Ignite Creation Date:
2025-12-25 @ 4:47 AM
Ignite Modification Date:
2026-03-08 @ 11:00 PM
Study NCT ID:
NCT02231918
Status:
COMPLETED
Last Update Posted:
2015-10-06
First Post:
2014-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Investigate Pharmacokinetics (PK) of Pramipexole in Pediatric Patients Who Are Individually Optimized to Stable Pramipexole Doses for the Treatment of Idiopathic Restless Legs Syndrome (RLS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012148', 'term': 'Restless Legs Syndrome'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, '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': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first drug administration until 24 hours after last study drug administration, upto 48 days', 'eventGroups': [{'id': 'EG000', 'title': 'MIRAPEX® (0.125 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.', 'otherNumAtRisk': 9, 'otherNumAffected': 2, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'MIRAPEX® (0.25 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.', 'otherNumAtRisk': 15, 'otherNumAffected': 3, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'MIRAPEX® (0.5 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.', 'otherNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}, {'term': 'Infusion site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}, {'term': 'Infusion site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}, {'term': 'Infusion site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}, {'term': 'Vessel puncture site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}, {'term': 'Vessel puncture site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 10.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cmax,ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX (MIRAPEX®, 0.125 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG001', 'title': 'PPX (MIRAPEX®, 0.25 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG002', 'title': 'PPX (MIRAPEX®, 0.5 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.'}], 'classes': [{'title': '6 to <12 years (N=5, 9, 0)', 'categories': [{'measurements': [{'value': '0.633', 'spread': '26.2', 'groupId': 'OG000'}, {'value': '1.13', 'spread': '35.3', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No patients were recruited for this category.', 'groupId': 'OG002'}]}]}, {'title': '12 to <18 years(N=4, 6, 2))', 'categories': [{'measurements': [{'value': '0.396', 'spread': '30.0', 'groupId': 'OG000'}, {'value': '0.677', 'spread': '40.3', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The reliable estimation can only be performed when at least 2/3 of the data are available and thus the geometric mean (gMean) and geometric coefficient of variation (gCV) is not calculated according to internal rules.', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.', 'description': 'Maximum concentration of the Pramipexole (PPX) in plasma at steady state over a uniform dosing interval (Cmax,ss).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.'}, {'type': 'PRIMARY', 'title': 'Cmin,ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX (MIRAPEX®, 0.125 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG001', 'title': 'PPX (MIRAPEX®, 0.25 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG002', 'title': 'PPX (MIRAPEX®, 0.5 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.'}], 'classes': [{'title': '6 to <12 years (N=5, 9, 0)', 'categories': [{'measurements': [{'value': '0.0872', 'spread': '35.5', 'groupId': 'OG000'}, {'value': '0.136', 'spread': '99.5', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No patients were recruited for this category.', 'groupId': 'OG002'}]}]}, {'title': '12 to <18 years(N=4, 6, 2)', 'categories': [{'measurements': [{'value': '0.0972', 'spread': '37.5', 'groupId': 'OG000'}, {'value': '0.122', 'spread': '53.8', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.', 'description': 'Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval (Cmin,ss).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.'}, {'type': 'PRIMARY', 'title': 'Cpre,N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX (MIRAPEX®, 0.125 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG001', 'title': 'PPX (MIRAPEX®, 0.25 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG002', 'title': 'PPX (MIRAPEX®, 0.5 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.'}], 'classes': [{'title': '6 to <12 years (N=4, 8, 0)', 'categories': [{'measurements': [{'value': '0.074', 'spread': '17.3', 'groupId': 'OG000'}, {'value': '0.147', 'spread': '75.3', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No patients were recruited for this category.', 'groupId': 'OG002'}]}]}, {'title': '12 to <18 years (N=1, 5, 1)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.', 'groupId': 'OG000'}, {'value': '0.112', 'spread': '60.7', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.', 'description': 'Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N (Cpre,N).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.'}, {'type': 'PRIMARY', 'title': 'Cavg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX (MIRAPEX®, 0.125 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG001', 'title': 'PPX (MIRAPEX®, 0.25 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG002', 'title': 'PPX (MIRAPEX®, 0.5 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.'}], 'classes': [{'title': '6 to <12 years (N=5, 8, 0)', 'categories': [{'measurements': [{'value': '0.213', 'spread': '27.4', 'groupId': 'OG000'}, {'value': '0.458', 'spread': '42.8', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No patients were recruited for this category.', 'groupId': 'OG002'}]}]}, {'title': '12 to <18 years (N=4, 6, 1)', 'categories': [{'measurements': [{'value': '0.137', 'spread': '21.3', 'groupId': 'OG000'}, {'value': '0.309', 'spread': '35.2', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.', 'description': 'Average concentration of the analyte in plasma at steady state (Cavg).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.'}, {'type': 'PRIMARY', 'title': 'Tmax,ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX (MIRAPEX®, 0.125 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG001', 'title': 'PPX (MIRAPEX®, 0.25 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG002', 'title': 'PPX (MIRAPEX®, 0.5 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.'