Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-03-03 @ 12:07 PM
Study NCT ID:
NCT02615002
Status:
COMPLETED
Last Update Posted:
2024-07-05
First Post:
2015-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Piromelatine in Mild Alzheimer's Disease Patients (ReCOGNITION)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C581609', 'term': 'N-(2-(5-methoxy-indol-3-yl)-ethyl)-4-oxo-4H-pyran-2-carboxamide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'talin@neurim.com', 'phone': '+972-3-7684902', 'title': 'Tali Nir, DVM, VP Clinical and Regulatory Affairs', 'organization': 'Neurim Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '28 weeks (2 weeks Run-In Phase + 26 weeks Dose Escalation Phase)', 'description': 'The data presented includes adverse events from the Run-In Phase (2 weeks of placebo, intended to assess eligibility into the dose escalation study), and the Dose Escalation Phase (26 weeks of treatment with investigational drug versus placebo).', 'eventGroups': [{'id': 'EG000', 'title': 'Piromelatine 5 mg', 'description': '5 mg Piromelatine tablets once daily for 26 weeks (Dose Escalation Phase = Weeks 2-28).', 'otherNumAtRisk': 88, 'deathsNumAtRisk': 88, 'otherNumAffected': 12, 'seriousNumAtRisk': 88, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Piromelatine 20 mg', 'description': '20 mg Piromelatine tablets once daily for 26 weeks (Dose Escalation Phase = Weeks 2-28).', 'otherNumAtRisk': 88, 'deathsNumAtRisk': 88, 'otherNumAffected': 14, 'seriousNumAtRisk': 88, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Piromelatine 50 mg', 'description': '50 mg Piromelatine tablets once daily for 26 weeks (Dose Escalation Phase = Weeks 2-28).', 'otherNumAtRisk': 87, 'deathsNumAtRisk': 87, 'otherNumAffected': 14, 'seriousNumAtRisk': 87, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Placebo Comparator', 'description': 'Placebo tablet once daily for 26 weeks (Dose Escalation Phase = Weeks 2-28).', 'otherNumAtRisk': 105, 'deathsNumAtRisk': 105, 'otherNumAffected': 29, 'seriousNumAtRisk': 105, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG004', 'title': 'Run-In Phase', 'description': 'Placebo tablet once daily for 2 weeks, intended to assess eligibility before starting the dose escalation phase (Weeks 0-2).', 'otherNumAtRisk': 368, 'deathsNumAtRisk': 368, 'otherNumAffected': 0, 'seriousNumAtRisk': 368, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'notes': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 15, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Abnormal dreams', 'notes': 'Abnormal dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dizziness', 'notes': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Somnolence', 'notes': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Head discomfort', 'notes': 'Head discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hypersomnia', 'notes': 'Hypersomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Sedation', 'notes': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Insomnia', 'notes': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Agitation', 'notes': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Initial insomnia', 'notes': 'Initial insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Disorientation', 'notes': 'Disorientation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Disturbance in sexual arousal', 'notes': 'Disturbance in sexual arousal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hallucination', 'notes': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Libido increased', 'notes': 'Libido increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Nausea', 'notes': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Constipation', 'notes': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Diarrhoea', 'notes': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Large intestine polyp', 'notes': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Abdominal distension', 'notes': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Abdominal pain', 'notes': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dry mouth', 'notes': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dyspepsia', 'notes': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Gastrooesophageal reflux', 'notes': 'Gastrooesophageal reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Nasopharyngitis', 'notes': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Kidney infection', 'notes': 'Kidney infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Sinusitis', 'notes': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Upper respiratory tract infection', 'notes': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Influenza', 'notes': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Staphylococcal infection', 'notes': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Tubo-ovarian abscess', 'notes': 'Tubo-ovarian abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Alopecia', 'notes': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dry skin', 'notes': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Rash', 'notes': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Fall', 'notes': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Cough', 'notes': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dyspnoea', 'notes': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Oropharyngeal pain', 'notes': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Asthenia', 'notes': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'seriousEvents': [{'term': 'Pneumonia', 'notes': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Kidney Infection', 'notes': 'Kidney Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Head Injury', 'notes': 'Head Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Fall', 'notes': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Ischaemic cardiomyopathy', 