Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-01-03 @ 4:01 PM
Study NCT ID:
NCT02202551
Status:
COMPLETED
Last Update Posted:
2020-10-06
First Post:
2014-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Open-Label Safety Study of ADS-5102 in PD Patients With LID
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}], 'ancestors': [{'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rjohnson@adamaspharma.com', 'phone': '510-450-3500', 'title': 'Reed Johnson', 'organization': 'Adamas Pharmaceuticals, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '100 weeks', 'description': 'Safety was assessed through adverse events (AEs), physical examinations, vital signs, and laboratory parameters (hematology, serum chemistry, urinalysis, and pregnancy testing, if appropriate).', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1a', 'description': 'Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1A received ADS-5102 in the prior study.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 47, 'seriousNumAtRisk': 60, 'deathsNumAffected': 4, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': 'Group 1P', 'description': 'Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1P received placebo in the prior study', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 61, 'seriousNumAtRisk': 78, 'deathsNumAffected': 2, 'seriousNumAffected': 21}, {'id': 'EG002', 'title': 'Group 2', 'description': 'Subjects in Group 2 completed previous LID study, enrolled ADS-AMT-PD302 after a time gap.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 21, 'seriousNumAtRisk': 24, 'deathsNumAffected': 2, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'Group 3', 'description': 'Subjects were not in a previous Adamas LID study and had prior DBS (deep brain stimulation)', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 45, 'seriousNumAtRisk': 61, 'deathsNumAffected': 1, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'Fall', 'notes': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 23}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hallucination (pooled)', 'notes': 'Hallucination (Pooled = combines all Preferred terms that contain the term "Hallucination."', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hallucination, visual', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Edema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Livedo reticularis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'On and off phenomenon', 'notes': 'These events were worsening of disease over the duration of the study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': "Parkinson's disease", 'notes': "Worsening of Parkinson's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Abnormal dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}], 'seriousEvents': [{'term': 'Colitis', 'notes': 'Acute colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Ostenecrosis', 'notes': 'Avascular necrosis of the right patella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Arthritis bacteria', 'notes': 'Septic right knee requiring right total nee arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Acute myocardial infarction', 'notes': 'Non-St-Elevation mycardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Supraventricular tachycardia', 'notes': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Volvulus', 'notes': 'Sigmoid, volvulus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Osteoarthritis', 'notes': 'Worsening right knee degenerative disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Colonic pseudo-obstruction', 'notes': 'Oglive Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Clostridium difficile sepsis', 'notes': 'C. diff sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Laceration', 'notes': 'Left knee laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Constipation', 'notes': 'Slow transit constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Psychiatric disorder', 'notes': 'Psychosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Septic shock', 'notes': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Encephalopathy', 'notes': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Lymphoadenopathy', 'notes': 'Lymphoadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Radius fracture', 'notes': 'Right distal radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Adenocarcinoma of the colon', 'notes': 'Adenocarcinoma of the ascending colon (right)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Confusional state', 'notes': 'Acute confusional syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Pseudomonal sepsis', 'notes': 'Pseudomona aeruginosa sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Neuroleptic malignant syndrome', 'notes': 'Malignant neuroleptic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Intestinal obstruction', 'notes': 'Intestinal oclusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Rib fracture', 'notes': 'Ribs fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': "Parkinson's