}], 'classes': [{'title': '6 to <12 years (N=5, 9, 0)', 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '2.00'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '3.00'}, {'value': 'NA', 'comment': 'No patients were recruited for this category.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '12 to <18 years (N=4, 6, 2)', 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '2.00'}, {'value': '1.96', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '5.00'}, {'value': 'NA', 'comment': 'The reliable estimation can only be performed when at least 2/3 of the data are available and thus the median and range are not calculated according to internal rules.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.', 'description': 'Time from dosing to maximum concentration at steady state (Tmax,ss).', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.'}, {'type': 'PRIMARY', 'title': 'Tmin,ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX (MIRAPEX®, 0.125 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG001', 'title': 'PPX (MIRAPEX®, 0.25 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG002', 'title': 'PPX (MIRAPEX®, 0.5 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.'}], 'classes': [{'title': '6 to <12 years (N=5, 9, 0)', 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '24.0'}, {'value': '24.0', 'groupId': 'OG001', 'lowerLimit': '0.25', 'upperLimit': '24.0'}, {'value': 'NA', 'comment': 'No patients were recruited for this category.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '12 to <18 years (N=4, 6, 2)', 'categories': [{'measurements': [{'value': '6.25', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '12.0'}, {'value': '23.9', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '24.0'}, {'value': 'NA', 'comment': 'The reliable estimation can only be performed when at least 2/3 of the data are available and thus the median and range are not calculated according to internal rules.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.', 'description': 'Time from dosing to minimum concentration at steady state (Tmin,ss ).', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PK): All evaluable subjects who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.'}, {'type': 'PRIMARY', 'title': 'AUCτ,ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX (MIRAPEX®, 0.125 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG001', 'title': 'PPX (MIRAPEX®, 0.25 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG002', 'title': 'PPX (MIRAPEX®, 0.5 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.'}], 'classes': [{'title': '6 to <12 years (N=5, 8, 0)', 'categories': [{'measurements': [{'value': '5.12', 'spread': '27.4', 'groupId': 'OG000'}, {'value': '11.0', 'spread': '42.8', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No patients were recruited for this category.', 'groupId': 'OG002'}]}]}, {'title': '12 to <18 years (N=4, 6, 1)', 'categories': [{'measurements': [{'value': '3.28', 'spread': '21.3', 'groupId': 'OG000'}, {'value': '7.42', 'spread': '35.2', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0.25h before the drug administration on day 1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on Day 1.', 'description': 'Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval (AUCτ,ss ).', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.'}, {'type': 'PRIMARY', 'title': 'λz,ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX (MIRAPEX®, 0.125 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG001', 'title': 'PPX (MIRAPEX®, 0.25 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG002', 'title': 'PPX (MIRAPEX®, 0.5 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.'}], 'classes': [{'title': '6 to <12 years (N=5, 8, 0)', 'categories': [{'measurements': [{'value': '0.132', 'spread': '22.6', 'groupId': 'OG000'}, {'value': '0.107', 'spread': '20.1', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No patients were recruited for this category.', 'groupId': 'OG002'}]}]}, {'title': '12 to <18 years (N=4, 6, 1)', 'categories': [{'measurements': [{'value': '0.113', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '0.0938', 'spread': '25.4', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.', 'description': 'Terminal rate constant in plasma at steady state (λz,ss ).', 'unitOfMeasure': '1/h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.'}, {'type': 'PRIMARY', 'title': 't1/2,ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX (MIRAPEX®, 0.125 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG001', 'title': 'PPX (MIRAPEX®, 0.25 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG002', 'title': 'PPX (MIRAPEX®, 0.5 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.'}], 'classes': [{'title': '6 to <12 years (N=5, 8, 0)', 'categories': [{'measurements': [{'value': '5.26', 'spread': '22.6', 'groupId': 'OG000'}, {'value': '6.50', 'spread': '20.1', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No patients were recruited for this category.', 'groupId': 'OG002'}]}]}, {'title': '12 to <18 years (N=4, 6, 1)', 'categories': [{'measurements': [{'value': '6.13', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '7.39', 'spread': '25.4', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.', 'description': 'Terminal half-life of the analyte in plasma at steady state (t1/2,ss ).', 'unitOfMeasure': 'hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.'}, {'type': 'PRIMARY', 'title': 'MRTpo,ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX (MIRAPEX®, 0.125 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG001', 'title': 'PPX (MIRAPEX®, 0.25 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG002', 'title': 'PPX (MIRAPEX®, 0.5 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.'}], 'classes': [{'title': '6 to <12 years (N=5, 8, 0)', 'categories': [{'measurements': [{'value': '8.19', 'spread': '13.1', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '19.5', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No patients were recruited for this category.', 'groupId': 'OG002'}]}]}, {'title': '12 to <18 years (N=4, 6, 1)', 'categories': [{'measurements': [{'value': '9.47', 'spread': '5.30', 'groupId': 'OG000'}, {'value': '11.6', 'spread': '23.3', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.', 'description': 'Mean residence time of the analyte in the body at steady state (MRTpo,ss).', 'unitOfMeasure': 'h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.'