Day -1, inclusive), Weeks 2, 4, 6, 8, 10, and 18', 'description': 'Change from baseline to Weeks 2, 4, 6, 8, 10, and 18 in weekly average of average daily pain score is reported. Participants assessed their perceived daily average neuropathic pain over the previous 24 hours using an 11-point NRS, with 0 representing no pain and 10 representing the worst pain imaginable. Participants were instructed to assess their average daily pain at approximately the same time every morning, and to record the response in a subject diary (ePRO).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all participants who received at least 1 dose of any double-blind study drug and have at least 1 daily NRS assessment while receiving the treatment. Here, number analyzed (n) denotes those participants who were evaluable at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With >= 30% and >= 50% Reductions in Weekly Average of Average Daily Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 6 doses of intravenous (IV) placebo infusion matched to MEDl7352 during 12-week treatment period.'}, {'id': 'OG001', 'title': 'MEDl7352 Low Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG002', 'title': 'MEDl7352 Meduim Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG003', 'title': 'MEDI7352 High Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}], 'classes': [{'title': '>=30%: Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}, {'value': '7.7', 'groupId': 'OG002'}, {'value': '34.3', 'groupId': 'OG003'}]}]}, {'title': '>=30%: Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '28.3', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}, {'value': '16.7', 'groupId': 'OG002'}, {'value': '57.6', 'groupId': 'OG003'}]}]}, {'title': '>=30%: Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '32.6', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}, {'value': '8.3', 'groupId': 'OG002'}, {'value': '66.7', 'groupId': 'OG003'}]}]}, {'title': '>=30%: Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '35.0', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}, {'value': '56.7', 'groupId': 'OG003'}]}]}, {'title': '>=50%: Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '14.3', 'groupId': 'OG003'}]}]}, {'title': '>=50%: Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}, {'value': '8.3', 'groupId': 'OG002'}, {'value': '36.4', 'groupId': 'OG003'}]}]}, {'title': '>=50%: Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '8.3', 'groupId': 'OG002'}, {'value': '42.4', 'groupId': 'OG003'}]}]}, {'title': '>=50%: Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '40.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day -7 to Day -1, inclusive), Weeks 4, 8, 12, and 18 (follow-up)', 'description': 'Percentage of participants with \\>= 30% and \\>= 50% decrease in weekly average of average daily pain score from baseline is reported. Participants assessed their perceived daily average neuropathic pain over the previous 24 hours using an 11-point NRS, with 0 representing no pain and 10 representing the worst pain imaginable. Participants were instructed to assess their average daily pain at approximately the same time every morning, and to record the response in a subject diary (ePRO).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all participants who received at least 1 dose of any double-blind study drug and have at least 1 daily NRS assessment while receiving the treatment. Here, number of participants analyzed (N) denotes those participants who were evaluable for the specified outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Galer Neuropathic Pain Scale (NPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 6 doses of intravenous (IV) placebo infusion matched to MEDl7352 during 12-week treatment period.'}, {'id': 'OG001', 'title': 'MEDl7352 Low Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG002', 'title': 'MEDl7352 Meduim Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG003', 'title': 'MEDI7352 High Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-13.333', 'spread': '29.0461', 'groupId': 'OG000'}, {'value': '-5.750', 'spread': '10.5317', 'groupId': 'OG001'}, {'value': '-10.727', 'spread': '21.3967', 'groupId': 'OG002'}, {'value': '-26.387', 'spread': '26.9922', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-19.136', 'spread': '31.5577', 'groupId': 'OG000'}, {'value': '-8.750', 'spread': '18.2094', 'groupId': 'OG001'}, {'value': '-19.333', 'spread': '23.7538', 'groupId': 'OG002'}, {'value': '-29.516', 'spread': '32.3140', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-24.385', 'spread': '31.1081', 'groupId': 'OG000'}, {'value': '-28.750', 'spread': '16.6808', 'groupId': 'OG001'}, {'value': '-22.000', 'spread': '28.9379', 'groupId': 'OG002'}, {'value': '-34.586', 'spread': '31.2622', 'groupId': 'OG003'}]}]}, {'title': 'Week 18 (follow-up)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-25.722', 'spread': '33.6151', 'groupId': 'OG000'}, {'value': '-23.000', 'spread': '23.3095', 'groupId': 'OG001'}, {'value': '-27.909', 'spread': '30.3725', 'groupId': 'OG002'}, {'value': '-25.414', 'spread': '25.8947', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -7 to Day -1, inclusive), Weeks 4, 8, 12, and 18 (follow-up)', 'description': 'Participants were assessed for their neuropathic pain using the Galer NPS, which included 2 descriptors of pain, including intensity and unpleasantness, and 8 descriptors that assessed specific qualities of neuropathic pain: sharp, hot, dull, cold, sensitive, itchy, deep, and surface pain. Each of these 10 dimensions had a 0 to 10 NRS in which 0 is equal to no pain and 10 equals most intense pain. Galer NPS total score (ranges from 0 to 100; with 0 and 100 representing the no and highest degree of neuropathic-like symptoms, respectively) is sum of pain intensity, pain unpleasantness, pain sharpness, pain hotness, pain dullness, pain coldness, pain sensitivity, pain itching, deep pain intensity, and surface pain intensity (all in an 11-point NRS). Change from baseline to Weeks 4, 8, 12, and 18 (follow-up) in Galer NPS total score is reported.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all participants who received at least 1 dose of any double-blind study drug and have at least 1 daily NRS assessment while receiving the treatment. Number of participants analyzed (N) denotes the number of participants evaluated for this outcome measure. Here, number analyzed (n) denotes those participants who were evaluable at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Daily Sleep Interference Scale (DSIS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 6 doses of intravenous (IV) placebo infusion matched to MEDl7352 during 12-week treatment period.'