Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-25 @ 4:32 PM
Study NCT ID:
NCT03567057
Status:
COMPLETED
Last Update Posted:
2022-01-18
First Post:
2018-05-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Safety and Efficacy Study of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'drugsafety@adamaspharma.com', 'phone': '+1 (510) 450-3500', 'title': 'Head, Regulatory Affairs', 'organization': 'Adamas Pharmaceuticals, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Approximately 1 year.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo/274 mg ADS-5102', 'description': 'Consists of subjects who received placebo in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)', 'otherNumAtRisk': 159, 'deathsNumAtRisk': 159, 'otherNumAffected': 122, 'seriousNumAtRisk': 159, 'deathsNumAffected': 1, 'seriousNumAffected': 20}, {'id': 'EG001', 'title': '137 mg ADS-5102/274 mg ADS-5102', 'description': 'Consists of subjects who received 137 mg ADS-5102 in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)', 'otherNumAtRisk': 151, 'deathsNumAtRisk': 151, 'otherNumAffected': 116, 'seriousNumAtRisk': 151, 'deathsNumAffected': 0, 'seriousNumAffected': 20}, {'id': 'EG002', 'title': '274 mg ADS-5102/274 mg ADS-5102', 'description': 'Consists of subjects who 274 mg ADS-5102 in both Studies ADS-AMT-MS301 and ADS-AMT-MS303', 'otherNumAtRisk': 114, 'deathsNumAtRisk': 114, 'otherNumAffected': 86, 'seriousNumAtRisk': 114, 'deathsNumAffected': 0, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Multiple sclerosis relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Balance disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Hallucination, visual', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Livedo reticularis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 17}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}], 'seriousEvents': [{'term': 'Multiple sclerosis relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': "Uhthoff's phenomenon", 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Generalized tonic-clonic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Metabolic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Atypical pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Bursitis infective staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pharyngeal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Rectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Viral sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Faecaloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Patella fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Catatonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Hallucination, visual', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Peripheral artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Endometrial adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Squamous cell carcinoma of the tongue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Immune thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/274 mg ADS-5102', 'description': 'Consists of subjects who received placebo in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)'}, {'id': 'OG001', 'title': '137 mg ADS-5102/274 mg ADS-5102', 'description': 'Consists of subjects who received 137 mg ADS-5102 in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)'}, {'id': 'OG002', 'title': '274 mg ADS-5102/274 mg ADS-5102', 'description': 'Consists of subjects who 274 mg ADS-5102 in both Studies ADS-AMT-MS301 and ADS-AMT-MS303'}], 'classes': [{'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, an average of 1 year.', 'description': 'The incidence of treatment-emergent adverse events was used as the measure for long-term safety and tolerability of ADS-5102.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Timed 25-Foot Walk (Feet/Second) (Baseline Value)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/274 mg ADS-5102', 'description': 'Consists of subjects who received placebo in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)'}, {'id': 'OG001', 'title': '137 mg ADS-5102/274 mg ADS-5102', 'description': 'Consists of subjects who received 137 mg ADS-5102 in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)'}, {'id': 'OG002', 'title': '274 mg ADS-5102/274 mg ADS-5102', 'description': 'Consists of subjects who 274 mg ADS-5102 in both Studies ADS-AMT-MS301 and ADS-AMT-MS303'}], 'classes': [{'categories': [{'measurements': [{'value': '2.43', 'spread': '0.853', 'groupId': 'OG000'}, {'value': '2.68', 'spread': '0.840', 'groupId': 'OG001'}, {'value': '2.66', 'spread': '0.878', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The timed 25-foot walk is a measure of lower extremity function. The subject is directed to a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the subject walk back the same distance. The result is reported as speed (feet per second). Improvement is indicated by an increase in speed.', 'unitOfMeasure': 