Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-01-28 @ 6:01 PM
Study NCT ID:
NCT00577460
Status:
COMPLETED
Last Update Posted:
2014-05-16
First Post:
2007-12-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Long-term Safety Study of Open-label Pramipexole ER in Patients With Advanced PD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077487', 'term': 'Pramipexole'}], 'ancestors': [{'id': 'D052160', 'term': 'Benzothiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '80 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'PPX ER (Previous Placebo)', 'description': 'Pramipexole ER Treatment with placebo in previous trial', 'otherNumAtRisk': 129, 'otherNumAffected': 87, 'seriousNumAtRisk': 129, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'PPX ER (Previous PPX ER)', 'description': 'Pramipexole ER Treatment with Pramipexole ER in previous trial', 'otherNumAtRisk': 123, 'otherNumAffected': 74, 'seriousNumAtRisk': 123, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'PPX ER (Previous PPX IR)', 'description': 'Pramipexole ER Treatment with Pramipexole IR in previous trial', 'otherNumAtRisk': 139, 'otherNumAffected': 81, 'seriousNumAtRisk': 139, 'seriousNumAffected': 14}, {'id': 'EG003', 'title': 'Total PPX ER', 'description': 'Pramipexole ER, all patients', 'otherNumAtRisk': 391, 'otherNumAffected': 242, 'seriousNumAtRisk': 391, 'seriousNumAffected': 39}], 'otherEvents': [{'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 23}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 23}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Muscle rigidity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 28}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 106}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dystonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 52}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 22}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 27}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cardiovascular insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Inguinal hernia strangulated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rectal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Drug withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Eyeball rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Facial bones fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Joint sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Muscle injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Thoracic vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Muscle rigidity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bile duct cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rectal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cerebellar haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cervicobrachial syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dystonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypertensive encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'On and off phenomenon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': "Parkinson's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cardiac neurosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Paramnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pathological gambling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Patients Successfully Switched From Pramipexole (PPX) IR or ER to ER Assessed on UPDRS II+III', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX ER (Previous PPX ER)', 'description': 'Pramipexole ER Treatment with Pramipexole ER in previous trial'}, {'id': 'OG001', 'title': 'PPX ER (Previous PPX IR)', 'description': 'Pramipexole ER Treatment with Pramipexole IR in previous trial'}], 'classes': [{'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One week', 'description': "Unified Parkinson's Disease Rating Scale (UPDRS) Successfully switched means: UPDRS II+III baseline score \\>20 without a relative worsening of UPDRS II+III score \\> 15% from baseline or UPDRS II+III baseline score \\<=20 without an absolute worsening of UPDRS II+III score \\> 3 from baseline UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms", 'unitOfMeasure': 'Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from Full Analysis Set (FAS included all patients who were dispensed study medication, had received at least one dose of study drug and had provided any post-baseline efficacy assessment) and who maintain the final dose of the previous study'}, {'type': 'SECONDARY', 'title': 'UPDRS II+III Change From Open Label (OL) Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX ER (Previous Placebo)', 'description': 'Pramipexole ER Treatment with placebo in previous trial'}, {'id': 'OG001', 'title': 'PPX ER (Previous PPX ER)', 'description': 'Pramipexole ER Treatment with Pramipexole ER in previous trial'}, {'id': 'OG002', 'title': 'PPX ER (Previous PPX IR)', 'description': 'Pramipexole ER Treatment with Pramipexole IR in previous trial'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.6', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '1.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0039', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'PPX ER versus Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance (ANCOVA) with factors treatment and country and covariate OL baseline', 'testedNonInferiority': False}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'PPX IR versus Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance (ANCOVA) with factors treatment and country and covariate OL baseline', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'OL Baseline and week 80', 'description': 'UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from FAS with values of UPDRS II+III at week 80'}, {'type': 'SECONDARY', 'title': 'Number of Participants With UPDRS II+III Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX ER (Previous Placebo)', 'description': 'Pramipexole ER Treatment with placebo in previous trial'}, {'id': 'OG001', 'title': 'PPX ER (Previous PPX ER)', 'description': 'Pramipexole ER Treatment with Pramipexole ER in previous trial'}, {'id': 'OG002', 'title': 'PPX ER (Previous PPX IR)', 'description': 'Pramipexole ER Treatment with Pramipexole IR in previous trial'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 80', 'description': 'A response means an improvement of \\>=20% in UPDRS II+III from OL baseline UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms', 'unitOfMeasure': 'Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from FAS with values of UPDRS II+III at week 80'}, {'type': 'SECONDARY', 'title': 'Number of Patients Successfully Switched From PPX IR or ER to ER Assessed on Off-time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX ER (Previous PPX ER)', 'description': 'Pramipexole ER Treatment