disease", 'notes': "Worsening of Parkinson's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Joint dislocation', 'notes': 'Shoulder luxation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Cardiac arrest', 'notes': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hip fracture', 'notes': 'Comminuted intertrichanteric right hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Ankle fracture', 'notes': 'Fractured right ankle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Urinary tract infection', 'notes': 'Persistent urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Rhabdomyolysis', 'notes': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Angina pectoris', 'notes': 'Cardiac chest pain (etiology unknown)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Adverse drug reaction', 'notes': 'Adverse drug reaction to melatonin and stool softner', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 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0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Paraesthesia', 'notes': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Traumatic fracture', 'notes': 'Traumatic serial rib fractures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, 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0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Constipation', 'notes': 'Abdominal pain (obstipation)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Wrist fracture', 'notes': 'Left wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Pneumonia', 'notes': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Staphylococcal sepsis', 'notes': 'MRSA bacteremia, presumably due to infected hardware', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 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{'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Anxiety', 'notes': 'Worsening anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Suicidal ideation', 'notes': 'Suicidal ideation with intent for self harm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Fall', 'notes': 'Dysfunction of deep brain stimulation device with increased disposition to fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Vertigo positional', 'notes': 'Benign paroxysmal positional vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Craniocerebral injury', 'notes': 'Craniocerebral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hypokinesia', 'notes': 'Hypokinesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Intercostal neuralgia', 'notes': 'Intercostal neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Forearm fracture', 'notes': 'Forearm fracture left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hypertensive crisis', 'notes': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hypersensitivity', 'notes': 'Tongue swelling due to allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Venous thrombosis', 'notes': 'Thrombosis of the vena saphena magna in the thigh and lower leg left side', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Acute myocardial infarction', 'notes': 'Semi-myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': "Parkinson's disease", 'notes': 'Parkinsonism aggravation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hypertensive cardiomyopathy', 'notes': 'Hypertensive cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Abasia', 'notes': 'Unable to walk', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Myocardial infarction', 'notes': 'Anterior myocardial infarction with acute pulmonary edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Joint effusion', 'notes': 'Left knee join effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Mania', 'notes': 'Acute psychiatric disorder (maniac manifestation)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Dyskinesia', 'notes': 'Worsening of dyskinesia (reassessment about alternative therapeutic)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Abdominal pain upper', 'notes': 'Epigastralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1a', 'description': 'Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1A received ADS-5102 in the prior study.'}, {'id': 'OG001', 'title': 'Group 1P', 'description': 'Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1P received placebo in the prior study'}, {'id': 'OG002', 'title': 'Group 2', 'description': 'Subjects in Group 2 completed previous LID study, enrolled ADS-AMT-PD302 after a time gap.'