}, {'id': 'OG001', 'title': 'MEDl7352 Low Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG002', 'title': 'MEDl7352 Meduim Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG003', 'title': 'MEDI7352 High Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.760', 'spread': '1.1212', 'groupId': 'OG000'}, {'value': '-2.810', 'spread': '2.6979', 'groupId': 'OG001'}, {'value': '-0.979', 'spread': '1.7930', 'groupId': 'OG002'}, {'value': '-1.790', 'spread': '1.5688', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.417', 'spread': '1.7654', 'groupId': 'OG000'}, {'value': '-3.143', 'spread': '2.7430', 'groupId': 'OG001'}, {'value': '-1.127', 'spread': '1.4907', 'groupId': 'OG002'}, {'value': '-2.373', 'spread': '2.1368', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.668', 'spread': '2.1928', 'groupId': 'OG000'}, {'value': '-3.735', 'spread': '2.7598', 'groupId': 'OG001'}, {'value': '-1.077', 'spread': '1.4769', 'groupId': 'OG002'}, {'value': '-2.725', 'spread': '2.2484', 'groupId': 'OG003'}]}]}, {'title': 'Week 18 (follow-up)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.824', 'spread': '2.2582', 'groupId': 'OG000'}, {'value': '-3.036', 'spread': '2.6557', 'groupId': 'OG001'}, {'value': '-0.865', 'spread': '1.2795', 'groupId': 'OG002'}, {'value': '-2.602', 'spread': '2.4427', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -7 to Day -1, inclusive), Weeks 4, 8, 12, and 18 (follow-up)', 'description': 'Participants were assessed for how their neuropathic pain interferes with their sleep using the DSIS. It has an 11 point Likert response scale (0-10) that asked participants to "select the number that best describes how much your pain has interfered with your sleep during the past 24 hours". Responses vary from 0 (did not interfere with sleep) to 10 (completely interfered with sleep-unable to sleep due to pain). The DSIS was completed by participants once a day (upon awakening) to accurately capture variability in sleep interference due to pain on a daily basis, thus minimizing recall bias. Change from baseline to Weeks 4, 8, 12, and 18 (follow-up) in DSIS is reported.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all participants who received at least 1 dose of any double-blind study drug and have at least 1 daily NRS assessment while receiving the treatment. Number of participants analyzed (N) denotes the number of participants evaluated for this outcome measure. Here, number analyzed (n) denotes those participants who were evaluable at the specified time point.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants With 'Improved', 'Much Improved', or 'Very Much Improved' Status in Patient Global Impression of Change (PGIC)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 6 doses of intravenous (IV) placebo infusion matched to MEDl7352 during 12-week treatment period.'}, {'id': 'OG001', 'title': 'MEDl7352 Low Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG002', 'title': 'MEDl7352 Meduim Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG003', 'title': 'MEDI7352 High Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}], 'classes': [{'title': 'Week 4: Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '45.5', 'groupId': 'OG002'}, {'value': '41.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 4: Much Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}, {'value': '27.3', 'groupId': 'OG002'}, {'value': '29.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 4: Very Much Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '6.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 8: Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}, {'value': '58.3', 'groupId': 'OG002'}, {'value': '41.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 8: Much Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '31.8', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '41.7', 'groupId': 'OG002'}, {'value': '38.7', 'groupId': 'OG003'}]}]}, {'title': 'Week 8: Very Much Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '6.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 12: Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '48.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '54.5', 'groupId': 'OG002'}, {'value': '44.8', 'groupId': 'OG003'}]}]}, {'title': 'Week 12: Much Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '28.2', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}, {'value': '36.4', 'groupId': 'OG002'}, {'value': '41.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 12: Very Much Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '10.3', 'groupId': 'OG003'}]}]}, {'title': 'Week 18: Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '36.1', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}, {'value': '27.3', 'groupId': 'OG002'}, {'value': '31.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 18: Much Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '54.5', 'groupId': 'OG002'}, {'value': '41.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 18: Very Much Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}, {'value': '9.1', 'groupId': 'OG002'}, {'value': '13.8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day -7 to Day -1, inclusive), Weeks 4, 8, 12, and 18 (follow-up)', 'description': 'Participants rated their overall improvement in health status using the PGIC. The PGIC consisted of a 7-point scale where 1 = very much improved and 7 = very much worse. The participants were asked the following question: How would you rate your overall improvement with treatment during the clinical study?, where the response options included the following: Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse, and Very Much Worse.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all participants who received at least 1 dose of any double-blind study drug and have at least 1 daily NRS assessment while receiving the treatment. Number of participants analyzed (N) denotes the number of participants who were PGIC responders. Here, number analyzed (n) denotes those participants who were evaluable at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 36-item Short-Form Health Survey (SF-36)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 6 doses of intravenous (IV) placebo infusion matched to MEDl7352 during 12-week treatment period.'}, {'id': 'OG001', 'title': 'MEDl7352 Low Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG002', 'title': 'MEDl7352 Meduim Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG003', 'title': 'MEDI7352 High Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}], 'classes': [{'title': 'Physical Functioning', 'categories': [{'measurements': [{'value': '11.282', 'spread': '17.0412', 'groupId': 'OG000'}, {'value': '21.248', 'spread': '13.1526', 'groupId': 'OG001'}, {'value': '0.417', 'spread': '19.7084', 'groupId': 'OG002'}, {'value': '12.759', 'spread': '16.6141', 'groupId': 'OG003'}]}]}, {'title': 'Role Physical', 'categories': [{'measurements': [{'value': '7.372', 'spread': '18.0159', 'groupId': 'OG000'}, {'value': '28.125', 'spread': '27.7169', 'groupId': 'OG001'}, {'value': '0.000', 'spread': '37.3101', 'groupId': 'OG002'}, {'value': '6.681', 'spread': '17.4338', 'groupId': 'OG003'}]}]}, {'title': 'Bodily Pain', 'categories': [{'measurements': [{'value': '8.3', 'spread': '20.51', 'groupId': 'OG000'}, {'value': '9.8', 'spread': '22.75', 'groupId': 'OG001'}, {'value': '12.1', 'spread': '23.11', 'groupId': 'OG002'}, {'value': '14.9', 'spread': '17.30', 'groupId': 'OG003'}]}]}, {'title': 'General Health', 'categories': [{'measurements': [{'value': '-2.6', 'spread': '17.70', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '5.00', 'groupId': 'OG001'}, {'value': '-5.3', 'spread': '17.72', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '19.98', 'groupId': 'OG003'}]}]}, {'title': 'Vitality', 'categories': [{'measurements': [{'value': '-0.160', 'spread': '20.6039', 'groupId': 'OG000'}, {'value': '3.125', 'spread': '16.5359', 'groupId': 'OG001'}, {'value': '-0.521', 'spread': '17.7695', 'groupId': 'OG002'}, {'value': '-4.095', 'spread': '24.0486', 'groupId': 'OG003'}]}]}, {'title': 'Social Functioning', 'categories': [{'measurements': [{'value': '1.92', 'spread': '19.772', 'groupId': 'OG000'}, {'value': '31.25', 'spread': '23.936', 'groupId': 'OG001'}, {'value': '-1.04', 'spread': '24.108', 'groupId': 'OG002'}, {'value': '9.05', 