Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-02-03 @ 2:50 PM
Study NCT ID:
NCT02296892
Status:
COMPLETED
Last Update Posted:
2020-03-18
First Post:
2014-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase III Study of Remimazolam in Patients Undergoing Bronchoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C522201', 'term': 'remimazolam'}, {'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'reg_paion@paion.com', 'phone': '+49 2414453101', 'title': 'Trial Information', 'organization': 'PAION UK Ltd'}, 'certainAgreement': {'otherDetails': 'At least 30 days prior to submission of communications, sponsor shall review and comment on the communications. Sponsor shall have the right to require institution and investigator to remove specifically identified confidential information and to delay the proposed publication an additional 45 days to enable sponsor to seek patent protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent Adverse Events were collected from Day 1 until end of Follow-Up (Day 4 [+3/-1 days]). TEAEs were followed-up until events were resolved, became stable or could be explained by another known cause(s)', 'description': 'Total number of participants affected with Other (Not Including Serious) Adverse Events represents any participant in the trial with a TEAE. The number of participants with Preferred Term (PT)TEAEs represents participants with non-serious TEAEs reported with a threshold of 5% in any of the arms', 'eventGroups': [{'id': 'EG000', 'title': 'Remimazolam', 'description': 'Remimazolam iv 5 mg for sedation induction, and 2.5 mg top-ups for sedation maintenance.', 'otherNumAtRisk': 303, 'deathsNumAtRisk': 303, 'otherNumAffected': 268, 'seriousNumAtRisk': 303, 'deathsNumAffected': 0, 'seriousNumAffected': 17}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo iv as inactive control arm', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 52, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Midazolam', 'description': 'Midazolam iv 1.75 mg\\* for sedation induction and 1.0 mg\\* for sedation maintenance. \\*1.0 mg for induction and 0.5 mg for maintenance in adults over 60, debilitated or chronically ill.', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 63, 'seriousNumAtRisk': 69, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 23}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 19}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diastolic hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 16}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Systolic hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 17}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diastolic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 16}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Tachypnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Respiratory rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'seriousEvents': [{'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Organising pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pneumomediastinum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With a Successful Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Remimazolam', 'description': 'Remimazolam iv 5 mg for sedation induction, and 2.5 mg top-ups for sedation maintenance.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo iv as inactive control arm'}, {'id': 'OG002', 'title': 'Midazolam', 'description': 'Midazolam iv 1.75 mg\\* for sedation induction and 1.0 mg\\* for sedation maintenance. \\*1.0 mg for induction and 0.5 mg for maintenance in adults over 60, debilitated or chronically ill.'}], 'classes': [{'categories': [{'measurements': [{'value': '250', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7588', 'ciLowerLimit': '0.6903', 'ciUpperLimit': '0.8274', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug to removal of bronchoscope (average time not known)', 'description': 'Success of Procedure measured by completion of bronchoscopy, no requirement for an alternative rescue sedative medication and no requirement for more than 5 doses of study medication within any 15 minute period in the blinded arms (remimazolam/placebo) or no requirement for more than 3 doses within any 12 minute window in the open-label midazolam arm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who were randomized and were analyzed as randomized.'}, {'type': 'SECONDARY', 'title': 'Time to Start of Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Remimazolam', 'description': 'Remimazolam iv 5 mg for sedation induction, and 2.5 mg top-ups for sedation maintenance.