'feet/second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat: subjects with available data'}, {'type': 'SECONDARY', 'title': 'Timed 25-Foot Walk (Feet/Second) (Week 24 Value)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/274 mg ADS-5102', 'description': 'Consists of subjects who received placebo in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)'}, {'id': 'OG001', 'title': '137 mg ADS-5102/274 mg ADS-5102', 'description': 'Consists of subjects who received 137 mg ADS-5102 in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)'}, {'id': 'OG002', 'title': '274 mg ADS-5102/274 mg ADS-5102', 'description': 'Consists of subjects who 274 mg ADS-5102 in both Studies ADS-AMT-MS301 and ADS-AMT-MS303'}], 'classes': [{'categories': [{'measurements': [{'value': '2.50', 'spread': '0.832', 'groupId': 'OG000'}, {'value': '2.72', 'spread': '0.969', 'groupId': 'OG001'}, {'value': '2.71', 'spread': '0.957', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'The timed 25-foot walk is a measure of lower extremity function. The subject is directed to a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the subject walk back the same distance. The result is reported as speed (feet per second). Improvement is indicated by an increase in speed.', 'unitOfMeasure': 'feet/second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat: subjects with available data'}, {'type': 'SECONDARY', 'title': 'Timed 25-Foot Walk (Feet/Second) (Week 52 Value)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/274 mg ADS-5102', 'description': 'Consists of subjects who received placebo in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)'}, {'id': 'OG001', 'title': '137 mg ADS-5102/274 mg ADS-5102', 'description': 'Consists of subjects who received 137 mg ADS-5102 in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)'}, {'id': 'OG002', 'title': '274 mg ADS-5102/274 mg ADS-5102', 'description': 'Consists of subjects who 274 mg ADS-5102 in both Studies ADS-AMT-MS301 and ADS-AMT-MS303'}], 'classes': [{'categories': [{'measurements': [{'value': '2.35', 'spread': '0.900', 'groupId': 'OG000'}, {'value': '2.68', 'spread': '1.055', 'groupId': 'OG001'}, {'value': '2.65', 'spread': '0.996', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 weeks', 'description': 'The timed 25-foot walk is a measure of lower extremity function. The subject is directed to a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the subject walk back the same distance. The result is reported as speed (feet per second). Improvement is indicated by an increase in speed.', 'unitOfMeasure': 'feet/second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat: subjects with available data'}, {'type': 'SECONDARY', 'title': 'Timed up and go (Baseline Value)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/274 mg ADS-5102', 'description': 'Consists of subjects who received placebo in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)'}, {'id': 'OG001', 'title': '137 mg ADS-5102/274 mg ADS-5102', 'description': 'Consists of subjects who received 137 mg ADS-5102 in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)'}, {'id': 'OG002', 'title': '274 mg ADS-5102/274 mg ADS-5102', 'description': 'Consists of subjects who 274 mg ADS-5102 in both Studies ADS-AMT-MS301 and ADS-AMT-MS303'}], 'classes': [{'categories': [{'measurements': [{'value': '17.60', 'spread': '8.516', 'groupId': 'OG000'}, {'value': '16.89', 'spread': '17.536', 'groupId': 'OG001'}, {'value': '16.80', 'spread': '10.652', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The "timed up and go" is a measure of lower extremity strength, balance, and coordination. The subject stands up from a chair, walks 3 meters then turns around and walks back to the chair to sit down. The result is reported in seconds. Improvement is indicated by negative change scores.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat population: subjects with available data'}, {'type': 'SECONDARY', 'title': 'Timed up and go (Week 24 Value)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/274 mg ADS-5102', 'description': 'Consists of subjects who received placebo in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)'}, {'id': 'OG001', 'title': '137 mg ADS-5102/274 mg ADS-5102', 'description': 'Consists of subjects who received 137 mg ADS-5102 in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)'}, {'id': 'OG002', 'title': '274 mg ADS-5102/274 mg ADS-5102', 'description': 'Consists of subjects who 274 mg ADS-5102 in both Studies ADS-AMT-MS301 and ADS-AMT-MS303'}], 'classes': [{'categories': [{'measurements': [{'value': '17.39', 'spread': '9.466', 'groupId': 'OG000'}, {'value': '15.36', 'spread': '9.109', 'groupId': 'OG001'}, {'value': '16.89', 'spread': '11.649', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'The "timed up and go" is a measure of lower extremity strength, balance, and coordination. The subject stands up from a chair, walks 3 meters then turns around and walks back to the chair to sit down. The result is reported in seconds. Improvement is indicated by negative change scores.