'spread': '23.121', 'groupId': 'OG003'}]}]}, {'title': 'Role Emotional', 'categories': [{'measurements': [{'value': '-1.923', 'spread': '25.3248', 'groupId': 'OG000'}, {'value': '8.333', 'spread': '31.9110', 'groupId': 'OG001'}, {'value': '-5.556', 'spread': '34.8748', 'groupId': 'OG002'}, {'value': '-1.724', 'spread': '19.9681', 'groupId': 'OG003'}]}]}, {'title': 'Mental Health', 'categories': [{'measurements': [{'value': '-5.9', 'spread': '21.82', 'groupId': 'OG000'}, {'value': '10.0', 'spread': '20.41', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '14.48', 'groupId': 'OG002'}, {'value': '-0.7', 'spread': '18.41', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -7 to Day -1, inclusive) and Week 12', 'description': 'Change from baseline to Week 12 in SF-36 is reported. The SF-36 assesses 8 health concepts: 1) limitations in physical activities because of health problems (physical functioning); 2) limitations in social activities because of physical or emotional problems (social functioning); 3) limitations in usual role activities because of physical health problems (role physical); 4) bodily pain; 5) general mental health; 6) limitations in usual role activities because of emotional problems (role emotional); 7) vitality; and 8) general health perceptions. The items use Likert-type scales with either 5 or 6 points, or 2 or 3 points. Higher SF-36 scores indicate a better state of health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all participants who received at least 1 dose of any double-blind study drug and have at least 1 daily NRS assessment while receiving the treatment. Number of participants analyzed (N) denotes the number of participants evaluated for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Taking Any Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 6 doses of intravenous (IV) placebo infusion matched to MEDl7352 during 12-week treatment period.'}, {'id': 'OG001', 'title': 'MEDl7352 Low Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG002', 'title': 'MEDl7352 Meduim Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG003', 'title': 'MEDI7352 High Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}, {'value': '8.6', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day -7 to Day -1, inclusive) through Week 12', 'description': 'Percentage of participants taking any rescue medication are reported. Participants were asked to record all rescue medications they take for neuropathic pain in a paper diary.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all participants who received at least 1 dose of any double-blind study drug and have at least 1 daily NRS assessment while receiving the treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 6 doses of intravenous (IV) placebo infusion matched to MEDl7352 during 12-week treatment period.'}, {'id': 'OG001', 'title': 'MEDl7352 Low Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG002', 'title': 'MEDl7352 Meduim Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG003', 'title': 'MEDI7352 High Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}], 'classes': [{'title': 'Any TEAEs', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}]}, {'title': 'Any TESAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through 20.42 weeks (maximum observed duration)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Vital Signs Reported as TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 6 doses of intravenous (IV) placebo infusion matched to MEDl7352 during 12-week treatment period.'}, {'id': 'OG001', 'title': 'MEDl7352 Low Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG002', 'title': 'MEDl7352 Meduim Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG003', 'title': 'MEDI7352 High Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}], 'classes': [{'title': 'Blood pressure increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Hypotension', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Orthostatic hypertension', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Orthostatic hypotension', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through 20.42 weeks (maximum observed duration)', 'description': 'Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal finding in the vital sign parameters (body temperature, diastolic blood pressure, systolic blood pressure, heart \\[pulse\\] rate, and respiratory rate).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Abnormal Electrocardiograms (ECGs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 6 doses of intravenous (IV) placebo infusion matched to MEDl7352 during 12-week treatment period.'}, {'id': 'OG001', 'title': 'MEDl7352 Low Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG002', 'title': 'MEDl7352 Meduim Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG003', 'title': 'MEDI7352 High Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Week 18 (follow-up)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through 20.42 weeks (maximum observed duration)', 'description': 'Number of participants with clinically significant abnormal ECGs are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received. Number of participants analyzed (N) denotes the number of participants who were evaluable for the specified outcome measure. Here, number analyzed (n) denotes those participants who were evaluable at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 6 doses of intravenous (IV) placebo infusion matched to MEDl7352 during 12-week treatment period.'}, {'id': 'OG001', 'title': 'MEDl7352 Low Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG002', 'title': 'MEDl7352 Meduim Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG003', 'title': 'MEDI7352 High Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}], 'classes': [{'title': 'Alanine aminotransferase increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Blood glucose decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Aspartate aminotransferase increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Blood glucose increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'C-reactive protein increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Coagulation test abnormal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Glomerular filtration rate decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'White blood cells urine positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Bacterial test positive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Blood bilirubin increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Protein urine present', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Urine analysis abnormal', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hypoglycemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Hypercholesterolaemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Hyperglycaemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through 20.42 weeks (maximum observed duration)', 'description': 'Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of hematology, clinical chemistry, coagulation, and urinalysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Findings in Physical Examination Reported as TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 6 doses of intravenous (IV) placebo infusion matched to MEDl7352 during 12-week treatment period.'