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo iv as inactive control arm'}, {'id': 'OG002', 'title': 'Midazolam', 'description': 'Midazolam iv 1.75 mg\\* for sedation induction and 1.0 mg\\* for sedation maintenance. \\*1.0 mg for induction and 0.5 mg for maintenance in adults over 60, debilitated or chronically ill.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '4.8'}, {'value': '17.0', 'groupId': 'OG001', 'lowerLimit': '16.0', 'upperLimit': '17.5'}, {'value': '15.5', 'groupId': 'OG002', 'lowerLimit': '13.8', 'upperLimit': '16.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study drug until insertion of the bronchoscope', 'description': 'The time from the first dose of study drug until bronchoscope insertion on Day 1', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who were randomized and were analyzed as randomized.'}, {'type': 'SECONDARY', 'title': 'Time to Fully Alert', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Remimazolam', 'description': 'Remimazolam iv 5 mg for sedation induction, and 2.5 mg top-ups for sedation maintenance.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo iv as inactive control arm'}, {'id': 'OG002', 'title': 'Midazolam', 'description': 'Midazolam iv 1.75 mg\\* for sedation induction and 1.0 mg\\* for sedation maintenance. \\*1.0 mg for induction and 0.5 mg for maintenance in adults over 60, debilitated or chronically ill.'}], 'classes': [{'title': 'After last dose of study drug or rescue sedative', 'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '12.8'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '15.3', 'upperLimit': '31.0'}, {'value': '18.0', 'groupId': 'OG002', 'lowerLimit': '15.0', 'upperLimit': '20.1'}]}]}, {'title': 'After bronchoscope out', 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '5.2', 'upperLimit': '7.1'}, {'value': '13.6', 'groupId': 'OG001', 'lowerLimit': '8.1', 'upperLimit': '24.0'}, {'value': '12.0', 'groupId': 'OG002', 'lowerLimit': '5.0', 'upperLimit': '15.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the last dose of study drug or rescue sedative AND from end of bronchoscopy until the patient has recovered to fully alert', 'description': "The time to fully alert defined as time to first of 3 consecutive Modified Observer's Assessment of Alertness and Sedation (MOAA/S) scores after the end of the bronchoscopy procedure (bronchoscope out).\n\nMOAA/S scores: 5 = Responds readily to name spoken in normal tone \\[alert\\], 4 =Lethargic response to name spoken in normal tone, 3 = Responds only after name is called loudly and/or repeatedly, 2 = Responds only after mild prodding or shaking, 1 = Responds only after painful trapezius squeeze, 0 = Does not respond to painful trapezius squeeze.\n\nMOAA/S scores were assessed by the investigators.", 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who do not reach the endpoint are censored at last MOAAS'}, {'type': 'SECONDARY', 'title': 'Time to Ready for Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Remimazolam', 'description': 'Remimazolam iv 5 mg for sedation induction, and 2.5 mg top-ups for sedation maintenance.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo iv as inactive control arm'}, {'id': 'OG002', 'title': 'Midazolam', 'description': 'Midazolam iv 1.75 mg\\* for sedation induction and 1.0 mg\\* for sedation maintenance. \\*1.0 mg for induction and 0.5 mg for maintenance in adults over 60, debilitated or chronically ill.'}], 'classes': [{'title': 'after last dose of study drug or rescue sedative', 'categories': [{'measurements': [{'value': '64.8', 'groupId': 'OG000', 'lowerLimit': '62.0', 'upperLimit': '68.5'}, {'value': '93.0', 'groupId': 'OG001', 'lowerLimit': '75.0', 'upperLimit': '107.0'}, {'value': '70.0', 'groupId': 'OG002', 'lowerLimit': '67.0', 'upperLimit': '87.0'}]}]}, {'title': 'After bronchoscope out', 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000', 'lowerLimit': '57.0', 'upperLimit': '63.0'}, {'value': '81.0', 'groupId': 'OG001', 'lowerLimit': '70.0', 'upperLimit': '100.0'}, {'value': '66.0', 'groupId': 'OG002', 'lowerLimit': '62.0', 'upperLimit': '72.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'After the last dose of study drug AND after the end of the bronchoscopy, until discharge', 'description': 'Time from the last dose of study drug or rescue sedative and from the end of bronchoscopy until discharge (defined as the ability to walk unassisted)', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who do not reach the endpoint are censored at last MOAAS'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Remimazolam', 'description': 'Remimazolam iv 5 mg for sedation induction, and 2.5 mg top-ups for sedation maintenance.