with Pramipexole ER in previous trial'}, {'id': 'OG001', 'title': 'PPX ER (Previous PPX IR)', 'description': 'Pramipexole ER Treatment with Pramipexole IR in previous trial'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One week', 'description': 'A patient was considered as successfully switched if he/she has converted to ER without a worsening of off time by more than 12.5% from baseline. Off-time is based on patient diary data and describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).', 'unitOfMeasure': 'Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from FAS and who maintain the final dose of the previous study'}, {'type': 'SECONDARY', 'title': 'Percentage Off Time During Waking Hours Total Score: Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX ER (Previous Placebo)', 'description': 'Pramipexole ER Treatment with placebo in previous trial'}, {'id': 'OG001', 'title': 'PPX ER (Previous PPX ER)', 'description': 'Pramipexole ER Treatment with Pramipexole ER in previous trial'}, {'id': 'OG002', 'title': 'PPX ER (Previous PPX IR)', 'description': 'Pramipexole ER Treatment with Pramipexole IR in previous trial'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '2.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.5590', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance with factors for treatment, country and baseline as a covariate', 'testedNonInferiority': False}, {'pValue': '0.1289', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance with factors for treatment, country and baseline as a covariate', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 80', 'description': 'Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).\n\nA negative change implies improvement', 'unitOfMeasure': 'percentage during waking hours', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from FAS with values of UPDRS II+III at week 80'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Response in Percentage Off Time During Waking Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}, {'value': '282', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX ER (Previous Placebo)', 'description': 'Pramipexole ER Treatment with placebo in previous trial'}, {'id': 'OG001', 'title': 'PPX ER (Previous PPX ER)', 'description': 'Pramipexole ER Treatment with Pramipexole ER in previous trial'}, {'id': 'OG002', 'title': 'PPX ER (Previous PPX IR)', 'description': 'Pramipexole ER Treatment with Pramipexole IR in previous trial'}, {'id': 'OG003', 'title': 'Total PPX ER', 'description': 'Pramipexole ER, all patients'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '80 weeks', 'description': 'Response means \\>=20% improvement relative to OL baseline in the % off-time during waking hours', 'unitOfMeasure': 'Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from FAS with values of off time during waking hours at 80 weeks'}, {'type': 'SECONDARY', 'title': 'Percentage on Time Without Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX ER (Previous Placebo)', 'description': 'Pramipexole ER Treatment with placebo in previous trial'}, {'id': 'OG001', 'title': 'PPX ER (Previous PPX ER)', 'description': 'Pramipexole ER Treatment with Pramipexole ER in previous trial'}, {'id': 'OG002', 'title': 'PPX ER (Previous PPX IR)', 'description': 'Pramipexole ER Treatment with Pramipexole IR in previous trial'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '2.7', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '2.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1073', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance with factors for treatment, country and baseline as a covariate', 'testedNonInferiority': False}, {'pValue': '0.8694', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance with factors for treatment, country and baseline as a covariate', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 80', 'description': 'Percentage on-time based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement.', 'unitOfMeasure': 'percentage during waking hours', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from FAS with values of on time during waking hours at week 80'}, {'type': 'SECONDARY', 'title': 'Percentage on Time With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX ER (Previous Placebo)', 'description': 'Pramipexole ER Treatment with placebo in previous trial'}, {'id': 'OG001', 'title': 'PPX ER (Previous PPX ER)', 'description': 'Pramipexole ER Treatment with Pramipexole ER in previous trial'}, {'id': 'OG002', 'title': 'PPX ER (Previous PPX IR)', 'description': 'Pramipexole ER Treatment with Pramipexole IR in previous trial'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '1.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0009', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance with factors for treatment, country and baseline as a covariate', 'testedNonInferiority': False}, {'pValue': '0.0573', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance with factors for treatment, country and baseline as a covariate', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 80', 'description': 'Percentage on-time with non troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement', 'unitOfMeasure': 'percentage during waking hours', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from FAS with values of on time during waking hours at week 80'}, {'type': 'SECONDARY', 'title': 'Percentage on Time Without Dyskinesia or With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX ER (Previous Placebo)', 'description': 'Pramipexole ER Treatment with placebo in previous trial'}, {'id': 'OG001', 'title': 'PPX ER (Previous PPX ER)', 'description': 'Pramipexole ER Treatment with Pramipexole ER in previous trial'}, {'id': 'OG002', 'title': 'PPX ER (Previous PPX IR)', 'description': 'Pramipexole ER Treatment with Pramipexole IR in previous trial'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '2.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.6434', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance with factors for treatment, country and baseline as a covariate', 'testedNonInferiority': False}, {'pValue': '0.2469', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance with factors for treatment, country and baseline as a covariate', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 80', 'description': 'Percentage on-time without dyskinesia or with non troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement', 'unitOfMeasure': 'percentage during waking hours', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from FAS with values of on time during waking hours at week 80'}, {'type': 'SECONDARY', 'title': 'Percentage on Time With Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX ER (Previous Placebo)', 'description': 'Pramipexole ER Treatment with placebo in previous trial'}, {'id': 'OG001', 'title': 'PPX ER (Previous PPX ER)', 'description': 'Pramipexole ER Treatment with Pramipexole ER in previous trial'}, {'id': 'OG002', 'title': 'PPX ER (Previous PPX IR)', 'description': 'Pramipexole ER Treatment with Pramipexole IR in previous trial'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '1.