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat population: subjects with available data'}, {'type': 'SECONDARY', 'title': 'Timed up and go (Week 52 Value)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/274 mg ADS-5102', 'description': 'Consists of subjects who received placebo in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)'}, {'id': 'OG001', 'title': '137 mg ADS-5102/274 mg ADS-5102', 'description': 'Consists of subjects who received 137 mg ADS-5102 in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)'}, {'id': 'OG002', 'title': '274 mg ADS-5102/274 mg ADS-5102', 'description': 'Consists of subjects who 274 mg ADS-5102 in both Studies ADS-AMT-MS301 and ADS-AMT-MS303'}], 'classes': [{'categories': [{'measurements': [{'value': '18.68', 'spread': '11.710', 'groupId': 'OG000'}, {'value': '15.92', 'spread': '11.820', 'groupId': 'OG001'}, {'value': '17.37', 'spread': '12.311', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 weeks', 'description': 'The "timed up and go" is a measure of lower extremity strength, balance, and coordination. The subject stands up from a chair, walks 3 meters then turns around and walks back to the chair to sit down. The result is reported in seconds. Improvement is indicated by negative change scores.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat population: subjects with available data'}, {'type': 'SECONDARY', 'title': '2-Minute Walk Test (Baseline Value)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/274 mg ADS-5102', 'description': 'Consists of subjects who received placebo in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)'}, {'id': 'OG001', 'title': '137 mg ADS-5102/274 mg ADS-5102', 'description': 'Consists of subjects who received 137 mg ADS-5102 in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)'}, {'id': 'OG002', 'title': '274 mg ADS-5102/274 mg ADS-5102', 'description': 'Consists of subjects who 274 mg ADS-5102 in both Studies ADS-AMT-MS301 and ADS-AMT-MS303'}], 'classes': [{'categories': [{'measurements': [{'value': '80.26', 'spread': '31.899', 'groupId': 'OG000'}, {'value': '89.99', 'spread': '31.679', 'groupId': 'OG001'}, {'value': '87.31', 'spread': '31.351', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The 2-Minute Walk test is a measure of lower extremity function. The subject is instructed to walk as far as possible in 2 minutes, and the distance is measured in meters. Improvement is indicated by positive change scores.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat: subjects with available data'}, {'type': 'SECONDARY', 'title': '2-Minute Walk Test (Week 24 Value)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/274 mg ADS-5102', 'description': 'Consists of subjects who received placebo in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)'}, {'id': 'OG001', 'title': '137 mg ADS-5102/274 mg ADS-5102', 'description': 'Consists of subjects who received 137 mg ADS-5102 in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)'}, {'id': 'OG002', 'title': '274 mg ADS-5102/274 mg ADS-5102', 'description': 'Consists of subjects who 274 mg ADS-5102 in both Studies ADS-AMT-MS301 and ADS-AMT-MS303'}], 'classes': [{'categories': [{'measurements': [{'value': '81.48', 'spread': '31.653', 'groupId': 'OG000'}, {'value': '87.99', 'spread': '34.195', 'groupId': 'OG001'}, {'value': '92.03', 'spread': '38.371', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'The 2-Minute Walk test is a measure of lower extremity function. The subject is instructed to walk as far as possible in 2 minutes, and the distance is measured in meters. Improvement is indicated by positive change scores.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat: subjects with available data'}, {'type': 'SECONDARY', 'title': '2-Minute Walk Test (Week 52 Value)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/274 mg ADS-5102', 'description': 'Consists of subjects who received placebo in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)'}, {'id': 'OG001', 'title': '137 mg ADS-5102/274 mg ADS-5102', 'description': 'Consists of subjects who received 137 mg ADS-5102 in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)'}, {'id': 'OG002', 'title': '274 mg ADS-5102/274 mg ADS-5102', 'description': 'Consists of subjects who 274 mg ADS-5102 in both Studies ADS-AMT-MS301 and ADS-AMT-MS303'}], 'classes': [{'categories': [{'measurements': [{'value': '77.45', 'spread': '34.147', 'groupId': 'OG000'}, {'value': '89.18', 'spread': '36.707', 'groupId': 'OG001'}, {'value': '89.14', 'spread': '37.295', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 weeks', 'description': 'The 2-Minute Walk test is a measure of lower extremity function. The subject is instructed to walk as far as possible in 2 minutes, and the distance is measured in meters. Improvement is indicated by positive change scores.