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo iv as inactive control arm'}, {'id': 'FG002', 'title': 'Midazolam', 'description': 'Midazolam iv 1.75 mg\\* for sedation induction and 1.0 mg\\* for sedation maintenance. \\*1.0 mg for induction and 0.5 mg for maintenance in adults over 60, debilitated or chronically ill.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '310'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '73'}]}, {'type': 'Safety Population', 'comment': 'All randomized patients who received any amount of the trial drug and were analyzed as treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '303'}, {'groupId': 'FG001', 'numSubjects': '59'}, {'groupId': 'FG002', 'numSubjects': '69'}]}, {'type': 'Complete Trial Treatment Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '303'}, {'groupId': 'FG001', 'numSubjects': '59'}, {'groupId': 'FG002', 'numSubjects': '69'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '298'}, {'groupId': 'FG001', 'numSubjects': '59'}, {'groupId': 'FG002', 'numSubjects': '68'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Exclusion Criteria at Day of Procedure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '431', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Remimazolam', 'description': 'Remimazolam iv 5 mg for sedation induction, and 2.5 mg top-ups for sedation maintenance.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo iv as inactive control arm'}, {'id': 'BG002', 'title': 'Midazolam', 'description': 'Midazolam iv 1.75 mg\\* for sedation induction and 1.0 mg\\* for sedation maintenance. \\*1.0 mg for induction and 0.5 mg for maintenance in adults over 60, debilitated or chronically ill.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.7', 'spread': '12.09', 'groupId': 'BG000'}, {'value': '60.8', 'spread': '12.08', 'groupId': 'BG001'}, {'value': '61.5', 'spread': '14.03', 'groupId': 'BG002'}, {'value': '62.3', 'spread': '12.41', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '154', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '222', 'groupId': 'BG003'}]}]}, {'title': '≥65 years', 'categories': [{'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '209', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '164', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '233', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '198', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '295', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '423', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '263', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '358', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '303', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '431', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '168.6', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '167.1', 'spread': '10.0', 'groupId': 'BG001'}, {'value': '170.0', 'spread': '9.87', 'groupId': 'BG002'}, {'value': '168.6', 'spread': '9.64', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '80.9', 'spread': '20.21', 'groupId': 'BG000'}, {'value': '77.7', 'spread': '21.17', 'groupId': 'BG001'}, {'value': '83.0', 'spread': '22.10', 'groupId': 'BG002'}, {'value': '80.8', 'spread': '20.66', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '28.4', 'spread': '6.39', 'groupId': 'BG000'}, {'value': '27.9', 'spread': '7.09', 'groupId': 'BG001'}, {'value': '28.0', 'spread': '5.79', 'groupId': 'BG002'}, {'value': '28.3', 'spread': '6.39', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Baseline Analysis Population is the Safety Population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-03-03', 'size': 1007721, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-02-15T07:25', 'hasProtocol': True}, {'date': '2017-06-09', 'size': 699411, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-02-15T07:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 446}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'dispFirstSubmitDate': '2018-08-28', 'completionDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-03', 'studyFirstSubmitDate': '2014-11-11', 'dispFirstSubmitQcDate': '2018-08-28', 'resultsFirstSubmitDate': '2019-02-12', 'studyFirstSubmitQcDate': '2014-11-20', 'dispFirstPostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-15', 'studyFirstPostDateStruct': {'date': '2014-11-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With a Successful Procedure', 'timeFrame': 'From first dose of study drug to removal of bronchoscope (average time not known)', 'description': 'Success of Procedure measured by completion of bronchoscopy, no requirement for an alternative rescue sedative medication and no requirement for more than 5 doses of study medication within any 15 minute period in the blinded arms (remimazolam/placebo) or no requirement for more than 3 doses within any 12 minute window in the open-label midazolam arm.'