}, {'type': 'PRIMARY', 'title': 'CL/F,ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX (MIRAPEX®, 0.125 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG001', 'title': 'PPX (MIRAPEX®, 0.25 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG002', 'title': 'PPX (MIRAPEX®, 0.5 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.'}], 'classes': [{'title': '6 to <12 years (N=5, 8, 0)', 'categories': [{'measurements': [{'value': '284', 'spread': '27.4', 'groupId': 'OG000'}, {'value': '265', 'spread': '42.8', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No patients were recruited for this category.', 'groupId': 'OG002'}]}]}, {'title': '12 to <18 years (N=4, 6, 1)', 'categories': [{'measurements': [{'value': '444', 'spread': '21.3', 'groupId': 'OG000'}, {'value': '393', 'spread': '35.2', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.', 'description': 'Apparent clearance of the analyte in the plasma after extravascular administration at steady state; F = absolute bioavailability factor (CL/F,ss ).', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.'}, {'type': 'PRIMARY', 'title': 'Vz/F,ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX (MIRAPEX®, 0.125 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG001', 'title': 'PPX (MIRAPEX®, 0.25 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG002', 'title': 'PPX (MIRAPEX®, 0.5 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.'}], 'classes': [{'title': '6 to <12 years (N=5, 8, 0)', 'categories': [{'measurements': [{'value': '129', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '149', 'spread': '29.7', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No patients were recruited for this category.', 'groupId': 'OG002'}]}]}, {'title': '12 to <18 years (N=4, 6,1)', 'categories': [{'measurements': [{'value': '236', 'spread': '19.4', 'groupId': 'OG000'}, {'value': '251', 'spread': '37.3', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.', 'description': 'Apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state (Vz/F,ss ).', 'unitOfMeasure': 'L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.'}, {'type': 'PRIMARY', 'title': 'Ae 0-12,ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX (MIRAPEX®, 0.125 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG001', 'title': 'PPX (MIRAPEX®, 0.25 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG002', 'title': 'PPX (MIRAPEX®, 0.5 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.'}], 'classes': [{'title': '6 to <12 years (N=4, 6, 0)', 'categories': [{'measurements': [{'value': '50600', 'spread': '14.6', 'groupId': 'OG000'}, {'value': '123000', 'spread': '50.7', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No patients were recruited for this category.', 'groupId': 'OG002'}]}]}, {'title': '12 to <18 years (N=3, 6, 0)', 'categories': [{'measurements': [{'value': '55200', 'spread': '41.5', 'groupId': 'OG000'}, {'value': '82300', 'spread': '52.7', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No data was available of any patients for this category, so there was no data to analyse.', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '12 hours after last study drug administration on day 1', 'description': 'Amount of analyte that is eliminated in urine at steady state over a time interval t1to t2 (0-12h).', 'unitOfMeasure': 'ng', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.'}, {'type': 'PRIMARY', 'title': 'fe 0-12,ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX (MIRAPEX®, 0.125 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG001', 'title': 'PPX (MIRAPEX®, 0.25 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG002', 'title': 'PPX (MIRAPEX®, 0.5 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.'}], 'classes': [{'title': '6 to <12 years (N=4, 2, 0)', 'categories': [{'measurements': [{'value': '58.0', 'spread': '14.6', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No patients were recruited for this category.', 'groupId': 'OG002'}]}]}, {'title': '12 to <18 years (N=2, 5, 0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.', 'groupId': 'OG000'}, {'value': '42.0', 'spread': '48.1', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No data was available of any patients for this category, so there was no data to analyse.', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '12 hours after last study drug administration on day 1.', 'description': 'Fraction of administered drug excreted unchanged in urine at steady state over a time interval t1 to t2 (fe 0-12,ss ).', 'unitOfMeasure': '% of PPX excreted', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.'}, {'type': 'PRIMARY', 'title': 'CLR,ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX (MIRAPEX®, 0.125 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG001', 'title': 'PPX (MIRAPEX®, 0.25 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG002', 'title': 'PPX (MIRAPEX®, 0.5 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.'}], 'classes': [{'title': '6 to <12 years (N=4, 2, 0)', 'categories': [{'measurements': [{'value': '201', 'spread': '34.1', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No subjects were recruited for this category.', 'groupId': 'OG002'}]}]}, {'title': '12 to <18 years (N=2, 5, 0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.', 'groupId': 'OG000'}, {'value': '253', 'spread': '34.1', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No data was available of any patients for this category, so there was no data to analyse.', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '12h after last study drug administration on day 1', 'description': 'Renal clearance of the analyte at steady state (CLR(0-12),ss ).', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.'}, {'type': 'PRIMARY', 'title': 'PTF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX (MIRAPEX®, 0.125 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG001', 'title': 'PPX (MIRAPEX®, 0.25 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG002', 'title': 'PPX (MIRAPEX®, 0.5 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.'