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat: subjects with available data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo/274 mg ADS-5102', 'description': 'Consists of subjects who received placebo in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)'}, {'id': 'FG001', 'title': '137 mg ADS-5102/274 mg ADS-5102', 'description': 'Consists of subjects who received 137 mg ADS-5102 in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)'}, {'id': 'FG002', 'title': '274 mg ADS-5102/274 mg ADS-5102', 'description': 'Consists of subjects who 274 mg ADS-5102 in both Studies ADS-AMT-MS301 and ADS-AMT-MS303'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '159'}, {'groupId': 'FG001', 'numSubjects': '151'}, {'groupId': 'FG002', 'numSubjects': '114'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '64'}, {'groupId': 'FG002', 'numSubjects': '68'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '87'}, {'groupId': 'FG002', 'numSubjects': '46'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '53'}, {'groupId': 'FG002', 'numSubjects': '28'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'COVID-19 pandemic', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Non-compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Unstable medical condition', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Medical history event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}, {'value': '424', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo/274 mg ADS-5102', 'description': 'Consists of subjects who received placebo in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)'}, {'id': 'BG001', 'title': '137 mg ADS-5102/274 mg ADS-5102', 'description': 'Consists of subjects who received 137 mg ADS-5102 in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)'}, {'id': 'BG002', 'title': '274 mg ADS-5102/274 mg ADS-5102', 'description': 'Consists of subjects who 274 mg ADS-5102 in both Studies ADS-AMT-MS301 and ADS-AMT-MS303'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.7', 'spread': '9.80', 'groupId': 'BG000'}, {'value': '54.8', 'spread': '9.12', 'groupId': 'BG001'}, {'value': '53.0', 'spread': '9.40', 'groupId': 'BG002'}, {'value': '54.3', 'spread': '9.47', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '284', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '140', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '360', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline T25FW', 'classes': [{'categories': [{'title': '<Median of enrolled population (9.4 seconds)', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '206', 'groupId': 'BG003'}]}, {'title': '>Median of enrolled population (9.4 seconds)', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '217', 'groupId': 'BG003'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-04-19', 'size': 657521, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-11-05T17:04', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 424}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-12', 'studyFirstSubmitDate': '2018-05-22', 'resultsFirstSubmitDate': '2021-11-05', 'studyFirstSubmitQcDate': '2018-06-21', 'lastUpdatePostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-12', 'studyFirstPostDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With Adverse Events', 'timeFrame': 'Through study completion, an average of 1 year.', 'description': 'The incidence of treatment-emergent adverse events was used as the measure for long-term safety and tolerability of ADS-5102.'}], 'secondaryOutcomes': [{'measure': 'Timed 25-Foot Walk (Feet/Second) (Baseline Value)', 'timeFrame': 'Baseline', 'description': 'The timed 25-foot walk is a measure of lower extremity function. The subject is directed to a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the subject walk back the same distance. The result is reported as speed (feet per second). Improvement is indicated by an increase in speed.'}, {'measure': 'Timed 25-Foot Walk (Feet/Second) (Week 24 Value)', 'timeFrame': '24 weeks', 'description': 'The timed 25-foot walk is a measure of lower extremity function. The subject is directed to a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the subject walk back the same distance. The result is reported as speed (feet per second). Improvement is indicated by an increase in speed.'}, {'measure': 'Timed 25-Foot Walk (Feet/Second) (Week 52 Value)', 'timeFrame': '52 weeks', 'description': 'The timed 25-foot walk is a measure of lower extremity function. The subject is directed to a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the subject walk back the same distance. The result is reported as speed (feet per second). Improvement is indicated by an increase in speed.'}, {'measure': 'Timed up and go (Baseline Value)', 'timeFrame': 'Baseline', 'description': 'The "timed up and go" is a measure of lower extremity strength, balance, and coordination. The subject stands up from a chair, walks 3 meters then turns around and walks back to the chair to sit down. The result is reported in seconds. Improvement is indicated by negative change scores.'