}, {'id': 'OG003', 'title': 'Group 3', 'description': 'Subjects were not in a previous Adamas LID study and had prior DBS (deep brain stimulation)'}], 'classes': [{'title': 'AE', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}]}, {'title': 'Study drug-related AE', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}, {'title': 'Permanent discontinuation due to AE', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Permanent discontinuation due to drug-related AE', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Mild AEs', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'Moderate AEs', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}]}, {'title': 'Mild drug-related AE', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Moderate drug-related AE', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}]}, {'title': 'Severe drug-related AE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 101 weeks', 'description': "The primary objective of the study was to evaluate the safety and tolerability of ADS-5102 oral capsules, an extended release (ER) formulation of amantadine, administered at a dose of 340 mg once daily at bedtime for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'ADS-5102 1A', 'description': 'Consisting of subjects who received ADS-5102 in the previous Adamas efficacy study'}, {'id': 'OG001', 'title': 'ADS-5102 Group 1P', 'description': 'Consisting of subjects who received placebo in the previous Adamas efficacy study'}, {'id': 'OG002', 'title': 'ADS-5102 Group 2', 'description': 'Subjects who completed a previous Adamas efficacy study evaluating ADS-5102 in LID and entered the current study with a time gap'}, {'id': 'OG003', 'title': 'ADS-5102 Group 3', 'description': 'Subjects who would have been deemed ineligible for participation in a previous Adamas efficacy study due to having undergone DBS'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '41.8', 'spread': '18.43', 'groupId': 'OG000'}, {'value': '45.6', 'spread': '19.24', 'groupId': 'OG001'}, {'value': '52.8', 'spread': '23.06', 'groupId': 'OG002'}, {'value': '52.4', 'spread': '16.55', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline at Week 8', 'categories': [{'measurements': [{'value': '1.2', 'spread': '10.03', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '14.11', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '12.00', 'groupId': 'OG002'}, {'value': '-5.3', 'spread': '10.74', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline at Week 16', 'categories': [{'measurements': [{'value': '1.6', 'spread': '13.41', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '16.22', 'groupId': 'OG001'}, {'value': '5.7', 'spread': '15.53', 'groupId': 'OG002'}, {'value': '-5.2', 'spread': '11.33', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline at Week 28', 'categories': [{'measurements': [{'value': '4.8', 'spread': '10.04', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '12.49', 'groupId': 'OG001'}, {'value': '6.5', 'spread': '14.18', 'groupId': 'OG002'}, {'value': '-5.3', 'spread': '12.99', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline at Week 40', 'categories': [{'measurements': [{'value': '7.5', 'spread': '15.43', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '15.20', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '18.29', 'groupId': 'OG002'}, {'value': '-4.8', 'spread': '12.49', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline at Week 52', 'categories': [{'measurements': [{'value': '13.2', 'spread': '16.78', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '14.57', 'groupId': 'OG001'}, {'value': '6.1', 'spread': '18.34', 'groupId': 'OG002'}, {'value': '-4.6', 'spread': '15.60', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline at Week 64', 'categories': [{'measurements': [{'value': '8.8', 'spread': '14.83', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '14.57', 'groupId': 'OG001'}, {'value': '6.1', 'spread': '18.34', 'groupId': 'OG002'}, {'value': '-4.6', 'spread': '15.60', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline at Week 76', 'categories': [{'measurements': [{'value': '11.7', 'spread': '19.58', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '19.18', 'groupId': 'OG001'}, {'value': '9.4', 'spread': '19.10', 'groupId': 'OG002'}, {'value': '-4.9', 'spread': '13.83', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline at Week 88', 'categories': [{'measurements': [{'value': '11.3', 'spread': '16.65', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '13.80', 'groupId': 'OG001'}, {'value': '6.4', 'spread': '22.65', 'groupId': 'OG002'}, {'value': '0.9', 'spread': '16.18', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline at Week 100', 'categories': [{'measurements': [{'value': '11.4', 'spread': '15.66', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '15.29', 'groupId': 'OG001'}, {'value': '6.5', 'spread': '16.46', 'groupId': 'OG002'}, {'value': '4.1', 'spread': '17.48', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 101 weeks. MDS-UPDRS was performed at the following visits: Screening, Week 8, Week 16, Week 28, Week 40, Week 52, Week 64, Week 76, Week 88, Week 100 (or ET).', 'description': 'To evaluate clinical progression of PD as assessed by the MDS-UPDRS, combined score, Parts I, II, and III.\n\nPart I - non-motor experiences of daily living; Part II - motor experiences of daily living; Part III - motor examination. Parts I and II each contain 13 questions measured on a 5-point scale (0-4). Part III contains 18 objective rater assessments of the motor signs of PD measured on a 5-point scale (0-4).