'notes': 'Ischaemic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Subdural haematoma', 'notes': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Malignant melanoma in situ', 'notes': 'Malignant melanoma in situMalignant melanoma in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Duodenal ulcer', 'notes': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Duodenitis', 'notes': 'Duodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Gastritis erosive', 'notes': 'Gastritis erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Gastrointestinal haemorrhage', 'notes': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Respiratory failure', 'notes': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Colitis', 'notes': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Cervix carcinoma', 'notes': 'Cervix carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Uterine cancer', 'notes': 'Uterine cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Acute myocardial infarction', 'notes': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Femur Fracture', 'notes': 'Femur Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Humerus Fracture', 'notes': 'Humerus Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Bradycardia', 'notes': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Cardio-respiratory Arrest', 'notes': 'Cardio-respiratory Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Ischemic Cardiopathy', 'notes': 'Ischemic Cardiopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Squamous cell carcinoma of skin', 'notes': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Syncope', 'notes': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Transient ischaemic attack', 'notes': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Anaemia', 'notes': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Multi-organ disorder', 'notes': 'Multi-organ disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Anxiety', 'notes': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Computerized Neuropsychological Test Battery (cNTB) Z-Scores - Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Piromelatine 5 mg', 'description': '5 mg Piromelatine tablets once daily'}, {'id': 'OG001', 'title': 'Piromelatine 20 mg', 'description': '20 mg Piromelatine tablets once daily'}, {'id': 'OG002', 'title': 'Piromelatine 50 mg', 'description': '50 mg Piromelatine tablets once daily'}, {'id': 'OG003', 'title': 'Placebo Comparator', 'description': 'Placebo tablet once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0434', 'groupId': 'OG000', 'lowerLimit': '-0.0728', 'upperLimit': '0.1391'}, {'value': '0.1175', 'groupId': 'OG001', 'lowerLimit': '0.0121', 'upperLimit': '0.2153'}, {'value': '0.0297', 'groupId': 'OG002', 'lowerLimit': '-0.0900', 'upperLimit': '0.1247'}, {'value': '0.0591', 'groupId': 'OG003', 'lowerLimit': '-0.0435', 'upperLimit': '0.1483'}]}]}], 'paramType': 'MEAN', 'timeFrame': '26 weeks', 'description': 'The global composite score of the cNTB combines the International Shopping List Test (ISLT), One Card Learning (OCL), Identification (IDN), Detection (DET), One Back Card (OBK), Controlled Oral Word Association Test (COWAT), and the Categorical Fluency Test (CFT). For each test, a z-score relative to the study baseline is calculated.\n\nThe cNTB global composite score is the mean of all z-scores from the tests listed above.\n\nThe scale range is from -3 to 3. Zero Z-score means no cognitive change. A negative value means decline, while a positive value means improvement.', 'unitOfMeasure': 'z-score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Global Impression of Change (CGIC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Piromelatine 5 mg', 'description': 'Piromelatine 5 mg tablet once daily'}, {'id': 'OG001', 'title': 'Experimental: Piromelatine 20 mg', 'description': 'Piromelatine 20 mg tablet once daily'}, {'id': 'OG002', 'title': 'Experimental: Piromelatine 50 mg', 'description': 'Piromelatine 50 mg tablet once daily'}, {'id': 'OG003', 'title': 'Placebo Comparator: Placebo', 'description': 'Placebo tablet given once daily'}], 'classes': [{'title': '13 weeks', 'categories': [{'measurements': [{'value': '3.93', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '3.95', 'spread': '0.78', 'groupId': 'OG001'}, {'value': '3.87', 'spread': '0.92', 'groupId': 'OG002'}, {'value': '3.89', 'spread': '0.80', 'groupId': 'OG003'}]}]}, {'title': '26 weeks', 'categories': [{'measurements': [{'value': '4.13', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '3.94', 'spread': '1.02', 'groupId': 'OG001'}, {'value': '3.87', 'spread': '0.98', 'groupId': 'OG002'}, {'value': '3.99', 'spread': '1.01', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 weeks, and 26 weeks', 'description': 'The Change From Baseline in Global Impression of Change (CGIC) rating is made on a 7-point Likert-type scale where the change from baseline is rated as marked improvement (1), moderate improvement (2), minimal improvement (3), no change (4), minimal worsening (5), moderate worsening (6), marked worsening (7).\n\nMean values at 13 and 26 weeks are relative to baseline.