}, {'id': 'OG001', 'title': 'MEDl7352 Low Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG002', 'title': 'MEDl7352 Meduim Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG003', 'title': 'MEDI7352 High Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through 20.42 weeks (maximum observed duration)', 'description': 'Number of participants with clinically significant findings in physical examination reported as TEAE are reported. A complete physical examination (excluding the genitourinary examination, unless warranted) was performed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Findings in Neurological Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 6 doses of intravenous (IV) placebo infusion matched to MEDl7352 during 12-week treatment period.'}, {'id': 'OG001', 'title': 'MEDl7352 Low Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG002', 'title': 'MEDl7352 Meduim Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG003', 'title': 'MEDI7352 High Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through 20.42 weeks (maximum observed duration)', 'description': 'Number of participants with clinically significant findings in neurological examination is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Dorsiflexion Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 6 doses of intravenous (IV) placebo infusion matched to MEDl7352 during 12-week treatment period.'}, {'id': 'OG001', 'title': 'MEDl7352 Low Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG002', 'title': 'MEDl7352 Meduim Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG003', 'title': 'MEDI7352 High Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}], 'classes': [{'title': 'Mild Weakness', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}]}, {'title': 'Moderate Weakness', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Severe Weakness', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Paralysis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through 20.42 weeks (maximum observed duration)', 'description': 'Number of participants with abnormal dorsiflexion strength is reported. Dorsiflexion strength is scored on 0-4 scale. The scale indicated 0 = normal power, 1 = mild weakness, 2 = moderate weakness, 3 = severe weakness, and 4 = paralysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received. Here, number of participants analyzed (N) denotes those participants who were assessed for strength and deep tendon reflexes assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Deep Tendon Reflex (Knee and Ankle)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 6 doses of intravenous (IV) placebo infusion matched to MEDl7352 during 12-week treatment period.'}, {'id': 'OG001', 'title': 'MEDl7352 Low Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG002', 'title': 'MEDl7352 Meduim Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG003', 'title': 'MEDI7352 High Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}], 'classes': [{'title': 'Ankle reflex reduced', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Ankle reflex absent', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Ankle reflex absent and knee reflex reduced', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'All reflexes absent', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through 20.42 weeks (maximum observed duration)', 'description': 'Number of participants with abnormal deep tendon reflex are reported. Deep tendon reflex (knee and ankle) strength is scored on 0-4 scale. The scale indicated 0 = normal, 1 = ankle reflex reduced, 2 = ankle reflex absent, 3 = ankle reflex absent and knee reflex reduced, and 4 = all reflexes (both ankle and knee) absent. Participants within a specific row are not included in any other row in the data table below.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received. Here, number of participants analyzed (N) denotes those participants who were assessed for strength and deep tendon reflexes assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Neuropathy Score-Nurse (TNSn)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 6 doses of intravenous (IV) placebo infusion matched to MEDl7352 during 12-week treatment period.'}, {'id': 'OG001', 'title': 'MEDl7352 Low Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG002', 'title': 'MEDl7352 Meduim Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG003', 'title': 'MEDI7352 High Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.25', 'spread': '0.957', 'groupId': 'OG000'}, {'value': '1.00', 'spread': 'NA', 'comment': 'Standard deviation was not reported as only one participant was evaluable for this arm', 'groupId': 'OG003'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.54', 'spread': '1.304', 'groupId': 'OG000'}, {'value': '-1.25', 'spread': '1.258', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '1.354', 'groupId': 'OG002'}, {'value': '-0.94', 'spread': '2.117', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.90', 'spread': '1.982', 'groupId': 'OG000'}, {'value': '-2.50', 'spread': '3.786', 'groupId': 'OG001'}, {'value': '-0.85', 'spread': '1.819', 'groupId': 'OG002'}, {'value': '-1.19', 'spread': '1.891', 'groupId': 'OG003'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.40', 'spread': '2.071', 'groupId': 'OG000'}, {'value': '-0.75', 'spread': '2.872', 'groupId': 'OG001'}, {'value': '-1.00', 'spread': '1.859', 'groupId': 'OG002'}, {'value': '-1.85', 'spread': '2.093', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.40', 'spread': '2.082', 'groupId': 'OG000'}, {'value': '-2.50', 'spread': '3.000', 'groupId': 'OG001'}, {'value': '-0.92', 'spread': '1.881', 'groupId': 'OG002'}, {'value': '-1.84', 'spread': '2.665', 'groupId': 'OG003'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.90', 'spread': '2.458', 'groupId': 'OG000'}, {'value': '-2.00', 'spread': '3.916', 'groupId': 'OG001'}, {'value': '-1.67', 'spread': '1.435', 'groupId': 'OG002'}, {'value': '-2.45', 'spread': '3.042', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.73', 'spread': '2.562', 'groupId': 'OG000'}, {'value': '-2.25', 'spread': '2.062', 'groupId': 'OG001'}, {'value': '-2.17', 'spread': '1.899', 'groupId': 'OG002'}, {'value': '-2.53', 'spread': '2.515', 'groupId': 'OG003'}]}]}, {'title': 'Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.00', 'spread': '2.631', 'groupId': 'OG000'}, {'value': '-2.50', 'spread': '3.512', 'groupId': 'OG001'}, {'value': '-2.17', 'spread': '2.329', 'groupId': 'OG002'}, {'value': '-2.30', 'spread': '3.053', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -45 to -1), pre-dose on Day 1, Weeks 2, 4, 6, 8, 10, 12, and 18/early termination', 'description': 'The TNSn, a semi-quantitative clinical assessment of peripheral nervous system function, was administered at baseline (Screening), Day 1, Weeks 2, 4, 6, 8, 10, 12 and Week 18/early termination. The TNSn provides for an assessment of motor symptom score, autonomic symptom score, pin sensibility score, and vibration sensibility score. Each neuropathy item is scored on a 0-4 scale. The scores are summed to obtain a total score ranging from 0 to 20. Higher total scores correlate with more severe neuropathy. Not all of the early terminated participants completed the 18 week assessment. Only 3 early terminated participants contributed data at the Week 18 assessment.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received. Number of participants analyzed (N) denotes the number of participants evaluated for this outcome measure. Here, number analyzed (n) denotes those participants who were evaluable at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Investigator Reported Significant Changes From Baseline in Motor and Sensory Nerve Conduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 6 doses of intravenous (IV) placebo infusion matched to MEDl7352 during 12-week treatment period.'