Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-02-20 @ 8:09 PM
Study NCT ID:
NCT01618669
Status:
COMPLETED
Last Update Posted:
2016-02-08
First Post:
2012-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess Regadenoson Administration Following an Inadequate Exercise Stress Test as Compared to Regadenoson Alone for Myocardial Perfusion Imaging (MPI) Using Single Photon Emission Computed Tomography (SPECT)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C430916', 'term': 'regadenoson'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Astellas.resultsdisclosure@astellas.com', 'title': 'Senior Medical Director, Medical Affairs', 'organization': 'Astellas Pharma Global Development, Inc. (APGD)'}, 'certainAgreement': {'otherDetails': "Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data or 18 months after data-lock, whichever is first. Sponsor must receive a site's manuscript at least 45 days prior to publication for review and comment. Sponsor may delay the publication for up to 60 days to seek patent protection.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the time of administration of regadenoson to within 24 hours of administration of regadenoson for each stress MPI.', 'eventGroups': [{'id': 'EG000', 'title': 'Regadenoson After Peak Exercise: MPI 1', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.', 'otherNumAtRisk': 575, 'otherNumAffected': 277, 'seriousNumAtRisk': 575, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Regadenoson After Peak Exercise: MPI 2', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.', 'otherNumAtRisk': 544, 'otherNumAffected': 274, 'seriousNumAtRisk': 544, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Regadenoson Alone: MPI 1', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.', 'otherNumAtRisk': 567, 'otherNumAffected': 307, 'seriousNumAtRisk': 567, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Regadenoson Alone: MPI 2', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.', 'otherNumAtRisk': 548, 'otherNumAffected': 290, 'seriousNumAtRisk': 548, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 575, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 544, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 567, 'numAffected': 35}, {'groupId': 'EG003', 'numAtRisk': 548, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 575, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 544, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 567, 'numAffected': 45}, {'groupId': 'EG003', 'numAtRisk': 548, 'numAffected': 41}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 575, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 544, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 567, 'numAffected': 54}, {'groupId': 'EG003', 'numAtRisk': 548, 'numAffected': 43}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 575, 'numAffected': 106}, {'groupId': 'EG001', 'numAtRisk': 544, 'numAffected': 75}, {'groupId': 'EG002', 'numAtRisk': 567, 'numAffected': 89}, {'groupId': 'EG003', 'numAtRisk': 548, 'numAffected': 81}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 575, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 544, 'numAffected': 108}, {'groupId': 'EG002', 'numAtRisk': 567, 'numAffected': 137}, {'groupId': 'EG003', 'numAtRisk': 548, 'numAffected': 118}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 575, 'numAffected': 141}, {'groupId': 'EG001', 'numAtRisk': 544, 'numAffected': 125}, {'groupId': 'EG002', 'numAtRisk': 567, 'numAffected': 161}, {'groupId': 'EG003', 'numAtRisk': 548, 'numAffected': 152}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 575, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 544, 'numAffected': 78}, {'groupId': 'EG002', 'numAtRisk': 567, 'numAffected': 79}, {'groupId': 'EG003', 'numAtRisk': 548, 'numAffected': 69}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'seriousEvents': [{'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 575, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 544, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 567, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 548, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 575, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 544, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 567, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 548, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 575, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 544, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 567, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 548, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 575, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 544, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 567, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 548, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 575, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 544, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 567, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 548, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 575, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 544, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 567, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 548, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Anticoagulation drug level below therapeutic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 575, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 544, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 567, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 548, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hepatic enzyme abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 575, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 544, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 567, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 548, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 575, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 544, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 567, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 548, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Speech disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 575, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 544, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 567, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 548, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 575, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 544, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 567, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 548, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Participants With Majority Reader Self-agreement in Ischemia Assessment Between First and Second Stress Scans', 'denoms': [{'units': 'Participants', 'counts': [{'value': '538', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Regadenoson After Peak Exercise', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}, {'id': 'OG001', 'title': 'Regadenoson Alone', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.92', 'groupId': 'OG000', 'lowerLimit': '0.89', 'upperLimit': '0.94'}, {'value': '0.95', 'groupId': 'OG001', 'lowerLimit': '0.93', 'upperLimit': '0.97'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '-0.00', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.015', 'estimateComment': 'Difference equals Regadenoson After Peak Exercise minus Regadenoson Alone', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'If the lower confidence bound of the 1-sided alpha level of 0.025 of the difference in the proportion of participants with majority reader self-agreement exceeded -0.075, non-inferiority would be demonstrated.'