\n\nTotal range for combined score (Part I-III) is = 0-176. Generally for MDS-UPDRS scores and sub-scores, the lower the score, the better.\n\nParts I, II, and III are summed to make the total score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1a', 'description': 'Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1A received ADS-5102 in the prior study.'}, {'id': 'OG001', 'title': 'Group 1P', 'description': 'Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1P received placebo in the prior study'}, {'id': 'OG002', 'title': 'Group 2', 'description': 'Subjects in Group 2 completed previous LID study, enrolled ADS-AMT-PD302 after a time gap.'}, {'id': 'OG003', 'title': 'Group 3', 'description': 'Subjects were not in a previous Adamas LID study and had prior DBS (deep brain stimulation)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.5', 'spread': '3.38', 'groupId': 'OG000'}, {'value': '9.6', 'spread': '3.07', 'groupId': 'OG001'}, {'value': '9.8', 'spread': '3.92', 'groupId': 'OG002'}, {'value': '10.4', 'spread': '2.77', 'groupId': 'OG003'}]}]}, {'title': 'Change in Baseline from Week 8', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '3.21', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '3.27', 'groupId': 'OG001'}, {'value': '-3.6', 'spread': '4.16', 'groupId': 'OG002'}, {'value': '-4.0', 'spread': '4.20', 'groupId': 'OG003'}]}]}, {'title': 'Change in Baseline from Week 16', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '3.61', 'groupId': 'OG000'}, {'value': '-3.2', 'spread': '3.61', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '5.03', 'groupId': 'OG002'}, {'value': '-3.9', 'spread': '3.68', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline at Week 28', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '3.61', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '3.12', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '3.84', 'groupId': 'OG002'}, {'value': '-4.4', 'spread': '3.79', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline at Week 40', 'categories': [{'measurements': [{'value': '0.0', 'spread': '3.95', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '3.39', 'groupId': 'OG001'}, {'value': '-2.9', 'spread': '4.81', 'groupId': 'OG002'}, {'value': '-4.7', 'spread': '4.06', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline at Week 52', 'categories': [{'measurements': [{'value': '0.2', 'spread': '3.64', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '3.56', 'groupId': 'OG001'}, {'value': '-2.5', 'spread': '4.40', 'groupId': 'OG002'}, {'value': '-3.6', 'spread': '3.62', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline at Week 64', 'categories': [{'measurements': [{'value': '0.4', 'spread': '3.82', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '3.42', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '4.32', 'groupId': 'OG002'}, {'value': '-2.5', 'spread': '4.22', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline at Week 76', 'categories': [{'measurements': [{'value': '0.9', 'spread': '4.20', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '3.67', 'groupId': 'OG001'}, {'value': '-2.7', 'spread': '3.90', 'groupId': 'OG002'}, {'value': '-3.7', 'spread': '3.68', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline at Week 88', 'categories': [{'measurements': [{'value': '0.4', 'spread': '3.77', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '3.60', 'groupId': 'OG001'}, {'value': '-3.7', 'spread': '4.69', 'groupId': 'OG002'}, {'value': '-4.3', 'spread': '3.55', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline at Week 100', 'categories': [{'measurements': [{'value': '0.4', 'spread': '3.28', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '4.19', 'groupId': 'OG001'}, {'value': '-3.6', 'spread': '3.66', 'groupId': 'OG002'}, {'value': '-3.6', 'spread': '3.94', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '100 Weeks. MDS-UPDRS was performed at the following visits: Screening, Week 8, Week 16, Week 28, Week 40, Week 52, Week 64, Week 76, Week 88, Week 100 (or ET).', 'description': 'This component (Questions 4.1 - 4.6) includes time spent with dyskinesia, functional impact of dyskinesia, time spent in OFF state, functional impact of fluctuations, complexity of motor fluctuations, painful OFF-state dystonia. Questions 4.1-4.6 are summed to make the Part IV score.\n\nGenerally for MDS-UPDRS scores and sub-scores, the lower the score, the better. Total range for Part IV is = 0-24', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1a', 'description': 'Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1A received ADS-5102 in the prior study.'}, {'id': 'FG001', 'title': 'Group 1P', 'description': 'Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1P received placebo in the prior study'}, {'id': 'FG002', 'title': 'Group 2', 'description': 'Subjects in Group 2 completed previous LID study, enrolled ADS-AMT-PD302 after a time gap.'