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.9741', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance with factors for treatment, country and baseline as a covariate', 'testedNonInferiority': False}, {'pValue': '0.7620', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance with factors for treatment, country and baseline as a covariate', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 80', 'description': 'Percentage on-time with troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement', 'unitOfMeasure': 'percentage during waking hours', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from FAS with values of on time during waking hours at week 80'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Response in CGI-I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}, {'value': '363', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX ER (Previous Placebo)', 'description': 'Pramipexole ER Treatment with placebo in previous trial'}, {'id': 'OG001', 'title': 'PPX ER (Previous PPX ER)', 'description': 'Pramipexole ER Treatment with Pramipexole ER in previous trial'}, {'id': 'OG002', 'title': 'PPX ER (Previous PPX IR)', 'description': 'Pramipexole ER Treatment with Pramipexole IR in previous trial'}, {'id': 'OG003', 'title': 'Total PPX ER', 'description': 'Pramipexole ER, all patients'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}, {'value': '270', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '32 weeks', 'description': 'Clinical Global Impression of Improvement (CGI-I), CGI-I scores ranging from \'1\' (very much improved) to \'7\' (very much worse). For patients previously treated with Placebo, all patients with at least "much improved" were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much improved were considered as responders', 'unitOfMeasure': 'Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from FAS with values of CGI-I at week 32'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Response in PGI-I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}, {'value': '363', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX ER (Previous Placebo)', 'description': 'Pramipexole ER Treatment with placebo in previous trial'}, {'id': 'OG001', 'title': 'PPX ER (Previous PPX ER)', 'description': 'Pramipexole ER Treatment with Pramipexole ER in previous trial'}, {'id': 'OG002', 'title': 'PPX ER (Previous PPX IR)', 'description': 'Pramipexole ER Treatment with Pramipexole IR in previous trial'}, {'id': 'OG003', 'title': 'Total PPX ER', 'description': 'Pramipexole ER, all patients'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}, {'value': '260', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '32 weeks', 'description': 'Patient Global Impression of Improvement (PGI-I), PGI-I scores ranging from \'1\' (very much better) to \'7\' (very much worse). For patients previously treated with Placebo, all patients with at least "much better" were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much better were considered as responders', 'unitOfMeasure': 'Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from FAS with values of PGI-I at week 32'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Response in PGI-I for Early Morning Off Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '366', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX ER (Previous Placebo)', 'description': 'Pramipexole ER Treatment with placebo in previous trial'}, {'id': 'OG001', 'title': 'PPX ER (Previous PPX ER)', 'description': 'Pramipexole ER Treatment with Pramipexole ER in previous trial'}, {'id': 'OG002', 'title': 'PPX ER (Previous PPX IR)', 'description': 'Pramipexole ER Treatment with Pramipexole IR in previous trial'}, {'id': 'OG003', 'title': 'Total PPX ER', 'description': 'Pramipexole ER, all patients'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '260', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '32 weeks', 'description': 'Patient Global Impression of Improvement (PGI-I) for early morning off symptoms, PGI-I scores ranging from \'1\' (very much better) to \'7\' (very much worse). For patients previously treated with Placebo, all patients with at least "much better" were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much better were considered as responders', 'unitOfMeasure': 'Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from FAS with values of PGI-I for early morning off symptoms at week 32'}, {'type': 'SECONDARY', 'title': 'UPDRS I Total Score and Change From OL Baseline at Week 80', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX ER (Previous Placebo)', 'description': 'Pramipexole ER Treatment with placebo in previous trial'}, {'id': 'OG001', 'title': 'PPX ER (Previous PPX ER)', 'description': 'Pramipexole ER Treatment with Pramipexole ER in previous trial'}, {'id': 'OG002', 'title': 'PPX ER (Previous PPX IR)', 'description': 'Pramipexole ER Treatment with Pramipexole IR in previous trial'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0831', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance with factors for treatment, country and baseline as a covariate', 'testedNonInferiority': False}, {'pValue': '0.0759', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance with factors for treatment, country and baseline as a covariate', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'OL baseline and week 80', 'description': 'UPDRS I ranging from 0 (normal) to 16 (severe). UPDRS I measures Mentation, Behavior and Mood', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from FAS with values of UPDRS I at week 80'}, {'type': 'SECONDARY', 'title': 'UPDRS II Total Score and Change From OL Baseline at Week 80', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX ER (Previous Placebo)', 'description': 'Pramipexole ER Treatment with placebo in previous trial'}, {'id': 'OG001', 'title': 'PPX ER (Previous PPX ER)', 'description': 'Pramipexole ER Treatment with Pramipexole ER in previous trial'}, {'id': 'OG002', 'title': 'PPX ER (Previous PPX IR)', 'description': 'Pramipexole ER Treatment with Pramipexole IR in previous trial'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '0.