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (rest scan and first stress scan) and Day 2 -15 (second stress scan)', 'description': 'SPECT scans were reviewed in a blinded fashion by 3 independent expert readers using the 17-segment model for standardized myocardial segmentation. At rest and stress, each segment was scored on a 0 (normal) to 4 (absent contrast/radiotracer uptake) scale by each of the 3 blinded readers according to the amount of contrast or radiotracer the myocardium in the segment absorbed. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect.\n\nThe number of segments with reversible defects was categorized as absence (0 - 1 reversible segments) or presence (≥ 2 defects reversible segments) of ischemia.\n\nEach reader was defined as having self-agreement based upon identical categorization of a given participant as absent or present for ischemia for both the initial and second stress visits.\n\nMajority agreement is if at least 2 out of the 3 blinded readers demonstrated self-agreement for a given participant.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '575', 'groupId': 'OG000'}, {'value': '544', 'groupId': 'OG001'}, {'value': '567', 'groupId': 'OG002'}, {'value': '548', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Regadenoson After Peak Exercise: MPI 1', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}, {'id': 'OG001', 'title': 'Regadenoson After Peak Exercise: MPI 2', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}, {'id': 'OG002', 'title': 'Regadenoson Alone: MPI 1', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}, {'id': 'OG003', 'title': 'Regadenoson Alone: MPI 2', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}], 'classes': [{'title': 'Any Event', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}, {'value': '0.5', 'groupId': 'OG002'}, {'value': '0.4', 'groupId': 'OG003'}]}]}, {'title': 'Any Holter/12-Lead ECG Abnormality', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}, {'value': '0.5', 'groupId': 'OG002'}, {'value': '0.4', 'groupId': 'OG003'}]}]}, {'title': 'Sustained Ventricular Tachycardia', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Ventricular Fibrillation or Ventricular Flutter', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Torsade de Pointes', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'ST-T Depression (≥ 2 mm)', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}, {'value': '0.6', 'groupId': 'OG001'}, {'value': '0.4', 'groupId': 'OG002'}, {'value': '0.4', 'groupId': 'OG003'}]}]}, {'title': 'ST-T Elevation (≥ 1 mm)', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}, {'value': '0.2', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': '2:1 AV Block', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Mobitz I Second Degree AV Block', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Mobitz II Second Degree AV Block', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Complete Heart Block', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Pause > 3.0 seconds', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Any TEAE per SMQ for Myocardial Infarction', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Acute Coronary Syndrome', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Myocardial Infarction', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Adverse Event of Angina Unstable', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 1 hour for ECG events and up to 24 hours for adverse events after administration of regadenoson', 'description': 'A clinically significant cardiac event is defined as:\n\n* Any of the following events found on the Holter electrocardiogram (ECG)/12-Lead ECG within 1 hour after regadenoson administration:\n\n * ventricular arrhythmias (sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes, ventricular flutter),\n * ST-T depression (\\> 2 mm),\n * ST-T elevation (≥1 mm),\n * Atrioventricular (AV) block (2:1 AV block, AV Mobitz I, AV Mobitz II, complete heart block)\n * sinus arrest \\> 3 seconds in duration\n\nOr\n\n* a treatment-emergent adverse event (TEAE) per the Medical Dictionary for Regulatory Activities (MedDRA) Standardised MedDRA Queries (SMQ) (Narrow Scope) for myocardial infarction\n\nOr\n\n* a TEAE preferred term of angina unstable within 24 hours of regadenoson administration.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set (all randomized participants who received at least 1 dose of regadenoson study drug)'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Agreement in the Assessment of Absence or Presence of Ischemia Between First and Second Stress Scans', 'denoms': [{'units': 'Participants', 'counts': [{'value': '538', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Regadenoson After Peak Exercise', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}, {'id': 'OG001', 'title': 'Regadenoson Alone', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.75', 'groupId': 'OG000', 'lowerLimit': '0.68', 'upperLimit': '0.83'}, {'value': '0.77', 'groupId': 'OG001', 'lowerLimit': '0.67', 'upperLimit': '0.86'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.063', 'estimateComment': 'Difference equals Regadenoson After Peak Exercise minus Regadenoson Alone', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The lower confidence bound of the 1-sided alpha level of 0.025 of the difference in agreement rates must exceed -0.10 in order to demonstrate non-inferiority.'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (stress MPI 1) and Day 2 -15 (stress MPI 2)', 'description': 'The number of segments with reversible defects was assessed by each of the 3 blinded independent expert readers. Based on the median count of the number of reversible defects across the 3 readers, categorized as absence (0 to 1 reversible segments) or presence (≥ 2 reversible defects) of ischemia, the proportion of participants with agreement in the presence and absence of ischemia between the first and second stress scans was calculated.