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Alzheimer's Disease Cooperative Study/Activities of Daily Living Scale Adapted for MCI (Mild Cognitive Impairment) Patients (ADCS-MCI-ADL)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Piromelatine 5 mg', 'description': '5 mg Piromelatine tablets once daily'}, {'id': 'OG001', 'title': 'Piromelatine 20 mg', 'description': '20 mg Piromelatine tablets once daily'}, {'id': 'OG002', 'title': 'Piromelatine 50 mg', 'description': '50 mg Piromelatine tablets once daily'}, {'id': 'OG003', 'title': 'Placebo Comparator', 'description': 'Placebo tablet once daily'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '40.7', 'spread': '6.73', 'groupId': 'OG000'}, {'value': '38.4', 'spread': '8.98', 'groupId': 'OG001'}, {'value': '39.2', 'spread': '7.60', 'groupId': 'OG002'}, {'value': '39.4', 'spread': '8.60', 'groupId': 'OG003'}]}]}, {'title': '13 weeks', 'categories': [{'measurements': [{'value': '40.4', 'spread': '6.72', 'groupId': 'OG000'}, {'value': '39.6', 'spread': '8.89', 'groupId': 'OG001'}, {'value': '39.1', 'spread': '8.81', 'groupId': 'OG002'}, {'value': '39.5', 'spread': '8.06', 'groupId': 'OG003'}]}]}, {'title': '26 weeks', 'categories': [{'measurements': [{'value': '40.6', 'spread': '6.59', 'groupId': 'OG000'}, {'value': '39.3', 'spread': '9.11', 'groupId': 'OG001'}, {'value': '39.8', 'spread': '7.94', 'groupId': 'OG002'}, {'value': '40.4', 'spread': '8.07', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 13 weeks, and 26 weeks', 'description': 'ADCS-MCI-ADL is an evaluation scale with information provided by an informant/caregiver to describe the functional impairment of patients with mild cognitive impairment (MCI).\n\nThe ADCS-ADL is a 23-item scale that includes 6 basic ADLs (BADLs) and 17 Instrumental Activities of Daily Living (IADLs) that provide a total score of 0-78, with a lower score indicating greater severity, meaning a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog14)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Piromelatine 5 mg', 'description': '5 mg tablets Piromelatine once daily'}, {'id': 'OG001', 'title': 'Piromelatine 20 mg', 'description': '20 mg Piromelatine tablets once daily'}, {'id': 'OG002', 'title': 'Piromelatine 50 mg', 'description': '50 mg Piromelatine tablets once daily'}, {'id': 'OG003', 'title': 'Placebo Comparator', 'description': 'Placebo tablet once daily'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '26.1', 'spread': '7.72', 'groupId': 'OG000'}, {'value': '26.3', 'spread': '9.16', 'groupId': 'OG001'}, {'value': '26.4', 'spread': '7.91', 'groupId': 'OG002'}, {'value': '26.6', 'spread': '8.62', 'groupId': 'OG003'}]}]}, {'title': '13 weeks', 'categories': [{'measurements': [{'value': '25.1', 'spread': '8.39', 'groupId': 'OG000'}, {'value': '26.7', 'spread': '9.37', 'groupId': 'OG001'}, {'value': '25.5', 'spread': '10.01', 'groupId': 'OG002'}, {'value': '26.6', 'spread': '9.87', 'groupId': 'OG003'}]}]}, {'title': '26 weeks', 'categories': [{'measurements': [{'value': '25.3', 'spread': '8.93', 'groupId': 'OG000'}, {'value': '26.0', 'spread': '10.12', 'groupId': 'OG001'}, {'value': '24.9', 'spread': '9.35', 'groupId': 'OG002'}, {'value': '25.2', 'spread': '9.97', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 13 weeks, and 26 weeks', 'description': 'The ADAS was designed to measure the severity of the most important symptoms of AD. Its subscale, ADAS-cog, is the most popular cognitive testing instrument used in clinical trials, measuring the disturbances of memory, language, praxis, attention, and other cognitive abilities that are often referred to as the core symptoms of AD.\n\nADAS-cog14 comprises 14 items summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability - Blood Pressure (mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Piromelatine 5 mg', 'description': '5 mg tablets Piromelatine once daily'}, {'id': 'OG001', 'title': 'Piromelatine 20 mg', 'description': '20 mg Piromelatine tablets once daily'}, {'id': 'OG002', 'title': 'Piromelatine 50 mg', 'description': '50 mg Piromelatine tablets once daily'}, {'id': 'OG003', 'title': 'Placebo Comparator', 'description': 'Placebo tablet once daily'}], 'classes': [{'title': 'Systolic BP - Baseline', 'categories': [{'measurements': [{'value': '128.7', 'spread': '14.51', 'groupId': 'OG000'}, {'value': '130.8', 'spread': '13.19', 'groupId': 'OG001'}, {'value': '128.5', 'spread': '11.35', 'groupId': 'OG002'}, {'value': '132.3', 'spread': '15.13', 'groupId': 'OG003'}]}]}, {'title': 'Systolic BP - 26 weeks', 'categories': [{'measurements': [{'value': '131.9', 'spread': '13.61', 'groupId': 'OG000'}, {'value': '132.4', 'spread': '12.31', 'groupId': 'OG001'}, {'value': '129.9', 'spread': '10.01', 'groupId': 'OG002'}, {'value': '131.5', 'spread': '12.93', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic BP - Baseline', 'categories': [{'measurements': [{'value': '75.3', 'spread': '9.15', 'groupId': 'OG000'}, {'value': '76.5', 'spread': '8.37', 'groupId': 'OG001'}, {'value': '76.3', 'spread': '7.57', 'groupId': 'OG002'}, {'value': '76.3', 'spread': '8.26', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic BP - 26 weeeks', 'categories': [{'measurements': [{'value': '76.3', 'spread': '8.48', 'groupId': 'OG000'}, {'value': '76.2', 'spread': '8.47', 'groupId': 'OG001'}, {'value': '77.3', 'spread': '8.78', 'groupId': 'OG002'}, {'value': '76.3', 'spread': '8.52', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and 26 weeks', 'description': 'Systolic and Diastolic Blood Pressure is followed during the study, as safety and tolerability measures.\n\nChanges in BP following treatment, leading to values out of the normal limits mean a worse outcome.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability - Heart Rate (Bpm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Piromelatine 5 mg', 'description': 'Piromelatine 5 mg tablet once daily'}, {'id': 'OG001', 'title': 'Experimental: Piromelatine 20 mg', 'description': 'Piromelatine 20 mg tablet once daily'}, {'id': 'OG002', 'title': 'Experimental: Piromelatine 50 mg', 'description': 'Piromelatine 50 mg tablet once daily'}, {'id': 'OG003', 'title': 'Placebo Comparator: Placebo', 'description': 'Placebo tablet given once daily'}], 'classes': [{'title': 'Heart rate - baseline', 'categories': [{'measurements': [{'value': '68.1', 'spread': '10.67', 'groupId': 'OG000'}, {'value': '68.7', 'spread': '9.44', 'groupId': 'OG001'}, {'value': '69.6', 'spread': '9.55', 'groupId': 'OG002'}, {'value': '67.2', 'spread': '9.68', 'groupId': 'OG003'}]}]}, {'title': 'Heart rate - 26 weeks', 'categories': [{'measurements': [{'value': '65.9', 'spread': '9.89', 