}], 'classes': [{'title': '6 to <12 years (N=5, 8, 0)', 'categories': [{'measurements': [{'value': '250', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '209', 'spread': '31.8', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No subjects were recruited for this category.', 'groupId': 'OG002'}]}]}, {'title': '12 to <18 years (N=4, 6, 1)', 'categories': [{'measurements': [{'value': '216', 'spread': '24.0', 'groupId': 'OG000'}, {'value': '168', 'spread': '34.2', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.', 'description': 'Peak-trough fluctuation (PTF) is defined as the difference between Cmax and Cmin divided by Cavg and multiplied with 100% at steady-state.', 'unitOfMeasure': '% of PTF', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Drug Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX (MIRAPEX®, 0.125 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG001', 'title': 'PPX (MIRAPEX®, 0.25 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG002', 'title': 'PPX (MIRAPEX®, 0.5 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first drug administration until 24 hours after last study drug administration, upto 48 days', 'description': 'Number of patients with adverse events due to study drug.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set: The safety population comprised all patients who provided informed consent and received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Vital Signs (Systolic and Diastolic Blood Pressure)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX (MIRAPEX®, 0.125 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG001', 'title': 'PPX (MIRAPEX®, 0.25 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG002', 'title': 'PPX (MIRAPEX®, 0.5 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.'}], 'classes': [{'title': 'Systolic blood pressure-supine(N= 9,15,2): -0:15h', 'categories': [{'measurements': [{'value': '109.33', 'spread': '6.76', 'groupId': 'OG000'}, {'value': '109.20', 'spread': '10.80', 'groupId': 'OG001'}, {'value': '117.00', 'spread': '4.24', 'groupId': 'OG002'}]}]}, {'title': 'Systolic blood pressure-supine(N= 9,15,2): 0:30h', 'categories': [{'measurements': [{'value': '112.89', 'spread': '13.90', 'groupId': 'OG000'}, {'value': '110.33', 'spread': '14.07', 'groupId': 'OG001'}, {'value': '116.00', 'spread': '4.24', 'groupId': 'OG002'}]}]}, {'title': 'Systolic blood pressure-supine(N= 9,15,2): 1:00h', 'categories': [{'measurements': [{'value': '113.00', 'spread': '11.07', 'groupId': 'OG000'}, {'value': '108.07', 'spread': '12.92', 'groupId': 'OG001'}, {'value': '105.50', 'spread': '0.71', 'groupId': 'OG002'}]}]}, {'title': 'Systolic blood pressure-supine(N= 9,15,2): 2:00h', 'categories': [{'measurements': [{'value': '111.00', 'spread': '7.43', 'groupId': 'OG000'}, {'value': '111.93', 'spread': '13.79', 'groupId': 'OG001'}, {'value': '113.00', 'spread': '9.90', 'groupId': 'OG002'}]}]}, {'title': 'Systolic blood pressure-supine(N= 9,15,1): 3:00h', 'categories': [{'measurements': [{'value': '106.89', 'spread': '10.40', 'groupId': 'OG000'}, {'value': '110.53', 'spread': '11.34', 'groupId': 'OG001'}, {'value': '113.00', 'spread': 'NA', 'comment': 'The data of only one patient is available and thus Standard Deviation is not calculable.', 'groupId': 'OG002'}]}]}, {'title': 'Systolic blood pressure-supine(N= 9,15,1): 5:00h', 'categories': [{'measurements': [{'value': '105.11', 'spread': '12.71', 'groupId': 'OG000'}, {'value': '108.80', 'spread': '14.89', 'groupId': 'OG001'}, {'value': '104.00', 'spread': 'NA', 'comment': 'The data of only one patient is available and thus Standard Deviation is not calculable.', 'groupId': 'OG002'}]}]}, {'title': 'Systolic blood pressure-supine(N= 9,14,1): 7:00h', 'categories': [{'measurements': [{'value': '108.44', 'spread': '12.27', 'groupId': 'OG000'}, {'value': '109.86', 'spread': '14.11', 'groupId': 'OG001'}, {'value': '108.00', 'spread': 'NA', 'comment': 'The data of only one patient is available and thus Standard Deviation is not calculable.', 'groupId': 'OG002'}]}]}, {'title': 'Systolic blood pressure-supine(N= 9,14,1): 12:00h', 'categories': [{'measurements': [{'value': '107.56', 'spread': '16.38', 'groupId': 'OG000'}, {'value': '106.93', 'spread': '16.28', 'groupId': 'OG001'}, {'value': '109.00', 'spread': 'NA', 'comment': 'The data of only one patient is available and thus Standard Deviation is not calculable.', 'groupId': 'OG002'}]}]}, {'title': 'Systolic blood pressure-supine(N= 9,14,1): 24:00h', 'categories': [{'measurements': [{'value': '109.22', 'spread': '11.38', 'groupId': 'OG000'}, {'value': '112.21', 'spread': '13.76', 'groupId': 'OG001'}, {'value': '120.00', 'spread': 'NA', 'comment': 'The data of only one patient is available and thus Standard Deviation is not calculable.', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure-supine(N= 9,15,2): -0:15', 'categories': [{'measurements': [{'value': '66.67', 'spread': '7.35', 'groupId': 'OG000'}, {'value': '65.73', 'spread': '10.19', 'groupId': 'OG001'}, {'value': '76.00', 'spread': '0.00', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure-supine(N= 9,15,2): 0:30', 'categories': [{'measurements': [{'value': '68.67', 'spread': '8.93', 'groupId': 'OG000'}, {'value': '65.80', 'spread': '12.62', 'groupId': 'OG001'}, {'value': '73.00', 'spread': '2.83', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure-supine(N= 9,15,2): 1:00', 'categories': [{'measurements': [{'value': '69.33', 'spread': '6.52', 'groupId': 'OG000'}, {'value': '65.73', 'spread': '7.80', 'groupId': 'OG001'}, {'value': '64.00', 'spread': '12.73', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure-supine(N= 9,15,2): 2:00', 'categories': [{'measurements': [{'value': '66.00', 'spread': '8.23', 'groupId': 'OG000'}, {'value': '65.80', 'spread': '8.76', 'groupId': 'OG001'}, {'value': '75.00', 'spread': '8.49', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure-supine(N= 9,15,1): 3:00', 'categories': [{'measurements': [{'value': '66.78', 'spread': '9.36', 'groupId': 'OG000'}, {'value': '65.40', 'spread': '9.96', 'groupId': 'OG001'}, {'value': '75.00', 'spread': 'NA', 'comment': 'The data of only one patient is available and thus Standard Deviation is not calculable.', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure-supine(N= 9,15,1): 5:00', 'categories': [{'measurements': [{'value': '64.22', 'spread': '9.83', 'groupId': 'OG000'}, {'value': '63.87', 'spread': '9.78', 'groupId': 'OG001'}, {'value': '70.00', 'spread': 'NA', 'comment': 'The data of only one patient is available and thus Standard Deviation is not calculable.', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure-supine(N= 