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Agreement in the Assessment of Reversible Defects in 3 Categories of Ischemia Between First and Second Stress Scans', 'denoms': [{'units': 'Participants', 'counts': [{'value': '538', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Regadenoson After Peak Exercise', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}, {'id': 'OG001', 'title': 'Regadenoson Alone', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.73', 'groupId': 'OG000', 'lowerLimit': '0.69', 'upperLimit': '0.77'}, {'value': '0.75', 'groupId': 'OG001', 'lowerLimit': '0.71', 'upperLimit': '0.78'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.027', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The lower confidence bound of the 1-sided alpha level of 0.025 of the difference in agreement rates must exceed -0.133 in order to demonstrate non-inferiority. Non-inferiority could not be assessed because of insufficient data in the Regadenoson Alone group.'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (stress MPI 1) and Day 2 - 15 (stress MPI 2)', 'description': 'The number of segments with reversible defects was assessed by each of the 3 blinded independent expert readers. Based on the median count of the number of reversible defects across the 3 readers, categorized as 0 to 1, 2 to 4, or ≥ 5 reversible segments, the proportion of participants with agreement in the three ischemia categories between the first and second stress scans was to be calculated. In the reported data, these proportions only include the 0-1 and 2-4 categories; the ≥ 5 category was not included because there were no participants in this category for the Regadenoson Alone group for the initial stress MPI.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Agreement in the Summed Stress Score (SSS) Between First and Second Stress Scans', 'denoms': [{'units': 'Participants', 'counts': [{'value': '538', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Regadenoson After Peak Exercise', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}, {'id': 'OG001', 'title': 'Regadenoson Alone', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.86', 'groupId': 'OG000'}, {'value': '0.84', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '0.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.022', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (stress MPI 1) and Day 2 - 15 (stress MPI 2)', 'description': 'The 17-segment model for standardized myocardial segmentation was used to analyze MPI scans. Each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:\n\n* 0: normal perfusion\n* 1: slightly reduced contrast/radiotracer uptake\n* 2: moderately reduced contrast/radiotracer uptake\n* 3: severely reduced contrast/radiotracer uptake\n* 4: absent contrast/radiotracer uptake.\n\nThe Summed Stress Score (SSS) was calculated as the sum of the stress scores across the 17 segments. The mean value (rounded to the nearest integer) across the 3 readers was computed and the SSS was categorized into 4 group categorical variables based on the score: 0 to 3, 4 to 7, 8 to 11, and ≥ 12. The proportion of participants with agreement in respect to these categories between the two stress scans was calculated.', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Agreement in the Summed Difference Score (SDS) Between First and Second Stress Scans', 'denoms': [{'units': 'Participants', 'counts': [{'value': '538', 'groupId': 'OG000'}, {'value': '538', 'groupId': 'OG001'}, {'value': '538', 'groupId': 'OG002'}, {'value': '535', 'groupId': 'OG003'}, {'value': '535', 'groupId': 'OG004'}, {'value': '535', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'REG APEX: MPI 2 SDS 0-6', 'description': 'Participants in the Regadenoson After Peak Exercise (APEX) group who had an SDS from 0 to 6 on their second stress scan.'}, {'id': 'OG001', 'title': 'REG APEX: MPI 2 7-13', 'description': 'Participants in the Regadenoson After Peak Exercise (REG APEX) group who had an SDS from 7 to 13 on their second stress scan.'}, {'id': 'OG002', 'title': 'REG APEX: MPI 2 SDS ≥ 14', 'description': 'Participants in the Regadenoson After Peak Exercise (REG APEX) group who had an SDS ≥ 14 on their second stress scan.'}, {'id': 'OG003', 'title': 'REG Alone: MPI 2 SDS 0-6', 'description': 'Participants in the Regadenoson (REG) Alone group who had an SDS from 0 to 6 on their second stress scan.'}, {'id': 'OG004', 'title': 'REG Alone: MPI 2 SDS 7-13', 'description': 'Participants in the Regadenoson (REG) Alone group who had an SDS from 7 to 13 on their second stress scan.'}, {'id': 'OG005', 'title': 'REG Alone: MPI 2 SDS ≥ 14', 'description': 'Participants in the Regadenoson (REG) Alone group who had an SDS ≥ 14 on their second stress scan.'}], 'classes': [{'title': 'MPI 1 SDS 0-6', 'categories': [{'measurements': [{'value': '531', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '527', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'MPI 1 SDS 7-13', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'MPI 1 SDS ≥ 14', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (rest MPI and stress MPI 1) and Day 2 - 15 (stress MPI 2)', 'description': 'The 17-segment model for standardized myocardial segmentation was used to analyze MPI scans. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:\n\n* 0: normal perfusion\n* 1: slightly reduced contrast/ uptake\n* 2: moderately reduced contrast/uptake\n* 3: severely reduced contrast/uptake\n* 4: absent contrast/uptake.\n\nSSS was calculated as the sum of the stress scores across the 17 segments and the Summed Rest Score (SRS) was calculated as the sum of the rest scores across the 17 segments. The Summed Difference Score (SDS) is the difference in the SSS and SRS (SSS - SRS).\n\nThe mean value (rounded to the nearest integer) across the 3 readers was computed and the SDS was categorized into 3 categorical variables based on the score: 0 to 6, 7 to 13 and ≥ 14. The proportion of participants with agreement in respect to these categories between the two stress scans was calculated.