'groupId': 'OG000'}, {'value': '67.0', 'spread': '9.95', 'groupId': 'OG001'}, {'value': '66.9', 'spread': '9.28', 'groupId': 'OG002'}, {'value': '67.9', 'spread': '10.13', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and 26 weeks', 'description': 'Heart Rate within normal limits = 60-100 beats per minute (bpm) during the study means a good outcome in terms of safety.', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability - ECG Interval Results - QTcF (Msec)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Piromelatine 5 mg', 'description': 'Piromelatine 5 mg tablet once daily'}, {'id': 'OG001', 'title': 'Experimental: Piromelatine 20 mg', 'description': 'Piromelatine 20 mg tablet once daily'}, {'id': 'OG002', 'title': 'Experimental: Piromelatine 50 mg', 'description': 'Piromelatine 50 mg tablet once daily'}, {'id': 'OG003', 'title': 'Placebo Comparator: Placebo', 'description': 'Placebo tablet given once daily'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '417.1', 'spread': '24.16', 'groupId': 'OG000'}, {'value': '416.4', 'spread': '34.97', 'groupId': 'OG001'}, {'value': '413.9', 'spread': '50.48', 'groupId': 'OG002'}, {'value': '416.5', 'spread': '20.57', 'groupId': 'OG003'}]}]}, {'title': '26 weeks', 'categories': [{'measurements': [{'value': '414.3', 'spread': '27.29', 'groupId': 'OG000'}, {'value': '421.2', 'spread': '24.86', 'groupId': 'OG001'}, {'value': '416.6', 'spread': '24.87', 'groupId': 'OG002'}, {'value': '408.9', 'spread': '54.47', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and 26 weeks', 'description': "QT interval corrected for heart rate by Fridericia's cube root formula (QTcF). The QTc is considered normal at \\< 450 msec in males, and \\< 470 msec in females.", 'unitOfMeasure': 'msec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability - Hematology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Piromelatine 5 mg', 'description': '5 mg Piromelatine tablets once daily'}, {'id': 'OG001', 'title': 'Piromelatine 20 mg', 'description': '20 mg Piromelatine tablets once daily'}, {'id': 'OG002', 'title': 'Piromelatine 50 mg', 'description': '50 mg Piromelatine tablets once daily'}, {'id': 'OG003', 'title': 'Placebo Comparator', 'description': 'Placebo tablet once daily'}], 'classes': [{'title': 'Basophils - baseline', 'categories': [{'measurements': [{'value': '0.050', 'spread': '0.0141', 'groupId': 'OG000'}, {'value': '0.070', 'spread': '0.0141', 'groupId': 'OG001'}, {'value': '0.067', 'spread': '0.0153', 'groupId': 'OG002'}, {'value': '0.063', 'spread': '0.0153', 'groupId': 'OG003'}]}]}, {'title': 'Basophils - 26 weeks', 'categories': [{'measurements': [{'value': '0.080', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.050', 'spread': '0', 'groupId': 'OG001'}, {'value': '0.050', 'spread': '0.0141', 'groupId': 'OG002'}, {'value': '0.080', 'spread': '0.0283', 'groupId': 'OG003'}]}]}, {'title': 'Eosinophils - baseline', 'categories': [{'measurements': [{'value': '0.290', 'spread': '0.0990', 'groupId': 'OG000'}, {'value': '0.215', 'spread': '0.0354', 'groupId': 'OG001'}, {'value': '0.110', 'spread': '0.0693', 'groupId': 'OG002'}, {'value': '0.153', 'spread': '0.0208', 'groupId': 'OG003'}]}]}, {'title': 'Eosinophils - 26 weeks', 'categories': [{'measurements': [{'value': '0.170', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.180', 'spread': '0', 'groupId': 'OG001'}, {'value': '0.130', 'spread': '0.0283', 'groupId': 'OG002'}, {'value': '0.250', 'spread': '0.0283', 'groupId': 'OG003'}]}]}, {'title': 'Leukocytes - baseline', 'categories': [{'measurements': [{'value': '6.455', 'spread': '1.5768', 'groupId': 'OG000'}, {'value': '8.715', 'spread': '2.7224', 'groupId': 'OG001'}, {'value': '6.140', 'spread': '0.6940', 'groupId': 'OG002'}, {'value': '5.407', 'spread': '0.8755', 'groupId': 'OG003'}]}]}, {'title': 'Leukocytes - 26 weeks', 'categories': [{'measurements': [{'value': '5.210', 'spread': '0', 'groupId': 'OG000'}, {'value': '10.050', 'spread': '0', 'groupId': 'OG001'}, {'value': '5.885', 'spread': '0.3465', 'groupId': 'OG002'}, {'value': '6.970', 'spread': '0.9617', 'groupId': 'OG003'}]}]}, {'title': 'Lymphocytes - baseline (GI/L)', 'categories': [{'measurements': [{'value': '1.605', 'spread': '0.7425', 'groupId': 'OG000'}, {'value': '2.535', 'spread': '0.0071', 'groupId': 'OG001'}, {'value': '1.943', 'spread': '0.2397', 'groupId': 'OG002'}, {'value': '1.363', 'spread': '0.3320', 'groupId': 'OG003'}]}]}, {'title': 'Lymphocytes - 26 weeks', 'categories': [{'measurements': [{'value': '0.920', 'spread': '0', 'groupId': 'OG000'}, {'value': '2.370', 'spread': '0', 'groupId': 'OG001'}, {'value': '1.805', 'spread': '0.3182', 'groupId': 'OG002'}, {'value': '2.085', 'spread': '1.3223', 'groupId': 'OG003'}]}]}, {'title': 'Monocytes - baseline', 'categories': [{'measurements': [{'value': '0.510', 'spread': '0.2828', 'groupId': 'OG000'}, {'value': '0.405', 'spread': '0.0919', 'groupId': 'OG001'}, {'value': '0.357', 'spread': '0.1102', 'groupId': 'OG002'}, {'value': '0.347', 'spread': '0.0611', 'groupId': 'OG003'}]}]}, {'title': 'Monocytes - 26 weeks', 'categories': [{'measurements': [{'value': '0.450', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.700', 'spread': '0', 'groupId': 'OG001'}, {'value': '0.370', 'spread': '0.0141', 'groupId': 'OG002'}, {'value': '0.345', 'spread': '0.0495', 'groupId': 'OG003'}]}]}, {'title': 'Neutrophils - baseline', 'categories': [{'measurements': [{'value': '3.990', 'spread': '0.4525', 'groupId': 'OG000'}, {'value': '5.495', 'spread': '2.6658', 'groupId': 'OG001'}, {'value': '3.660', 'spread': '0.2905', 'groupId': 'OG002'}, {'value': '3.483', 'spread': '1.1801', 'groupId': 'OG003'}]}]}, {'title': 'Neutrophils - 26 weeks', 'categories': [{'measurements': [{'value': '3.600', 'spread': '0', 'groupId': 'OG000'}, {'value': '6.750', 'spread': '0', 'groupId': 'OG001'}, {'value': '3.525', 'spread': '0.0071', 'groupId': 'OG002'}, {'value': '4.205', 'spread': '0.3041', 'groupId': 'OG003'}]}]}, {'title': 'Platelets - baseline', 'categories': [{'measurements': [{'value': '238.5', 'spread': '84.15', 'groupId': 'OG000'}, {'value': '299.0', 'spread': '2.83', 'groupId': 'OG001'}, {'value': '241.0', 'spread': '46.13', 'groupId': 'OG002'}, {'value': '167.3', 'spread': '26.95', 'groupId': 'OG003'}]}]}, {'title': 'Platelets - 26 weeks', 'categories': [{'measurements': [{'value': '144.0', 'spread': '0', 'groupId': 'OG000'}, {'value': '301.0', 'spread': '0', 'groupId': 'OG001'}, {'value': '223.0', 'spread': '48.08', 'groupId': 'OG002'}, {'value': '283.0', 'spread': '111.72', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and 26 weeks', 'description': 'Hematology (GI/L).