9,14,1): 7:00', 'categories': [{'measurements': [{'value': '67.56', 'spread': '13.47', 'groupId': 'OG000'}, {'value': '62.43', 'spread': '8.08', 'groupId': 'OG001'}, {'value': '67.00', 'spread': 'NA', 'comment': 'The data of only one patient is available and thus Standard Deviation is not calculable.', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure-supine(N= 9,14,1): 12:00', 'categories': [{'measurements': [{'value': '70.00', 'spread': '12.03', 'groupId': 'OG000'}, {'value': '61.00', 'spread': '9.12', 'groupId': 'OG001'}, {'value': '66.00', 'spread': 'NA', 'comment': 'The data of only one patient is available and thus Standard Deviation is not calculable.', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure-supine(N= 9,14,1): 24:00', 'categories': [{'measurements': [{'value': '66.56', 'spread': '6.00', 'groupId': 'OG000'}, {'value': '65.71', 'spread': '7.61', 'groupId': 'OG001'}, {'value': '78.00', 'spread': 'NA', 'comment': 'The data of only one patient is available and thus Standard Deviation is not calculable.', 'groupId': 'OG002'}]}]}, {'title': 'Systolic blood pressure-standing(N= 9,15,2):-0:15h', 'categories': [{'measurements': [{'value': '109.89', 'spread': '8.57', 'groupId': 'OG000'}, {'value': '113.93', 'spread': '9.97', 'groupId': 'OG001'}, {'value': '122.00', 'spread': '9.90', 'groupId': 'OG002'}]}]}, {'title': 'Systolic blood pressure-standing(N= 9,15,2): 0:30h', 'categories': [{'measurements': [{'value': '113.56', 'spread': '13.62', 'groupId': 'OG000'}, {'value': '113.67', 'spread': '13.69', 'groupId': 'OG001'}, {'value': '115.50', 'spread': '6.36', 'groupId': 'OG002'}]}]}, {'title': 'Systolic blood pressure-standing(N= 9,15,2): 1:00h', 'categories': [{'measurements': [{'value': '110.11', 'spread': '13.81', 'groupId': 'OG000'}, {'value': '110.07', 'spread': '14.26', 'groupId': 'OG001'}, {'value': '125.50', 'spread': '23.33', 'groupId': 'OG002'}]}]}, {'title': 'Systolic blood pressure-standing(N= 9,15,2): 2:00h', 'categories': [{'measurements': [{'value': '110.33', 'spread': '8.76', 'groupId': 'OG000'}, {'value': '112.27', 'spread': '12.26', 'groupId': 'OG001'}, {'value': '115.00', 'spread': '2.83', 'groupId': 'OG002'}]}]}, {'title': 'Systolic blood pressure-standing(N= 9,15,1): 3:00h', 'categories': [{'measurements': [{'value': '110.11', 'spread': '16.50', 'groupId': 'OG000'}, {'value': '113.07', 'spread': '16.15', 'groupId': 'OG001'}, {'value': '108.00', 'spread': 'NA', 'comment': 'The data of only one patient is available and thus Standard Deviation is not calculable.', 'groupId': 'OG002'}]}]}, {'title': 'Systolic blood pressure-standing(N= 9,14,1): 5:00h', 'categories': [{'measurements': [{'value': '110.22', 'spread': '11.88', 'groupId': 'OG000'}, {'value': '111.93', 'spread': '14.91', 'groupId': 'OG001'}, {'value': '115.00', 'spread': 'NA', 'comment': 'The data of only one patient is available and thus Standard Deviation is not calculable.', 'groupId': 'OG002'}]}]}, {'title': 'Systolic blood pressure-standing(N= 9,13,1): 7:00h', 'categories': [{'measurements': [{'value': '109.11', 'spread': '11.76', 'groupId': 'OG000'}, {'value': '103.85', 'spread': '17.56', 'groupId': 'OG001'}, {'value': '65.00', 'spread': 'NA', 'comment': 'The data of only one patient is available and thus Standard Deviation is not calculable.', 'groupId': 'OG002'}]}]}, {'title': 'Systolic blood pressure-standing(N=9,14,1): 12:00h', 'categories': [{'measurements': [{'value': '108.22', 'spread': '9.59', 'groupId': 'OG000'}, {'value': '107.14', 'spread': '15.83', 'groupId': 'OG001'}, {'value': '100.00', 'spread': 'NA', 'comment': 'The data of only one patient is available and thus Standard Deviation is not calculable.', 'groupId': 'OG002'}]}]}, {'title': 'Systolic blood pressure-standing(N=9,14,1): 24:00h', 'categories': [{'measurements': [{'value': '113.89', 'spread': '11.25', 'groupId': 'OG000'}, {'value': '115.50', 'spread': '14.43', 'groupId': 'OG001'}, {'value': '102.00', 'spread': 'NA', 'comment': 'The data of only one patient is available and thus Standard Deviation is not calculable.', 'groupId': 'OG002'}]}]}, {'title': 'Diastolicblood pressure-standing(N=9,15,2): -0:15h', 'categories': [{'measurements': [{'value': '68.11', 'spread': '11.87', 'groupId': 'OG000'}, {'value': '71.20', 'spread': '8.09', 'groupId': 'OG001'}, {'value': '86.00', 'spread': '0.00', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure-standing(N=9,15,2): 0:30h', 'categories': [{'measurements': [{'value': '70.11', 'spread': '7.44', 'groupId': 'OG000'}, {'value': '69.20', 'spread': '12.11', 'groupId': 'OG001'}, {'value': '80.00', 'spread': '1.41', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure-standing(N=9,15,2): 1:00h', 'categories': [{'measurements': [{'value': '69.22', 'spread': '6.36', 'groupId': 'OG000'}, {'value': '72.00', 'spread': '9.54', 'groupId': 'OG001'}, {'value': '91.00', 'spread': '7.07', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure-standing(N=9,15,2): 2:00h', 'categories': [{'measurements': [{'value': '71.11', 'spread': '8.82', 'groupId': 'OG000'}, {'value': '73.13', 'spread': '9.36', 'groupId': 'OG001'}, {'value': '86.50', 'spread': '3.54', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure-standing(N=9,15,1): 3:00h', 'categories': [{'measurements': [{'value': '72.67', 'spread': '5.94', 'groupId': 'OG000'}, {'value': '71.47', 'spread': '8.98', 'groupId': 'OG001'}, {'value': '79.00', 'spread': 'NA', 'comment': 'The data of only one patient is available and thus Standard Deviation is not calculable.', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure-standing(N=9,14,1): 5:00h', 'categories': [{'measurements': [{'value': '74.00', 'spread': '10.82', 'groupId': 'OG000'}, {'value': '70.57', 'spread': '9.20', 'groupId': 'OG001'}, {'value': '98.00', 'spread': 'NA', 'comment': 'The data of only one patient is available and thus Standard Deviation is not calculable.', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure-standing(N=9,13,1):7:00h', 'categories': [{'measurements': [{'value': '72.00', 'spread': '13.01', 'groupId': 'OG000'}, {'value': '66.69', 'spread': '10.90', 'groupId': 'OG001'}, {'value': '48.00', 'spread': 'NA', 'comment': 'The data of only one patient is available and thus Standard Deviation is not calculable.', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure-standing(N=9,14,1):12:00h', 'categories': [{'measurements': [{'value': '74.33', 'spread': '11.19', 'groupId': 'OG000'}, {'value': '70.07', 'spread': '10.51', 'groupId': 'OG001'}, {'value': '62.00', 'spread': 'NA', 'comment': 'The data of only one patient is available and thus Standard Deviation is not calculable.', 'groupId': 'OG002'}]}]}, {'title': 'Diastolicblood pressure-standing(N=9,14,1):24:00h', 'categories': [{'measurements': [{'value': '73.11', 'spread': '8.13', 'groupId': 'OG000'}, {'value': '73.57', 'spread': '9.62', 'groupId': 'OG001'}, {'value': '84.00', 'spread': 'NA', 'comment': 'The data of only one patient is available and thus Standard Deviation is not calculable.', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '-0:15h(hours) pre-dose, and 0:30h, 1:00h, 2:00h, 3:00h, 5:00h, 7:00h, 12:00h, 24:00h post-dose.', 'description': 'Vital signs (Systolic and diastolic blood pressure (both supine and after standing for 1 minute)).