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1713', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance with factors for treatment, country and baseline as a covariate', 'testedNonInferiority': False}, {'pValue': '0.0130', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance with factors for treatment, country and baseline as a covariate', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'OL baseline and week 80', 'description': 'UPDRS II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS part II at on and UPDRS part II at off-period for each of the 13 activities', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from FAS with values of UPDRS II at week 80'}, {'type': 'SECONDARY', 'title': 'UPDRS III Total Score and Change From OL Baseline at Week 80', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX ER (Previous Placebo)', 'description': 'Pramipexole ER Treatment with placebo in previous trial'}, {'id': 'OG001', 'title': 'PPX ER (Previous PPX ER)', 'description': 'Pramipexole ER Treatment with Pramipexole ER in previous trial'}, {'id': 'OG002', 'title': 'PPX ER (Previous PPX IR)', 'description': 'Pramipexole ER Treatment with Pramipexole IR in previous trial'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.1', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '1.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0015', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance with factors for treatment, country and baseline as a covariate', 'testedNonInferiority': False}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance with factors for treatment, country and baseline as a covariate', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'OL baseline and week 80', 'description': 'UPDRS III ranging from 0 (normal) to 108 (severe). UPDRS part III measures motor symptoms', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from FAS with values of UPDRS III at week 80'}, {'type': 'SECONDARY', 'title': 'UPDRS IV Total Score and Change From OL Baseline at Week 80', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX ER (Previous Placebo)', 'description': 'Pramipexole ER Treatment with placebo in previous trial'}, {'id': 'OG001', 'title': 'PPX ER (Previous PPX ER)', 'description': 'Pramipexole ER Treatment with Pramipexole ER in previous trial'}, {'id': 'OG002', 'title': 'PPX ER (Previous PPX IR)', 'description': 'Pramipexole ER Treatment with Pramipexole IR in previous trial'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.8760', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance with factors for treatment, country and baseline as a covariate', 'testedNonInferiority': False}, {'pValue': '0.5113', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance with factors for treatment, country and baseline as a covariate', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'OL baseline and week 80', 'description': 'UPDRS IV ranging from 0 (normal) to 23 (severe). UPDRS IV measures complications of therapy', 'unitOfMeasure': 'Unit on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from FAS with values of UPDRS IV at week 80'}, {'type': 'SECONDARY', 'title': 'Parkinson Fatigue Scale (PFS-16) Score and Change From OL Baseline at Week 80', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX ER (Previous Placebo)', 'description': 'Pramipexole ER Treatment with placebo in previous trial'}, {'id': 'OG001', 'title': 'PPX ER (Previous PPX ER)', 'description': 'Pramipexole ER Treatment with Pramipexole ER in previous trial'}, {'id': 'OG002', 'title': 'PPX ER (Previous PPX IR)', 'description': 'Pramipexole ER Treatment with Pramipexole IR in previous trial'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '1.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0148', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance with factors for treatment, country and baseline as a covariate', 'testedNonInferiority': False}, {'pValue': '0.0201', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance with factors for treatment, country and baseline as a covariate', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'OL baseline and week 80', 'description': 'PFS-16 (Parkinson fatigue scale) ranging from 16 (better perceived health status) to 80 (severe symptoms of the disease) measuring aspects of fatigue that are relevant to patients with PD', 'unitOfMeasure': 'Unit on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from FAS with values of PFS-16 score at week 80'}, {'type': 'SECONDARY', 'title': 'Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}, {'value': '371', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX ER (Previous Placebo)', 'description': 'Pramipexole ER Treatment with placebo in previous trial'}, {'id': 'OG001', 'title': 'PPX ER (Previous PPX ER)', 'description': 'Pramipexole ER Treatment with Pramipexole ER in previous trial'}, {'id': 'OG002', 'title': 'PPX ER (Previous PPX IR)', 'description': 'Pramipexole ER Treatment with Pramipexole IR in previous trial'}, {'id': 'OG003', 'title': 'Total PPX ER', 'description': 'Pramipexole ER, all patients'}], 'classes': [{'title': 'Decrease', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}]}, {'title': 'Increase', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '270', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'OL baseline and week 80', 'unitOfMeasure': 'Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from FAS with documentation of levodopa (L-DOPA) daily dose at week 80'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '366', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX ER (Previous Placebo)', 'description': 'Pramipexole ER Treatment with placebo in previous trial'}, {'id': 'OG001', 'title': 'PPX ER (Previous PPX ER)', 'description': 'Pramipexole ER Treatment with Pramipexole ER in previous trial'}, {'id': 'OG002', 'title': 'PPX ER (Previous PPX IR)', 'description': 'Pramipexole ER Treatment with Pramipexole IR in previous trial'}, {'id': 'OG003', 'title': 'Total PPX ER', 'description': 'Pramipexole ER, all patients'}], 'classes': [{'title': 'Reduced', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '115', 'groupId': 'OG003'}]}]}, {'title': 'Unchanged', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}]}, {'title': 'Increased', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '115', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'OL baseline and week 80', 'unitOfMeasure': 'Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from Treated Set (all patients who were dispensed study drug and were documented to have at least one dose of investigational treatment) and treated until week 80'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}, {'value': '391', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX ER (Previous Placebo)', 'description': 'Pramipexole ER Treatment with placebo in previous trial'}, {'id': 'OG001', 'title': 'PPX ER (Previous PPX ER)', 'description': 'Pramipexole ER Treatment with Pramipexole ER in previous trial'}, {'id': 'OG002', 'title': 'PPX ER (Previous PPX IR)', 'description': 'Pramipexole ER Treatment with Pramipexole IR in previous trial'}, {'id': 'OG003', 'title': 'Total PPX ER', 'description': 'Pramipexole ER, all