\n\n1 gill (GI) = 0.118294118 liter (L). No major changes or shifts from baseline mean good safety and tolerability.', 'unitOfMeasure': 'GI/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability - Blood Chemistry (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Piromelatine 5 mg', 'description': 'Piromelatine 5 mg tablet once daily'}, {'id': 'OG001', 'title': 'Experimental: Piromelatine 20 mg', 'description': 'Piromelatine 20 mg tablet once daily'}, {'id': 'OG002', 'title': 'Experimental: Piromelatine 50 mg', 'description': 'Piromelatine 50 mg tablet once daily'}, {'id': 'OG003', 'title': 'Placebo Comparator: Placebo', 'description': 'Placebo tablet given once daily'}], 'classes': [{'title': 'Glucose - baseline', 'categories': [{'measurements': [{'value': '5.89', 'spread': '1.883', 'groupId': 'OG000'}, {'value': '5.97', 'spread': '2.045', 'groupId': 'OG001'}, {'value': '5.51', 'spread': '1.322', 'groupId': 'OG002'}, {'value': '5.78', 'spread': '1.598', 'groupId': 'OG003'}]}]}, {'title': 'Glucose - 26 weeks', 'categories': [{'measurements': [{'value': '5.86', 'spread': '1.770', 'groupId': 'OG000'}, {'value': '6.25', 'spread': '2.121', 'groupId': 'OG001'}, {'value': '5.99', 'spread': '2.351', 'groupId': 'OG002'}, {'value': '5.80', 'spread': '1.461', 'groupId': 'OG003'}]}]}, {'title': 'Calcium - baseline', 'categories': [{'measurements': [{'value': '2.385', 'spread': '0.1626', 'groupId': 'OG000'}, {'value': '2.470', 'spread': '0.0707', 'groupId': 'OG001'}, {'value': '2.307', 'spread': '0.1007', 'groupId': 'OG002'}, {'value': '2.363', 'spread': '0.1290', 'groupId': 'OG003'}]}]}, {'title': 'Calcium - 26 weeks', 'categories': [{'measurements': [{'value': '2.270', 'spread': '0', 'groupId': 'OG000'}, {'value': '2.370', 'spread': '0', 'groupId': 'OG001'}, {'value': '2.300', 'spread': '0', 'groupId': 'OG002'}, {'value': '2.335', 'spread': '0.0495', 'groupId': 'OG003'}]}]}, {'title': 'Sodium - baseline', 'categories': [{'measurements': [{'value': '140.5', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '141.5', 'spread': '0.71', 'groupId': 'OG001'}, {'value': '139.3', 'spread': '2.31', 'groupId': 'OG002'}, {'value': '139.0', 'spread': '1.73', 'groupId': 'OG003'}]}]}, {'title': 'Sodium -26 weeks', 'categories': [{'measurements': [{'value': '135.0', 'spread': '0', 'groupId': 'OG000'}, {'value': '141.0', 'spread': '0', 'groupId': 'OG001'}, {'value': '143.0', 'spread': '2.83', 'groupId': 'OG002'}, {'value': '140.0', 'spread': '1.41', 'groupId': 'OG003'}]}]}, {'title': 'Urea Nitrogen - baseline', 'categories': [{'measurements': [{'value': '7.35', 'spread': '0.778', 'groupId': 'OG000'}, {'value': '7.70', 'spread': '3.818', 'groupId': 'OG001'}, {'value': '5.00', 'spread': '0.400', 'groupId': 'OG002'}, {'value': '5.00', 'spread': '1.212', 'groupId': 'OG003'}]}]}, {'title': 'Urea Nitrogen - 26 weeks', 'categories': [{'measurements': [{'value': '8.20', 'spread': '0', 'groupId': 'OG000'}, {'value': '5.70', 'spread': '0', 'groupId': 'OG001'}, {'value': '5.35', 'spread': '0.495', 'groupId': 'OG002'}, {'value': '4.50', 'spread': '1.273', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and 26 weeks', 'description': 'Blood Chemistry follow-up during the experiment. No major changes or shifts from baseline mean good safety and tolerability.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'NeuroPsychiatric Inventory (NPI) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Piromelatine 5 mg', 'description': '5 mg Piromelatine tablets once daily'}, {'id': 'OG001', 'title': 'Piromelatine 20 mg', 'description': '20 mg Piromelatine tablets once daily'}, {'id': 'OG002', 'title': 'Piromelatine 50 mg', 'description': '50 mg Piromelatine tablets once daily'}, {'id': 'OG003', 'title': 'Placebo Comparator', 'description': 'Placebo tablet once daily'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '11.2', 'spread': '10.30', 'groupId': 'OG000'}, {'value': '10.3', 'spread': '8.39', 'groupId': 'OG001'}, {'value': '12.0', 'spread': '8.75', 'groupId': 'OG002'}, {'value': '10.8', 'spread': '10.13', 'groupId': 'OG003'}]}]}, {'title': '26 weeks', 'categories': [{'measurements': [{'value': '11.4', 'spread': '11.60', 'groupId': 'OG000'}, {'value': '9.0', 'spread': '7.85', 'groupId': 'OG001'}, {'value': '11.9', 'spread': '10.66', 'groupId': 'OG002'}, {'value': '9.8', 'spread': '10.34', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and 26 weeks', 'description': 'The NPI scale consists of 12 domains that are rated for both frequency (range 1 to 4) and severity (range 1 to 3). A composite score for each domain is calculated (frequency × severity), and it ranges from 1 to 12.\n\nFor each item, there is a leading question. If the symptom is absent, then the frequency, severity, and distress scores are not completed. In this case, the score is 0 for the item. The sum of the composite scores yields the NPI total score (1-12).