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set: The safety population comprised all patients who provided informed consent and received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Vital Signs (Pulse Rate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX (MIRAPEX®, 0.125 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG001', 'title': 'PPX (MIRAPEX®, 0.25 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'OG002', 'title': 'PPX (MIRAPEX®, 0.5 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.'}], 'classes': [{'title': 'Pulse rate-supine(N=9,15,2): -0:15h', 'categories': [{'measurements': [{'value': '82.4', 'spread': '18.6', 'groupId': 'OG000'}, {'value': '73.3', 'spread': '6.8', 'groupId': 'OG001'}, {'value': '75.5', 'spread': '24.7', 'groupId': 'OG002'}]}]}, {'title': 'Pulse rate-supine(N=9,15,2): 0:30h', 'categories': [{'measurements': [{'value': '76.7', 'spread': '17.5', 'groupId': 'OG000'}, {'value': '78.0', 'spread': '11.7', 'groupId': 'OG001'}, {'value': '92.0', 'spread': '32.5', 'groupId': 'OG002'}]}]}, {'title': 'Pulse rate-supine(N=9,15,2): 1:00h', 'categories': [{'measurements': [{'value': '82.7', 'spread': '22.2', 'groupId': 'OG000'}, {'value': '75.2', 'spread': '6.8', 'groupId': 'OG001'}, {'value': '87.0', 'spread': '36.8', 'groupId': 'OG002'}]}]}, {'title': 'Pulse rate-supine(N=9,15,2): 2:00h', 'categories': [{'measurements': [{'value': '85.4', 'spread': '19.6', 'groupId': 'OG000'}, {'value': '77.9', 'spread': '8.0', 'groupId': 'OG001'}, {'value': '94.5', 'spread': '26.2', 'groupId': 'OG002'}]}]}, {'title': 'Pulse rate-supine(N=9,15,1): 3:00h', 'categories': [{'measurements': [{'value': '89.3', 'spread': '19.1', 'groupId': 'OG000'}, {'value': '79.9', 'spread': '13.6', 'groupId': 'OG001'}, {'value': '72.0', 'spread': 'NA', 'comment': 'The data of only one patient is available and thus Standard Deviation is not calculable.', 'groupId': 'OG002'}]}]}, {'title': 'Pulse rate-supine(N=9,15,1): 5:00h', 'categories': [{'measurements': [{'value': '82.7', 'spread': '16.0', 'groupId': 'OG000'}, {'value': '75.9', 'spread': '6.9', 'groupId': 'OG001'}, {'value': '77.0', 'spread': 'NA', 'comment': 'The data of only one patient is available and thus Standard Deviation is not calculable.', 'groupId': 'OG002'}]}]}, {'title': 'Pulse rate-supine(N=9,14,1): 7:00h', 'categories': [{'measurements': [{'value': '88.1', 'spread': '18.1', 'groupId': 'OG000'}, {'value': '72.0', 'spread': '9.0', 'groupId': 'OG001'}, {'value': '78.0', 'spread': 'NA', 'comment': 'The data of only one patient is available and thus Standard Deviation is not calculable.', 'groupId': 'OG002'}]}]}, {'title': 'Pulse rate-supine(N=9,14,1): 12:00h', 'categories': [{'measurements': [{'value': '77.8', 'spread': '15.2', 'groupId': 'OG000'}, {'value': '68.6', 'spread': '6.2', 'groupId': 'OG001'}, {'value': '69.0', 'spread': 'NA', 'comment': 'The data of only one patient is available and thus Standard Deviation is not calculable.', 'groupId': 'OG002'}]}]}, {'title': 'Pulse rate-supine(N=9,14,1): 24:00h', 'categories': [{'measurements': [{'value': '77.9', 'spread': '13.6', 'groupId': 'OG000'}, {'value': '77.6', 'spread': '8.5', 'groupId': 'OG001'}, {'value': '77.0', 'spread': 'NA', 'comment': 'The data of only one patient is available and thus Standard Deviation is not calculable.', 'groupId': 'OG002'}]}]}, {'title': 'Pulse rate- standing(N=9,15,2):-0:15h', 'categories': [{'measurements': [{'value': '90.8', 'spread': '18.3', 'groupId': 'OG000'}, {'value': '79.4', 'spread': '8.7', 'groupId': 'OG001'}, {'value': '99.0', 'spread': '22.6', 'groupId': 'OG002'}]}]}, {'title': 'Pulse rate- standing(N=9,15,2): 0:30h', 'categories': [{'measurements': [{'value': '84.7', 'spread': '15.5', 'groupId': 'OG000'}, {'value': '81.5', 'spread': '12.2', 'groupId': 'OG001'}, {'value': '103', 'spread': '27.6', 'groupId': 'OG002'}]}]}, {'title': 'Pulse rate- standing(N=9,15,2): 1:00h', 'categories': [{'measurements': [{'value': '94.8', 'spread': '20.3', 'groupId': 'OG000'}, {'value': '85.4', 'spread': '10.9', 'groupId': 'OG001'}, {'value': '123', 'spread': '43.1', 'groupId': 'OG002'}]}]}, {'title': 'Pulse rate- standing (N=9,15,2): 2:00h', 'categories': [{'measurements': [{'value': '92.8', 'spread': '17.0', 'groupId': 'OG000'}, {'value': '89.3', 'spread': '11.2', 'groupId': 'OG001'}, {'value': '121', 'spread': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Pulse rate- standing (N=9,15,1): 3:00h', 'categories': [{'measurements': [{'value': '99.0', 'spread': '18.2', 'groupId': 'OG000'}, {'value': '92.7', 'spread': '12.9', 'groupId': 'OG001'}, {'value': '109', 'spread': 'NA', 'comment': 'The data of only one patient is available and thus Standard Deviation is not calculable.', 'groupId': 'OG002'}]}]}, {'title': 'Pulse rate- standing (N=9,14,1): 5:00h', 'categories': [{'measurements': [{'value': '99.3', 'spread': '27.0', 'groupId': 'OG000'}, {'value': '87.1', 'spread': '11.4', 'groupId': 'OG001'}, {'value': '76.0', 'spread': 'NA', 'comment': 'The data of only one patient is available and thus Standard Deviation is not calculable.', 'groupId': 'OG002'}]}]}, {'title': 'Pulse rate- standing (N=9,13,1): 7:00h', 'categories': [{'measurements': [{'value': '100', 'spread': '17.0', 'groupId': 'OG000'}, {'value': '82.1', 'spread': '14.4', 'groupId': 'OG001'}, {'value': '72.0', 'spread': 'NA', 'comment': 'The data of only one patient is available and thus Standard Deviation is not calculable.', 'groupId': 'OG002'}]}]}, {'title': 'Pulse rate- standing (N=9,14,1): 12:00h', 'categories': [{'measurements': [{'value': '97.8', 