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Participants With Less, the Same, or More Reversible Perfusion Defects Shown by the First Stress Scan When Compared to the Second Stress Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '538', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Regadenoson After Peak Exercise', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}, {'id': 'OG001', 'title': 'Regadenoson Alone', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}], 'classes': [{'title': 'Less Reversible Perfusion Defects', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Same Number of Reversible Perfusion Defects', 'categories': [{'measurements': [{'value': '441', 'groupId': 'OG000'}, {'value': '459', 'groupId': 'OG001'}]}]}, {'title': 'More Reversible Perfusion Defects', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (stress MPI 1) and Day 2-15 (stress MPI 2)', 'description': "Each reader evaluated the initial stress SPECT MPI scan compared to the participant's second stress SPECT MPI scan (blinded at time of the evaluation) for whether there was Less (-1), the Same (0) or More (1) reversible perfusion defects. The median assessment of the 3 blinded readers was used to summarize the number of participants in each category.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Overall Assessment of Image Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '538', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Regadenoson After Peak Exercise', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}, {'id': 'OG001', 'title': 'Regadenoson Alone', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}], 'classes': [{'title': 'Rest MPI: Excellent', 'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}]}, {'title': 'Rest MPI: Good', 'categories': [{'measurements': [{'value': '307', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}]}, {'title': 'Rest MPI: Fair', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}, {'title': 'Rest MPI: Poor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Stress MPI 1: Excellent', 'categories': [{'measurements': [{'value': '224', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}]}, {'title': 'Stress MPI 1: Good', 'categories': [{'measurements': [{'value': '287', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}]}, {'title': 'Stress MPI 1: Fair', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Stress MPI 1: Poor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Stress MPI 2: Excellent', 'categories': [{'measurements': [{'value': '192', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}]}, {'title': 'Stress MPI 2: Good', 'categories': [{'measurements': [{'value': '303', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}]}]}, {'title': 'Stress MPI 2: Fair', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Stress MPI 2: Poor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (rest MPI and stress MPI 1) and Day 2 - 15 (stress MPI 2)', 'description': 'The image quality for each scan was rated by each independent reader as 1 = Poor, 2 = Fair, 3 = Good, 4 = Excellent. Based on the median rating of overall image quality across the three readers, the number of participants with each rating is reported for each scan.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Target to Background Radiotracer Uptake Ratios From the First and Second Stress Scans', 'denoms': [{'units': 'Participants', 'counts': [{'value': '514', 'groupId': 'OG000'}, {'value': '525', 'groupId': 'OG001'}, {'value': '518', 'groupId': 'OG002'}, {'value': '523', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Regadenoson After Peak Exercise: MPI 1', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}, {'id': 'OG001', 'title': 'Regadenoson After Peak Exercise: MPI 2', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}, {'id': 'OG002', 'title': 'Regadenoson Alone: MPI 1', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}, {'id': 'OG003', 'title': 'Regadenoson Alone: MPI 2', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}], 'classes': [{'title': 'Heart-to-Liver', 'categories': [{'measurements': [{'value': '1.05', 'spread': '0.399', 'groupId': 'OG000'}, {'value': '0.94', 'spread': '0.373', 'groupId': 'OG001'}, {'value': '0.96', 'spread': '0.365', 'groupId': 'OG002'}, {'value': '0.95', 'spread': '0.362', 'groupId': 'OG003'}]}]}, {'title': 'Heart-to-Gut', 'categories': [{'measurements': [{'value': '1.12', 'spread': '0.436', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '0.399', 'groupId': 'OG001'}, {'value': '1.05', 'spread': '0.428', 'groupId': 'OG002'}, {'value': '0.99', 'spread': '0.387', 'groupId': 'OG003'}]}]}, {'title': 'Heart-to-(Liver/Gut)', 'categories': [{'measurements': [{'value': '1.02', 'spread': '0.296', 'groupId': 'OG000'}, {'value': '0.90', 'spread': '0.260', 'groupId': 'OG001'}, {'value': '0.94', 'spread': '0.274', 'groupId': 'OG002'}, {'value': '0.91', 'spread': '0.259', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (stress MPI 1) and Day 2 - 15 (stress MPI 2)', 'description': 'Image quality was assessed through radiotracer uptake in the heart (target organ) compared to liver, gut and combined liver plus gut (background interference).', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set participants who have planar images available for each scan'}, {'type': 'SECONDARY', 'title': 'Percentage of Scans With Subdiaphragmatic Interference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '270', 'groupId': 'OG002'}, {'value': '270', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Regadenoson After Peak Exercise: MPI 1', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}, {'id': 'OG001', 'title': 'Regadenoson After Peak Exercise: MPI 2', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}, {'id': 'OG002', 'title': 'Regadenoson Alone: MPI 1', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}, {'id': 'OG003', 'title': 'Regadenoson Alone: MPI 2', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Slight', 'categories': [{'measurements': [{'value': '71.8', 'groupId': 'OG000'}, {'value': '63.7', 'groupId': 'OG001'}, {'value': '68.1', 'groupId': 'OG002'}, {'value': '67.4', 'groupId': 'OG003'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '27.5', 'groupId': 'OG000'}, {'value': '36.3', 'groupId': 'OG001'}, {'value': '31.5', 'groupId': 'OG002'}, {'value': '32.6', 'groupId': 'OG003'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.4', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (stress MPI 1) and Day 2 -15 (stress MPI 2)', 'description': 'Each reader assessed the sub-diaphragmatic radiotracer interference with cardiac image quality using a 4-point scale of 0 = none, 1 = slight, 2 = moderate or 3 = severe for each stress SPECT MPI. The median rating across the 3 readers was used to summarize the percentage of scans with interference.', 'unitOfMeasure': 'percentage of stress MPI scans', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '538', 'groupId': 'OG000'}, {'value': '538', 'groupId': 'OG001'}, {'value': '535', 'groupId': 'OG002'}, {'value': '535', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Regadenoson After Peak Exercise: MPI 1', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}, {'id': 'OG001', 'title': 'Regadenoson After Peak Exercise: MPI 2', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}, {'id': 'OG002', 