patients'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '80 weeks', 'unitOfMeasure': 'Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'The Treated Set (TS) included all patients who were dispensed study drug and were documented to have at least one dose of investigational treatment'}, {'type': 'PRIMARY', 'title': 'Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Treatment with matching placebo in previous trial (NCT00466167)'}, {'id': 'OG001', 'title': 'PPX ER', 'description': 'Treatment with Pramipexole ER in previous trial'}, {'id': 'OG002', 'title': 'PPX IR', 'description': 'Treatment with Pramipexole IR in previous trial'}], 'classes': [{'title': 'Percentage of Patients with Adverse Events', 'categories': [{'measurements': [{'value': '85.3', 'groupId': 'OG000'}, {'value': '83.7', 'groupId': 'OG001'}, {'value': '79.9', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of Patients with Adverse Drug Reactions', 'categories': [{'measurements': [{'value': '52.7', 'groupId': 'OG000'}, {'value': '48.8', 'groupId': 'OG001'}, {'value': '45.3', 'groupId': 'OG002'}]}]}, {'title': 'Percentage of Patients with Serious Adverse Events', 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000'}, {'value': '8.9', 'groupId': 'OG001'}, {'value': '10.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '80 weeks', 'description': "The aim of this study was to obtain long-term safety and tolerability data on pramipexole ER, in patients who have previously completed a pramipexole double blind study in advanced Parkinson's Disease (PD) (248.525 (NCT00466167)). Therefore these items were considered as a safety evaluation.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from Treated Set (defined as all patients who were dispensed study drug and were documented to have at least one dose of investigational treatment)'}, {'type': 'SECONDARY', 'title': 'Supine Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX ER (Previous Placebo)', 'description': 'Pramipexole ER Treatment with placebo in previous trial'}, {'id': 'OG001', 'title': 'PPX ER (Previous PPX ER)', 'description': 'Pramipexole ER Treatment with Pramipexole ER in previous trial'}, {'id': 'OG002', 'title': 'PPX ER (Previous PPX IR)', 'description': 'Pramipexole ER Treatment with Pramipexole IR in previous trial'}], 'classes': [{'title': 'OL Baseline', 'categories': [{'measurements': [{'value': '77.4', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '77.3', 'spread': '8.6', 'groupId': 'OG001'}, {'value': '77.6', 'spread': '9.4', 'groupId': 'OG002'}]}]}, {'title': 'End of OL', 'categories': [{'measurements': [{'value': '77.4', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '78.3', 'spread': '8.9', 'groupId': 'OG001'}, {'value': '77.2', 'spread': '8.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'OL Baseline and Week 80', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data'}, {'type': 'SECONDARY', 'title': 'Standing Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX ER (Previous Placebo)', 'description': 'Pramipexole ER Treatment with placebo in previous trial'}, {'id': 'OG001', 'title': 'PPX ER (Previous PPX ER)', 'description': 'Pramipexole ER Treatment with Pramipexole ER in previous trial'}, {'id': 'OG002', 'title': 'PPX ER (Previous PPX IR)', 'description': 'Pramipexole ER Treatment with Pramipexole IR in previous trial'}], 'classes': [{'title': 'OL Baseline', 'categories': [{'measurements': [{'value': '77.8', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '77.3', 'spread': '9.1', 'groupId': 'OG001'}, {'value': '77.6', 'spread': '9.9', 'groupId': 'OG002'}]}]}, {'title': 'End of OL', 'categories': [{'measurements': [{'value': '77.6', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '78.1', 'spread': '9.3', 'groupId': 'OG001'}, {'value': '76.4', 'spread': '9.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'OL Baseline and Week 80', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data'}, {'type': 'SECONDARY', 'title': 'Supine Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX ER (Previous Placebo)', 'description': 'Pramipexole ER Treatment with placebo in previous trial'}, {'id': 'OG001', 'title': 'PPX ER (Previous PPX ER)', 'description': 'Pramipexole ER Treatment with Pramipexole ER in previous trial'}, {'id': 'OG002', 'title': 'PPX ER (Previous PPX IR)', 'description': 'Pramipexole ER Treatment with Pramipexole IR in previous trial'}], 'classes': [{'title': 'OL Baseline', 'categories': [{'measurements': [{'value': '121.6', 'spread': '12.2', 'groupId': 'OG000'}, {'value': '124.5', 'spread': '15.4', 'groupId': 'OG001'}, {'value': '125.7', 'spread': '14.8', 'groupId': 'OG002'}]}]}, {'title': 'End of OL', 'categories': [{'measurements': [{'value': '124.2', 'spread': '13.5', 'groupId': 'OG000'}, {'value': '123.8', 'spread': '14.2', 'groupId': 'OG001'}, {'value': '124.4', 'spread': '14.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'OL Baseline and Week 80', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data'}, {'type': 'SECONDARY', 'title': 'Standing Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX ER (Previous Placebo)', 'description': 'Pramipexole ER Treatment with placebo in previous trial'}, {'id': 'OG001', 'title': 'PPX ER (Previous PPX ER)', 'description': 'Pramipexole ER Treatment with Pramipexole ER in previous trial'}, {'id': 'OG002', 'title': 'PPX ER (Previous PPX IR)', 'description': 'Pramipexole ER Treatment with Pramipexole IR in previous trial'}], 'classes': [{'title': 'OL Baseline', 'categories': [{'measurements': [{'value': '120.2', 'spread': '13.9', 'groupId': 'OG000'}, {'value': '121.1', 'spread': '16.4', 'groupId': 'OG001'}, {'value': '120.9', 'spread': '15.9', 'groupId': 'OG002'}]}]}, {'title': 'End of OL', 'categories': [{'measurements': [{'value': '121.9', 'spread': '15.0', 'groupId': 'OG000'}, {'value': '121.6', 'spread': '14.3', 'groupId': 'OG001'}, {'value': '120.5', 'spread': '16.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'OL Baseline and Week 80', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data'}, {'type': 'SECONDARY', 'title': 'Supine Pulse Rate, Baseline and Week 80, Vital Signs Treated Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX ER (Previous Placebo)', 'description': 'Pramipexole ER Treatment with placebo in previous trial'}, {'id': 'OG001', 'title': 'PPX ER (Previous PPX ER)', 'description': 'Pramipexole ER Treatment with Pramipexole ER in previous trial'}, {'id': 'OG002', 'title': 'PPX ER (Previous PPX IR)', 'description': 'Pramipexole ER Treatment with Pramipexole IR in previous trial'}], 'classes': [{'title': 'OL Baseline', 'categories': [{'measurements': [{'value': '73.6', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '72.6', 'spread': '9.2', 'groupId': 'OG001'}, {'value': '73.2', 'spread': '9.0', 'groupId': 'OG002'}]}]}, {'title': 'End of OL', 'categories': [{'measurements': [{'value': '75.8', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '74.2', 'spread': '7.9', 'groupId': 'OG001'}, {'value': '74.4', 'spread': '10.