}, {'id': 'FG003', 'title': 'Group 3', 'description': 'Subjects were not in a previous Adamas LID study and had prior DBS (deep brain stimulation)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '78'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Needed to take excluded medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Subject moved away', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'DBS surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Dyskinesia upon taper', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Site closure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Unable to complete visits per protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Worsening Dyskinesia', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': "Sponsor's decision", 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Subject unwilling to proceed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Subject consent withdrawn', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'eGFR<50mL/min/m2', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}, {'value': '223', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1a', 'description': 'Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1A received ADS-5102 in the prior study.'}, {'id': 'BG001', 'title': 'Group 1P', 'description': 'Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1P received placebo in the prior study'}, {'id': 'BG002', 'title': 'Group 2', 'description': 'Subjects in Group 2 completed previous LID study, enrolled ADS-AMT-PD302 after a time gap.'}, {'id': 'BG003', 'title': 'Group 3', 'description': 'Subjects were not in a previous Adamas LID study and had prior DBS (deep brain stimulation)'}, {'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': '28', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '109', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '114', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.0', 'spread': '9.81', 'groupId': 'BG000'}, {'value': '65.9', 'spread': '8.80', 'groupId': 'BG001'}, {'value': '64.4', 'spread': '7.81', 'groupId': 'BG002'}, {'value': '60.2', 'spread': '9.20', 'groupId': 'BG003'}, {'value': '63.7', 'spread': '9.32', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '92', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '131', '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': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '8', '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': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}, {'value': '208', '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': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '25.86', 'spread': '25.42', 'groupId': 'BG000'}, {'value': '25.72', 'spread': '24.63', 'groupId': 'BG001'}, {'value': '25.26', 'spread': '23.24', 'groupId': 'BG002'}, {'value': '27.29', 'spread': '4.891', 'groupId': 'BG003'}, {'value': '26.14', 'spread': '5.220', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'eGFR', 'classes': [{'categories': [{'measurements': [{'value': '88.7', 'spread': '24.31', 'groupId': 'BG000'}, {'value': '92.2', 'spread': '19.64', 'groupId': 'BG001'}, {'value': '96.3', 'spread': '20.54', 'groupId': 'BG002'}, {'value': '92.1', 'spread': '19.95', 'groupId': 'BG003'}, {'value': '91.6', 'spread': '21.16', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mL/min/1.73 m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-07-16', 'size': 1190469, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-07-08T14:02', 'hasProtocol': True}, {'date': '2015-11-13', 'size': 1541590, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-07-08T14:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 223}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-15', 'studyFirstSubmitDate': '2014-07-25', 'resultsFirstSubmitDate': '2020-07-08', 'studyFirstSubmitQcDate': '2014-07-25', 'lastUpdatePostDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-26', 'studyFirstPostDateStruct': {'date': '2014-07-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations', 'timeFrame': 'Up to 101 weeks', 'description': "The primary objective of the study was to evaluate the safety and tolerability of ADS-5102 oral capsules, an extended release (ER) formulation of amantadine, administered at a dose of 340 mg once daily at bedtime for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD)."}], 'secondaryOutcomes': [{'measure': "Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores)", 'timeFrame': 'Up to 101 weeks. MDS-UPDRS was performed at the following visits: Screening, Week 8, Week 16, Week 28, Week 40, Week 52, Week 64, Week 76, Week 88, Week 100 (or ET).', 'description': 'To evaluate clinical progression of PD as assessed by the MDS-UPDRS, combined score, Parts I, II, and III.\n\nPart I - non-motor experiences of daily living; Part II - motor experiences of daily living; Part III - motor examination. Parts I and II each contain 13 questions measured on a 5-point scale (0-4). Part III contains 18 objective rater assessments of the motor signs of PD measured on a 5-point scale (0-4).