}, {'id': 'OG001', 'title': 'MEDl7352 Low Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG002', 'title': 'MEDl7352 Meduim Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG003', 'title': 'MEDI7352 High Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through 20.42 weeks (maximum observed duration)', 'description': 'Motor and sensory nerve conduction studies were performed in relevant lower and upper limb nerves (sural, peroneal, median/ulnar, fibular, and tibial nerves) wherein amplitude, peak latency, conduction velocity, and duration of nerve action potentials were recorded.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of any study drug and were analyzed according to the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least One Concomitant Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 6 doses of intravenous (IV) placebo infusion matched to MEDl7352 during 12-week treatment period.'}, {'id': 'OG001', 'title': 'MEDl7352 Low Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG002', 'title': 'MEDl7352 Meduim Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG003', 'title': 'MEDI7352 High Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through 20.42 weeks (maximum observed duration)', 'description': 'Number of participants with at least one concomitant medication is reported. A concomitant medication is defined as any medication continuing or starting after first dose of study medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Injection Site Reaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 6 doses of intravenous (IV) placebo infusion matched to MEDl7352 during 12-week treatment period.'}, {'id': 'OG001', 'title': 'MEDl7352 Low Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG002', 'title': 'MEDl7352 Meduim Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG003', 'title': 'MEDI7352 High Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through 20.42 weeks (maximum observed duration)', 'description': 'Number of participants with injection site reaction is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Infusion Reaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 6 doses of intravenous (IV) placebo infusion matched to MEDl7352 during 12-week treatment period.'}, {'id': 'OG001', 'title': 'MEDl7352 Low Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG002', 'title': 'MEDl7352 Meduim Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG003', 'title': 'MEDI7352 High Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through 20.42 weeks (maximum observed duration)', 'description': 'Number of participants with infusion reaction is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Serum Total Nerve Growth Factor (NGF) Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 6 doses of intravenous (IV) placebo infusion matched to MEDl7352 during 12-week treatment period.'}, {'id': 'OG001', 'title': 'MEDl7352 Low Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG002', 'title': 'MEDl7352 Meduim Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG003', 'title': 'MEDI7352 High Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '52.303', 'spread': '11.6178', 'groupId': 'OG000'}, {'value': '65.687', 'spread': '60.4036', 'groupId': 'OG003'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '62.613', 'spread': '15.1088', 'groupId': 'OG000'}, {'value': '2384.760', 'spread': '1989.0309', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '78.209', 'spread': '92.0122', 'groupId': 'OG000'}, {'value': '2213.699', 'spread': '2408.3112', 'groupId': 'OG003'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '64.661', 'spread': '18.6478', 'groupId': 'OG000'}, {'value': '2361.855', 'spread': '2645.8141', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '63.291', 'spread': '16.5332', 'groupId': 'OG000'}, {'value': '1992.129', 'spread': '2507.9826', 'groupId': 'OG003'}]}]}, {'title': 'Week 10 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '173.383', 'spread': '563.8921', 'groupId': 'OG000'}, {'value': '1681.073', 'spread': '2455.0666', 'groupId': 'OG003'}]}]}, {'title': 'Week 10 (before end of infusion)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '57.308', 'spread': '13.3588', 'groupId': 'OG000'}, {'value': '1992.756', 'spread': '2968.1285', 'groupId': 'OG003'}]}]}, {'title': 'Week 10 (8 hours post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '177.323', 'spread': '554.8131', 'groupId': 'OG000'}, {'value': '2012.384', 'spread': '2795.8138', 'groupId': 'OG003'}]}]}, {'title': 'Week 10 (post 24 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '222.980', 'spread': '772.9408', 'groupId': 'OG000'}, {'value': '1849.835', 'spread': '2671.9526', 'groupId': 'OG003'}]}]}, {'title': 'Week 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '59.441', 'spread': '13.6892', 'groupId': 'OG000'}, {'value': '1743.100', 'spread': '2621.0687', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '63.416', 'spread': '18.4243', 'groupId': 'OG000'}, {'value': '1710.966', 'spread': '2838.0975', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (pre-dose; baseline), Weeks 2, 4, 6, 8, 10 (Day 70; pre-dose, immediately before end of infusion, 8 hours and 24 hours post Day 70 infusion [Day 71]), 11, and 12 (approximately same time of day as Week 10 infusion)', 'description': 'Serum concentrations of total NGF in ADA positive or negative participants are reported.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: participants received at least 1 dose of any double-blind study drug and were analyzed according to treatment actually received. Number of participants analyzed: participants evaluated for this outcome measure. Number analyzed (n): participants evaluable at specified time point. MEDl7352 low and medium dose group data is not reported due to change in assay during course of study and stability data not supporting re-analysis of early study samples with new in-house assay.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI7352', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 6 doses of intravenous (IV) placebo infusion matched to MEDl7352 during 12-week treatment period.'}, {'id': 'OG001', 'title': 'MEDl7352 Low Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG002', 'title': 'MEDl7352 Meduim Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'OG003', 'title': 'MEDI7352 High Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}], 'classes': [{'title': 'Treatment-induced ADA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}]}, {'title': 'Treatment-boosted ADA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Persistently positive ADA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}]}, {'title': 'Transiently positive ADA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-dose at baseline (Day -45 to -1) and Study Weeks 2, 4, 8, 10, 12, and 18 (follow-up)', 'description': 'Number of participants with positive ADA to MEDI7352 are reported. Treatment-induced ADA positive is defined as ADA negative at baseline and positive at least 1 post-baseline assessment. Treatment-boosted ADA positive is defined as ADA positive at baseline with pre-existing titre boosted by 4-fold or greater during the study period. Persistent positive is defined as ADA negative at baseline and positive at least 2 post-baseline assessments (with \\>= 16 weeks between first and last positive) or ADA positive at last post-baseline assessment. Transiently positive is defined as ADA negative at baseline and at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received. Here, number of participants analyzed (N) denotes those participants who had adequate ADA sample.