'title': 'Regadenoson Alone: MPI 1', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}, {'id': 'OG003', 'title': 'Regadenoson Alone: MPI 2', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}], 'classes': [{'title': 'Reader 1: Segment 1', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Reader 1: Segment 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Reader 1: Segment 3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Reader 1: Segment 4', 'categories': [{'measurements': [{'value': '33.6', 'groupId': 'OG000'}, {'value': '37.2', 'groupId': 'OG001'}, {'value': '34.2', 'groupId': 'OG002'}, {'value': '37.4', 'groupId': 'OG003'}]}]}, {'title': 'Reader 1: Segment 5', 'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000'}, {'value': '8.4', 'groupId': 'OG001'}, {'value': '7.9', 'groupId': 'OG002'}, {'value': '7.7', 'groupId': 'OG003'}]}]}, {'title': 'Reader 1: Segment 6', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Reader 1: Segment 7', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Reader 1: Segment 8', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Reader 1: Segment 9', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Reader 1: Segment 10', 'categories': [{'measurements': [{'value': '31.6', 'groupId': 'OG000'}, {'value': '35.5', 'groupId': 'OG001'}, {'value': '32.3', 'groupId': 'OG002'}, {'value': '36.3', 'groupId': 'OG003'}]}]}, {'title': 'Reader 1: Segment 11', 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000'}, {'value': '8.2', 'groupId': 'OG001'}, {'value': '7.5', 'groupId': 'OG002'}, {'value': '7.5', 'groupId': 'OG003'}]}]}, {'title': 'Reader 1: Segment 12', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Reader 1: Segment 13', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Reader 1: Segment 14', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Reader 1: Segment 15', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}, {'value': '2.4', 'groupId': 'OG002'}, {'value': '2.1', 'groupId': 'OG003'}]}]}, {'title': 'Reader 1: Segment 16', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.2', 'groupId': 'OG002'}, {'value': '0.2', 'groupId': 'OG003'}]}]}, {'title': 'Reader 1: Segment 17', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Reader 2: Segment 1', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Reader 2: Segment 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.2', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Reader 2: Segment 3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.2', 'groupId': 'OG002'}, {'value': '0.6', 'groupId': 'OG003'}]}]}, {'title': 'Reader 2: Segment 4', 'categories': [{'measurements': [{'value': '34.4', 'groupId': 'OG000'}, {'value': '35.1', 'groupId': 'OG001'}, {'value': '32.5', 'groupId': 'OG002'}, {'value': '32.5', 'groupId': 'OG003'}]}]}, {'title': 'Reader 2: Segment 5', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}, {'value': '0.7', 'groupId': 'OG002'}, {'value': '0.7', 'groupId': 'OG003'}]}]}, {'title': 'Reader 2: Segment 6', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Reader 2: Segment 7', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Reader 2: Segment 8', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.2', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Reader 2: Segment 9', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.4', 'groupId': 'OG002'}, {'value': '0.4', 'groupId': 'OG003'}]}]}, {'title': 'Reader 2: Segment 10', 'categories': [{'measurements': [{'value': '12.6', 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{'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Reader 2: Segment 15', 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}, {'value': '8.7', 'groupId': 'OG001'}, {'value': '10.5', 'groupId': 'OG002'}, {'value': '9.5', 'groupId': 'OG003'}]}]}, {'title': 'Reader 2: Segment 16', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.2', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Reader 2: Segment 17', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Reader 3: Segment 1', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.2', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Reader 3: Segment 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Reader 3: Segment 3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Reader 3: Segment 4', 'categories': [{'measurements': [{'value': '14.1', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}, {'value': '17.9', 'groupId': 'OG002'}, {'value': '17.2', 'groupId': 'OG003'}]}]}, {'title': 'Reader 3: Segment 5', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}, {'value': '0.7', 'groupId': 'OG002'}, {'value': '0.2', 'groupId': 'OG003'}]}]}, {'title': 'Reader 3: Segment 6', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Reader 3: Segment 7', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Reader 3: Segment 8', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Reader 3: Segment 9', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Reader 3: Segment 10', 'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000'}, {'value': '17.8', 'groupId': 'OG001'}, {'value': '18.5', 'groupId': 'OG002'}, {'value': '18.9', 'groupId': 'OG003'}]}]}, {'title': 'Reader 3: Segment 11', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '0.2', 'groupId': 'OG001'}, {'value': '0.6', 'groupId': 'OG002'}, {'value': '0.2', 'groupId': 'OG003'}]}]}, {'title': 'Reader 3: Segment 12', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Reader 3: Segment 13', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Reader 3: Segment 14', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Reader 3: Segment 15', 'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000'}, {'value': '13.8', 'groupId': 'OG001'}, {'value': '13.1', 'groupId': 'OG002'}, {'value': '14.6', 'groupId': 'OG003'}]}]}, {'title': 'Reader 3: Segment 16', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}, {'value': '0.4', 'groupId': 'OG002'}, {'value': '0.2', 'groupId': 'OG003'}]}]}, {'title': 'Reader 3: Segment 17', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}, {'value': '0.7', 'groupId': 'OG002'}, {'value': '0.6', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (stress MPI 1) and Day - 15 (stress MPI 2)', 'description': 'The number of cardiac segments obscured by the sub-diaphragmatic activity by group by stress SPECT MPI scan and by reader is reported.', 'unitOfMeasure': 'percentage of segments', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson', 'denoms': [{'units': 'Participants', 'counts': [{'value': '575', 'groupId': 'OG000'}, {'value': '544', 'groupId': 'OG001'}, {'value': '567', 'groupId': 'OG002'}, {'value': '548', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Regadenoson After Peak Exercise: MPI 1', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}, {'id': 