\n\nTotal range for combined score (Part I-III) is = 0-176. Generally for MDS-UPDRS scores and sub-scores, the lower the score, the better.\n\nParts I, II, and III are summed to make the total score.'}, {'measure': "Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications)", 'timeFrame': '100 Weeks. MDS-UPDRS was performed at the following visits: Screening, Week 8, Week 16, Week 28, Week 40, Week 52, Week 64, Week 76, Week 88, Week 100 (or ET).', 'description': 'This component (Questions 4.1 - 4.6) includes time spent with dyskinesia, functional impact of dyskinesia, time spent in OFF state, functional impact of fluctuations, complexity of motor fluctuations, painful OFF-state dystonia. Questions 4.1-4.6 are summed to make the Part IV score.\n\nGenerally for MDS-UPDRS scores and sub-scores, the lower the score, the better. Total range for Part IV is = 0-24'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Levodopa Induced Dyskinesia', 'LID', 'Parkinsonism', "Parkinson's Disease"], 'conditions': ['Dyskinesia', 'Levodopa Induced Dyskinesia (LID)', "Parkinson's Disease (PD)"]}, 'referencesModule': {'references': [{'pmid': '3280212', 'type': 'BACKGROUND', 'citation': 'Aoki FY, Sitar DS. Clinical pharmacokinetics of amantadine hydrochloride. Clin Pharmacokinet. 1988 Jan;14(1):35-51. doi: 10.2165/00003088-198814010-00003.'}, {'pmid': '20310033', 'type': 'BACKGROUND', 'citation': "Colosimo C, Martinez-Martin P, Fabbrini G, Hauser RA, Merello M, Miyasaki J, Poewe W, Sampaio C, Rascol O, Stebbins GT, Schrag A, Goetz CG. Task force report on scales to assess dyskinesia in Parkinson's disease: critique and recommendations. Mov Disord. 2010 Jul 15;25(9):1131-42. doi: 10.1002/mds.23072."}, {'pmid': '16154788', 'type': 'BACKGROUND', 'citation': 'da Silva-Junior FP, Braga-Neto P, Sueli Monte F, de Bruin VM. Amantadine reduces the duration of levodopa-induced dyskinesia: a randomized, double-blind, placebo-controlled study. Parkinsonism Relat Disord. 2005 Nov;11(7):449-52. doi: 10.1016/j.parkreldis.2005.05.008. Epub 2005 Sep 9.'}, {'pmid': '4919119', 'type': 'BACKGROUND', 'citation': "Dallos V, Heathfield K, Stone P, Allen FA. Use of amantadine in Parkinson's disease. Results of a double-blind trial. Br Med J. 1970 Oct 3;4(5726):24-6. doi: 10.1136/bmj.4.5726.24."}, {'pmid': '18821084', 'type': 'BACKGROUND', 'citation': 'Del Sorbo F, Albanese A. Levodopa-induced dyskinesias and their management. J Neurol. 2008 Aug;255 Suppl 4:32-41. doi: 10.1007/s00415-008-4006-5.'}, {'pmid': '18480609', 'type': 'BACKGROUND', 'citation': "Encarnacion EV, Hauser RA. Levodopa-induced dyskinesias in Parkinson's disease: etiology, impact on quality of life, and treatments. Eur Neurol. 2008;60(2):57-66. doi: 10.1159/000131893. Epub 2008 May 15."}, {'pmid': '10348482', 'type': 'BACKGROUND', 'citation': "Factor SA, Molho ES. Transient benefit of amantadine in Parkinson's disease: the facts about the myth. Mov Disord. 1999 May;14(3):515-7. doi: 10.1002/1531-8257(199905)14:33.0.co;2-z. No abstract available."}, {'pmid': '19025759', 'type': 'BACKGROUND', 'citation': 'Goetz CG, Nutt JG, Stebbins GT. The Unified Dyskinesia Rating Scale: presentation and clinimetric profile. Mov Disord. 2008 Dec 15;23(16):2398-403. doi: 10.1002/mds.22341.'}, {'pmid': '19025984', 'type': 'BACKGROUND', 'citation': "Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340."}, {'pmid': '23390076', 'type': 'BACKGROUND', 'citation': 'Goetz CG, Stebbins GT, Chung KA, Hauser RA, Miyasaki JM, Nicholas AP, Poewe W, Seppi K, Rascol O, Stacy MA, Nutt JG, Tanner CM, Urkowitz A, Jaglin JA, Ge S. Which dyskinesia scale best detects treatment response? Mov Disord. 2013 Mar;28(3):341-6. doi: 10.1002/mds.25321. Epub 2013 Feb 6.'}, {'pmid': '7347558', 'type': 'BACKGROUND', 'citation': 'Hayden FG, Gwaltney JM Jr, Van de Castle RL, Adams KF, Giordani B. Comparative toxicity of amantadine hydrochloride and rimantadine hydrochloride in healthy adults. Antimicrob Agents Chemother. 1981 Feb;19(2):226-33. doi: 10.1128/AAC.19.2.226.'}, {'type': 'BACKGROUND', 'citation': 'Jackson G, Stanley E, Lee Muldoon R. Chemoprophylaxis of viral respiratory diseases. Bulletin Pan Am Health Org. 1967; 147: 595-603.'}, {'pmid': '11009193', 'type': 'BACKGROUND', 'citation': "Luginger E, Wenning GK, Bosch S, Poewe W. Beneficial effects of amantadine on L-dopa-induced dyskinesias in Parkinson's disease. Mov Disord. 2000 Sep;15(5):873-8. doi: 10.1002/1531-8257(200009)15:53.0.co;2-i."}, {'pmid': '24371304', 'type': 'BACKGROUND', 'citation': 'Ory-Magne F, Corvol JC, Azulay JP, Bonnet AM, Brefel-Courbon C, Damier P, Dellapina E, Destee A, Durif F, Galitzky M, Lebouvier T, Meissner W, Thalamas C, Tison F, Salis A, Sommet A, Viallet F, Vidailhet M, Rascol O; NS-Park CIC Network. Withdrawing amantadine in dyskinetic patients with Parkinson disease: the AMANDYSK trial. Neurology. 2014 Jan 28;82(4):300-7. doi: 10.1212/WNL.0000000000000050. Epub 2013 Dec 26.'}, {'pmid': '11487209', 'type': 'BACKGROUND', 'citation': "Paci C, Thomas A, Onofrj M. Amantadine for dyskinesia in patients affected by severe Parkinson's disease. Neurol Sci. 2001 Feb;22(1):75-6. doi: 10.1007/s100720170054."