'spread': '12.4', 'groupId': 'OG000'}, {'value': '81.2', 'spread': '12.3', 'groupId': 'OG001'}, {'value': '86.0', 'spread': 'NA', 'comment': 'The data of only one patient is available and thus Standard Deviation is not calculable.', 'groupId': 'OG002'}]}]}, {'title': 'Pulse rate- standing (N=9,14,1): 24:00h', 'categories': [{'measurements': [{'value': '90.0', 'spread': '18.8', 'groupId': 'OG000'}, {'value': '85.8', 'spread': '6.7', 'groupId': 'OG001'}, {'value': '86.0', 'spread': 'NA', 'comment': 'The data of only one patient is available and thus Standard Deviation is not calculable.', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '-0:15h(hours) pre-dose, and 0:30h, 1:00h, 2:00h, 3:00h, 5:00h, 7:00h, 12:00h, 24:00h', 'description': 'Vital signs (Pulse rate (both supine and after standing for 1 minute)).', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PPX (MIRAPEX®, 0.125 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'FG001', 'title': 'PPX (MIRAPEX®, 0.25 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'FG002', 'title': 'PPX (MIRAPEX®, 0.5 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Open label, single dose pharmacokinetic study in pediatric patients with a diagnosis of idiopathic Restless Legs Syndrome(RLS). For the dose MIRAPEX(0.5 mg),Only 2 subjects (12 to\\<18 years) were recruited and it was not likely that patients for this dose will be fully recruited so the recruitment was stopped and terminated for this dose only.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'PPX (MIRAPEX®, 0.125 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'BG001', 'title': 'PPX (MIRAPEX®, 0.25 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'BG002', 'title': 'PPX (MIRAPEX®, 0.5 mg)', 'description': 'Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '10.6', 'spread': '4.3', 'groupId': 'BG000'}, {'value': '11.4', 'spread': '3.4', 'groupId': 'BG001'}, {'value': '15.0', 'spread': '0.0', 'groupId': 'BG002'}, {'value': '11.4', 'spread': '3.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety analysis set: The safety population comprised all patients who provided informed consent and received at least one dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'lastUpdateSubmitDate': '2015-09-02', 'studyFirstSubmitDate': '2014-09-03', 'resultsFirstSubmitDate': '2015-07-17', 'studyFirstSubmitQcDate': '2014-09-03', 'lastUpdatePostDateStruct': {'date': '2015-10-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-09-02', 'studyFirstPostDateStruct': {'date': '2014-09-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax,ss', 'timeFrame': '0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.', 'description': 'Maximum concentration of the Pramipexole (PPX) in plasma at steady state over a uniform dosing interval (Cmax,ss).'}, {'measure': 'Cmin,ss', 'timeFrame': '0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.', 'description': 'Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval (Cmin,ss).'}, {'measure': 'Cpre,N', 'timeFrame': '0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.', 'description': 'Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N (Cpre,N).'}, {'measure': 'Cavg', 'timeFrame': '0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.', 'description': 'Average concentration of the analyte in plasma at steady state (Cavg).'}, {'measure': 'Tmax,ss', 'timeFrame': '0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.', 'description': 'Time from dosing to maximum concentration at steady state (Tmax,ss).'}, {'measure': 'Tmin,ss', 'timeFrame': '0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.', 'description': 'Time from dosing to minimum concentration at steady state (Tmin,ss ).'}, {'measure': 'AUCτ,ss', 'timeFrame': '0.25h before the drug administration on day 1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on Day 1.', 'description': 'Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval (AUCτ,ss ).'}, {'measure': 'λz,ss', 'timeFrame': '0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.', 'description': 'Terminal rate constant in plasma at steady state (λz,ss ).'}, {'measure': 't1/2,ss', 'timeFrame': '0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.', 'description': 'Terminal half-life of the analyte in plasma at steady state (t1/2,ss ).'}, {'measure': 'MRTpo,ss', 'timeFrame': '0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.', 'description': 'Mean residence time of the analyte in the body at steady state (MRTpo,ss).'}, {'measure': 'CL/F,ss', 'timeFrame': '0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.', 'description': 'Apparent clearance of the analyte in the plasma after extravascular administration at steady state; F = absolute bioavailability factor (CL/F,ss ).'}, {'measure': 'Vz/F,ss', 'timeFrame': '0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.', 'description': 'Apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state (Vz/F,ss ).'}, {'measure': 'Ae 0-12,ss', 'timeFrame': '12 hours after last study drug administration on day 1', 'description': 'Amount of analyte that is eliminated in urine at steady state over a time interval t1to t2 (0-12h).'}, {'measure': 'fe 0-12,ss', 'timeFrame': '12 hours after last study drug administration on day 1.', 'description': 'Fraction of administered drug excreted unchanged in urine at steady state over a time interval t1 to t2 (fe 0-12,ss ).'}, {'measure': 'CLR,ss', 'timeFrame': '12h after last study drug administration on day 1', 'description': 'Renal clearance of the analyte at steady state (CLR(0-12),ss ).'}, {'measure': 'PTF', 'timeFrame': '0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.', 'description': 'Peak-trough fluctuation (PTF) is defined as the difference between Cmax and Cmin divided by Cavg and multiplied with 100% at steady-state.'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With Drug Related Adverse Events', 'timeFrame': 'From first drug administration until 24 hours after last study drug administration, upto 48 days', 'description': 'Number of patients with adverse events due to study drug.'}, {'measure': 'Vital Signs (Systolic and Diastolic Blood Pressure)', 'timeFrame': '-0:15h(hours) pre-dose, and 0:30h, 1:00h, 2:00h, 3:00h, 5:00h, 7:00h, 12:00h, 24:00h post-dose.', 'description': 'Vital signs (Systolic and diastolic blood pressure (both supine and after standing for 1 minute)).'