}], 'secondaryOutcomes': [{'measure': 'Time to Start of Procedure', 'timeFrame': 'From first dose of study drug until insertion of the bronchoscope', 'description': 'The time from the first dose of study drug until bronchoscope insertion on Day 1'}, {'measure': 'Time to Fully Alert', 'timeFrame': 'From the last dose of study drug or rescue sedative AND from end of bronchoscopy until the patient has recovered to fully alert', 'description': "The time to fully alert defined as time to first of 3 consecutive Modified Observer's Assessment of Alertness and Sedation (MOAA/S) scores after the end of the bronchoscopy procedure (bronchoscope out).\n\nMOAA/S scores: 5 = Responds readily to name spoken in normal tone \\[alert\\], 4 =Lethargic response to name spoken in normal tone, 3 = Responds only after name is called loudly and/or repeatedly, 2 = Responds only after mild prodding or shaking, 1 = Responds only after painful trapezius squeeze, 0 = Does not respond to painful trapezius squeeze.\n\nMOAA/S scores were assessed by the investigators."}, {'measure': 'Time to Ready for Discharge', 'timeFrame': 'After the last dose of study drug AND after the end of the bronchoscopy, until discharge', 'description': 'Time from the last dose of study drug or rescue sedative and from the end of bronchoscopy until discharge (defined as the ability to walk unassisted)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Remimazolam, midazolam, bronchoscopy, procedural sedation'], 'conditions': ['Bronchoscopy']}, 'referencesModule': {'references': [{'pmid': '30292760', 'type': 'RESULT', 'citation': 'Pastis NJ, Yarmus LB, Schippers F, Ostroff R, Chen A, Akulian J, Wahidi M, Shojaee S, Tanner NT, Callahan SP, Feldman G, Lorch DG Jr, Ndukwu I, Pritchett MA, Silvestri GA; PAION Investigators. Safety and Efficacy of Remimazolam Compared With Placebo and Midazolam for Moderate Sedation During Bronchoscopy. Chest. 2019 Jan;155(1):137-146. doi: 10.1016/j.chest.2018.09.015. Epub 2018 Oct 4.'}]}, 'descriptionModule': {'briefSummary': 'A prospective, double-blind, randomized, placebo and active controlled, multi-center, parallel group study comparing remimazolam to placebo, with an additional open label arm for midazolam, in patients undergoing a bronchoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male and female patients, aged ≥18 years, scheduled to undergo a diagnostic or therapeutic flexible bronchoscopy in the bronchoscopy suite (therapeutic bronchoscopies could include eg, lavage, biopsies, brushings, and foreign body extraction).\n2. American Society of Anesthesiologists Physical Status Score (ASA PS) 1 through 3.\n3. Body mass index (BMI) ≤ 45.\n4. Peripheral blood oxygen saturation (measured by pulse oximetry: SpO2) ≥ 90% in ambient air or with no more than 2 L/min of oxygen support.\n5. For all female patients, negative result of urine pregnancy test. Additionally, for women of child bearing potential only, use of birth control during the study period (from the time of consent until all specified observations were completed).\n6. Patients voluntarily signed and dated an informed consent form that was approved by an IRB prior to the conduct of any study procedure, including screening procedures.\n7. Patient was willing and able to comply with study requirements and available for a follow up phone call on Day Day 4 (+3/ 1 days) after the bronchoscopy.\n\nExclusion Criteria:\n\n1. Patients with a known sensitivity to benzodiazepines, flumazenil, opioids, naloxone, or a medical condition such that these agents were contraindicated.\n2. Bronchoscopy outside the bronchoscopy unit (eg, intensive care unit).\n3. Patients on mechanical ventilation.\n4. Tracheal stenosis.\n5. Planned laser bronchoscopy, rigid scope bronchoscopy.