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received 6 doses of intravenous (IV) placebo infusion matched to MEDl7352 during 12-week treatment period.'}, {'id': 'FG001', 'title': 'MEDl7352 Low Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'FG002', 'title': 'MEDl7352 Meduim Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'FG003', 'title': 'MEDI7352 High Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '36'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study was conducted at 45 sites in 4 countries (the United Kingdom, Hungary, Poland, and Romania).', 'preAssignmentDetails': 'A total of 112 participants were randomized, of which 107 participants received at least one dose of study drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '112', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received 6 doses of intravenous (IV) placebo infusion matched to MEDl7352 during 12-week treatment period.'}, {'id': 'BG001', 'title': 'MEDl7352 Low Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'BG002', 'title': 'MEDl7352 Meduim Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'BG003', 'title': 'MEDI7352 High Dose', 'description': 'Participants received 6 doses of IV MEDl7352 during 12-week treatment period.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.7', 'spread': '8.02', 'groupId': 'BG000'}, {'value': '60.7', 'spread': '17.14', 'groupId': 'BG001'}, {'value': '60.1', 'spread': '11.49', 'groupId': 'BG002'}, {'value': '60.1', 'spread': '10.21', 'groupId': 'BG003'}, {'value': '60.4', 'spread': '9.73', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '72', 'groupId': 'BG004'}]}]}], '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'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '112', 'groupId': 'BG004'}]}, {'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'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'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'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '109', 'groupId': 'BG004'}]}, {'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'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Screening Population includes all participants who were enrolled and provided informed consent and demographic and/or baseline screening assessments.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-13', 'size': 11233530, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-08-16T04:35', 'hasProtocol': True}, {'date': '2023-10-04', 'size': 6619676, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-08-16T04:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'whyStopped': 'The study was prematurely terminated due to longer enrolment time than was anticipated.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-16', 'studyFirstSubmitDate': '2018-10-31', 'resultsFirstSubmitDate': '2024-06-28', 'studyFirstSubmitQcDate': '2018-11-26', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-16', 'studyFirstPostDateStruct': {'date': '2018-11-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Weekly Average of Average Daily Pain Score to Week 12', 'timeFrame': 'Baseline (Day -7 to Day -1, inclusive) through Week 12', 'description': 'Change from baseline to Week 12 in weekly average of average daily pain score is reported. Participants assessed their perceived daily average neuropathic pain over the previous 24 hours using an 11-point numerical rating scale (NRS), with 0 representing no pain and 10 representing the worst pain imaginable. Participants were instructed to assess their average daily pain at approximately the same time every morning, and to record the response in a subject diary (electronic patient-reported outcome \\[ePRO\\]).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Weekly Average of Average Daily Pain Score', 'timeFrame': 'Baseline (Day -7 to Day -1, inclusive), Weeks 2, 4, 6, 8, 10, and 18', 'description': 'Change from baseline to Weeks 2, 4, 6, 8, 10, and 18 in weekly average of average daily pain score is reported. Participants assessed their perceived daily average neuropathic pain over the previous 24 hours using an 11-point NRS, with 0 representing no pain and 10 representing the worst pain imaginable. Participants were instructed to assess their average daily pain at approximately the same time every morning, and to record the response in a subject diary (ePRO).'}, {'measure': 'Percentage of Participants With >= 30% and >= 50% Reductions in Weekly Average of Average Daily Pain Score', 'timeFrame': 'Baseline (Day -7 to Day -1, inclusive), Weeks 4, 8, 12, and 18 (follow-up)', 'description': 'Percentage of participants with \\>= 30% and \\>= 50% decrease in weekly average of average daily pain score from baseline is reported. Participants assessed their perceived daily average neuropathic pain over the previous 24 hours using an 11-point NRS, with 0 representing no pain and 10 representing the worst pain imaginable. Participants were instructed to assess their average daily pain at approximately the same time every morning, and to record the response in a subject diary (ePRO).'}, {'measure': 'Change From Baseline in Galer Neuropathic Pain Scale (NPS)', 'timeFrame': 'Baseline (Day -7 to Day -1, inclusive), Weeks 4, 8, 12, and 18 (follow-up)', 'description': 'Participants were assessed for their neuropathic pain using the Galer NPS, which included 2 descriptors of pain, including intensity and unpleasantness, and 8 descriptors that assessed specific qualities of neuropathic pain: sharp, hot, dull, cold, sensitive, itchy, deep, and surface pain. Each of these 10 dimensions had a 0 to 10 NRS in which 0 is equal to no pain and 10 equals most intense pain. Galer NPS total score (ranges from 0 to 100; with 0 and 100 representing the no and highest degree of neuropathic-like symptoms, respectively) is sum of pain intensity, pain unpleasantness, pain sharpness, pain hotness, pain dullness, pain coldness, pain sensitivity, pain itching, deep pain intensity, and surface pain intensity (all in an 11-point NRS). Change from baseline to Weeks 4, 8, 12, and 18 (follow-up) in Galer NPS total score is reported.'}, {'measure': 'Change From Baseline in Daily Sleep Interference Scale (DSIS)', 'timeFrame': 'Baseline (Day -7 to Day -1, inclusive), Weeks 4, 8, 12, and 18 (follow-up)', 'description': 'Participants were assessed for how their neuropathic pain interferes with their sleep using the DSIS. It has an 11 point Likert response scale (0-10) that asked participants to "select the number that best describes how much your pain has interfered with your sleep during the past 24 hours". Responses vary from 0 (did not interfere with sleep) to 10 (completely interfered with sleep-unable to sleep due to pain). The DSIS was completed by participants once a day (upon awakening) to accurately capture variability in sleep interference due to pain on a daily basis, thus minimizing recall bias. Change from baseline to Weeks 4, 8, 12, and 18 (follow-up) in DSIS is reported.'