\n\nA negative change in the score indicates an improvement from baseline (symptom reduction).', 'unitOfMeasure': 'NPI total score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Pittsburgh Sleep Quality Index (PSQI) - Global Component Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Piromelatine 5 mg', 'description': '5 mg Piromelatine tablets once daily'}, {'id': 'OG001', 'title': 'Piromelatine 20 mg', 'description': '20 mg Piromelatine tablets once daily'}, {'id': 'OG002', 'title': 'Piromelatine 50 mg', 'description': '50 mg Piromelatine tablets once daily'}, {'id': 'OG003', 'title': 'Placebo Comparator', 'description': 'Placebo tablet once daily'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.8', 'spread': '4.39', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '3.99', 'groupId': 'OG001'}, {'value': '6.0', 'spread': '4.14', 'groupId': 'OG002'}, {'value': '5.6', 'spread': '3.66', 'groupId': 'OG003'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '5.8', 'spread': '3.97', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '3.36', 'groupId': 'OG001'}, {'value': '5.4', 'spread': '3.56', 'groupId': 'OG002'}, {'value': '5.6', 'spread': '3.39', 'groupId': 'OG003'}]}]}, {'title': '13 weeks', 'categories': [{'measurements': [{'value': '6.2', 'spread': '3.85', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '3.04', 'groupId': 'OG001'}, {'value': '5.5', 'spread': '3.20', 'groupId': 'OG002'}, {'value': '5.1', 'spread': '3.11', 'groupId': 'OG003'}]}]}, {'title': '26 weeks', 'categories': [{'measurements': [{'value': '5.7', 'spread': '3.62', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '3.26', 'groupId': 'OG001'}, {'value': '5.2', 'spread': '3.21', 'groupId': 'OG002'}, {'value': '5.1', 'spread': '3.68', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 weeks, 13 weeks, 26 weeks', 'description': 'PSQI is an effective instrument used to measure the quality and patterns of sleep in older adults.\n\nIt differentiates "poor" from "good" sleep by measuring 7 areas: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction over the last month.\n\nPSQI includes seven components, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.', 'unitOfMeasure': 'PSQI global score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental: Piromelatine 5 mg', 'description': 'Run-In placebo (2 weeks), followed by 5 mg Piromelatine once daily (26 weeks)'}, {'id': 'FG001', 'title': 'Experimental: Piromelatine 20 mg', 'description': 'Run-In placebo (2 weeks), followed by 20 mg Piromelatine once daily (26 weeks).'}, {'id': 'FG002', 'title': 'Experimental: Piromelatine 50 mg', 'description': 'Run-In placebo (2 weeks), followed by 50 mg Piromelatine once daily (26 weeks).'}, {'id': 'FG003', 'title': 'Placebo Comparator', 'description': 'Run-In placebo (2 weeks), followed by Placebo control once daily (26 weeks).'}], 'periods': [{'title': 'Run-In Phase (2 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '88'}, {'groupId': 'FG002', 'numSubjects': '88'}, {'groupId': 'FG003', 'numSubjects': '106'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '88'}, {'groupId': 'FG002', 'numSubjects': '88'}, {'groupId': 'FG003', 'numSubjects': '106'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Double Blind Dose Escalation (26 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '88'}, {'groupId': 'FG002', 'numSubjects': '88'}, {'groupId': 'FG003', 'numSubjects': '106'}]}, {'type': 'Number of Baseline Participants', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '87'}, {'groupId': 'FG002', 'numSubjects': '80'}, {'groupId': 'FG003', 'numSubjects': '102'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '88'}, {'groupId': 'FG002', 'numSubjects': '88'}, {'groupId': 'FG003', 'numSubjects': '85'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '21'}]}]}], 'preAssignmentDetails': 'The first period of the study consisted of a run-in phase where all participants received Placebo, followed by a second period where participants were randomized to "Piromelatine 5mg", "Piromelatine 20mg", "Piromelatine 50mg", or "Placebo" Arm/Groups for the dose escalation phase.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}, {'value': '352', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental: Piromelatine 5 mg', 'description': 'Piromelatine 5 mg tablet once daily'}, {'id': 'BG001', 'title': 'Experimental: Piromelatine 20 mg', 'description': 'Piromelatine 20 mg tablet once daily'}, {'id': 'BG002', 'title': 'Experimental: Piromelatine 50 mg', 'description': 'Piromelatine 50 mg tablet once daily'}, {'id': 'BG003', 'title': 'Placebo Comparator: Placebo', 'description': 'Placebo tablet given once daily'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}, {'value': '352', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.1', 'spread': '6.65', 'groupId': 'BG000'}, {'value': '72.7', 'spread': '7.97', 'groupId': 'BG001'}, {'value': '73.3', 'spread': '6.62', 'groupId': 'BG002'}, {'value': '73.3', 'spread': '7.11', 'groupId': 'BG003'}, {'value': '73.1', 'spread': '7.10', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}, {'value': '200', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}, {'value': '152', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '83', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}, {'value': '269', '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': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '312', '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': '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': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}, {'value': '352', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Out of 371 patients randomized, 368 were included in the Safety Analysis Set (SS), 352 were in the Full Analysis Set (FAS), and 315 were in the Per Protocol Set (PPS).\n\nOut of 368 patients included in the SS, 16 were not included in the FAS because they did not have efficacy data for the primary endpoint at baseline and at least 1 postbaseline measurement. Of the 352 patients included in the FAS, 37 patients were not included in the PPS because they experienced major protocol deviations.