'OG001', 'title': 'Regadenoson After Peak Exercise: MPI 2', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}, {'id': 'OG002', 'title': 'Regadenoson Alone: MPI 1', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}, {'id': 'OG003', 'title': 'Regadenoson Alone: MPI 2', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}], 'classes': [{'title': 'Any adverse event', 'categories': [{'measurements': [{'value': '302', 'groupId': 'OG000'}, {'value': '317', 'groupId': 'OG001'}, {'value': '329', 'groupId': 'OG002'}, {'value': '323', 'groupId': 'OG003'}]}]}, {'title': 'Drug-related adverse event', 'categories': [{'measurements': [{'value': '291', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '319', 'groupId': 'OG002'}, {'value': '308', 'groupId': 'OG003'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Serious adverse events', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Drug-related serious adverse events', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Adverse events leading to discontinuation', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Drug-related AEs leading to discontinuation', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 hours after study drug administration for each stress MPI (Day 1 and Day 2-15)', 'description': 'An adverse event is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes:\n\n* Results in death,\n* Is life threatening,\n* Results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions,\n* Results in congenital anomaly, or birth defect,\n* Requires inpatient hospitalization or leads to prolongation of hospitalization\n* Other medically important events.\n\nRelationship to study drug was assessed by the investigator.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Regadenoson After Peak Exercise', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT myocardial perfusion imaging (MPI). One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}, {'id': 'FG001', 'title': 'Regadenoson Alone', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '578'}, {'groupId': 'FG001', 'numSubjects': '569'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '575'}, {'groupId': 'FG001', 'numSubjects': '567'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '544'}, {'groupId': 'FG001', 'numSubjects': '546'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Randomized but Never Received Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Miscellaneous Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study was conducted at 49 sites in a total of 3 countries including the United States (44 sites), Argentina (4 sites) and Peru (1 site).', 'preAssignmentDetails': 'At Baseline, patients meeting all inclusion/exclusion criteria completed single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) while at rest. Participants then underwent a Bruce or modified Bruce exercise protocol; those unable to reach 85% maximum predicted heart rate and/or 5 metabolic equivalents were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '575', 'groupId': 'BG000'}, {'value': '567', 'groupId': 'BG001'}, {'value': '1142', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Regadenoson After Peak Exercise', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}, {'id': 'BG001', 'title': 'Regadenoson Alone', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.9', 'spread': '11.45', 'groupId': 'BG000'}, {'value': '61.9', 'spread': '11.19', 'groupId': 'BG001'}, {'value': '61.9', 'spread': '11.32', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '234', 'groupId': 'BG000'}, {'value': '239', 'groupId': 'BG001'}, {'value': '473', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '341', 'groupId': 'BG000'}, {'value': '328', 'groupId': 'BG001'}, {'value': '669', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Bruce Exercise Group', 'classes': [{'title': 'Standard Bruce Exercise', 'categories': [{'measurements': [{'value': '448', 'groupId': 'BG000'}, {'value': '442', 'groupId': 'BG001'}, {'value': '890', 'groupId': 'BG002'}]}]}, {'title': 'Modified Bruce Exercise', 'categories': [{'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '183', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'The Bruce exercise test involves walking on a treadmill while the heart is monitored by an electrocardiograph. The protocol consists of several stages of progressively greater workloads.\n\nThe Modified Bruce protocol starts at a lower workload than the standard test and is typically used for elderly or sedentary patients.\n\nData are reported for all randomized participants with interpretable SPECT scans at all visits as determined by at least 2 of the 3 blinded independent expert readers (full analysis set; 538 and 534 participants in each treatment group respectively).', 'unitOfMeasure': 'participants'}, {'title': 'Maximum Metabolic Equivalents Achieved', 'classes': [{'categories': [{'measurements': [{'value': '5.45', 'spread': '2.284', 'groupId': 'BG000'}, {'value': '5.37', 'spread': '2.331', 'groupId': 'BG001'}, {'value': '5.41', 'spread': '2.307', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'A metabolic unit used to quantify the intensity of physical activity, which is defined as the ratio of the metabolic rate during exercise to the metabolic rate at rest. One MET corresponds to an energy expenditure of approximately 1 kcal/kg/hour, or an oxygen uptake of 3.5 ml of O2 consumption/kg/hour.\n\nData are provided for the full analysis set (538 and 534 participants in each treatment group respectively).', 'unitOfMeasure': 'metabolic equivalents', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All randomized participants who took at least 1 dose of study drug (Safety Analysis Set).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1147}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-07', 'studyFirstSubmitDate': '2012-05-29', 'resultsFirstSubmitDate': '2015-12-14', 'studyFirstSubmitQcDate': '2012-06-12', 'lastUpdatePostDateStruct': {'date': '2016-02-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-01-07', 'studyFirstPostDateStruct': {'date': '2012-06-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants With Majority Reader Self-agreement in Ischemia Assessment Between First and Second Stress Scans', 'timeFrame': 'Day 1 (rest scan and first stress scan) and Day 2 -15 (second stress scan)', 'description': 'SPECT scans were reviewed in a blinded fashion by 3 independent expert readers using the 17-segment model for standardized myocardial segmentation. At rest and stress, each segment was scored on a 0 (normal) to 4 (absent contrast/radiotracer uptake) scale by each of the 3 blinded readers according to the amount of contrast or radiotracer the myocardium in the segment absorbed. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect.\n\nThe number of segments with reversible defects was categorized as absence (0 - 1 reversible segments) or presence (≥ 2 defects reversible segments) of ischemia.\n\nEach reader was defined as having self-agreement based upon identical categorization of a given participant as absent or present for ischemia for both the initial and second stress visits.\n\nMajority agreement is if at least 2 out of the 3 blinded readers demonstrated self-agreement for a given participant.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events', 'timeFrame': 'Within 1 hour for ECG events and up to 24 hours for adverse events after administration of regadenoson', 'description': 'A clinically significant cardiac event is defined as:\n\n* Any of the following events found on the Holter electrocardiogram (ECG)/12-Lead ECG within 1 hour after regadenoson administration:\n\n * ventricular arrhythmias (sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes, ventricular flutter),\n * ST-T depression (\\> 2 mm),\n * ST-T elevation (≥1 mm),\n * Atrioventricular (AV) block (2:1 AV block, AV Mobitz I, AV Mobitz II, complete heart block)\n * sinus arrest \\> 3 seconds in duration\n\nOr\n\n* a treatment-emergent adverse event (TEAE) per the Medical Dictionary for Regulatory Activities (MedDRA) Standardised MedDRA Queries (SMQ) (Narrow Scope) for myocardial infarction\n\nOr\n\n* a TEAE preferred term of angina unstable within 24 hours of regadenoson administration.'}, {'measure': 'Proportion of Participants With Agreement in the Assessment of Absence or Presence of Ischemia Between First and Second Stress Scans', 'timeFrame': 'Day 1 (stress MPI 1) and Day 2 -15 (stress MPI 2)', 'description': 'The number of segments with reversible defects was assessed by each of the 3 blinded independent expert readers. Based on the median count of the number of reversible defects across the 3 readers, categorized as absence (0 to 1 reversible segments) or presence (≥ 2 reversible defects) of ischemia, the proportion of participants with agreement in the presence and absence of ischemia between the first and second stress scans was calculated.'}, {'measure': 'Proportion of Participants With Agreement in the Assessment of Reversible Defects in 3 Categories of Ischemia Between First and Second Stress Scans', 'timeFrame': 'Day 1 (stress MPI 1) and Day 2 - 15 (stress MPI 2)', 'description': 'The number of segments with reversible defects was assessed by each of the 3 blinded independent expert readers. Based on the median count of the number of reversible defects across the 3 readers, categorized as 0 to 1, 2 to 4, or ≥ 5 reversible segments, the proportion of participants with agreement in the three ischemia categories between the first and second stress scans was to be calculated. In the reported data, these proportions only include the 0-1 and 2-4 categories; the ≥ 5 category was not included because there were no participants in this category for the Regadenoson Alone group for the initial stress MPI.'}, {'measure': 'Proportion of Participants With Agreement in the Summed Stress Score (SSS) Between First and Second Stress Scans', 'timeFrame': 'Day 1 (stress MPI 1) and Day 2 - 15 (stress MPI 2)', 'description': 'The 17-segment model for standardized myocardial segmentation was used to analyze MPI scans. Each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:\n\n* 0: normal perfusion\n* 1: slightly reduced contrast/radiotracer uptake\n* 2: moderately reduced contrast/radiotracer uptake\n* 3: severely reduced contrast/radiotracer uptake\n* 4: absent contrast/radiotracer uptake.\n\nThe Summed Stress Score (SSS) was calculated as the sum of the stress scores across the 17 segments. The mean value (rounded to the nearest integer) across the 3 readers was computed and the SSS was categorized into 4 group categorical variables based on the score: 0 to 3, 4 to 7, 8 to 11, and ≥ 12. The proportion of participants with agreement in respect to these categories between the two stress scans was calculated.'}, {'measure': 'Proportion of Participants With Agreement in the Summed Difference Score (SDS) Between First and Second Stress Scans', 'timeFrame': 'Day 1 (rest MPI and stress MPI 1) and Day 2 - 15 (stress MPI 2)', 'description': 'The 17-segment model for standardized myocardial segmentation was used to analyze MPI scans. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:\n\n* 0: normal perfusion\n* 1: slightly reduced contrast/ uptake\n* 2: moderately reduced contrast/uptake\n* 3: severely reduced contrast/uptake\n* 4: absent contrast/uptake.\n\nSSS was calculated as the sum of the stress scores across the 17 segments and the Summed Rest Score (SRS) was calculated as the sum of the rest scores across the 17 segments. The Summed Difference Score (SDS) is the difference in the SSS and SRS (SSS - SRS).\n\nThe mean value (rounded to the nearest integer) across the 3 readers was computed and the SDS was categorized into 3 categorical variables based on the score: 0 to 6, 7 to 13 and ≥ 14. The proportion of participants with agreement in respect to these categories between the two stress scans was calculated.'}, {'measure': 'Participants With Less, the Same, or More Reversible Perfusion Defects Shown by the First Stress Scan When Compared to the Second Stress Scan', 'timeFrame': 'Day 1 (stress MPI 1) and Day 2-15 (stress MPI 2)', 'description': "Each reader evaluated the initial stress SPECT MPI scan compared to the participant's second stress SPECT MPI scan (blinded at time of the evaluation) for whether there was Less (-1), the Same (0) or More (1) reversible perfusion defects. The median assessment of the 3 blinded readers was used to summarize the number of participants in each category."}, {'measure': 'Overall Assessment of Image Quality', 'timeFrame': 'Day 1 (rest MPI and stress MPI 1) and Day 2 - 15 (stress MPI 2)', 'description': 'The image quality for each scan was rated by each independent reader as 1 = Poor, 2 = Fair, 3 = Good, 4 = Excellent. Based on the median rating of overall image quality across the three readers, the number of participants with each rating is reported for each scan.'}, {'measure': 'Target to Background Radiotracer Uptake Ratios From the First and Second Stress Scans', 'timeFrame': 'Day 1 (stress MPI 1) and Day 2 - 15 (stress MPI 2)', 'description': 'Image quality was assessed through radiotracer uptake in the heart (target organ) compared to liver, gut and combined liver plus gut (background interference).'}, {'measure': 'Percentage of Scans With Subdiaphragmatic Interference', 'timeFrame': 'Day 1 (stress MPI 1) and Day 2 -15 (stress MPI 2)', 'description': 'Each reader assessed the sub-diaphragmatic radiotracer interference with cardiac image quality using a 4-point scale of 0 = none, 1 = slight, 2 = moderate or 3 = severe for each stress SPECT MPI. The median rating across the 3 readers was used to summarize the percentage of scans with interference.'