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'OL Baseline and Week 80', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data'}, {'type': 'SECONDARY', 'title': 'Standing Pulse Rate, Baseline and Week 80, Vital Signs Treated Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX ER (Previous Placebo)', 'description': 'Pramipexole ER Treatment with placebo in previous trial'}, {'id': 'OG001', 'title': 'PPX ER (Previous PPX ER)', 'description': 'Pramipexole ER Treatment with Pramipexole ER in previous trial'}, {'id': 'OG002', 'title': 'PPX ER (Previous PPX IR)', 'description': 'Pramipexole ER Treatment with Pramipexole IR in previous trial'}], 'classes': [{'title': 'OL Baseline', 'categories': [{'measurements': [{'value': '78.3', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '78.0', 'spread': '9.5', 'groupId': 'OG001'}, {'value': '77.7', 'spread': '9.9', 'groupId': 'OG002'}]}]}, {'title': 'End of OL', 'categories': [{'measurements': [{'value': '79.3', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '77.7', 'spread': '7.5', 'groupId': 'OG001'}, {'value': '78.8', 'spread': '10.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'OL Baseline and Week 80', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data'}, {'type': 'SECONDARY', 'title': 'Body Weight of Female Patients, Baseline and Week 80, Vital Signs Treated Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX ER (Previous Placebo)', 'description': 'Pramipexole ER Treatment with placebo in previous trial'}, {'id': 'OG001', 'title': 'PPX ER (Previous PPX ER)', 'description': 'Pramipexole ER Treatment with Pramipexole ER in previous trial'}, {'id': 'OG002', 'title': 'PPX ER (Previous PPX IR)', 'description': 'Pramipexole ER Treatment with Pramipexole IR in previous trial'}], 'classes': [{'title': 'OL Baseline', 'categories': [{'measurements': [{'value': '61.9', 'spread': '13.0', 'groupId': 'OG000'}, {'value': '61.7', 'spread': '14.0', 'groupId': 'OG001'}, {'value': '63.8', 'spread': '14.6', 'groupId': 'OG002'}]}]}, {'title': 'End of OL', 'categories': [{'measurements': [{'value': '63.6', 'spread': '13.8', 'groupId': 'OG000'}, {'value': '61.7', 'spread': '15.0', 'groupId': 'OG001'}, {'value': '63.6', 'spread': '16.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'OL Baseline and Week 80', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data'}, {'type': 'SECONDARY', 'title': 'Body Weight of Male Patients, Baseline and Week 80, Vital Signs Treated Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX ER (Previous Placebo)', 'description': 'Pramipexole ER Treatment with placebo in previous trial'}, {'id': 'OG001', 'title': 'PPX ER (Previous PPX ER)', 'description': 'Pramipexole ER Treatment with Pramipexole ER in previous trial'}, {'id': 'OG002', 'title': 'PPX ER (Previous PPX IR)', 'description': 'Pramipexole ER Treatment with Pramipexole IR in previous trial'}], 'classes': [{'title': 'OL Baseline', 'categories': [{'measurements': [{'value': '73.0', 'spread': '15.7', 'groupId': 'OG000'}, {'value': '72.1', 'spread': '12.2', 'groupId': 'OG001'}, {'value': '70.8', 'spread': '13.2', 'groupId': 'OG002'}]}]}, {'title': 'End of OL', 'categories': [{'measurements': [{'value': '73.9', 'spread': '16.4', 'groupId': 'OG000'}, {'value': '72.7', 'spread': '12.5', 'groupId': 'OG001'}, {'value': '72.0', 'spread': '14.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'OL Baseline and Week 80', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data'}, {'type': 'SECONDARY', 'title': 'Epworth Sleepiness Scale (ESS), Baseline and End of Open Label, Treated Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX ER (Previous Placebo)', 'description': 'Pramipexole ER Treatment with placebo in previous trial'}, {'id': 'OG001', 'title': 'PPX ER (Previous PPX ER)', 'description': 'Pramipexole ER Treatment with Pramipexole ER in previous trial'}, {'id': 'OG002', 'title': 'PPX ER (Previous PPX IR)', 'description': 'Pramipexole ER Treatment with Pramipexole IR in previous trial'}], 'classes': [{'title': 'OL Baseline', 'categories': [{'measurements': [{'value': '7.2', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '4.1', 'groupId': 'OG001'}, {'value': '8.1', 'spread': '4.9', 'groupId': 'OG002'}]}]}, {'title': 'Change from baseline at end of OL', 'categories': [{'measurements': [{'value': '0.5', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '4.7', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '4.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'OL Baseline and Week 80', 'description': 'ESS Total score ranges from zero (best) to 24 (worst); scale has 8 items, each rated from zero (no chance of dozing) to 3 (high chance of dozing)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Modified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX ER (Previous Placebo)', 'description': 'Pramipexole ER Treatment with placebo in previous trial'}, {'id': 'OG001', 'title': 'PPX ER (Previous PPX ER)', 'description': 'Pramipexole ER Treatment with Pramipexole ER in previous trial'}, {'id': 'OG002', 'title': 'PPX ER (Previous PPX IR)', 'description': 'Pramipexole ER Treatment with Pramipexole IR in previous trial'}], 'classes': [{'title': 'Abnormal behavior - pathological gambling', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Abnormal behavior - compulsive buying', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Abnormal behavior - compulsive sexual behavior', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 80 weeks', 'description': 'The mMIDI is a semi-structured interview designed to assess impulsive control disorders. The scale was modified to focus behaviors of: pathological gambling, compulsive buying and compulsive sexual behavioral.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set - all patients dispensed drug and documented to have taken at least one dose'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PPX ER (Previous Placebo)', 'description': 'Pramipexole ER Treatment with placebo in previous trial'}, {'id': 'FG001', 'title': 'PPX ER (Previous PPX ER)', 'description': 'Pramipexole ER Treatment with Pramipexole ER in previous trial'}, {'id': 'FG002', 'title': 'PPX ER (Previous PPX IR)', 'description': 'Pramipexole ER Treatment with Pramipexole Immediate Release (IR) in previous trial'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}, {'groupId': 'FG001', 'numSubjects': '123'}, {'groupId': 'FG002', 'numSubjects': '139'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '113'}, {'groupId': 'FG001', 'numSubjects': '104'}, {'groupId': 'FG002', 'numSubjects': '112'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '27'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}, {'value': '391', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'PPX ER (Previous Placebo)', 'description': 'Pramipexole ER Treatment with placebo in previous trial'}, {'id': 'BG001', 'title': 'PPX ER (Previous PPX ER)', 'description': 'Pramipexole ER Treatment with Pramipexole ER in previous trial'}, {'id': 'BG002', 'title': 'PPX ER (Previous PPX IR)', 'description': 'Pramipexole ER Treatment with Pramipexole IR in previous trial'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.3', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '61.7', 'spread': '9.8', 'groupId': 'BG001'}, {'value': '61.8', 'spread': '9.7', 'groupId': 'BG002'}, {'value': '61.6', 'spread': '9.