}, {'pmid': '4192093', 'type': 'BACKGROUND', 'citation': "Parkes JD, Zilkha KJ, Marsden P, Baxter RC, Knill-Jones RP. Amantadine dosage in treatment of Parkinson's disease. Lancet. 1970 May 30;1(7657):1130-3. doi: 10.1016/s0140-6736(70)91211-0. No abstract available."}, {'pmid': '21217832', 'type': 'BACKGROUND', 'citation': "Sawada H, Oeda T, Kuno S, Nomoto M, Yamamoto K, Yamamoto M, Hisanaga K, Kawamura T; Amantadine Study Group. Amantadine for dyskinesias in Parkinson's disease: a randomized controlled trial. PLoS One. 2010 Dec 31;5(12):e15298. doi: 10.1371/journal.pone.0015298."}, {'pmid': '11050029', 'type': 'BACKGROUND', 'citation': "Schrag A, Quinn N. Dyskinesias and motor fluctuations in Parkinson's disease. A community-based study. Brain. 2000 Nov;123 ( Pt 11):2297-305. doi: 10.1093/brain/123.11.2297."}, {'pmid': '4677928', 'type': 'BACKGROUND', 'citation': "Schwab RS, Poskanzer DC, England AC Jr, Young RR. Amantadine in Parkinson's disease. Review of more than two years' experience. JAMA. 1972 Nov 13;222(7):792-5. doi: 10.1001/jama.222.7.792. No abstract available."}, {'pmid': '10803797', 'type': 'BACKGROUND', 'citation': "Snow BJ, Macdonald L, Mcauley D, Wallis W. The effect of amantadine on levodopa-induced dyskinesias in Parkinson's disease: a double-blind, placebo-controlled study. Clin Neuropharmacol. 2000 Mar-Apr;23(2):82-5. doi: 10.1097/00002826-200003000-00004."}, {'pmid': '16513858', 'type': 'BACKGROUND', 'citation': 'Spencer TJ, Biederman J, Ciccone PE, Madras BK, Dougherty DD, Bonab AA, Livni E, Parasrampuria DA, Fischman AJ. PET study examining pharmacokinetics, detection and likeability, and dopamine transporter receptor occupancy of short- and long-acting oral methylphenidate. Am J Psychiatry. 2006 Mar;163(3):387-95. doi: 10.1176/appi.ajp.163.3.387.'}, {'pmid': '11864720', 'type': 'BACKGROUND', 'citation': 'Swanson JM, Volkow ND. Pharmacokinetic and pharmacodynamic properties of stimulants: implications for the design of new treatments for ADHD. Behav Brain Res. 2002 Mar 10;130(1-2):73-8. doi: 10.1016/s0166-4328(01)00433-8.'}, {'pmid': '14707325', 'type': 'BACKGROUND', 'citation': "Thomas A, Iacono D, Luciano AL, Armellino K, Di Iorio A, Onofrj M. Duration of amantadine benefit on dyskinesia of severe Parkinson's disease. J Neurol Neurosurg Psychiatry. 2004 Jan;75(1):141-3."}, {'pmid': '5317962', 'type': 'BACKGROUND', 'citation': 'Tyrrell DA, Bynoe ML, Hoorn B. Studies on the antiviral activity of 1-adamantanamine. Br J Exp Pathol. 1965 Aug;46(4):370-5. No abstract available.'}, {'pmid': '9595981', 'type': 'BACKGROUND', 'citation': "Verhagen Metman L, Del Dotto P, van den Munckhof P, Fang J, Mouradian MM, Chase TN. Amantadine as treatment for dyskinesias and motor fluctuations in Parkinson's disease. Neurology. 1998 May;50(5):1323-6. doi: 10.1212/wnl.50.5.1323."}, {'pmid': '10555659', 'type': 'BACKGROUND', 'citation': 'Metman LV, Del Dotto P, LePoole K, Konitsiotis S, Fang J, Chase TN. Amantadine for levodopa-induced dyskinesias: a 1-year follow-up study. Arch Neurol. 1999 Nov;56(11):1383-6. doi: 10.1001/archneur.56.11.1383.'}, {'pmid': '9766762', 'type': 'BACKGROUND', 'citation': 'Volkow ND, Wang GJ, Fowler JS, Gatley SJ, Logan J, Ding YS, Hitzemann R, Pappas N. Dopamine transporter occupancies in the human brain induced by therapeutic doses of oral methylphenidate. Am J Psychiatry. 1998 Oct;155(10):1325-31. doi: 10.1176/ajp.155.10.1325.'}, {'pmid': '20198649', 'type': 'BACKGROUND', 'citation': "Wolf E, Seppi K, Katzenschlager R, Hochschorner G, Ransmayr G, Schwingenschuh P, Ott E, Kloiber I, Haubenberger D, Auff E, Poewe W. Long-term antidyskinetic efficacy of amantadine in Parkinson's disease. Mov Disord. 2010 Jul 30;25(10):1357-63. doi: 10.1002/mds.23034."}, {'pmid': '20090375', 'type': 'BACKGROUND', 'citation': 'Wright Willis A, Evanoff BA, Lian M, Criswell SR, Racette BA. Geographic and ethnic variation in Parkinson disease: a population-based study of US Medicare beneficiaries. Neuroepidemiology. 2010;34(3):143-51. doi: 10.1159/000275491. Epub 2010 Jan 15.'}, {'pmid': '28777755', 'type': 'DERIVED', 'citation': "Hauser RA, Pahwa R, Tanner CM, Oertel W, Isaacson SH, Johnson R, Felt L, Stempien MJ. ADS-5102 (Amantadine) Extended-Release Capsules for Levodopa-Induced Dyskinesia in Parkinson's Disease (EASE LID 2 Study): Interim Results of an Open-Label Safety Study. J Parkinsons Dis. 2017;7(3):511-522. doi: 10.3233/JPD-171134."