\n6. Use of unstable doses of benzodiazepines and opioids for any indication, eg, insomnia, anxiety, or spasticity. An unstable dose means dose changes of more than 50% of the previous dose within 30 days prior to Day of procedure.\n7. Female patients with a positive pregnancy test at Screening or Baseline and lactating female patients.\n8. Patients with positive drugs of abuse screen (unless explained by concomitant medication) or a positive ethanol test at baseline.\n9. Patient with a history of drug or ethanol abuse within the past two years.\n10. Patients in receipt of any investigational drug or use of investigational device within 30 days or less than 7 t½ (whichever was longer) before the start of the study or scheduled to receive one during the study period.\n11. Participation in any previous clinical study with remimazolam.\n12. Patients with an inability to communicate well in English with the investigator or deemed unsuitable according to the investigator (in each case providing a reason).'}, 'identificationModule': {'nctId': 'NCT02296892', 'briefTitle': 'A Phase III Study of Remimazolam in Patients Undergoing Bronchoscopy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Paion UK Ltd.'}, 'officialTitle': 'A Phase III Study Evaluating the Efficacy and Safety of Remimazolam (CNS 7056) Compared to Placebo and Midazolam in Patients Undergoing Bronchoscopy', 'orgStudyIdInfo': {'id': 'CNS7056-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remimazolam', 'description': 'Double-blind Remimazolam arm: 5 mg iv for sedation induction, and 2.5 mg iv top-ups for sedation maintenance.\n\nFentanyl pre-treatment: 25-50 μg (or less for elderly/disabled subjects), and 25 μg top-up doses', 'interventionNames': ['Drug: Remimazolam']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Double-blind placebo arm as inactive control\n\nFentanyl pre-treatment: 25-50 μg (or less for elderly/disabled subjects), and 25 μg top-up doses', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Midazolam', 'description': 'Open-label Midazolam arm: 1.75 mg\\* iv for sedation induction and 1.0 mg\\* iv for sedation maintenance. \\*1.0 mg for induction and 0.5 mg for maintenance in adults over 60, debilitated or chronically ill.\n\nFentanyl pre-treatment: 25-50 μg (or less for elderly/disabled subjects), and 25 μg top-up doses', 'interventionNames': ['Drug: Midazolam']}], 'interventions': [{'name': 'Remimazolam', 'type': 'DRUG', 'otherNames': ['CNS7056'], 'description': 'For induction and maintenance of sedation', 'armGroupLabels': ['Remimazolam']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Inactive control arm', 'armGroupLabels': ['Placebo']}, {'name': 'Midazolam', 'type': 'DRUG', 'otherNames': ['Versed'], 'description': 'For induction and maintenance of sedation', 'armGroupLabels': ['Midazolam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33511', 'city': 'Brandon', 'state': 'Florida', 'country': 'United States', 'facility': 'Pab Clinical Research', 'geoPoint': {'lat': 27.9378, 'lon': -82.28592}}, {'zip': '33573', 'city': 'Sun City Center', 'state': 'Florida', 'country': 'United States', 'facility': 'Sun City Office', 'geoPoint': {'lat': 27.71809, 'lon': -82.35176}}, {'zip': '46360', 'city': 'Michigan City', 'state': 'Indiana', 'country': 'United States', 'facility': 'Laporte County Institute For Clinical Research', 'geoPoint': {'lat': 41.70754, 'lon': -86.89503}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Johns Hopkins Center for Interventional and Pulmonary Care', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine/Barnes-Jewish Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Unc Division of Pulmonary and Critical Care', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '28374', 'city': 'Pinehurst', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pinehurst Medical Clinic', 'geoPoint': {'lat': 35.19543, 'lon': -79.46948}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Health', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'S. Carolina Pharmaceutical Research', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '23225', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Pulmonary Associates of Richmond', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Multicare Institute For Research & Innovation', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}], 'overallOfficials': [{'name': 'Gerard Silvestri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina, US'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Paion UK Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Premier Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}