}, {'measure': "Percentage of Participants With 'Improved', 'Much Improved', or 'Very Much Improved' Status in Patient Global Impression of Change (PGIC)", 'timeFrame': 'Baseline (Day -7 to Day -1, inclusive), Weeks 4, 8, 12, and 18 (follow-up)', 'description': 'Participants rated their overall improvement in health status using the PGIC. The PGIC consisted of a 7-point scale where 1 = very much improved and 7 = very much worse. The participants were asked the following question: How would you rate your overall improvement with treatment during the clinical study?, where the response options included the following: Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse, and Very Much Worse.'}, {'measure': 'Change From Baseline in 36-item Short-Form Health Survey (SF-36)', 'timeFrame': 'Baseline (Day -7 to Day -1, inclusive) and Week 12', 'description': 'Change from baseline to Week 12 in SF-36 is reported. The SF-36 assesses 8 health concepts: 1) limitations in physical activities because of health problems (physical functioning); 2) limitations in social activities because of physical or emotional problems (social functioning); 3) limitations in usual role activities because of physical health problems (role physical); 4) bodily pain; 5) general mental health; 6) limitations in usual role activities because of emotional problems (role emotional); 7) vitality; and 8) general health perceptions. The items use Likert-type scales with either 5 or 6 points, or 2 or 3 points. Higher SF-36 scores indicate a better state of health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).'}, {'measure': 'Percentage of Participants Taking Any Rescue Medication', 'timeFrame': 'Baseline (Day -7 to Day -1, inclusive) through Week 12', 'description': 'Percentage of participants taking any rescue medication are reported. Participants were asked to record all rescue medications they take for neuropathic pain in a paper diary.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'Day 1 through 20.42 weeks (maximum observed duration)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.'}, {'measure': 'Number of Participants With Abnormal Vital Signs Reported as TEAEs', 'timeFrame': 'Day 1 through 20.42 weeks (maximum observed duration)', 'description': 'Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal finding in the vital sign parameters (body temperature, diastolic blood pressure, systolic blood pressure, heart \\[pulse\\] rate, and respiratory rate).'}, {'measure': 'Number of Participants With Clinically Significant Abnormal Electrocardiograms (ECGs)', 'timeFrame': 'Day 1 through 20.42 weeks (maximum observed duration)', 'description': 'Number of participants with clinically significant abnormal ECGs are reported.'}, {'measure': 'Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs', 'timeFrame': 'Day 1 through 20.42 weeks (maximum observed duration)', 'description': 'Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of hematology, clinical chemistry, coagulation, and urinalysis.'}, {'measure': 'Number of Participants With Clinically Significant Findings in Physical Examination Reported as TEAEs', 'timeFrame': 'Day 1 through 20.42 weeks (maximum observed duration)', 'description': 'Number of participants with clinically significant findings in physical examination reported as TEAE are reported. A complete physical examination (excluding the genitourinary examination, unless warranted) was performed.'}, {'measure': 'Number of Participants With Clinically Significant Findings in Neurological Examination', 'timeFrame': 'Day 1 through 20.42 weeks (maximum observed duration)', 'description': 'Number of participants with clinically significant findings in neurological examination is reported.'}, {'measure': 'Number of Participants With Abnormal Dorsiflexion Strength', 'timeFrame': 'Day 1 through 20.42 weeks (maximum observed duration)', 'description': 'Number of participants with abnormal dorsiflexion strength is reported. Dorsiflexion strength is scored on 0-4 scale. The scale indicated 0 = normal power, 1 = mild weakness, 2 = moderate weakness, 3 = severe weakness, and 4 = paralysis.'}, {'measure': 'Number of Participants With Abnormal Deep Tendon Reflex (Knee and Ankle)', 'timeFrame': 'Day 1 through 20.42 weeks (maximum observed duration)', 'description': 'Number of participants with abnormal deep tendon reflex are reported. Deep tendon reflex (knee and ankle) strength is scored on 0-4 scale. The scale indicated 0 = normal, 1 = ankle reflex reduced, 2 = ankle reflex absent, 3 = ankle reflex absent and knee reflex reduced, and 4 = all reflexes (both ankle and knee) absent. Participants within a specific row are not included in any other row in the data table below.'}, {'measure': 'Change From Baseline in Total Neuropathy Score-Nurse (TNSn)', 'timeFrame': 'Baseline (Day -45 to -1), pre-dose on Day 1, Weeks 2, 4, 6, 8, 10, 12, and 18/early termination', 'description': 'The TNSn, a semi-quantitative clinical assessment of peripheral nervous system function, was administered at baseline (Screening), Day 1, Weeks 2, 4, 6, 8, 10, 12 and Week 18/early termination. The TNSn provides for an assessment of motor symptom score, autonomic symptom score, pin sensibility score, and vibration sensibility score. Each neuropathy item is scored on a 0-4 scale. The scores are summed to obtain a total score ranging from 0 to 20. Higher total scores correlate with more severe neuropathy. Not all of the early terminated participants completed the 18 week assessment. Only 3 early terminated participants contributed data at the Week 18 assessment.'}, {'measure': 'Number of Participants With Investigator Reported Significant Changes From Baseline in Motor and Sensory Nerve Conduction', 'timeFrame': 'Day 1 through 20.42 weeks (maximum observed duration)', 'description': 'Motor and sensory nerve conduction studies were performed in relevant lower and upper limb nerves (sural, peroneal, median/ulnar, fibular, and tibial nerves) wherein amplitude, peak latency, conduction velocity, and duration of nerve action potentials were recorded.'}, {'measure': 'Number of Participants With at Least One Concomitant Medication', 'timeFrame': 'Day 1 through 20.42 weeks (maximum observed duration)', 'description': 'Number of participants with at least one concomitant medication is reported. A concomitant medication is defined as any medication continuing or starting after first dose of study medication.'}, {'measure': 'Number of Participants With Injection Site Reaction', 'timeFrame': 'Day 1 through 20.42 weeks (maximum observed duration)', 'description': 'Number of participants with injection site reaction is reported.'}, {'measure': 'Number of Participants With Infusion Reaction', 'timeFrame': 'Day 1 through 20.42 weeks (maximum observed duration)', 'description': 'Number of participants with infusion reaction is reported.'}, {'measure': 'Serum Total Nerve Growth Factor (NGF) Concentrations', 'timeFrame': 'Day 1 (pre-dose; baseline), Weeks 2, 4, 6, 8, 10 (Day 70; pre-dose, immediately before end of infusion, 8 hours and 24 hours post Day 70 infusion [Day 71]), 11, and 12 (approximately same time of day as Week 10 infusion)', 'description': 'Serum concentrations of total NGF in ADA positive or negative participants are reported.'