}]}, 'descriptionModule': {'briefSummary': "This is a 105-week open-label study to evaluate the safety and tolerability of ADS-5102 oral capsules, an extended release formulation of amantadine, in Parkinson's Disease (PD) patients with Levodopa Induced Dyskinesia (LID).", 'detailedDescription': 'Participation in this study was offered to subjects who were described by one of the following 3 groups:\n\n* Group 1: Subjects who completed an Adamas efficacy study evaluating ADS-5102 in LID and chose to immediately transition into the current study without a time gap; this group was subdivided into Group 1A, consisting of subjects who received ADS-5102 in the previous Adamas efficacy study, and Group 1P, consisting of subjects who received placebo in the previous Adamas efficacy study\n* Group 2: Subjects who completed a previous Adamas efficacy study evaluating ADS-5102 in LID and entered the current study with a time gap\n* Group 3: Subjects who would have been deemed ineligible for participation in a previous Adamas efficacy study due to having undergone DBS\n\nConsented subjects who completed Screening (Visit 1) and met study eligibility criteria were to have a Baseline Visit and receive study drug. During Week 1, subjects took 170 mg of ADS-5102 (1 capsule) daily at bedtime. For Week 2, the dose was increased to 340 mg (2 capsules) daily at bedtime; this dose was to continue through Week 100. During the final week (Week 101) of the study, the ADS-5102 dose was reduced to 170 mg (1 capsule) daily at bedtime. Subjects were enrolled into the study at Visit 2 (Baseline/Week 0) and were to return to the clinic after 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 weeks of study drug dosing. Subjects were to receive a telephone reminder at the end of Week 1 to increase their dose during Week 2. At the Week 100 Visit, subjects were instructed to reduce their dose to 1 capsule daily at bedtime for 1 week. The amount of available, unused drug was assessed during the Week 100 Visit; subjects were given an additional bottle of study drug, if needed, to complete the 1 week of reduced dosing.\n\nEfficacy, as measured with the MDS-UPDRS, was to be evaluated at all study visits, beginning with the Screening Visit, and excluding the Baseline and Week 4 Visits. A Safety Follow-up Visit was to occur approximately 2 weeks following the completion of treatment. AEs were recorded beginning with the first dose of study drug and continued through the Safety Follow-up Visit. Concomitant medications were recorded throughout the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed a current IRB/REB/IEC-approved informed consent form\n* Completed all study visits in previous Adamas efficacy study or were ineligible for participation in previous Adamas studies due to having undergone prior deep brain stimulation.\n* Parkinson's disease, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria\n* On a stable regimen of antiparkinson's medications at least 30 days prior to screening, including a levodopa preparation administered not less than three times daily.\n* History of peak dose dyskinesia that might benefit from specific dyskinesia treatment in the judgment of the subject and clinical investigator\n\nExclusion Criteria:\n\n* Discontinued ADS-5102 in previous Adamas efficacy study due to intolerable or unacceptable AEs considered to be related to ADS-5102\n* History of neurosurgical intervention related to Parkinson's disease, with the exception of deep brain stimulation\n* History of seizures since completion of participation in previous Adamas studies or within 2 years\n* History of stroke or TIA since completion of participation in previous Adamas studies or within 2 years\n* History of cancer since completion of participation in previous Adamas studies or within 2 years, with the following exceptions: adequately treated non-melanomatous skin cancers, localized bladder cancer, non-metastatic prostate cancer or in situ cervical cancer\n* Presence of cognitive impairment, as evidenced by a Mini-Mental Status Examination (MMSE) score of less than 24 during screening\n* If female is pregnant or lactating\n* If a sexually active female, is not surgically sterile or at least 2 years post-menopausal, or does not agree to utilize an effective method of contraception from screening through at least 4 weeks after the completion of study treatment.\n* Treatment with an investigational drug (other than ADS-5102) or device within 30 days prior to screening\n* Treatment with an investigational biologic within 6 months prior to screening\n* Current or planned participation in another interventional clinical trial"}, 'identificationModule': {'nctId': 'NCT02202551', 'briefTitle': 'Open-Label Safety Study of ADS-5102 in PD Patients With LID', 'organization': {'class': 'INDUSTRY', 'fullName': 'Adamas Pharmaceuticals, Inc.'}, 'officialTitle': 'Open-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia (LID)', 'orgStudyIdInfo': {'id': 'ADS-AMT-PD302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ADS-5102', 'description': 'amantadine HCl extended release', 'interventionNames': ['Drug: ADS-5102']}], 'interventions': [{'name': 'ADS-5102', 'type': 'DRUG', 'otherNames': ['amantadine HCl extended release'], 'armGroupLabels': ['ADS-5102']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85351', 'city': 'Sun City', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.59754, 'lon': -112.27182}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '91335', 'city': 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