}, {'measure': 'Vital Signs (Pulse Rate)', 'timeFrame': '-0:15h(hours) pre-dose, and 0:30h, 1:00h, 2:00h, 3:00h, 5:00h, 7:00h, 12:00h, 24:00h', 'description': 'Vital signs (Pulse rate (both supine and after standing for 1 minute)).'}]}, 'conditionsModule': {'conditions': ['Restless Legs Syndrome']}, 'descriptionModule': {'briefSummary': 'Study to determine the pharmacokinetics (PK) of pramipexole (PPX) after administration of a single dose orally (p.o.) in pediatric patients with the diagnosis of RLS'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female patients ages 6 years to 16 years (two age groups, 6 to 11 years and 12 to 16 years, with the same number of patients if possible)\n2. Diagnosis of idiopathic Restless Legs Syndrome (RLS) according to the Clinical RLS criteria of the International Restless Legs Syndrome Study Group (IRLSSG)\n\n All 4 of the following criteria must be present:\n * An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs. (Sometimes the urge to move is present without the uncomfortable sensations and sometimes the arms or other body parts are involved in addition to the legs.)\n * The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting\n * The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues\n * The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night. (When symptoms are very severe, the worsening at night may not be noticeable but must have been previously present.)\n3. Must meet all 4 of the diagnostic criteria for adult RLS (see inclusion criterion No. 2 above) and either:\n\n 1. The child must be able to describe the leg discomfort in their own words or\n 2. The child must have 2 or 3 of the following:\n\n * Sleep disturbance\n * Periodic Limb Movements During Sleep (PLMS) index \\>5 per hour of sleep, or\n * A biological parent or sibling with definite RLS\n4. Written informed consent consistent with International Conference on Harmonisation (ICH)/ Good Clinical Practice (GCP) and Local Institutional Review Board requirements for children obtained prior to any study procedures being performed\n5. Ability and willingness to comply with the study treatment regimen and to attend study assessments\n6. Must be on PPX treatment at the same evening maintenance dose for a minimum of 7 days prior to entry into this study as determined by the investigator\n7. A patient who is taking PPX but not as an evening maintenance dose may return for a repeat screening if the patient can be successfully switched and re-stabilized to an evening PPX maintenance dose\n\nExclusion criteria:\n\n1. Any women of childbearing potential having a positive serum pregnancy test at screening\n2. Any women of childbearing potential not using a medically accepted method of contraceptive (Intra-Uterine Device, oral, implantable, injectable contraceptives and estrogen patch, double barrier method \\[spermicide + diaphragm\\], or abstinence at the discretion of the investigator)\n3. Patients who have a clinically significant renal disease or serum creatinine level greater than 1.0 mg/dL at screening\n4. Any of the following lab results at screening:\n\n * Hemoglobin (Hgb) below the lower limit of normal (LLN), which is determined to be clinically significant\n * Basal thyroid stimulating hormone (TSH), triiodothyronine (T3) or thyroxine (T4) clinically significantly (at the investigator's discretion) out of the normal range at screening (if not caused by substitution therapy according to the investigator's opinion)\n * Patients with any clinically significant abnormalities in laboratory parameters at screening at the investigator's discretion\n5. Other clinically significant metabolic-endocrine, hematological, gastrointestinal disease, pulmonary disease (such as severe asthma) which in the opinion of the investigator would preclude the patient from participating in this study\n6. History or clinical signs of any neurological disease with potential to secondarily cause RLS symptoms\n7. Presence of any other sleep disorder such as Rapid Eye Movement (REM) sleep behavior disorder, narcolepsy, or sleep apnea syndrome\n8. History of schizophrenia or any psychotic disorder, history of mental disorders, or any present Axis I psychiatric disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) requiring any medical therapy\n9. History of/or clinical signs of epilepsy or seizures other than fever-related seizures in early childhood\n10. History of/or clinical signs of any malignant neoplasm including suspicious undiagnosed skin lesions (which may be melanoma), melanoma, or a history of melanoma\n11. Any other conditions that, in the opinion of the investigator, would interfere with the evaluation of the results or constitute a health hazard for the patient\n12. Allergic response to PPX or the inactive ingredients in its tablet formulation\n13. Had previous treatment with dopamine agonists other than PPX within 14 days prior to the baseline visit\n14. Had any other medical treatment for RLS besides the study medication within 14 days prior to the baseline visit\n15. Had withdrawal symptoms of any medication at screening or at the baseline visit"}, 'identificationModule': {'nctId': 'NCT02231918', 'briefTitle': 'Study to Investigate Pharmacokinetics (PK) of Pramipexole in Pediatric Patients Who Are Individually Optimized to Stable Pramipexole Doses for the Treatment of Idiopathic Restless Legs Syndrome (RLS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'An Open-label Clinical Study to Investigate Pharmacokinetics (PK) of Different Doses (0.125 mg, 0.25 mg, 0.5 mg) of Pramipexole Administered Once Daily Orally in Pediatric Patients Who Are Individually Optimized to Stable Pramipexole Doses for the Treatment of Idiopathic Restless Legs Syndrome (RLS)', 'orgStudyIdInfo': {'id': '248.600'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MIRAPEX® - low', 'interventionNames': ['Drug: MIRAPEX® - low']}, {'type': 'EXPERIMENTAL', 'label': 'MIRAPEX® - medium', 'interventionNames': ['Drug: MIRAPEX® - medium']}, {'type': 'EXPERIMENTAL', 'label': 'MIRAPEX® - high', 'interventionNames': ['Drug: MIRAPEX® - high']}], 'interventions': [{'name': 'MIRAPEX® - low', 'type': 'DRUG', 'armGroupLabels': ['MIRAPEX® - low']}, {'name': 'MIRAPEX® - medium', 'type': 'DRUG', 'armGroupLabels': ['MIRAPEX® - medium']}, {'name': 'MIRAPEX® - high', 'type': 'DRUG', 'armGroupLabels': ['MIRAPEX® - high']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}