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-04-10', 'size': 1614997, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-01-30T08:00', 'hasProtocol': True}, {'date': '2019-05-20', 'size': 1196936, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-01-30T08:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 371}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-02', 'studyFirstSubmitDate': '2015-11-18', 'resultsFirstSubmitDate': '2024-02-05', 'studyFirstSubmitQcDate': '2015-11-22', 'lastUpdatePostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-02', 'studyFirstPostDateStruct': {'date': '2015-11-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'NeuroPsychiatric Inventory (NPI) Total Score', 'timeFrame': 'Baseline, and 26 weeks', 'description': 'The NPI scale consists of 12 domains that are rated for both frequency (range 1 to 4) and severity (range 1 to 3). A composite score for each domain is calculated (frequency × severity), and it ranges from 1 to 12.\n\nFor each item, there is a leading question. If the symptom is absent, then the frequency, severity, and distress scores are not completed. In this case, the score is 0 for the item. The sum of the composite scores yields the NPI total score (1-12).\n\nA negative change in the score indicates an improvement from baseline (symptom reduction).'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI) - Global Component Score', 'timeFrame': 'Baseline, 4 weeks, 13 weeks, 26 weeks', 'description': 'PSQI is an effective instrument used to measure the quality and patterns of sleep in older adults.\n\nIt differentiates "poor" from "good" sleep by measuring 7 areas: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction over the last month.\n\nPSQI includes seven components, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.'}], 'primaryOutcomes': [{'measure': 'Computerized Neuropsychological Test Battery (cNTB) Z-Scores - Change From Baseline', 'timeFrame': '26 weeks', 'description': 'The global composite score of the cNTB combines the International Shopping List Test (ISLT), One Card Learning (OCL), Identification (IDN), Detection (DET), One Back Card (OBK), Controlled Oral Word Association Test (COWAT), and the Categorical Fluency Test (CFT). For each test, a z-score relative to the study baseline is calculated.\n\nThe cNTB global composite score is the mean of all z-scores from the tests listed above.\n\nThe scale range is from -3 to 3. Zero Z-score means no cognitive change. A negative value means decline, while a positive value means improvement.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Global Impression of Change (CGIC)', 'timeFrame': '13 weeks, and 26 weeks', 'description': 'The Change From Baseline in Global Impression of Change (CGIC) rating is made on a 7-point Likert-type scale where the change from baseline is rated as marked improvement (1), moderate improvement (2), minimal improvement (3), no change (4), minimal worsening (5), moderate worsening (6), marked worsening (7).\n\nMean values at 13 and 26 weeks are relative to baseline.'}, {'measure': "Alzheimer's Disease Cooperative Study/Activities of Daily Living Scale Adapted for MCI (Mild Cognitive Impairment) Patients (ADCS-MCI-ADL)", 'timeFrame': 'Baseline, 13 weeks, and 26 weeks', 'description': 'ADCS-MCI-ADL is an evaluation scale with information provided by an informant/caregiver to describe the functional impairment of patients with mild cognitive impairment (MCI).\n\nThe ADCS-ADL is a 23-item scale that includes 6 basic ADLs (BADLs) and 17 Instrumental Activities of Daily Living (IADLs) that provide a total score of 0-78, with a lower score indicating greater severity, meaning a worse outcome.'}, {'measure': "Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog14)", 'timeFrame': 'Baseline, 13 weeks, and 26 weeks', 'description': 'The ADAS was designed to measure the severity of the most important symptoms of AD. Its subscale, ADAS-cog, is the most popular cognitive testing instrument used in clinical trials, measuring the disturbances of memory, language, praxis, attention, and other cognitive abilities that are often referred to as the core symptoms of AD.\n\nADAS-cog14 comprises 14 items summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment.'}, {'measure': 'Safety and Tolerability - Blood Pressure (mmHg)', 'timeFrame': 'Baseline, and 26 weeks', 'description': 'Systolic and Diastolic Blood Pressure is followed during the study, as safety and tolerability measures.\n\nChanges in BP following treatment, leading to values out of the normal limits mean a worse outcome.'}, {'measure': 'Safety and Tolerability - Heart Rate (Bpm)', 'timeFrame': 'Baseline, and 26 weeks', 'description': 'Heart Rate within normal limits = 60-100 beats per minute (bpm) during the study means a good outcome in terms of safety.'}, {'measure': 'Safety and Tolerability - ECG Interval Results - QTcF (Msec)', 'timeFrame': 'Baseline, and 26 weeks', 'description': "QT interval corrected for heart rate by Fridericia's cube root formula (QTcF). The QTc is considered normal at \\< 450 msec in males, and \\< 470 msec in females."}, {'measure': 'Safety and Tolerability - Hematology', 'timeFrame': 'Baseline, and 26 weeks', 'description': 'Hematology (GI/L).\n\n1 gill (GI) = 0.118294118 liter (L). No major changes or shifts from baseline mean good safety and tolerability.'}, {'measure': 'Safety and Tolerability - Blood Chemistry (mmol/L)', 'timeFrame': 'Baseline, and 26 weeks', 'description': 'Blood Chemistry follow-up during the experiment. No major changes or shifts from baseline mean good safety and tolerability.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cognition', "mild Alzheimer's disease", 'Sleep'], 'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'availIpds': [{'url': 'http://www.recognitionstudy.com', 'type': 'Study website'}], 'references': [{'pmid': '35542997', 'type': 'DERIVED', 'citation': "Schneider LS, Laudon M, Nir T, Caceres J, Ianniciello G, Capulli M, Zisapel N. A Polymorphism Cluster at the 2q12 locus May Predict Response to Piromelatine in Patients with Mild Alzheimer's Disease. J Prev Alzheimers Dis. 2022;9(2):247-254. doi: 10.14283/jpad.2021.61."