}, {'measure': 'Timed up and go (Week 24 Value)', 'timeFrame': '24 weeks', 'description': 'The "timed up and go" is a measure of lower extremity strength, balance, and coordination. The subject stands up from a chair, walks 3 meters then turns around and walks back to the chair to sit down. The result is reported in seconds. Improvement is indicated by negative change scores.'}, {'measure': 'Timed up and go (Week 52 Value)', 'timeFrame': '52 weeks', 'description': 'The "timed up and go" is a measure of lower extremity strength, balance, and coordination. The subject stands up from a chair, walks 3 meters then turns around and walks back to the chair to sit down. The result is reported in seconds. Improvement is indicated by negative change scores.'}, {'measure': '2-Minute Walk Test (Baseline Value)', 'timeFrame': 'Baseline', 'description': 'The 2-Minute Walk test is a measure of lower extremity function. The subject is instructed to walk as far as possible in 2 minutes, and the distance is measured in meters. Improvement is indicated by positive change scores.'}, {'measure': '2-Minute Walk Test (Week 24 Value)', 'timeFrame': '24 weeks', 'description': 'The 2-Minute Walk test is a measure of lower extremity function. The subject is instructed to walk as far as possible in 2 minutes, and the distance is measured in meters. Improvement is indicated by positive change scores.'}, {'measure': '2-Minute Walk Test (Week 52 Value)', 'timeFrame': '52 weeks', 'description': 'The 2-Minute Walk test is a measure of lower extremity function. The subject is instructed to walk as far as possible in 2 minutes, and the distance is measured in meters. Improvement is indicated by positive change scores.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis', 'Walking Impairment']}, 'descriptionModule': {'briefSummary': 'This study assessed the long-term safety and tolerability of ADS-5102 in subjects with MS and walking impairment who had completed the double-blind, placebo-controlled study of ADS-5102 in subjects with MS (ADS-AMT-301).', 'detailedDescription': "This was a multicenter, open-label study of ADS-5102 (amantadine) extended-release capsules in subjects with MS and walking impairment who completed study drug treatment for 16 weeks and completed a Week 16 visit in Study ADS-AMT-MS301.\n\nAll enrolled subjects were to receive ADS-5102 at 137 mg for the first week, 205.5 mg for the second week, and 274 mg for the remainder of the 52-week open-label treatment period.\n\nSubjects returned to the clinic for safety and efficacy assessments at Weeks 4, 24, and 52. In addition, a telephone visit for safety assessments was conducted at Week 2 and Week 38. Subjects who withdrew from the study prior to completion of the Week 52 visit had an early termination (ET) visit that included safety and efficacy assessments. Subjects who completed 52 weeks of open-label treatment had a final visit for post-treatment safety follow-up and efficacy assessment at Week 54.\n\nAll study visits and efficacy assessments were to be scheduled to occur at approximately the same time of day for each individual subject. Each subject's efficacy assessment was to be performed by the same clinical rater, if possible."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed a current IRB-approved informed consent form\n* Successful completion of a prior double blind study of ADS-5102 in patients with MS walking impairment.\n\nExclusion Criteria:\n\n* Based on the judgment of the investigator or Medical Monitor, participation in the study would jeopardize the safety of the subject.\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 a highly effective hormonal method of contraception (an IUD, or vasectomized male partner is also acceptable), in combination with a barrier method, from baseline through at least 4 weeks after the completion of study treatment. If a sexually active male, does not agree to utilize condoms from screening through at least 4 weeks after the completion of study treatment.\n* Anticipated treatment with any amantadine formulation other than ADS-5102\n* Planned participation in another interventional clinical trial'}, 'identificationModule': {'nctId': 'NCT03567057', 'briefTitle': 'A Safety and Efficacy Study of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Adamas Pharmaceuticals, Inc.'}, 'officialTitle': 'A Multicenter, Open-Label Safety and Efficacy Study of ADS-5102 Amantadine Extended Release Capsules in Patients With Multiple Sclerosis and Walking Impairment', 'orgStudyIdInfo': {'id': 'ADS-AMT-MS303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ADS-5102, 274 mg', 'description': '274 mg ADS-5102, administered once daily at bedtime for up to 52 weeks', 'interventionNames': ['Drug: ADS-5102, 274 mg']}], 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