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '178', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '213', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated Set, all patients dispensed study drug and documented to have taken at least one dose'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 391}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'lastUpdateSubmitDate': '2014-05-07', 'studyFirstSubmitDate': '2007-12-19', 'resultsFirstSubmitDate': '2011-06-16', 'studyFirstSubmitQcDate': '2007-12-19', 'lastUpdatePostDateStruct': {'date': '2014-05-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-06-16', 'studyFirstPostDateStruct': {'date': '2007-12-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events', 'timeFrame': '80 weeks', 'description': "The aim of this study was to obtain long-term safety and tolerability data on pramipexole ER, in patients who have previously completed a pramipexole double blind study in advanced Parkinson's Disease (PD) (248.525 (NCT00466167)). Therefore these items were considered as a safety evaluation."}], 'secondaryOutcomes': [{'measure': 'Patients Successfully Switched From Pramipexole (PPX) IR or ER to ER Assessed on UPDRS II+III', 'timeFrame': 'One week', 'description': "Unified Parkinson's Disease Rating Scale (UPDRS) Successfully switched means: UPDRS II+III baseline score \\>20 without a relative worsening of UPDRS II+III score \\> 15% from baseline or UPDRS II+III baseline score \\<=20 without an absolute worsening of UPDRS II+III score \\> 3 from baseline UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms"}, {'measure': 'UPDRS II+III Change From Open Label (OL) Baseline', 'timeFrame': 'OL Baseline and week 80', 'description': 'UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms'}, {'measure': 'Number of Participants With UPDRS II+III Response', 'timeFrame': 'Week 80', 'description': 'A response means an improvement of \\>=20% in UPDRS II+III from OL baseline UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms'}, {'measure': 'Number of Patients Successfully Switched From PPX IR or ER to ER Assessed on Off-time', 'timeFrame': 'One week', 'description': 'A patient was considered as successfully switched if he/she has converted to ER without a worsening of off time by more than 12.5% from baseline. Off-time is based on patient diary data and describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).'}, {'measure': 'Percentage Off Time During Waking Hours Total Score: Change From Baseline', 'timeFrame': 'Baseline and week 80', 'description': 'Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).\n\nA negative change implies improvement'}, {'measure': 'Number of Participants With Response in Percentage Off Time During Waking Hours', 'timeFrame': '80 weeks', 'description': 'Response means \\>=20% improvement relative to OL baseline in the % off-time during waking hours'}, {'measure': 'Percentage on Time Without Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks', 'timeFrame': 'Baseline and week 80', 'description': 'Percentage on-time based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement.'}, {'measure': 'Percentage on Time With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks', 'timeFrame': 'Baseline and week 80', 'description': 'Percentage on-time with non troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement'}, {'measure': 'Percentage on Time Without Dyskinesia or With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks', 'timeFrame': 'Baseline and week 80', 'description': 'Percentage on-time without dyskinesia or with non troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement'}, {'measure': 'Percentage on Time With Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks', 'timeFrame': 'Baseline and week 80', 'description': 'Percentage on-time with troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement'}, {'measure': 'Number of Participants With Response in CGI-I', 'timeFrame': '32 weeks', 'description': 'Clinical Global Impression of Improvement (CGI-I), CGI-I scores ranging from \'1\' (very much improved) to \'7\' (very much worse). For patients previously treated with Placebo, all patients with at least "much improved" were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much improved were considered as responders'}, {'measure': 'Number of Participants With Response in PGI-I', 'timeFrame': '32 weeks', 'description': 'Patient Global Impression of Improvement (PGI-I), PGI-I scores ranging from \'1\' (very much better) to \'7\' (very much worse). For patients previously treated with Placebo, all patients with at least "much better" were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much better were considered as responders'}, {'measure': 'Number of Participants With Response in PGI-I for Early Morning Off Symptoms', 'timeFrame': '32 weeks', 'description': 'Patient Global Impression of Improvement (PGI-I) for early morning off symptoms, PGI-I scores ranging from \'1\' (very much better) to \'7\' (very much worse). For patients previously treated with Placebo, all patients with at least "much better" were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much better were considered as responders'}, {'measure': 'UPDRS I Total Score and Change From OL Baseline at Week 80', 'timeFrame': 'OL baseline and week 80', 'description': 'UPDRS I ranging from 0 (normal) to 16 (severe). UPDRS I measures Mentation, Behavior and Mood'}, {'measure': 'UPDRS II Total Score and Change From OL Baseline at Week 80', 'timeFrame': 'OL baseline and week 80', 'description': 'UPDRS II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS part II at on and UPDRS part II at off-period for each of the 13 activities'}, {'measure': 'UPDRS III Total Score and Change From OL Baseline at Week 80', 'timeFrame': 'OL baseline and week 80', 'description': 'UPDRS III ranging from 0 (normal) to 108 (severe). UPDRS part III measures motor symptoms'}, {'measure': 'UPDRS IV Total Score and Change From OL Baseline at Week 80', 'timeFrame': 'OL baseline and week 80', 'description': 'UPDRS IV ranging from 0 (normal) to 23 (severe). UPDRS IV measures complications of therapy'}, {'measure': 'Parkinson Fatigue Scale (PFS-16) Score and Change From OL Baseline