}, {'measure': 'Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI7352', 'timeFrame': 'Pre-dose at baseline (Day -45 to -1) and Study Weeks 2, 4, 8, 10, 12, and 18 (follow-up)', 'description': 'Number of participants with positive ADA to MEDI7352 are reported. Treatment-induced ADA positive is defined as ADA negative at baseline and positive at least 1 post-baseline assessment. Treatment-boosted ADA positive is defined as ADA positive at baseline with pre-existing titre boosted by 4-fold or greater during the study period. Persistent positive is defined as ADA negative at baseline and positive at least 2 post-baseline assessments (with \\>= 16 weeks between first and last positive) or ADA positive at last post-baseline assessment. Transiently positive is defined as ADA negative at baseline and at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Painful Diabetic Neuropathy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5680C00002&attachmentIdentifier=047c595c-3112-4e4f-972f-f0ff1c0af44f&fileName=synopsis-Redacted.pdf&versionIdentifier=', 'label': 'CSR synopsis'}]}, 'descriptionModule': {'briefSummary': 'This is a study investigating the effect of MEDI7352 on chronic pain in participants with painful diabetic neuropathy.\n\nThe study incudes a screening period of up to 45 days and a 12-week treatment period during which MEDI7352 or placebo will be administered intravenously (IV) on 6 occasions, with each dose separated by 14 days. There will be a 6-week follow-up period.\n\nParticipants will randomly be assigned to double-blind treatment with one of 4 dose levels of MEDI7352 or placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion criteria:\n\n* Male, or postmenopausal or surgically sterile female, 18 to 80 years of age\n* Body mass index of ≤ 42 kg/m\\^2.\n* Chronic painful diabetic neuropathy (PDN) persistent for 6 months or longer, not adequately controlled by standard of care treatments.\n* Mean pain intensity score of ≥ 4, as measured on an 11-point (0-10) numerical rating scale (NRS).\n* Willing and able to discontinue all non-steroidal anti-inflammatory drug (NSAID) or cyclooxygenase-2 (COX-2) analgesic therapy.\n* Currently be taking medication for the treatment of PDN. Participants should be taking at least one of the first-line medications (consistent with regional or local standard of care guidelines for PDN).\n\nKey Exclusion criteria:\n\n* Presence of other clinically significant neuropathy (eg, hereditary neuropathy, inflammatory neuropathy) or other clinically significant disorder (eg, nerve compression injury) involving abnormal peripheral sensation, with an aetiology that is considered to be distinct from that of PDN, and that is likely to interfere with assessment of peripheral nerve function, as judged by the investigator.\n* History of osteonecrosis, rapidly progressing osteoarthritis (OA), subchondral insufficiency fractures, neurogenic arthropathy, or analgesia-induced arthropathy.\n* Diagnosis of clinically significant OA currently affecting a major joint in the upper extremity (shoulder, elbow, or wrist) or lower extremity (hip, knee, or ankle) or axial spine; or other degenerative disease affecting any joint in participants for whom, in the opinion of the investigator, there is an identified risk of osteonecrosis, rapidly progressing OA, subchondral insufficiency fractures, neurogenic arthropathy, or analgesia-induced arthropathy.\n* Chronic pain condition, other than PDN, that is likely to interfere with the evaluation of the participant's PDN pain, as judged by the investigator.\n* Haemoglobin A1C greater than 10.0% (\\> 10.0%)."}, 'identificationModule': {'nctId': 'NCT03755934', 'briefTitle': 'Efficacy and Safety of MEDI7352 in Participants With Painful Diabetic Neuropathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomised, Double-Blind, Placebo-Controlled, Dose-Response Study of the Efficacy and Safety of MEDI7352 in Subjects With Painful Diabetic Neuropathy', 'orgStudyIdInfo': {'id': 'D5680C00002'}, 'secondaryIdInfos': [{'id': '2018-002523-42', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received 6 doses of intravenous (IV) placebo infusion matched to MEDl7352 during 12-week treatment period.', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'MEDl7352 Low Dose', 'description': 'Participants received 6 doses of IV MEDl7352 low dose during 12-week treatment period.', 'interventionNames': ['Drug: MEDI7352']}, {'type': 'EXPERIMENTAL', 'label': 'MEDl7352 Medium Dose', 'description': 'Participants received 6 doses of IV MEDl7352 medium dose during 12-week treatment period.', 'interventionNames': ['Drug: MEDI7352']}, {'type': 'EXPERIMENTAL', 'label': 'MEDI7352 High Dose', 'description': 'Participants received 6 doses of IV MEDl7352 high dose during 12-week treatment period.', 'interventionNames': ['Drug: MEDI7352']}], 'interventions': [{'name': 'MEDI7352', 'type': 'DRUG', 'description': 'Participants will receive IV infusion of MEDI7352 as stated in arm description.', 'armGroupLabels': ['MEDI7352 High Dose', 'MEDl7352 Low Dose', 'MEDl7352 Medium Dose']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Participants will receive IV infusion of placebo as stated in arm description.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2820', 'city': 'Gentofte Municipality', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.74903, 'lon': 12.54601}}, {'zip': '8230', 'city': 'Balatonfüred', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 46.96188, 'lon': 17.87187}}, {'zip': '1036', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '85-065', 'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '80-382', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '40-040', 'city': 'Katowice', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '40-282', 'city': 'Katowice', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '30-534', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '20-093', 'city': 'Lublin', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '20064', 'city': 'Lublin', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '10117', 'city': 'Olsztyn', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 53.78376, 'lon': 20.49272}}, {'zip': '60-702', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '96-500', 'city': 'Sochaczew', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 52.22944, 'lon': 20.23838}}, {'zip': '87100', 'city': 'Torun', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 53.01375, 'lon': 18.59814}}, {'zip': '01-192', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '01144', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '53-413', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '011025', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '917080', 'city': 'Călăraşi', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 44.2051, 'lon': 27.31356}}, {'zip': '200505', 'city': 'Craiova', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'zip': '800291', 'city': 'Galati', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 45.43687, 'lon': 28.05028}}, {'zip': '540142', 'city': 'Târgu Mureş', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 46.54245, 'lon': 24.55747}}, {'zip': 'S75 3DL', 'city': 'Barnsley', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.55, 'lon': -1.48333}}, {'zip': 'FY2 0JH', 'city': 'Blackpool', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.81667, 'lon': -3.05}}, {'zip': 'WS11 0BN', 'city': 'Cannock', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 52.69045, 'lon': -2.03085}}, {'zip': 'CF14 4XW', 'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'LS10 1DU', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'NW10 7EW', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M13 9NQ', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'L34 1BH', 'city': 'Prescot', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.42948, 'lon': -2.80031}}, {'zip': 'TS17 6EW', 'city': 'Stockton-on-Tees', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 54.56848, 'lon': -1.3187}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}