}]}, 'descriptionModule': {'briefSummary': "This study is a Phase 2, randomized, placebo-controlled, dose-ranging study of piromelatine (5, 20, and 50 mg daily for 6 months) versus placebo to determine an effective dose based on efficacy (cognitive performance), safety, and tolerability in patients with mild dementia due to Alzheimer's Disease (AD).", 'detailedDescription': "Patients with a documented history of mild dementia due to AD for at least 6 months, having a Mini-Mental State Examination (MMSE) score of 20 to 27 (inclusive) at Screening.\n\nA score of 27 is allowed only if accompanied by a score of ≥ 12 in the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-cog) ADAS-cog11 portion of the ADAS-cog14 at screening, and a Clinical Dementia Rating Global Score (CDR-GS) of 0.5 or 1 will be recruited and further screened for eligibility. Caregiver commitment to the study is also necessary.\n\nAt Screening (Visit 1), patients will undergo neuropsychiatric assessments, psychometric testing, and general medical assessments (including medical history, pre-existing conditions, physical examination, vital signs, and ECG). If patients have not had brain imaging with findings consistent with the diagnosis of dementia due to AD in the last 12 months, a computed tomography (CT) or magnetic resonance imaging (MRI) scan will be obtained to rule out clinically significant comorbid pathologies.\n\nEligible patients will start a 2-week run-in period of placebo (single-blind), followed by 26 weeks of double-blind treatment comprising administration of piromelatine or placebo, for a total treatment duration of 28 weeks. During the double-blind period, patients will be enrolled in a 1.2:1:1:1 randomization ratio to the 4 trial arms (placebo \\[1.2\\], and the equal piromelatine treatment arms 5, 20, and 50 mg \\[1:1:1\\]).\n\nIntermediate visits will be carried out at 4 weeks (Visit 3) and 13 weeks (Visit 4) after randomization. A follow-up phone call to elicit any safety concerns will be completed 2 weeks after the last dose of study medication. Patients who discontinue before Visit 5 (Week 26) will be brought back for a termination visit.\n\nAssuming an effect size between the treatment dose and placebo of 0.35 over 26 weeks, a significant level (α) of 0.05, and power of 88%, a sample size of 143 patients for the placebo arm and 119 patients for each of the 3 piromelatine arms is calculated. Assuming a 50% screen failure rate and allowing for 15% patient withdrawal, 1150 patients should be screened to randomly assign 575 patients, of whom it is expected that 500 will complete the study.\n\nPiromelatine (5, 20, and 50 mg tablets) and placebo will be administered orally, once daily after a meal, before habitual bedtime, preferably between 2100h and 2300h. Patients will be required to spend at least 2 hours a day exposed to daylight."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient and caregiver are willing to take part in the entire study\n* Signed informed consent from the patient and the caregiver\n* Patient has a documented history either in medical records or from an informant of cognitive decline over at least 6 months\n* Patient has mild probable AD as consistent with criteria established by the National Institute on Aging and Alzheimer's Association (NIA-AA).\n* CT/MRI scan with finding consisting of probable AD obtained during the last 12 months before Screening\n* Patient has an MMSE score of 21-26 (inclusive) at Screening\n* Patient has a Clinical Dementia Rating Global Score (CDR-GS) of 0.5-1 (mild dementia) at Screening\n* Patients receiving prescribed drugs for treatment of AD including acetyl cholinesterase inhibitors \\[eg, donepezil, galantamine, rivastigmine\\] should be on a stable dose for at least 3 months before Screening\n* Patient has a negative drug screen (benzodiazepines or opiates) at Screening\n* Female patients must have had last natural menstruation ≥ 24 months before Screening, OR being surgically sterile\n* Male patients must agree to the use of effective contraception if the female partner is of childbearing potential, OR be surgically sterile\n\nExclusion Criteria:\n\n* Patient has an alternative cause for dementia other than AD as determined by CT or MRI scan\n* Patient has evidence of any clinically significant neurodegenerative disease\n* Patient has been diagnosed with the following Axis I disorders (DSM V criteria)\n* Patient has a history of uncontrolled or untreated cardiovascular, endocrine, gastrointestinal, respiratory, or rheumatologic disorders within the past 5 years\n* Patient has severe pain that is likely to interfere with sleep\n* Continuous use of benzodiazepines or other sedative-hypnotics during the 2 weeks before Screening\n* Use of any kind of melatonin/melatonin agonist during the 2 weeks before Screening\n* Patient has known or suspected hypersensitivity to exogenous melatonin or melatonin receptor agonists\n* Patients with an irregular lifestyle or life pattern (eg, shift workers, patients likely to be jet lagged)."}, 'identificationModule': {'nctId': 'NCT02615002', 'briefTitle': "Safety and Efficacy of Piromelatine in Mild Alzheimer's Disease Patients (ReCOGNITION)", 'organization': {'class': 'INDUSTRY', 'fullName': 'Neurim Pharmaceuticals Ltd.'}, 'officialTitle': "Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose Ranging Study of Piromelatine in Patients With Mild Dementia Due to Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'NeuP11-AD2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Piromelatine 5 mg', 'description': '2 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