at Week 80', 'timeFrame': 'OL baseline and week 80', 'description': 'PFS-16 (Parkinson fatigue scale) ranging from 16 (better perceived health status) to 80 (severe symptoms of the disease) measuring aspects of fatigue that are relevant to patients with PD'}, {'measure': 'Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80', 'timeFrame': 'OL baseline and week 80'}, {'measure': 'Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline', 'timeFrame': 'OL baseline and week 80'}, {'measure': 'Number of Participants With Serious Adverse Events', 'timeFrame': '80 weeks'}, {'measure': 'Supine Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set', 'timeFrame': 'OL Baseline and Week 80'}, {'measure': 'Standing Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set', 'timeFrame': 'OL Baseline and Week 80'}, {'measure': 'Supine Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set', 'timeFrame': 'OL Baseline and Week 80'}, {'measure': 'Standing Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set', 'timeFrame': 'OL Baseline and Week 80'}, {'measure': 'Supine Pulse Rate, Baseline and Week 80, Vital Signs Treated Set', 'timeFrame': 'OL Baseline and Week 80'}, {'measure': 'Standing Pulse Rate, Baseline and Week 80, Vital Signs Treated Set', 'timeFrame': 'OL Baseline and Week 80'}, {'measure': 'Body Weight of Female Patients, Baseline and Week 80, Vital Signs Treated Set', 'timeFrame': 'OL Baseline and Week 80'}, {'measure': 'Body Weight of Male Patients, Baseline and Week 80, Vital Signs Treated Set', 'timeFrame': 'OL Baseline and Week 80'}, {'measure': 'Epworth Sleepiness Scale (ESS), Baseline and End of Open Label, Treated Set', 'timeFrame': 'OL Baseline and Week 80', 'description': 'ESS Total score ranges from zero (best) to 24 (worst); scale has 8 items, each rated from zero (no chance of dozing) to 3 (high chance of dozing)'}, {'measure': 'Modified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set', 'timeFrame': 'Baseline, 80 weeks', 'description': 'The mMIDI is a semi-structured interview designed to assess impulsive control disorders. The scale was modified to focus behaviors of: pathological gambling, compulsive buying and compulsive sexual behavioral.'}]}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "The general aim of this study is to obtain long-term safety and tolerability data on pramipexole extended release (ER), in daily doses from 0.375mg to 4.5mg once daily (qd), in patients who have previously completed a pramipexole double-blind study in advanced Parkinson's disease (PD) (248.525 trial)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '32 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n1. Completion of the double-blind trial 248.525\n2. Male or female patient with advanced idiopathic Parkinson's disease (PD), with a Modified Hoehn and Yahr stage of 2 to 4 at on-time, and a concomitant treatment with standard or controlled release L-Dopa+, or a combination of L-Dopa+ and entacapone.\n3. Patient willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. In particular the patient should be able to recognise the off-time and on-time periods during waking hours and the patient (or a family member or a guardian) should be able to record them accurately in the patient diary.\n4. Signed informed consent obtained before any study procedures are carried out (in accordance with International Conference of Harmonization - Good Clinical Practice (ICH-GCP) guidelines and local legislation).\n\nExclusion criteria:\n\n1. Patients prematurely withdrawn from the double-blind trial 248.525\n2. Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases\n3. Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria that could prevent compliance or completion of the study and/or put the patient at risk if he/she takes part in the study\n4. History of psychosis, except history of drug induced hallucinations\n5. History of deep brain stimulation\n6. Clinically significant ECG abnormalities at baseline\n7. Clinically significant hypotension and/or symptomatic orthostatic hypotension at baseline\n8. Malignant melanoma or history of previously treated malignant melanoma\n9. Any other clinically significant disease, whether treated or not, that could put the patient at risk or could prevent compliance or completion of the study\n10. Pregnancy or breast-feeding\n11. Sexually active female of childbearing potential not using a medically approved method of birth control\n12. Serum levels of aspartate transaminase (AST) (serum glutamic oxaloacetic transaminase (SGOT)), alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase) (SGPT)), alkaline phosphatase (AP) or bilirubin \\> 2 upper limit normal (ULN) at baseline\n13. Patients with a creatinine clearance \\< 50 mL/min at baseline\n14. Any medication with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit\n15. Any of the following drugs within 4 weeks prior to baseline visit: methylphenidate, cinnarizine, amphetamines\n16. Flunarizine within 3 months prior to baseline\n17. Known hypersensitivity to pramipexole or its excipients\n18. Drug abuse, according to investigators judgement, within 2 years prior to baseline\n19. Participation in investigational drug studies other than the trial 248.525, or use of other investigational drugs within one month or five times the half-life of the investigational drug (whichever is longer) prior to baseline"}, 'identificationModule': {'nctId': 'NCT00577460', 'briefTitle': 'Long-term Safety Study of Open-label Pramipexole ER in Patients With Advanced PD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': "Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Advanced Parkinson's Disease (PD)", 'orgStudyIdInfo': {'id': '248.634'}, 'secondaryIdInfos': [{'id': '2007-004235-37', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pramipexole', 'description': 'Patients to receive Pramipexole ER 0.375 - 4.5 mg in tablet form daily', 'interventionNames': ['Drug: Pramipexole']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients to receive placebo tablets identical to Pramipexole ER tablets only during transfer phase', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Pramipexole', 'type': 'DRUG', 'description': 'Pramipexole ER 0.375 -4.5 mg', 'armGroupLabels': ['Pramipexole']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablets identical to Pramipexole ER tablets', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Linz', 'country': 'Austria', 'facility': '248.634.43005 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'city': 'Pardubice', 'country': 'Czechia', 'facility': '248.634.42003 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.04075, 'lon': 15.77659}}, {'city': 'Prague', 'country': 'Czechia', 'facility': '248.634.42001 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Rakovník', 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