}, {'measure': 'Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity', 'timeFrame': 'Day 1 (stress MPI 1) and Day - 15 (stress MPI 2)', 'description': 'The number of cardiac segments obscured by the sub-diaphragmatic activity by group by stress SPECT MPI scan and by reader is reported.'}, {'measure': 'Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson', 'timeFrame': 'Up to 24 hours after study drug administration for each stress MPI (Day 1 and Day 2-15)', 'description': 'An adverse event is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes:\n\n* Results in death,\n* Is life threatening,\n* Results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions,\n* Results in congenital anomaly, or birth defect,\n* Requires inpatient hospitalization or leads to prolongation of hospitalization\n* Other medically important events.\n\nRelationship to study drug was assessed by the investigator.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Coronary Artery Disease (CAD)', 'regadenoson', 'pharmacologic stress'], 'conditions': ['Coronary Artery Disease (CAD)']}, 'referencesModule': {'references': [{'pmid': '28224449', 'type': 'DERIVED', 'citation': 'Thomas GS, Cullom SJ, Kitt TM, Feaheny KM, Ananthasubramaniam K, Gropler RJ, Jain D, Thompson RC. The EXERRT trial: "EXErcise to Regadenoson in Recovery Trial": A phase 3b, open-label, parallel group, randomized, multicenter study to assess regadenoson administration following an inadequate exercise stress test as compared to regadenoson without exercise for myocardial perfusion imaging using a SPECT protocol. J Nucl Cardiol. 2017 Jun;24(3):788-802. doi: 10.1007/s12350-017-0813-3. Epub 2017 Feb 21.'}], 'seeAlsoLinks': [{'url': 'https://www.astellasclinicalstudyresults.com/study.aspx?ID=3606-CL-3004', 'label': 'Link to results on Astellas Clinical Study Results Web site'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate that the strength of agreement between single photon emission computed tomography (SPECT) imaging with regadenoson following inadequate exercise stress testing and SPECT imaging with regadenoson alone is not inferior to the strength of agreement between two sequential regadenoson SPECT images without exercise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects referred for an exercise or pharmacologic stress test SPECT MPI procedure for the evaluation of coronary artery disease (CAD) are eligible for study participation. Subjects referred for pharmacologic stress should have a reasonable potential of attempting exercise stress. Subject must have one of the following:\n\n * a. Past ischemia on any prior imaging stress test without invasive intervention on the artery subtending this territory\n * b. Subject with known CAD who have symptoms similar to previous ischemic symptoms, or recent onset of symptoms or recently worsened symptoms suggestive of ischemia\n * c. Diamond Forrester estimated pretest probability of CAD of ≥ 50%\n * d. History of most recent coronary artery bypass surgery or most recent percutaneous coronary intervention (PCI) \\> 10 years (patients who are \\> 30 days but less than 10 years post coronary artery bypass graft (CABG) or PCI can be included if they meet criteria a, b, or e)\n * e. Previously demonstrated 100% occlusion by invasive coronary or computed tomography (CT) angiography without successful intervening revascularization as these foods may alter regadenoson effects\n\nExclusion Criteria:\n\n* Subject has a clinically significant illness, medical condition, or laboratory abnormality\n* Female subject who is pregnant or lactating\n* Subject is on dialysis for end stage renal disease or has a history of glomerular filtration rate (GFR) \\< 15 mL/min (calculated using MDRD \\[Modification of Diet in Renal Disease\\] formula)\n* Subject has a history of coronary revascularization by either PCI or CABG within 1 month prior to the rest myocardial perfusion imaging (MPI)\n* Subject has a pacemaker or an implantable cardioverter defibrillator (ICD)\n* Subject has a history of acute myocardial infarction (MI) or high risk unstable angina within 30 days prior to the rest MPI or has had cardiac transplantation\n* Subject has uncontrolled hypertension at any point on Visit 2 prior to exercise testing (i.e., systolic blood pressure (SBP) ≥ 180 or diastolic blood pressure (DBP) ≥ 95 mmHg on two consecutive measurements while at rest).\n* Subject has severe aortic stenosis or hypertrophic cardiomyopathy with obstruction or has decompensated congestive heart failure\n* Subject has a history of severe respiratory disease including: asthma, chronic obstructive pulmonary disease (COPD) or other bronchospastic reactive airway disease or who is on 24-hour continuous oxygen'}, 'identificationModule': {'nctId': 'NCT01618669', 'acronym': 'EXERRT', 'briefTitle': 'A Study to Assess Regadenoson Administration Following an Inadequate Exercise Stress Test as Compared to Regadenoson Alone for Myocardial Perfusion Imaging (MPI) Using Single Photon Emission Computed Tomography (SPECT)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Phase 3b, Open-Label, Parallel Group, Randomized, Multicenter Study to Assess Regadenoson Administration Following an Inadequate Exercise Stress Test as Compared to Regadenoson Alone for Myocardial Perfusion Imaging (MPI) Using Single Photon Emission Computed Tomography (SPECT)', 'orgStudyIdInfo': {'id': '3606-CL-3004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Regadenoson After Peak Exercise', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.', 'interventionNames': ['Drug: Regadenoson', 'Procedure: Single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Regadenoson Alone', 'description': 'On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus (1 hour after exercise recovery), and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.', 'interventionNames': ['Drug: Regadenoson', 'Procedure: Single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI)']}], 'interventions': [{'name': 'Regadenoson', 'type': 'DRUG', 'otherNames': ['Lexiscan', 'CVT3146'], 'description': 'Administered as an intravenous (IV) bolus', 'armGroupLabels': ['Regadenoson After Peak Exercise', 'Regadenoson Alone']}, {'name': 'Single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI)', 'type': 'PROCEDURE', 'armGroupLabels': ['Regadenoson After Peak Exercise', 'Regadenoson Alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Mobile Heart Specialists, PC', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '94538', 'city': 'Fremont', 'state': 'California', 'country': 'United States', 'facility': 'Silicon 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